chrisvoncsefalvay/vaers-outcomes huggingface dataset:
running temperature of 100.4 then it went to 101.2; hurting at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (running temperature of 100.4 then it went to 101.2) and VACCINATION SITE PAIN (hurting at the injection site) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) 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) (unknown route) 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 PYREXIA (running temperature of 100.4 then it went to 101.2) and VACCINATION SITE PAIN (hurting at the injection site). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PYREXIA (running temperature of 100.4 then it went to 101.2) and VACCINATION SITE PAIN (hurting at the injection site) outcome was unknown. Not Provided          Patient is taking two doses of acetaminophen.
Increased axillary temperature 6 hours after vaccinations.  No antipyretic. Measured temperature in medical office 10AM (14 hours later and less than 24 hours after vaccination 1.2.8 rectal
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot # M020521 with expiry date 17-NOV-2017 (exact dose and route of administration were not reported). The doses were exposed to the temperature of 46.8 degrees Fahrenheit for 13 hours. Previous temperature excursions included 48.2 degrees Fahrenheit for 13 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA010705:
COVID-19 vaccination with Moderna and Janssen vaccines; Extremely bitter taste in the back of mouth on tongue/similar to bitter grapefruit; It woke me up several times throughout the night; First dose was administered on 11-Mar-2021, and second dose was taken on 20-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Extremely bitter taste in the back of mouth on tongue/similar to bitter grapefruit), SLEEP DISORDER (It woke me up several times throughout the night), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 11-Mar-2021, and second dose was taken on 20-Apr-2021) and INTERCHANGE OF VACCINE PRODUCTS (COVID-19 vaccination with Moderna and Janssen vaccines) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 038A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janseen (Batch/Lot No: 20J14-03) in December 2021. Past adverse reactions to the above products included No adverse event with Janseen. Concurrent medical conditions included Depression. Concomitant products included DULOXETINE from July 2020 to an unknown date and AMLODIPINE from March 2022 to an unknown date for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 11-Mar-2021, and second dose was taken on 20-Apr-2021). On 18-May-2022, the patient experienced DYSGEUSIA (Extremely bitter taste in the back of mouth on tongue/similar to bitter grapefruit) and SLEEP DISORDER (It woke me up several times throughout the night). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (COVID-19 vaccination with Moderna and Janssen vaccines). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ALKA SELTZER PLUS AND FLU) on 18-May-2022 at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Extremely bitter taste in the back of mouth on tongue/similar to bitter grapefruit) and SLEEP DISORDER (It woke me up several times throughout the night) had not resolved, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 11-Mar-2021, and second dose was taken on 20-Apr-2021) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (COVID-19 vaccination with Moderna and Janssen vaccines) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient had no drug allergy.  The patient had taken unspecified Pfizer drug on 18-May-2022 for the COVID-19 treatment with batch number as GA1188.
2MAR93; awakened w/sore wrists; 3MAR recvd Hep inject sl pain rt shoulder later in day; 4MAR stiffness both hands, hands felt swollen, knees ached; 5MAR feet & toes had swelling sensation, could hardly grip, rt knee pain, sore wrists;
Shot 1: Sore arm for a week Shot 2: fever, chills, migraine within six hours. Fever and Migraine lasted two days.  Shot 3: upset stomach, low grade fever next morning throughout the day.   Period now heavier, PMS symptoms are worse, cramps, bloating and heavy bleeding
11/4/00 at 15:00, temperature was 103.4F, trembling and was given Tylenol. Had increased cough, rhinitis, labored respirations for 25 minutes, cyanosis of nails, temperature 105F. O2 4/L per NC; increased to 6/L per NC. Temperature 106F. Ambulance here and transferred to hospital for the night. At 18:00, admitted to hospital. Temperature has remained down. On 11/5/00, returned home from hospital with orders to resume all previous meds, diet and activity. According to progress notes-no papers have arrived from hospital yet.
4th DTaP dose at 3 years; 5th DTaP dose not received; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTap (received 3 doses on an unknown date).   On an unknown date, the patient received the 4th dose of DTaP vaccine and did not receive the 5th dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced inappropriate age at vaccine administration and incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The medical assistant called in to  inquired about the need to administer a 5th dose of Tdap to patient correcting herself later in the call  by saying that it was DTap and not Tdap.  The patient received a 4th dose of DTap when was 3 years old and 11 month of age, stating that they were not aware of the name and just mentioned Dtap, with the specifics of the vaccination not interrogated because the reporter did not know if a GlaxoSmithKline product was involved.  The reporter said that they understand that the 5th dose was not required if the patient receives the 4th dose after age 4 and that the patient was now 8 years old.  The reporter asked that the patient need a 5th dose or she did not knew if this 5th dose would be a GlaxoSmithKline product. The call was very muddled due to the fact that the reporter did not know the name of the vaccine nor the generic formulation of the vaccine which was applied when the patient was 3 years and 11 months old or the one that would be applied now.  The reporter consented to follow-up. Additional supportive information: The patient received 4th dose of DTap at inappropriate age, which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive the 5th dose of DTap, which led to incomplete course of vaccination. In worst approach, only inappropriate age at vaccine administration event was coded for 4th dose as we don't know proper vaccination details for past vaccinations and also it was not clear the interval between the 3rd dose and 4th dose to considered drug dose administration interval too long and the event incomplete course of vaccination was coded for 5th dose considering that the patient did not receive it till the time of reporting and the patient's has cross the age recommendation interval for the vaccination.
Information has been received from a physician concerning a 73 year old male who was vaccinated with pneumococcal vaccine 23polyvalent. The physician reported that the patient developed left upper extremity cellulitus. Unspecified medical attention was sought. Subsequently, the patient recovered from left upper extremity cellulitis. Additional information is not expected.
I have Mast cell and was waiting to get the vaccine. I was told to have it done in a hospital, take 2 epipens with me along with an antihistamine that was given 30minutes to an hour before. The faculty kept me there for 2 hours. I was told to take the histamine for 4 days following . First shot went smooth I never felt it go in. Later arm tiny sore (no big deal) tired for few days after. Probably from anti Histamine) Second shot hurt from moment it went in my arm. Pain. 11 hours later i felt like I got hit by a bus. Every muscle hurt in my body. Even the cheeks of my butt. I stay in bed all day Thursday. I woke up Friday with no pain anywhere. I walked to the table and sat down talking to my daughter. I just got done saying I feel so much better. My vision then clouded up I said oh my vision is funny. She then said my eye rolled back in my head and I made a funny noise inmy throat. She tried to pour water on me , with no luck i kept coming out of it and doing it 3 more times. She got the epipen an administered it.I jerked up and was out again. EMS arrived and I did it again. They took me to the hospital where they thought I had a stroke. Did not.
Light pink, mildly itchy rash on left hand and right side of my neck/lower face area.; This is a spontaneous report received from a contactable patient. A 30-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EW0169) in left arm on 28Apr2021 at 18:15 (at the age of 30 years-old) as a single dose for COVID-19 immunisation. The patient's concomitant medications included TRI SPRINTEC and IC PERMETHRIN cream within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021 at 09:00, the patient experienced light pink, mildly itchy rash on left hand and right side of neck/lower face area.  Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. On an unknown date, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome of the event light pink, mildly itchy rash on left hand and right side of neck/lower face area was not resolved.   No follow-up attempts are needed. No further information is expected.
blood in stool; The initial case was missing the following minimum criteria: of No Adverse Event Upon receipt of follow-up information on 19Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 04Feb2021 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included open heart surgery in 2019 (two years ago), brain stroke, ongoing dizziness from 2018 (3 years ago), ongoing blood pressure from 2018 (3 years ago), heart beat high, ongoing anxiety from 2018 (3 years ago), urine frequency. Concomitant medications include metoprolol fumarate for blood pressure, mirabegron (MYRBETRIQ) for urine frequency, sertraline hydrochloride, nifedipine, atorvastatin, acetylsalicylic acid (ASPIRIN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 13Jan2021 (at the age of 71-years-old) for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first administration date of the vaccine. On an unspecified date, the patient experienced a lot of blood in the stool. In Feb2021 (two months ago), the patient had a colonoscopy with unknown results. The patient still had blood in the stool but not as much as before. The clinical outcome of blood in the stool was resolving.
MILD FEVER & SORE THROAT 8-9 DAYS AFTER VACCINATION WITH SMALLPOX THEN RASH DEVELOPED ABOUT ABOUT 10 DAYS AFTER VACCINATION ON CHEST AND TRUNK.
Chronic inflammation wrists, shoulders, back, enlarge prostate, tingling and numbness in lower leg.    Carpal tunnel surgery both wrists, cortizone shot both shoulders, 8 week physical therapy on shoulders. 6 weeks therapy on back.  Meds for enlarged prostate, lost 20+ lbs, changed blood pressure meds, taking celecoxib for inflammation.  Fatigue easily. Loss of energy
Bad multiple sclerosis relapse; This spontaneous case was reported by a patient and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (Bad multiple sclerosis relapse) in a 54-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis.    In 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (Bad multiple sclerosis relapse) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (Bad multiple sclerosis relapse) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication reported.  It was reported that patient received first moderna shot about 2 months before reporting. The patient could not walk for 3 days, really bad vertigo, could not walk, additionally mentioned her legs would not support her, vertigo was horrid, the patient believed the Moderna put her in a bad multiple sclerosis relapse, lasted for 3-4 days and then resolved. GAIT INABILITY (Patient could not walk for 3 days/ my legs wouldn't support me) and VERTIGO (Had really bad vertigo/ Vertigo was horrid) were the possible symptoms of multiple sclerosis relapse.  No treatment medication reported.  Company comment This is a spontaneous case concerning a 54-year-old female patient with medical history of Multiple sclerosis, who experienced the serious, Medically Significant, unexpected AESI event of Multiple sclerosis relapse and received the first dose of mRNA-1273 and had recovered at the time of the last observation. Exact vaccination date and event onset date are unknown, thus, exact latency between vaccination and onset of the event could not be assessed. It was reported that he received the first dose, and the patient could not walk for three days, had a really bad vertigo and could not walk. This lasted three to four days and then resolved. The mentioned medical history could be a confounder for the event. No further clinical information was provided for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old female patient with medical history of Multiple sclerosis, who experienced the serious, Medically Significant, unexpected AESI event of Multiple sclerosis relapse and received the first dose of mRNA-1273 and had recovered at the time of the last observation. Exact vaccination date and event onset date are unknown, thus, exact latency between vaccination and onset of the event could not be assessed. It was reported that he received the first dose, and the patient could not walk for three days, had a really bad vertigo and could not walk. This lasted three to four days and then resolved. The mentioned medical history could be a confounder for the event. No further clinical information was provided for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient starting bleeding immediately following injection and immediately started bruising/swelling at injection site. She then states she was dizzy.
Lightheaded; flushed; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Dec2020 (Batch/lot number: EJ1685) at a single dose on left arm, and received the second dose, intramuscular on 08Jan2021 (Batch/lot number: EK9231) at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded and flushed on an unspecified date. Treatment not received for the adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
The patient experienced a fever of 99.9F and redness, slight edema and pain of the deltoid area. The patient had severe fatigue for 2 days.
From 09-DEC-1983 to 13-JAN-1984, 21 cases of measles occurred. The outbreak involved 16 high school students, all of whom had histories of measles vaccination after 15 months of age. The affected high school had 276 students and was in the same building as the junior high school with 135 students. A review of health records in the high school showed that all 411 students had documentation of measles vaccination on or after the first birthday, in accordance with the law. This outbreak demonstrated that transmission of measles can occur within a school population with a documented immunization level of 100%. During 2006, a total of 6584 confirmed and probable cases of mumps were reported to the Centers for Disease Control and Prevention, college campuses with mumps outbreaks included ones with 77 percent to 97 percent of students having had 2 dosage of mumps vaccine. On an unknown date unknown patients were vaccinated with M-M-R II (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patients experienced infectious disease outbreaks despite high vaccination coverage (vaccination failure). The action taken with the therapy with vaccination failure was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with M-M-R II was related. Additional information has been requested.
The day following the injections, 01/24/2017 client noticed pain, redness and some swelling around injection sites (bilateral deltoids). Mother provided Ibuprofen for comfort.  The following day, 01/25/2017 approx. mid day, client began to develop rash from just below shoulder, down to approx. 2 inches above elbow bilaterally.  Rash has been itchy.  mom has treated with OTC anti-itch cream (unknown brand)with minimal improvement.  Rash still remains 8 days after vaccination.
Information has been received from medical records regarding a case in litigation (MARRS # 2012SP017341) concerning a 20 year old female with no known drug allergies and a history of acute tonsillitis who received the GARDASIL. On 11APR2007 the patient was seen by a physician for complaints of left arm pain. She had a GARDASIL on 03APR2007 into her left shoulder and arm. At the time of her injection she had some numbness shooting down into her arm and hands. Since then she had been complaining of numbness and tingling in her left arm and shoulder. The patient reported it was more difficult to lift her arm up above her head and she could not lie on that side. The physician noted the patient had not had any redness, swelling or warmth at the injection site and could not tell where the injection was given on the skin. The physician assessed the patient with left arm neuritis. The physician noted the only possibility for the etiology of her symptoms was that the medicine may have been injected near a nerve site or a nerve sheath and that she had some local inflammation around the nerve causing her to have some numbness and tingling into her left arm and pain in the shoulder. The patient correlated the beginning of her symptoms directly with receiving the GARDASIL into her left shoulder. The physician treated her with NARPROSYN, range of motion exercises and a sling to take the weight off of her shoulder. Additional information has been requested. All available medical records will be provided upon request.
Multiple diffuse 2-3cm diameter bruise of the trunk & extremities w/sparse periorbital & perpheral petechiae; Devel 10 days p/MMR/HIB; platelet count 9,000 compatible w/ITP;
No discomfort or anything that first day. That evening it was a little tender. The next morning it there was a red band on my arm and I could feel a bump there. Today is day 8 and it's itching more than ever before. Every now and then it stings a little bit. Not as red as it was, but still red. Its fading a little about around the edges.
p/vax pt rt arm swollen from deltoid area to approx 1" above elbow;reddened area approx 4" x 4" area to posterior area of upper arm;warm to touch no knot noted;pt states almost fainted;infection;
Moderna Bivalent Booster was administered as a second dose for this patient. She was intended to receive the 2nd dose of Moderna primary.
Information has been received from a physician concerning a male patient "in his 40's" with a history of mumps and rubella as a child who on an unspecified date was vaccinated with a dose of MMR II.  Subsequently the patient had a "severe local reaction with swelling at the injection site".  Medical attention was sought, the patient spoke to the physician.  It was unspecified if lab studies were performed.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Food aversion!!! Several foods I previously loved, now seem repulsive. I?m suddenly extra sensitive to the smell, texture, and tastes of many foods (meat/chicken/pork, etc in particular). Sometimes I can?t even get my morning coffee down...usually I throw back multiple cups a day. A baked potato just made me gag. Even when I?m hungry, I?d rather not eat.
4 inch by 3 inch hard, hot, red spot at site of injection. Larger on day 3 vs day 2 when it showed up
Pt was given MENVEO when they should have been given MMR. No adverse reaction happened. Pt was notified and correct MMR vaccine was given.
Confusion, disorientation- onset approx 2-3 hrs after vaccine, lasted between 9-16 hours. (Went to bed and seemed better the next day) Diarrhea- onset day after vaccine, lasted approx 4-5 days Loss of appetite- onset approx 4 hrs after vaccine, has continued through day 5 post vaccine Stuffy nose- onset 3 days post vaccine Extreme Fatigue- onset approx 6 hrs post vaccine, has continued through day 5