chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching at the injection site; itchy bump at the injection site; Redness at the injection site; Small, swollen bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Small, swollen bump at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PRURITUS (itchy bump at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Blood cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Small, swollen bump at the injection site), VACCINATION SITE PRURITUS (itchy bump at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 14-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. On 05-Apr-2021, VACCINATION SITE INDURATION (Small, swollen bump at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) had not resolved and VACCINATION SITE PRURITUS (itchy bump at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Concomitant medications included cholesterol medications and BP medications.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up information received on 14-APR-2021, contains no new information.
Information has been received from a medical assistant, concerning a female patient who on an unknown date was vaccinated intramuscularly in the deltoid muscle with a first dose of GARDASIL (dose and lot number not provided). The medical assistant reported that the patient had a really sore arm in the deltoid muscle after receiving her first dose of GARDASIL. On an unknown date, a day after vaccination, the patient recovered. The patient did not seek medical attention. Follow up information has been received from a physician concerning the 22 year old female patient with no illness at the time of vaccination and no pre-existing allergies or medical conditions. Concomitant medications included AVIANE. On 24-OCT-2008 the patient's arm was very sore and achy after injection. The patient requested the second shot of GARDAIL to be given in her gluteus maximus. No laboratory or diagnostic tests were performed. Additional information is not expected.
Cardiac Arrest/Respiratory Failure Severe global HIE brain injury Aspiration Pneumonia R/O Vaccine Encephalopathy per Pediatric Neurologist
Admitted 11/21/2022 from ED to ICU with at least 1 week history of severe weakness with frequent falls associated with lower extremity weakness in particular.  Mostly having proximal muscle weakness.  She is now weak to the point that she requires assistance of 2 people to get into a wheelchair.  She has had 4 falls at home over the past 48 hours.  She was intubated 11/25 and remains intubated in ICU at this time.  She received 5 doses of IVIG.  She is on day 5 of antibiotics.
Rash covering entire body, swollen glands in cheeks and neck. begining 8 days after vaccination was given.  No treatment.
Patient was seen at the urgent care clinic on 4/19/2021 having congestion for a couple of days as well as cough, news throat the head and troubles breathing was noted to have normal oxygen saturation and was given an albuterol inhaler and told that she had a virus.  She followed up in the PCP office on 4/21/2021 with worsening troubles breathing and was given Decadron in the office, 4days of prednisone, CXR and labwork.  CXR showed possible reactive airway disease and was to do steroid and continue out albuterol every 4 hours.  Had negative/normal lab work and positive Covid antibodies.  History of Covid 10/2020.  Felt almost completely back to normal by Sunday, her last day of steroids.  On Monday had worsening of her breathing throughout the day, increased troubles breathing again after softball that night.  Albuterol did seem to help up.  Called the office as she woke up Tuesday morning with worsening and would started on Flovent.  With no improvement return to PCP office on 4/29/2020 with marked inspiratory stridor.  Was admitted to the hospital for work-up of return of stridor.  Had a normal chest x-ray and neck/soft tissue x-ray.  With continued troubles breathing and chest pains with decreased heart rate was elected to go to  Hospital where she could have further work-up.  When the ARNP came helicopter, was concerned about her airway and she intubated to fly to hospital.  Was dx there with Sudden Acute Onset of Vocal Cord Dysfunction and is continuing with therapies.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VAQTA lot # M012261, expiration date: 01-FEB-2018 (dose and route of administration were not reported). Temperature excursion ranged from 32 to 35 degrees Fahrenheit (from 0 to 1 degrees Celsius) for 2 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010600: US-009507513-1703USA010599:
2 hours after immunizations, right arm became very sore. During the night, cold sweats. Next day right arm swollen, erythematous shoulder to elbow. Day 2, a little less edematous/erythematous. Denies numbness and itchiness.
The patient called on 10-4-22 to state that she is still having side effects post vaccine.  She states she is lethargic and has body aches, especially in her legs.  She indicated that is has been going on for 9 days now.
pulse over 140, no temp; Woke up at 2 am.  Uncontrollable shaking; Teeth were chattering so much thought my teeth would crack; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 18-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, in the right arm on 28Mar2021 at 16:00 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medications and other medications the patient received within 2 weeks of vaccination were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 29Mar2021 at 02:00, the patient woke up at 2 am. Uncontrollable shaking, pulse over 140, no temp. Teeth were chattering so much thought her teeth would crack. Patient was taken to local emergency room. Vitals where a high pulse, 143, blood pressure was high. The shaking continued in the ER until 3:30 ish. Therapeutic measures were taken as a result of events. They administered 1000 mg of Tylonol. Events were considered serious nut seriousness criteria not reported. Adverse events resulted emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement was 143 mmhg on 29Mar2021, heart rate increased was 140 on 29Mar2021, negative rapid, nasal swab, sars-cov-2 test on 17Mar2021, negative PCR nasal swab sars-cov-2 test on 17Mar2021. Outcome of the events was not resolved.  Information of the Batch/lot number has been requested.
Extreme pain at injection site. Nausea & vomiting. Redness at injection site.
vaccination site pain; Cough; Rash over arms; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Cough), RASH (Rash over arms) and VACCINATION SITE PAIN (vaccination site pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 003B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    The patient's past medical history included Smoker (one pack per day) from 1975 to 2001. Concurrent medical conditions included Alcoholic (Beer one-two bottles per week) since 1975 and Rheumatoid arthritis. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disease, unspecified, FOLIC ACID for Rheumatoid arthritis, MULTIVITAMIN [VITAMINS NOS], VITAMIN D3 and VITAMIN B12 NOS for Vitamin supplementation, METHOTREXATE and LOSARTAN for an unknown indication.   In 2004, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) .4 ml. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced RASH (Rash over arms). On 15-Apr-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 18-Mar-2021, RASH (Rash over arms) had resolved. On 15-Apr-2021, COUGH (Cough) had resolved. At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RASH (Rash over arms) to be probably related and COUGH (Cough) to be not related. No further causality assessment was provided for VACCINATION SITE PAIN (vaccination site pain).    No corrective treatment was provided.
Temperature excursion occurred; No Adverse event; Temperature excursion occurred; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, 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 01-Dec-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred).    No concomitant drug information was provided.  It was reported that the temperature excursion of the vaccine had occurred on 29Nov2022. A total of 16 doses were administered.   Reportedly, Temperature excursion occurred on 29-Nov-2022. A total of 16 doses were administered on 29-Nov-2022 (5 doses), 30-Nov-2022 (4 doses), 01-Dec-2022 (2 doses), 02-Dec-2022 (2 doses), 03-Dec-2022 (1 doses) and 05-Dec-2022 (2 doses).  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication information was provided. The case is reported for one of the 2 adult patients who received the vaccine on 1Dec2022, as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688061 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688061:1 adult patient (1DEC2022)
Slight headache and body aches the night that I got the second dose but my first period after, which has always been very regular and predictable, was four days late.
1. Within first 15 minutes -  burning at injection site; resting heart rate rapid/ increased and recorded by staff to 130's; trembling 2. 9-10 days after injection; swollen lymph node and discomfort in armpit of same arm where injection occurred
Information has been received from a consumer concerning his 84 year old sister who was vaccinated with her first dose of PNEUMOVAX vaccine when she was 82 year old. Recently the patient was vaccinated with her second dose of PNEUMOVAX vaccine. After receiving the second dose the patient developed cold symptoms with swollen lymph nodes on her neck. The outcome of the patient's cold symptoms with swollen lymph nodes on her neck was not reported. No further information is available.
The patient complained that her left arm (where the pneumonia vaccine was given) became very tight, and then she noticed it was difficult to swallow.  She was seen in the ED.
PATIENT WAS HOT AND DIZZY AND FAINTED. AFTER 10 MINUTES OF GETTING THE JANSSEN COVID VACCINE.  WE ADMINISTERED AN EPI-PEN DOSE AND CALLED 911. SHE REGAINED CONSIOUS APPROXIMATELY 30 SECONDS LATER. WE APPLIED COOL CLOTHS TO NECK .. PATIENT STATED SHE HAD NOT EATEN ANY BREAKFAST AND A LIGHT SUPPER. WE CALLED 911 AND THEY CAME AS WELL.
No adverse effects reported.; the patient was administered a dose of MMRII intramuscularly rather than subcutaneously.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On 17-MAR-2019, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(strength, dose detail, lot # and expiration date were not reported) intramuscularly rather than subcutaneously(incorrect route of product administration) for prophylaxis. No adverse effects was reported. The causality of the event was not provided.
Seven days after getting the shot, the area around the vaccination site on my arm suddenly became very swollen and sore. There is a large red patch/rash, and  the area is hard and feels very warm to touch.
09/12/2022 at around 01:00AM  I felt the pain in my neck and shoulder area. When I woke up I couldn't move my neck at all. At around 2:00PM I felt there was a lymph on my left shoulder blade it was hot to the touch. The pain was moderate.  On 09/12/2022 I was able to have an appointment through video with my doctor. My doctor told me to take TYLENOL and hot pad on the lymph. She also told me if It gets worse to contact her immediately.
pt began exp deep pain in rt deltoid early am of 30APR97;reported a throbbing pain woke up 3 noc in next few weeks;no redness;no edema;no bruising;tender w/palpation dec rt arm;
Patient noticed a 4 in by 3 in area of redness, warmth and tenderness on site where vaccine was administered, 24 hrs after administration.  Unchanged the following morning (2/5/9).  No improvement on 2/6, KEFLEX given for 10 days.  Per mom on 2/6/9.
receiving on 09/02/21 only the adjuvant component of Shingrix; receiving on 09/02/21 only the adjuvant component of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number BM27F, expiry date unknown) for prophylaxis.   On 2nd September 2021, the patient received Shingrix. On 2nd September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: The health care professional reported that male patient receivied only the adjuvant component of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. Reporter consented to follow-up.
Information has been received from a registered nurse concerning a patient who was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  It was reported that the patient subsequently developed measles.  Unspecified medical attention was sought.  Follow up information has been received from a registered nurse indicating that titers were run on the patient and the titers were normal.  Therefore they have determined that the patient did not contract measles.  The reporter states that the adverse event would be disregarded.  Additional information is not expected.
PATIENT WAS GIVEB 0.2ML OF THE 30MCG FORMULA INSTEAD 0F 0.2ML OF THE 10MCG FORMULA,
Bell's Palsy grade III-Right side of face numb and decreased movement. Treated with prednisone 60 mg. po qd x 1 wk. Also Valtrex 1000 mg.TID
On May 20th  he came down with a cough and not feeling well. Went to hospital on May 22 and was diagnosed with pneumonia.  Gave iv antibiotics and fluids. Sent home. On may 24 went back because he was worse.  Temperature and high blood pressure and a headache. They admitted him to the hospital then checked him for covid.  He was positive.  They gave him a shot on may 24 and May 25th in the stomach for blood clots.  On may 25th they sent him home. He started feeling better may 28. Then on June 17th he fell out of his chair complaining of severe dizziness. Called 911 and they transported him to hospital.  Did a procedure to see if there were any blood clots. It was determined that he had a blood clot in his artery in the neck. They gave him tPA to break up the clot right away. Then transported him to the hospital to the icu. It was determined that the blood clot caused the stroke.  Still having severe dizziness. Released him to rehab on 6/18 @ 4:30 pm
This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored oral, ROTATEQ (strength, dose and frequency were not reported, lot # L020859, expiry date: 19-JAN-2017). No adverse events were reported. No further information was provided. Product quality complaint was not filed. This case is one of several reports received from the same reporter. Additional information has been requested.
FELT FINE PRIOR TO GOING TO BED EXCEPT MY SHOULD WAS SLIGHTLY SORE DURING THE DAY BUT GRADUALLY BECAME VERY SORE THROUGH THE NIGHT. AT 1:00AM., I AWOKE WITH A FEVER OF 99.2.  AT 3:00 AM, MY TEMPERATURE HAD RISEN TO 100.2.  AT 7:30 AM, MY TEMPERATURE HAD SUBSIDED TO 99.2.  I TOOK 1 600 MG ACETOMENEPHEN AND 1 IBUPROHEN AS I HAD TO LEAVE MY HOUSE.  WHEN I RETURNED HOME AT 1:00 PM, MY TEMPERATURE HAD RETURNED TO 98.6. I FELT DEHYDRATED AND DRANK AT LEAST 32 OUNCES OF WATER DURING THE NIGHT.  NORMALLY, I DON'T DRINK ANY WATER AT NIGHT.  AT THIS TIME, I.E. 7:33 PM, MY SHOULDER STILL FEELS A BIT SORE.
Pain in right knee started  several days after  receiving  second  shot.  Knee had a total replacement  several years ago.
Mom reported hives over entire body on 8-28-09 which lasted until 9-2-09.  No fever.  States child seemed more tired then usual on day before hives appeared.  Mom states she dosed child with BENADRYL 2 X 1d after hives appeared.
PAINFUL UNILATERAL RASH (L2 DERMATOME) RASH RESOLVED WITHIN 4 WEEKS WITHOUT COMPLICATION.
caught mild COVID-19 between the first and second booster (ie between shot#3 of Pfizer (11/2021) and shot #4 of Pfizer this month). All shots in the COVID-19 series of shots have been the Pfizer one. Positive PCR test for COVID-19 was at Facility walk in testing site in same location on Jan 12, 2022.
Client seen 7-29-09 for travel, was given oral Typhoid, 1st dose TWINRIX. On 7-30-09 wife called stating the previous evening, day of immunizations, husband c/o nausea, fatigue with stomach distress. Cancelled business trip and was able to see private MD that day to rule out vaccine reaction vs food poison. Follow-up with private MD, she advised not to administer any additional vaccines. Patient recovered fully 3-4 day after initial symptoms. Patient had not started oral Typhoid. Follow-up with patient after Typhoid completion; admits to no problems.
Vx administered 2 days after reconstitution/ inadvertently administered to a patient this morning on 1/5/23; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 23E5G, expiry date 11th February 2024) for prophylaxis.   Previously administered products included Shingrix (first dose was received on an 23 August 2022).   On 5th January 2023, the patient received the 2nd dose of Shingrix. On 5th January 2023, unknown after receiving Shingrix, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.   Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's comments: The pharmacist had called up to inquired about any guidance.  The pharmacist had reported that, shingrix was reconstituted two days ago before the reporting and then was inadvertently administered to a patient this morning, at the time of reporting as the patient second dose. The reporter did not consent to follow-up. Additional supportive information: The patient had received the Shingrix vaccine that was reconstituted two days ago on Monday then inadvertently administered to a patient this morning, which had led to wrong technique in drug usage process.
Pt. developed significant loose water stools 8 days after vaccine given.  Pt. had at least 20 large stools per day.
sinus infections; I just got over a bronchitis, cold like a slight bronchitis; I just got over a bronchitis, cold like a slight bronchitis; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. OOn an unspecified date, the patient experienced sinus infections, i just got over a bronchitis, cold like a slight bronchitis. Reporter was asked if elderly parents can get vaccine because little congested, coughing.The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.