chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt called stating his arm was very sore, could hardly reach over his head. Advised him to use an ice pack and take tylenol, had a fever and chills as well, feeling light headed and fatigued. But feeling slightly better than this morning. Last night after the shot was the worst.
devel fever & fell asleep awoke w/severe pain in back; severe pain inthe rt upper extremity; hand & arm are numb; thumb & under finger very numb; now has golf balls in the back of neck (muscles); numerous MD visit;
On 4/8 developed headache and chills early morning hours.  Continued with chills and fever of above 101 but below 102 degrees.  Lack of energy and stayed in bed most of the day.  On 4/9, somewhat  better, no fever, but still sluggish.  By 4/10 back to feeling myself.
Complained of being really dizzy; eyes became foggy with bright light; She collapsed on the kitchen floor; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She collapsed on the kitchen floor) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, the patient experienced LOSS OF CONSCIOUSNESS (She collapsed on the kitchen floor) (seriousness criterion medically significant), DIZZINESS (Complained of being really dizzy) and VISION BLURRED (eyes became foggy with bright light). At the time of the report, LOSS OF CONSCIOUSNESS (She collapsed on the kitchen floor), DIZZINESS (Complained of being really dizzy) and VISION BLURRED (eyes became foggy with bright light) outcome was unknown.            No concomitant medications were reported  No treatment information was provided  The patient got the second vaccine and when she got home, she complained of being really dizzy when they were outside. Then her eyes became foggy with bright light and her husband hardly got her inside when she collapsed on the kitchen floor. She questioned if this is a normal side effect.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Pain at injection site and down entire arm to wrist. Tingling in middle, ring and pinky fingers.
Possible cellulitis and swelling right upper arm. Keflex po given qid x 10 days
Pt's mother reports same symptoms for both the 2nd and 4th month shots, 24-36 hours of fever and irritable; otherwise, not sick.
Arm soreness - occurred same day, recovered by day 3 Neck stiffness - occurred same day lasted about a week Shingle-like pain in back - started about 4 days after the vaccine, sporadically still occur Dizziness - occurred about 4 days after the vaccine and sporadically still occurs - stomach cramps - occurred about 3 weeks after the vaccine, still occurs - chest pain - feels like pain in heart and other areas of chest - occurred about a week after the vaccine and still occurs - restless legs - occurred about 3 weeks after the vaccine and still occurs
Severe hives and swelling in face/lips appx 3.5 days after getting 1st dose of Covid-19 Moderna Vaccine. Blood test showed that I am suddenly highly allergic to 19 different food groups. I have no known food allergies prior to C19 Moderna Vaccine. I have had hives every single day since they 1st appeared (3.5 days after vaccine). I have had multiple days of facial swelling as well and have been to the hospital multiple times. To this date (date of this report) I still have hives and facial swelling. Facial swelling is intermittent. I have stayed away from the list of foods that I am apparently suddenly allergic to and I still have hives and swelling. I occasionally have a irritated throat which makes it difficult to breathe in. I have a specialist appointment with an allergy/immunology doctor this coming Thursday to see what thier diagnosis is. My family doctor believes my potential angioedema diagnosis is directly related to my 1st dose of C19 Moderna Vaccine.
About 25 days after the 3rd dose, he had pelvic pain in the same area, but it eased up a bit; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC PAIN (About 25 days after the 3rd dose, he had pelvic pain in the same area, but it eased up a bit) 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 Kidney stone.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PELVIC PAIN (About 25 days after the 3rd dose, he had pelvic pain in the same area, but it eased up a bit). At the time of the report, PELVIC PAIN (About 25 days after the 3rd dose, he had pelvic pain in the same area, but it eased up a bit) was resolving.            No concomitant and treatment drug information was provided.   This case was linked to MOD-2022-475998 (Patient Link).
Patient contracted COVID after being fully vaccinated Cough, runny nose, cough, congestion, loss of taste.
Entire dose ran down her arm/didn't get the full dose; Entire dose ran down her arm/didn't get the full dose; A spontaneous report was received from a 61-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and entire dose ran down her arm/didn't get the full dose. (PT: Product administration error) (PT: Underdose)    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011M20A/ 011W20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient reported she did not receive the entire dose of vaccine as it ran down her arm .   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The event entire dose ran down her arm/didn't get the full dose. (PT: Product administration error) (PT: Underdose), was considered resolved.  The reporter did not provide an assessment for the event entire dose ran down her arm/didn't get the full dose. (PT: Product administration error) (PT: Underdose); Reporter's Comments: This report refers to a case of Product administration error and. underdose for mRNA-1273 (lot # 011M20A/ 011W20A) with no associated AEs reported.
This spontaneous report as received from Novartis and was assigned manufacturer report number 11014746, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The patient reported that ZOSTAVAX caused her to be diagnosed with polymyalgia rheumatica. The outcome of polymyalgia rheumatica is unknown. The original reporting source was not provided. Additional information is not expected.
Patient is a 78 year old female w/ PMH of HTN, CHF, pulmonary hypertension, atrial fibrillation on chronic anticoagulation with warfarin, seizure disorder, parkinsonism, depression, history of CVA, and dementia who presented to the ED after a fall at home. Patient tried to get up from bed felt weak and fell, hitting her head. Her husband woke up to the sound of her falling. Patient is not the best historian. She states that she felt weak before her fall. She did not have LOC. She was able to stand up after her fall. She states that she uses a walker at baseline. She was using this when she fell. She does not have a history of chronic falls. She does not report any decreased intake over the past few weeks. She denies fevers/chills. She denies increased SOB. Denies changes in bowel or bladder habits, however husband reported decreased urination. Denies chest pain, palpitations. Her husband was COVID-19 positive on 02/05, she is COVID-19 positive today. She does wear oxygen at home requiring approximately 3.5 L.
This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (scratchy throat), HYPERTENSION (High blood pressure), HEART RATE INCREASED (Pulse over 120) and COUGH (uncontrollable cough) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 01-Mar-2021. Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (scratchy throat), HYPERTENSION (High blood pressure), HEART RATE INCREASED (Pulse over 120) and COUGH (uncontrollable cough). On 20-Mar-2021, OROPHARYNGEAL PAIN (scratchy throat) and HYPERTENSION (High blood pressure) had resolved. At the time of the report, HEART RATE INCREASED (Pulse over 120) and COUGH (uncontrollable cough) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. In March 2021, Heart rate: 120 (High) 120. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt's mother did not immunization done due to religious reasons. Mother addressed with MA after injection given.
I had the shot at 12:15 in the afternoon and by 8:15 pm I had to go to bed. My husbands says around 2 am I woke him up and told him I am going down and next thing I know I am on the ground. The only thing I can remember from being on the floor and I herd my son say dad I don't know how we are going to get her up. I told them grab me by the ankles and slide me out (on hard wood  floors) I was between the wall and the bed. They were finally able to get me up, they would try to talk to me and the only thing I would say  is "what" they took me to the ER at Hospital. 12/29/2022 admitted to the hospital for 3 days, they wanted to put me on rehab but the symptoms went away almost as quick as they came so I was able to spend New Years at home. I saw my family dr. on 1/9/2023  Dr.
Within 24 hours of receiving Menactra, developed fever to 102.6 max, headache, myalgia and malaise which responded fairly well to ibuprofen until complete resolution of symptoms within 24 hours from onset.
Have been up all night long freezing, shaking; had to take a hot bath just to warm up; Every time I get up, I get light headed; I had COVID back in March and I feel the same way I felt then except the breathing is normal; Very weak; This is a spontaneous report from a contactable consumer reporting for herself.  A 66-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on  23Dec2020 at single dose for covid-19 immunisation .  Medical history included blood pressure measurement on an unknown date. The patient had been up all night long freezing, shaking; had to take a hot bath just to warm up  on 24Dec2020 with outcome of unknown , every time she got up, she got light headed  on 24Dec2020 with outcome of unknown , she had Covid back in March and she felt the same way except the breathing is normal  on 24Dec2020 with outcome of unknown , very weak  on 24Dec2020 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Mar2020.  Information about Lot /batch number has been requested.
Headache, Myalgia, Fever, NauseaVomiting, Vertigo X 3 days, fever X3 days and as high as 102.0, neck pain, fatigue Narrative:
Fever, Rash, ErythemaMultiform, NauseaVomiting, Palpitations, chills, fatigue,  Narrative:
no ad; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no ad) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no ad). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no ad) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no ad) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. Patient received Moderna vaccine beyond the 30 days beyond use date. Beyond use date for lot was 17-Feb-2022 and patient received vaccine on 04-Mar-2022. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Non Significant follow Up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Information has been received from a physician concerning a 2 month old female, with no medical history and no allergies, who was vaccinated with an oral first dose of Rotateq. There was no concomitant medication. Two days later receiving Rotateq the patient developed mild diarrhea that lasted for about one day. The patient had since been administered her second dose, at 4 months of age, of Rotateq and did not develop any diarrhea. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. NO product quality complaint was involved. Additional information has been requested.
Next day, nose congestion,  increased phlegm build up ,  and "severe" throat irritation.
Information has been received from a registered nurse referring to a 3 year old White male patient. On 24-JAN-2015 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, Subcutaneous injection (Lot# was reported as K007977, expired date, strength, dose and frequency were unspecified). On 04-FEB-2015 at 11:00 AM the patient experienced hard, red, itching, knot at the injection site, the area of erythema was 3 cm. patient was given clod cloth, BENADRYL. The patient had seen the doctor. The outcome of all the events was recovered on unspecified date in FEB-2015. Additional information has been requested.
One day following the vaccine, the patient developed erythema, swelling, and induration in a 4 inch diameter around the injection site.  He also developed a few linear vesicles over the site.  The area was tender and mildly pruritic.  He was treated with atarax, antibiotics, and icepacks.  He is scheduled to follow up in 1-2 days.
Adverse reactions severe body aches, including spine and neck, headache, ear pain, diarrhea. Symptoms increased. Today body aches are less.
Wheezing, hoarseness. Treatment: Self Primateen Mist, BENADRYL 30 mg. Time unknown.
IDIOPATHIC PULMONARY FIBROSIS (IPF); This spontaneous report received from a patient via a company representative via social media concerned a patient of an unspecified age, sex, race and ethnicity. 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date for months later, the patient was diagnosed with idiopathic pulmonary fibrosis (IPF) and the patient was on oxygen 24/7 since JAN-2022. It was reported that "I had the J and J and for months later I was diagnosed with IPF and have been on on oxygen 24/7 since Jan 2022". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from idiopathic pulmonary fibrosis (ipf). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221242058- idiopathic pulmonary fibrosis (IPF). Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 at 14:00 as dose 2, single (Lot number: FK9893) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetic" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Three weeks after ending the Paxlovoid pills I have developed a severe case of itching, from head to toe. This condition has been going on from 26Jun2022 to present. I can find no relief for the constant itching. I have applied anti-itch creams and lotions plus soaked 30 mins per night in Oatmeal Bath. Nothing so far seems to help.
I developed a  breast lump within a few months of receiving my second dose of the COVID-19 vaccine.  The lump was discovered in mid-June 2021.  I had a mammogram with ultrasound in July 2021 and a core needle biopsy on August 3, 2021.  The result was a benign breast tumor called a Fibroadenoma.  It does not need to be removed unless it grows in size.
This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # L033343 (expiry 13-SEP-2017) (dose and route not reported). The temperature excursion time frame was reported as "11 C for 3 hours (also reported as 34 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a female patient of unknown age who reported on herself. It was reported that the patient informed the physician that she had never had chickenpox but he insisted she receive the vaccine. On 27-MAR-2014 the patient was vaccinated subcutaneously with an unspecified dose ("1 single shot") of ZOSTAVAX (lot number and expiration date not reported). On 01-MAY-2014 the patient experienced chickenpox. The outcome of chickenpox was reported as not recovered. The relatedness between chickenpox and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a registered nurse concerning a 22 year old "nurse" who works in the same physician's office who was vaccinated with first dose of Gardasil. Subsequently, her menstrual cycle did not arrive on time. Her menstruation lasted for 2 weeks and it was a heavier flow. the patient's menstrual cycle ended and then started again. The patient experienced 2 cycles in one month. After her second dose of Gardasil, the patient's menstrual cycle arrived on time but it was a heavier flow. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007.  Follow up information was received from the patients physician which stated that the patient is a 22 year old female who on 14-Nov-2006 received the firse dose of GARDASIL (Lot # not provided). On 19-Feb-2007 at 15:30 the patient received the second vaccination in the left arm of GARDISIL (Lot # 1424F). It was reported that after receiving the second dose of the vaccine the patient experienced heavy menstraul bleeding for two weeks. Additional information has been requested.
Back of left arm where injection site area  is swollen very hot, tender since yesterday, photo has been taken and its worse measurements 3 inches today. yesterday was 2inches. it seem getting worse.   beside that I have fever, my joints hurts. felt weak.
Moderate to severe local reaction with redness, increased temp and induration.  Occurred several hours after immunization given and resulted in return to dotor's office for visit.
This case was reported by a physician via call center representative and described the occurrence of generalized rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced full body rash following administration of SHINGRIX. The HCP terminated the call when asked for patient details. No further information was obtained. This case has been created from case from case US2018188530 and US2018GSK192915 reported by the same reporter.
On Thursday, December 31, 2020, I received my first dose of the Moderna vaccine. It was not until a week later (1/7/2021) in the evening, I began to experience symptoms. That Thursday night, I only experienced pain just as I would with the flu vaccine.  On Friday, January 8, 2021, I woke up with a painful (pain level #8 on a scale of 1-10), extremely itchy and inflamed hot to touch right upper arm. The noticeable symptoms to me were the upper arm being extremely hot, inflamed and itchy. There was also swelling in the upper arm. I took aspirin and applied hydrocortisone cream daily.  Saturday morning, the inflammation had gone done tremendously. To date, I am still experiencing itching, not as extreme. I am still applying the hydrocortisone cream to have relief.  The area is not as hot but there is still redness and itching. No more swelling.