chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives all over the body; Progressive Itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body) and PRURITUS (Progressive Itching) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037BQ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and OMEPRAZOLE for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced URTICARIA (Hives all over the body) and PRURITUS (Progressive Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over the body) and PRURITUS (Progressive Itching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient developed fever and chills after receiving vaccinations. Area of injection developed a red erythema area. Patient admitted to hospital for suspicion of cellulitis and started on intravenous antibiotics.
shingles; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: el92103), via an unspecified route of administration, administered in Arm Right on 31Jan2021 14:45 (at the age of 50years) as 1ST DOSE, SINGLE for Covid-19 immunization. Medical history included hypertension high blood pressure and high blood cholesterol increased; both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that within 2 days of vaccine he started having left arm pain. On the 3rd day, he had arm pain with the start of a rash. On the 4th day, he had shooting pain down his arm to his hand, arm pain, and more rash. It is then that he sought out medical care and was diagnosed with shingles. The rash covered his left arm and 5 weeks later he was still suffering from extreme pain. The event onset date was reported as 02Feb2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated for the adverse evet and he was on second round of antiviral's, pain medications. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was not recovered.
Migraine headache unresponsive to migraine medication, lasting 24 hours, mild fever, dehydration. Weak/tired for the following 24 hours.
7/16: onset of 3 days of fever 101-102 without other symptoms.  No rash. 7/18: stuttering, which has persisted without change.
Dose1- Fatigue  and headache Dose2-fever of 103, headache, vomiting and diarrhea , fatigue, joint and muscle pain. Patient was in bed for 2days following the vaccine Dose3- fever of 103, headache,  diarrhea ,  fatigue, joint and muscle pain Patient was in bed for 2days following the vaccine, chills Large lump under your right arm-size of avocado-Dose 3
When trying to drive to work the next day, I experienced extreme light sensitivity.  While I am light-sensitive in the morning when the sun is low on the horizon, especially when there is snow on the ground, as was the case that morning, this was far more extreme than usual.  I was wearing a very good pair of sunglasses I bought at an eye-doctor's office that protected from both the front and the sides.  Still, I felt as though I had a strobe light flashing directly into my eyes. I was driving through town, in very familiar area, I realized when I got out of town into less familiar area, it would be unsafe to drive. I went back home and called work and told them I was not well enough to go to work that day. I later called the nurse who gave the vaccine and explained the situation to her.  I received no treatment.  I had my eyes examined the next morning and was told to use eye-drops four times daily for at least two months.
My wife had a miscarriage 6 days after she received the first dose. She was 9 weeks pregnant. My wife was 142 lbs. healthy.  Baby had a normal ultrasound 3 weeks prior.
Immediately following immunization patient reported feeling light headed  Patient remained seated for approximately 15 minutes after immunization and returned to normal. Patient stated he typically has this reaction after needle sticks and/or blood draws.
FLUZONE HD administered on 10.27.14 to patient. Patient stated it burned a little at the time of administration. Patient came back on 10.30.14 and her arm had a large red area at vaccine site and was very sore. Pt was going to take BENADRYL, TYLENOL and heat area.
This spontaneous report as received from a physician, as part of a marketing research program, refers to a 15 year old female patient. In 2009 the patient was vaccinated with the first dose of GARASIL (lot # not provided). In 2009 the patient experienced "dizziness" and she was "almost" fainted, blood pressure was normal in 10-15 minutes and she went home. The physician noted that the patient was vaccinated on an empty stomach. The outcome of the events was reported as recovering, the events did not prevent administration of 2, 3 doses of GARDASIL. The reporter consider the AE to be related to GARDASIL. Additional information is not expected as the reporter was not willing to be contacted.
Rash/ swelling hot raised wheal on side of vaccinated arm (not at site of injection)  Symptomatic for COVID body aches, chills, severe headache
This case was reported by a pharmacist and described the occurrence of swelling in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received SHINGRIX. On 16th June 2018, 1 days after receiving SHINGRIX, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown. It was unknown if the reporter considered the swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received shot 1 of SHINGRIX vaccine. The patient noticed some raised redness. On 17th June 2018, the raised redness continued to get worse to a size of about 5 by 3 inches. On 18th June 2018, the size was slightly less red and raised and slightly smaller.
Chills, aches headache tiredness lasting for 72 hours. Still weak after 72 hours. Took about a month to not feel week. Tingling on lower lip lasted about two months.
Not immunocompromised/gave booster dose; Vomiting after 3rd dose; Temperature 100.3F after 3rd dose; Abdominal pain  after 3rd dose; Diarrhea after 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN (Abdominal pain  after 3rd dose), DIARRHOEA (Diarrhea after 3rd dose), OFF LABEL USE (Not immunocompromised/gave booster dose), VOMITING (Vomiting after 3rd dose) and PYREXIA (Temperature 100.3F after 3rd dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     Concurrent medical conditions included Pancreatitis (Patient has Pancreatitis which has been under control for the past 3 years.) and Heart disorder.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain  after 3rd dose), DIARRHOEA (Diarrhea after 3rd dose), VOMITING (Vomiting after 3rd dose) and PYREXIA (Temperature 100.3F after 3rd dose). On an unknown date, the patient experienced OFF LABEL USE (Not immunocompromised/gave booster dose). At the time of the report, ABDOMINAL PAIN (Abdominal pain  after 3rd dose), DIARRHOEA (Diarrhea after 3rd dose), OFF LABEL USE (Not immunocompromised/gave booster dose), VOMITING (Vomiting after 3rd dose) and PYREXIA (Temperature 100.3F after 3rd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Body temperature: 100.3 (High) 100.3 F.         No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.  Patient received the first dose of Moderna COVID-19 vaccine on 04FEB2021 (Lot number: 031L20A and Exp. Date: 22JUL2021). He received the second dose of Moderna COVID-19 vaccine on 04MAR2021 (Lot number 013A21A and Exp. Date: 20AUG2021). On13 Sep 2021, He was able to hold down clear liquids. His medical history of Pancreatitis was under control for the past 3 years and he had a heart condition. Reporter stated that patient was not immunocompromised. However, took the booster dose. Later, found out that the 3rd slot was for immunocompromised people only.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Apr-2021 at 1:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  The excursion time on initial supply was 09am, temperature was 34 and total 210 doses were administered for that day. Vaccine was not frozen prior to administration. Vaccine moved to fridge on 30-Mar-2021 and moved to clinic on 03-Apr-2021. 20 vial was sent to the clinic. BUD date was 29-Apr-2021. Vials only punctured right before administration.  Vial was stored on cooler 1, on 03-Apr-2021, Excursion temperature at 09 AM was 34.  Treatment medications were not reported.
No other adverse effects were reported.; a patient received a dose of PROQUAD following a temperature excursion.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.  On 03-MAR-2020, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot# S006830, expiration date 02-SEP-2020, strength, dose and route were not provided) for prophylaxis following a temperature excursion with Merck sterile diluent 5 ml (lot # and expiration date were unknown).  The improperly stored of vaccine experienced a temperature of 6 degrees Fahrenheit (F) to 14 F (-14 degree Celsius to -10 degree Celsius) (-9.9 degree Celsius) for 2 hours. The previous temperature excursion included 15 F to 46 F (-9 degree Celsius to 8 degree Celsius) (-1.9 degree Celsius) for 2 hours 30 minutes. The digital data logger was involved. No other adverse effects were reported.
Very sore arm with feeling of heaviness in upper arm that has lasted over 2 weeks after imm.
Information has been received from a physician concerning a 7 year old male who when he was one year old, in approximately 1999, was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy included several immunosupressive medications.  It was reported that the patient was recently titered and did not show seroconversion.  It was noted that the patient has no symptoms.  No medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Follow up information from a physician indicated that he could not remember the patient in question.  Additional information is not expected.
Have a tiny mark where it was given. Has been six months and looks like a tiny pen mark. No redness, no irritation, no issues. Mom asking to submit vears given it not gone away.
Rash, itchy, red, rt arm . started 10 days after vaccine (Feb 27th) - still spreading.
I received the first dose on February. 13th at 10:56 AM. in my right arm. I experienced pain and swelling at that time. On February 21st during the night I began to feel itching at the sight. After awakening on the 22nd. I noticed an itchy rash that I still have today on February 26th.  The itch is subsiding but the rash appears to be spreading. I call my pcp on February 23rd and told to take two Zyrtec 10 mg each and apply Benadryl cream 3 times a day. The doctor did not believe I needed to be seen when I called to report the problem.
Information has been received from a physician concerning a 17 year old female who on 26 Jan 2007 was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil. On 26 Jan 2007 the patient developed a rash at her injection site. The patient sought unspecified medical attention. On 27 Jan 2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Small patch of shingles on my forehead, noticed pain/itch on 6/26/18 and woke up with blistery looking patch appears similar to shingles.
PATIENT IS A PHYSICIAN.  ALMOST 12 HOURS AFTER INJECTION, BEGAN HAVING BODY ACHES AND CHILLS - RESTLESS ALL NIGHT.  IN A.M. WAS 101.0 F, TOOK TYLENOL EVERY 4 HOURS, ABOUT 2100 WAS 104.3F.  FEVER STAYED ABOUT 100 TO 101 THROUGH NEXT DAY.  SUNDAY, FEVER BROKE, MINOR CHILLS.  FEELING "FINE" TODAY - NO SX'S.
4/3/2021,  Initial Stinging pain at time of injection 4/3/2021 - 4/5/2021,  Pain on the left arm (injection site) extending into my shoulder and down to my wrist. 4/5//2021 - Current, Pain Reduced, but will be setting up an provider appointment. 4/3/2021 - 4/5/2021, Nauseas  4/3/2021 - 4/5/2021, Severe Headache, used Tylenol medication to reduce the pain. 4/5//2021 - Current, Light headache, Using Tylenol for relief
Palpitations, rapid resting heart rate between 85 and 90, increased diastolic pressure, onset of symptoms later then 12 hours after the Moderna vaccine administration, duration approximately 72 hours, then appears spontaneously of short duration as early as 8 and 9 days after vaccination, more commonly at rest.
pt returned to school, started c/o nausea, dizziness, entire lt side of body was numb;had fever;went to MD did not give any tx or prescribe anything;
soon as got shot, arm started swelling;fever, vomited;didn't feel good for about 2 wk;lt arm still hurts;states can't lift anything-arm hurts & is weak;pt still feels tired;
FLARE UP OF ULCERITIS COLITIS AFTER 7 MONTHS FREE. BLEEDING IN STOOL, PAIN ON LEFT SIDE OF ABDOMEN, HEART PALPITATIONS, INTENSE TINGLING IN LEGS ESPECIALLY IN LEFT LEG, INTENSE PAIN THROUGHOUT ENTIRE BODY, BACK PAINS, DIZZINESS, LOSS OF FOCUS, FATIQUE, NAUSEAU, SENSITIVITY TO LIGHT AND SOUNDS, DIFFICULTY BREATHING WHEN INTENSE FLARE UP OF NERVE SYSTEM, LOSS OF BALANCE, TREMOURS THROUGHT BODY DURING FLARE UPS. INABILITY TO CONTROL MUSCLES, MUSCLE TWICHES/SPAMS, INTERMITTENT HEADACHES, SWEATY PALMS WITH INTENSE PAINS, "CHARLIE HORSE" CRAMPS IN MUSCLES AFTER MUSCLE SPASMS, WEIGHT LOSS. BEGAN FEELING EFFECTS APPROXIMATELY 26-27TH JUNE 2021, ADMITTED 7/9 & IS CURRENTLY AT HOSPITAL AS AT 7/17/2021.
Patient reports no side effects other than a sore arm following her first dose of Moderna on 3/10/21.  Received 2nd dose of Moderna on 4/9/21.  Reports noticing itching, hives, shortness of breath and bumps on her head the next morning (approximately 9am).  Symptoms continued and lip swelling developed. Patient reports she sought care at Urgent Care on 4/12/21 for same.  Was given steroid shot and Benadryl.  Reports symptoms had greatly improved by the following morning (4/13/21), but itching has continued off and on since receiving 2nd dose of vaccine.    Continues to tak e Benadryl as needed.  Reports extreme fatigue as well.  Advised to follow with PCP.
Patient received the vaccine around 2:30 pm on Sunday, April 15. He said around bedtime about 10 pm that evening he felt very cold and couldn't get warm. The next morning, April 16, he woke up and felt light headed after rising. His wife helped in back to bed and laid for about 10-15 minutes and felt better. He then said around 9 pm he started with some redness and blotches and by the following morning he was covered with redness/blotches/itchy on all over both legs, both arms, and on side of abdomen. He went to see his primary care MD, on Tuesday am. He saw the nurse practitioner that day who gave him a steroid shot. The nurse practitioner recommended BENADRYL, PEPCID, and a MEDROL dose pack. His wife came into the pharmacy on Thursday, April 19 to report what had happened and I got further details from him. He said he was doing better today and still needed to complete the MEDROL dose pack and it would be the last day of the BENADRYL and PEPCID.
Woke up with high fever on 9/18/11 with chills and red welps around injection site.  Fever reached 103.6 on 9/19/2011. Complained of arm pain and would not use arm at all for two days and then limited used for two additional days.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 weeks old female patient who experienced inadvertently administering expired PENTACEL to client, who is 5 weeks and 3 days old, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received Hepatitis B vaccine, PREVENAR 13 and ROTATEQ as concomitant medication. On 30-Oct-2018, the patient received a first dose of 0.5 ml of suspect PENTACEL lot C5440AA, expiry date- 29-Oct-2018 via intramuscular route in right leg. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for inadvertently administering expired PENTACEL to client, who is 5 weeks and 3 days old. 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 and Module VI of the 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.
lightheadedness, pulse increase to 112 bpm,  temperature increase, headache/migraine, blurry vision.
COUGH, CHEST CONGESTION, BODY ACHES, CHILLS, LOW-GRADE FEVER, EAR PAIN
That evening I began to have a fever and chills.  I took tylenol to try to help reduce the fever, which it did not help.  during the middle of the night I was woke up with an urge to vomit.  I ended up vomiting multiple times throughout the day and had a debilitating migraine.  after 26 hours since the shot was given I would finally be able to function as the migraine started to subside as well as the nausea.   My arm was also quite sore for about 4 days after the shot.
vaccine used beyond the used date of 09 oct 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine used beyond the used date of 09 oct 2021) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine used beyond the used date of 09 oct 2021). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccine used beyond the used date of 09 oct 2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided by the reporter.  This case concerns a 75-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 75-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
sinusitis, allergies, muscle pain, lower back, neck, hands. Permanent and with treatment fluticasone, loratadine, ibuprofen, aspirin 83mcg.
Right lower part of leg (closest to knee) has 3 inch x 3 inch round petechia area with x 1 <2cm pustule, several pin point areas around pustule scabbed over. Mother states he had another injection above the affected one, and x1 injection in the left leg. Mother states he limps on leg and c/o it hurting. Advised mother to apply ice and given Tylenol for discomfort and continue to monitor it.
Left arm, site of injection, reddened & slightly warm to touch. Swollen from shoulder to elbow. Local reaction. Resolved with no intervention.
Information has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 26-JAN-2017, the patient was vaccinated with M-M-R II (lot # M016233 with expiration date 31-MAR-2018) (dose, dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 8°F but less than 25 °F for 7 hours 54 minutes without any previous temperature excursion. No data logger issue and 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-009507513-1702USA001057.