chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am sick on my stomach; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (I am sick on my stomach), PAIN (Body aches) and PYREXIA (Fever) in a 68-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (I am sick on my stomach), PAIN (Body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (I am sick on my stomach), PAIN (Body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155 (High) 155. On an unknown date, Body temperature: 100.6 (High) 100.6 and 103.6 (High) 103.6. On an unknown date, Oxygen saturation: 80.93 (Low) 80.93.         No concomitant product information was provided.   This case was linked to MOD-2021-042608 (Patient Link).
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) 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 (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medication information was reported. Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients.  No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master
Information has been received from a registered nurse concerning a 25-week-old female with no pertinent medical history and no drug reactions/allergies who on 16-MAY-2007 and 12-JUL-2007 was vaccinated PO with the first and second 2mL doses of Rotateq (Lot #'s 656385/0030U and 657292/0551U, respectively). There was no concomitant medication. On 04-SEP-2007 the patient experienced symptoms of intussusception. The patient initially experienced vomiting that was followed by bloody diarrhea 12 hours later. The patient was brought to the emergency room and then transferred to another hospital. The intussusception was treated with a barium enema and the patient was discharged on 05-SEP-2007. On 05-SEP-2007, the patient recovered from intussusception. There were no lab diagnostic studies performed. No further information is available. There was no product quality complaint. The event was considered to be immediately life-threatening and other important medical event by the reporter. Additional information has been requested.  9/28/07 Received hospital x 2 medical records which reveal patient seen in outlying ER for intermittent abdominal pain, vomiting, lethargy, pallor, dehydration & bloody diarrhea.  Transferred to higher level of care for successful air contrast enema reduction.  Admitted & d/c on 9/5/2007 w/o complication.   FINAL DX: Intussusception, enema reduced. 10/5/07 Received vax record.  VAERS database updated w/same.  Records faxed to CDC.
Positive for covid with at-home test. No treatment. Only symptom was fatigue for 1-2 days. Outcome: Felt normal 2 days after positive covid test.
After patient received the vaccine of Janssen I saw a hand shake.  When I was going over side effect patient's hand was shaking more.  I asked the patient if hand shaking was normal she stated no and she passed out.  I was able to her upper body from falling.  I asked her husband to hold her and I got an epinephrine 0.3mg Lot # 026a20aa exp 02/22.  I injected epi into her left thigh.  patient woke up after 20 second but she didn't have any memories what happened
pt recvd vax 6FEB93 & returned to facility 12APR93 w/c/o pain, swelling @ inject site since that time was treated w/dx of sterile abcess rt shoulder inject site;
08/29/2021- Heart rate increased dramatically. resting heart rate is 50, heart rate was at 150. 08/30/2021- Diarrhea for 16 hours, followed by dehydration and headache, continued heart rate increase 08/31/2021-  fever of 103, followed by sweats and chills, continued heart rate increase 09/01/2021-runny nose, red eyes, continued heart rate increase 09/02/2021- dry cough and very congested, continued heart rate increase 09/03/2021- chest pain and continued heart rate increase
Pt stated difficulty breathing for about 4 hrs at the same day of vaccination, and burning sensation all over the body for about 8 hrs on the same day of vaccination.
There were vaccines drawn from an expired Moderna vial. The vial expired 12/09/21 at  11:05 pm  and the dose was given 12/10.  Patient has not exhibited adverse events post vaccination.  Moderna was called to inquire about further steps and whether or not the patient needs to be contacted to be revaccinated. The case was escalated and the turn around time for a response is 3 days.
I called pt about an unrelated matter. She reported an adverse reaction to her Td. Starting 05/01 at 10:33am  x 6 hours, she had chills, feverish, and had body aches. She treated herself at home with rest and Tylenol. She was also very sore at the site x 4 days.
Pt presented to a different area hospital where she was diagnosed with new Bell's Palsy and was given prednisone and acyclovir.  She presented to our facility for follow up on 11/10/2010.
Pt was vaccinated on Thursday Feb 3rd.  Reports that on Friday Feb 4that 6am she woke up with a rapid heartrate of 154, Shortness of Breath, heaviness in chest and pain with inhalation.  She also reported that at times she could not hear well out of one ear.  Her mother contacted the primarily medical provider and was advised to go to an Emergency room for cardiac workup. Patient went to a larger area Emergency Department where she underwent multiple EKG's, 2 Chest X-Rays and lab work over several hours. She received 2 bags of fluids for dehydration prior to discharge and was advised to make an appointment with cardiologist.  Her symptoms had slightly improved but were still present on 2/5,2/6 and 2/7.  After 2/5 she reported that her heartrate would elevate into the 130s with activity, And occasionally she would have elevated heartrate with rest. She also reported that she was tired and would get short of breath with walking long distances.
extremely sore at the injection site.   I had overnight chills starting at 9pm on 1/21/2002 through morning. I took my temp on 1/21 at 9am and it was normal.    (98.4)   Body aches, and nausea most of the day on 1/21/2021.   treatment:  Ibuprofen 600mg BID X 2 days.
Moderna COVID-19 Vaccine EUA 3" red rash on bicep of injection arm, below injection site.  Rash is tender to touch like a bruise (looks bruised underneath) and itchy, hot to the touch.  Rash appeared around 11 am day after 2nd injection, still present 3 days later.  Applied aloe to relieve itch.  Also taking claritin-d for seasonal allergies, and aleve for pain.
Broke out on arms; arms were red; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Broke out on arms), VACCINATION SITE ERYTHEMA (arms were red) and VACCINATION SITE PRURITUS (itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Broke out on arms), VACCINATION SITE ERYTHEMA (arms were red) and VACCINATION SITE PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (Broke out on arms), VACCINATION SITE ERYTHEMA (arms were red) and VACCINATION SITE PRURITUS (itching) outcome was unknown.            No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-028873, MOD-2021-018253 (Patient Link).
With first dose didn?t get period when it was due. With 2nd dose got period about two weeks later and it hasn?t stopped since. It is now over 30 days with no end in sight
ACTUALLY, HAD THE SAME REACTION AFTER MY 1ST COVID VACCINE, BUT THOUGHT IT WAS A COINCIDENCE.  MY EYES  BECAME ITCHY, RED, WATERY AND PUFFY.  I AM TAKING BENEDRYL AND PATADAY EYE DROPS.  IT IS A LITTLE BETTER, BUT STILL HAVING SYMPTOMS
(L) total arm was paralyzed for almost 3 days and I had extreme pain in the arm, pain as I had never felt before. I took VICODIN for the pain it didn't touch it, and chest pain.
Was given (2) 0.25 mL of influenza IM (R) thigh into 1 injection. No adverse reactions noted or reported. Should have only been given (1) 0.25 mL dose.
Arm pain and soreness: began 4/17, ended 4/18 Stuffy nose: began 4/17, ended 4/18 Severe headache: began 4/17, ended 4/18 Chills: began 4/17, ended 4/18 Fatigue: began 4/17, still some remaining fatigue Sensitivity to cold: began 4/17, still some remaining sensitivity to cold
pain from elbow to wrist; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain from elbow to wrist) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain from elbow to wrist). At the time of the report, PAIN (pain from elbow to wrist) outcome was unknown.
I have had a history of shoulder issues and had shoulder surgery back in 2011 so periodically I will have shoulder discomfort. But after receiving my 3rd dose, I woke up with shoulder pain and wrist pain that was to the point disturbing my sleep 5 to 6 times a night. I took some ibuprofen which was not helping much, so my doctor advised that I attend physical therapy. The wrist pain got better within a month and the shoulder pain continued for 4-5 months but it lessened with physical therapy.
Fever of 101...aches, pains and chills that lasted for 36 hours.  Took Acetaminophen every 4 hours (waited 24 hours to take 1st dose on advise of worker who gave the shot.
Abnormal liver function test; This spontaneous case was reported by a nurse and describes the occurrence of LIVER FUNCTION TEST ABNORMAL (Abnormal liver function test) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included BENZOYL PEROXIDE, CLINDAMYCIN PHOSPHATE (BENZACLIN TOPICAL) for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced LIVER FUNCTION TEST ABNORMAL (Abnormal liver function test). At the time of the report, LIVER FUNCTION TEST ABNORMAL (Abnormal liver function test) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided.
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long QT syndrome" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 06Apr2023 to 10Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(1) Severe, persistent nausea. Was only able to lay down, could not do anything else the nausea was so intense. Woke up 4 times during the night on the date of vaccination (11/22), all day the next day (11/23) - went to urgent care, and all day the following day (11/24). Nausea resolved with Zofran (2) Hot internal chest pain/pressure in the middle of the sternum. Not consistent - came and went. Lasted for 15-30 minutes, then went away, and only happened a few times each day on 11/22-11/24
Back was itchy, normal for him, no hives visible. Allergy to grasses, normally itchy with runny nose and eyes. Itchiness deteriorated after sitting. released at 5:05pm
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccine on 2/10/21, 3/09/21 and 9/18/21. COVID + via at home 1/28/22, presented to OSF ED c/o SOB, dx'ed w/PNA, sent home w/doxycycline. Presented to BSW ED 2/7/22 hypoxic, admitted for acute hypoxic resp failure 2/2 Covid PNA . Emergently intubated 2/20. Multiple emboli throughout aorta, L upper and L lower extremity arterial vasculature, L external iliac artery embolism with extension into the femoral artery, nonopacification of the distal brachial, ulnar, and radial arteries on 2/21. Tx'd w/dexamethasone, levaquin, remdesivir, tocizilumab, vancomycin, and cefepime. 2/26/22 experienced refractory hypoxemia, code status changed to DNR-AND/comfort care. Expired on 2/26/22.
28Jun90 pt vax w/ booster dose.  29Jun90 devel rt sided arm, neck, & back pain & muscle spasms.  Tx in ER w/ muscle relaxant & recovered.
Patient reports a little lump or induration under the skin of his left arm that has been there since the shot in September.  It has been slowly getting smaller.  Does not hurt and does not look infected.  Patient will monitor for any changes and massage the site to help work it out
Information has been received from a medical assistant concerning a 4 month old breastfed patient who was vaccinated with the second dose of Rotateq.  Subsequently the patient experienced projectile vomiting.  It was unknown whether medical attention was sought.  The patient's outcome was unknown.  This is one of several reports from the same source.  Additional information has been requested.
Had nasal FLUMIST started itching about 1/2 hour later all over. No known allergies to eggs.
Within 15 minutes after the first, second and third dose of the moderna vaccine I had muscle twitching and tingling in my legs.  I didn?t place much thought about it the first two times and the muscle fasciculations subsided within a week.  After all three doses I also had a massive headache within 2 hours of taking the vaccine. Tylenol  helped the first two times, however not so much after the 3rd dose.  Since the third dose I have severe muscle fasciculations in my legs and arms that persist, also with the sensation of pins and needles. Additionally, Tuesday night I woke up in a night sweat- completely soaking my bed and pjs, my heart pounding and beating so fast that I thought I was going to have to call 911. (my average heart beat is low 40) I was running a fever of 102 while taking Tylenol  q/4 hrs. The night sweat occurred again Wednesday night (I never have experienced night sweats before). The fever finally broke Thursday morning.  Thursday I experienced chills all day despite having no fever. I was running cold around 96. In the afternoon I was standing at my computer and my toes and feet went completely numb, with the exception of my big toe. This scared me. I have never experienced this before. I am healthy, not diabetic etc. In an effort to warm up I went for a walk to see if I would gain the feeling in my feet/toes. The was walk initially painful on my feet. Finally 40 minutes into the  walk I started to regain the feeling in my toes. They burned and tingled. Today, Friday morning I am reporting this as I did not sleep once again last night due to severe muscle fasciculations and tingling which is now also in my arms and hands.
Pain left arm, armpit, down side from armpit.  0 swelling.  0 fever.  Pain started in arm - spread over the last couple of days.
Missed period for two months; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 at 07:30 (at the age of 28 years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced missed period for two months. Therapeutic measures were not taken as a result of the event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event missed period for two months was resolved on an unknown date.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient who received only liquid portion of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not received. On 17-Dec-2018, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine, lot C5288BA via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recv vax on 5/4/98; on 5/7/98 pt exp injection site rx of 1 in area of fine, rosy, maculopapular rash &pea-size nodule.  Pt saw M.D.; pt imp in 10 day.
3/3/10, Day after DTAP & HEP A, pt woke up vomiting - 2 Emesis X 12 in 3hrs. Even with sips of liquid are thrown right back up. No rash or other symptoms. Sent to ER for risk dehydration.
This spontaneous report was received from a medical assistant, via a company representative, reporting on two female patients of approximately 11 years of age, reported as "around 11 years old". On an separate unspecified dates, in approximately May 2018, reported as "separate unspecified date "within last month""), the patients were vaccinated with GARDASIL 9 for prevention of Human papillomaviruses (HPV) related cancer and diseases (dose, route of administration, lot number and expiration date were not reported), and both patients "passed out after receiving GARDASIL 9". Both patients visited the physician's office as a consequence of the event; there was no need for the patients' hospitalization. The event was not life threatening and there was no overdose involved. No further clarifying information was provided. It was also reported by the medical assistant that both patients were "doing fine" at the time of the report (recovered). The reporter did not provide a causal assessment between the therapy with GARDASIL 9 and the syncope.
Since receiving both of my initial doses of Moderna, and my booster of Pfizer, I have been experiencing many adverse health conditions that I had never encountered before. 1. Dry/flaking skin, possibly psoriasis on my face on body. 2. Experienced pain in my chest for a couple of months, it was amplified when taking deep breaths. 3. Begun to experience chronic/persistent stomach pains/aches that I never had experienced before. 4. Hair loss at increased rate. 5. Eyes becoming increasingly dry, adversely affecting my vision.