chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 21-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Pt noticed red spots on upper half of thigh bilaterally on 1/1/20. The spots worsened until 1/8/20. The spots cause a burning sensation with touch of clothes or skin.
shot hurts like hail; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot hurts like hail). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient received shingles shot hurts like hail The follow-up could not be possible as no contact details were available.
100 degree fever for 2 days; chills/shivering; body aches; fatigue; felt fluish; whole arm hurt; red swollen very tender and sore spot the width of a softball at the site of the injection. 3rd day symptoms much better but still noticeable but could resume all activities. I have never had a reaction to an immunization in all the years of getting vaccines and flu shots or at least not to the degree that I ever noticed. This wiped me out for 2 days. I had previously had the older version of this immunization and no reaction.
started experiencing excruciating lower back pain radiating through legs; excruciating lower back pain radiating through my legs. pain was unbearable and could barely stand completely upright; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04May2021 at 07:00(at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and hashimoto's disease. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), cyanocobalamin (B12), colecalciferol (VIT D3)all from unknown date for unknown indication. The patient has allergies to Gluten and dairy intolerant. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 13Apr2021 at 07:00(at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 04May2021 at 20:15 the patient started experiencing excruciating lower back pain(back pain) radiating through her legs. she have not experienced any lower back or leg pain previously nor she have a history of anytime of pain in the lower extremities. The pain was unbearable that she could barely stand completely upright(pain in lower extremities). She explains about her as a healthy eating and exercise routine, Vegan, Work out 4x per week, No Alcohol, No Tobacco or Drugs. Therapeutic measures were taken as a result of adverse event and included treatment with several over the counter pain relievers (so that she could sleep comfortably, but she was still experiencing pain on the first day post vaccination). The clinical outcome of the event started experiencing excruciating lower back pain(back pain) radiating through legs(pain in lower extremities) were not resolved.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended medical history.
After administration, pt went shopping with his wife and kid. While shopping within the store, pt reports he fainted, fell down to the ground on his forehead and sustained a deep cut injury right above his left eye. He was bleeding profusely, first aid was rendered and his wife drove him to the ER
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 20-JUN-2017, the patients were inadvertently vaccinated subcutaneously with improperly stored single doses of PROQUAD injection (lot # M044020; expiration date: 01-MAY-2018; exact doses were not reported). The doses of PROQUAD were reconstituted with a properly stored sterile diluent (MERCK). The reporter stated that the administered doses of PROQUAD were stored at temperature range between 15 degrees Fahrenheit (F) to 46 degrees F for 30 minutes on an unknown date. Previous temperature excursions included storage at the temperature in the range of 6 degrees F to 14 degrees F for 5 hours 49 minutes on unknown dates. Data logger was used to detect temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1706USA009892.
Information has been received from a medical assistant concerning a now 66 year old patient who was vaccinated with a dose of VARIVAX (Merck) (lot # 662447/1548X) instead of ZOSTAVAX (Merck) in December. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected.
Pt recvd vax & exp dizziness & nausea 4 days p/vax; pt felt might be getting a cold when vax recvd; No further details were provided;
Pt developed arthralgia diffusely, as well as chest discomfort and SOB, pain with inspiration.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 24-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 08-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received. patient contact details added. event onset date updated. vaccine start date updated. On 09-Aug-2021: Follow-up information include no new information
Rec'd a booster of Engerix-B on 22SEP90; Experienced arthritic back, knee, shoulder, & neck pain. Knee involved w/arthritic pain was not the knee which had surgery.
Information has been received from a registered nurse, concerning a 5 year old female patient with no known drug reactions or allergies, who on 14-JUN-2006, was vaccinated with the first dose of VARIVAX (Merck) (dose, route and lot number not provided). On 19-MAY-2010, after receiving the dose of VARIVAX (Merck), the patient was diagnosed with varicella. The patient also had fever of 101F and a cough. On 19-MAY-2010, the patient went to the emergency room and was released the same day. A rapid strep test was performed and the result was negative. The physician at the emergency room stated it was the worse case of varicella he had ever seen. At the time of reporting the patient's outcome was unknown. Follow up information has been received from a registered nurse. The patient with not known allergies, on 14-JUN-2006 received a first dose of VARIVAX (Merck) (Lot # 649734/0789R), in the right arm. Concomitant vaccinations included a first dose of MMR II (Lot # 649805/0465R) in the left arm, a fourth dose of DAPTACEL (Lot # C240AA) in the left arm, and ACTHIB (Lot # VE709AA) in the right arm, all of them given on the same day at prior primary care physician office. On 20-MAY-2010 the patient was diagnosed with chickenpox. The patient presented to ER with fever of 101 degrees, cough, and pox type rash. At ER the patient had performed a rapid strept test which was negative per mother via phone call. On an unspecified date the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Arm went numb and tingly the next day along with heavy feeling. Tingling went up into neck and face. By Saturday afternoon jaw-line felt like it was down to participants chest. Sunday symptoms got much worse along with feeling of sores on head. Pimple like things on right shoulder.
Dose 1 administration date Sep2021/Dose 2 administration date 17Sep2021; Heavier menstrual cycle; Cramping than normal; Very uncomfortable; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Sep2021 13:15 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetes" (unspecified if ongoing), notes: pre diabetes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: unknown), administration date: Sep2021, when the patient was 17 years old, for COVID-19 immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset Sep2021, outcome "recovering", described as "Heavier menstrual cycle"; DYSMENORRHOEA (non-serious) with onset Sep2021, outcome "recovering", described as "Cramping than normal"; DISCOMFORT (non-serious) with onset Sep2021, outcome "recovering", described as "Very uncomfortable"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Sep2021 13:15, outcome "unknown", described as "Dose 1 administration date Sep2021/Dose 2 administration date 17Sep2021". The events "heavier menstrual cycle", "cramping than normal" and "very uncomfortable" were evaluated at the physician office visit. Therapeutic measures were taken as a result of heavy menstrual bleeding, dysmenorrhoea, discomfort.  Additional Information: On an unknown date in Sep2021, the patient experienced heavier menstrual cycle, cramping than normal and patient was very uncomfortable. The events result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified pain medication. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received the shot on Thursday September 30th in the morning at 0900am. That night at 8:00pm I had horrible body aches, fever, cold sweats and chills. The next day Friday October 1st I felt much better. That night/ early morning Saturday October 2nd at 0100am I woke from my sleep in extreme pain in my lower right abdomen. I went to the ER, got a CT scan and was told that I had appendicitis and that I needed emergency surgery. I was operated on that morning early. I was released from the hospital later that day and placed on Light Limited Duty status for 8 weeks. I only took Tylenol for pain.  I am in the military. This is greatly hindered my ability to do my job.
On the eighth (8) day post-vaccination, I developed an intense red reaction over the site of the previous vaccine in the right shoulder. The Size was  between 3 inches in the longitudinal plane and 2 inches over the transversal plane . . . my husband whom is a Physician gave me treatment with (1) Loratadine once a day and (2) Advil 200 mgrs b.i.d., as well as (3) old packs with ice over the area. I have been taking this medicines for the last 5 days. The dermatological reaction has improved gradually over this last 5 days and did not have any other symptoms. However, even today the size of the "redness" remains oover the right shoulder. It does not hurts, does not itch, but remains there.
I wake up the middle of the night with numbing of the right-hand and right foot that is accompanied by pin prick feeling and burning sensation. I also get this same sensation randomly throughout the day.
This spontaneous report as received from a other health professional refers to a 21 year old female patient. The reporter reported the out of range temp logs and the vaccine hemophilus B conjugate vaccine (meningococcal protein conjugate (manufacturer unknown) (dose, frequency, lot number and route were unknown) that had been administered to the patient in the right deltoid. Additional information has been requested.
Injection site reaction w/redness, throbbing, large welt, itching and pain. Occurred day after shot. No treatment other than ice.
Patient experienced a syncopal episode 10 minutes after receiving the Pfizer vaccine. Prior to passing out she experienced  diaphoresis and tunnel vision. EMS was called. Patient was found to have a low blood pressure.  She felt nauseated while being evaluated by EMS. Was recommended to go to the ER. EMS transported patient to the ER. On the way to the hospital patient felt close to baseline. Once she arrived and found she would have to wait to be seen she left AMA.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 23-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.
No adverse events; 3rd dose administered 6 weeks after the 2nd dose; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-MAY-2019, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, schedule, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 25-OCT-2019, the patient was vaccinated with second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and on 06-DEC-2019, the patient was vaccinated with third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strengths, doses, schedules, routes of administration, anatomical locations, lot # and expiration dates were not reported) both for prophylaxis (Inappropriate schedule of product administration).
An attorney reported that a 5 year old female child received a series of Tripedia, ActHib, Engerix B, Varivax and MMR II, as well as, Orimune and Tetramune vaccines from 10/28/96 through 2/3/98. It is alleged that the vaccine contained "toxic" mercury in the form of thimerosal. The reporter indicated that the pt "has not manifested any signs or symptoms that her parents, or her doctors, attribute to mercury exposure." This event was considered medically important (OMIC). (Related case HQ0230428JAN2002 was cancelled).
Bell's Palsy, significant left side forehead and eyelid droop within 4 hours.  Treatment:  antiviral medication for one week, steroids for one week.  Fortunately patient has had history with Bell's Palsy, knew what it was right away.  Sought treatment and medication.
Vaccine given 11/13/2021 in the left deltoid.  Developed a "fullness" and tenderness of the the left axilla on 11/15/2021.  No worsening, no improvement.  Pt otherwise feels well.  No chills, no fever, no loss of appetite, no rash.   Tenderness of the left axillary lymph noted noted on exam.  No erythema, drainage noted.
Ringing in both ears; Dizziness; Headache; Nauseas; Trouble sleeping; Chills; Tiredness; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), INSOMNIA (Trouble sleeping), TINNITUS (Ringing in both ears), DIZZINESS (Dizziness) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 0381421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation, Stroke (mini stroke in 1998) in 1998 and Pacemaker insertion (cardiac). Concurrent medical conditions included Drug allergy (Eliquis), Drug allergy (Xarelto), Drug allergy (Omeprazole), Drug allergy (Amiodarone) and Drug allergy (Pantoprazole).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Trouble sleeping), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nauseas). On 26-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On 27-Apr-2021, the patient experienced TINNITUS (Ringing in both ears). The patient was treated with WARFARIN at a dose of 1 dosage form and LAMOTRIGINE at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm hurt), INSOMNIA (Trouble sleeping), TINNITUS (Ringing in both ears), DIZZINESS (Dizziness), CHILLS (Chills), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nauseas) outcome was unknown.            This case was linked to MOD-2021-091984 (Patient Link).
This spontaneous report was received from a clinic office purchasing manager regarding a medical assistant of unknown age and gender. The medical assistant's medical history, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the medical assistant was handling a defective VAQTA 25U/0,5mL PED prefilled (PF) syringe (SYR) (lot # N020950, expiration date: 17-OCT-2018) that began leaking while a dose was being prepared for an unspecified patient. The reporter stated that it could not be ruled out the possibility that the medical assistant came in direct skin contact with the leaking product. The unspecified intended patient did not miss a dose since the patient was able to receive an injection from a different syringe. No adverse effects were reported.
Huge rectangular itchy redness on right arm around injection site. Warmness on the inside of the rectangle. Sore arm overall. Not feeling wonderful and  may seek professional help.
Information has been received from a Medical Assistant (M.A) concerning a 15 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on approximately 16-AUG-2009 was vaccinated with the first 0.5 mL dose of GARDASIL intramuscularly. Concomitant vaccines given on the same day included MENACTRA and ADACEL. It was reported that on approximately 16-AUG-2009 the patient said her "arm felt really weird and then she passed out". The patient sought unspecified medical attention. There were no laboratory diagnostic tests performed. It was reported that she regained consciousness "about 5 seconds later but she was confused". The patient became reoriented "a few seconds later". It was also reported that the patient "was very nervous about getting the vaccinations" when she came to the office. It was reported that the patient had recovered at the time of the report. Additional information has been requested.
GARDASIL vaccine giving 12/5/07 and second injection 3/5/08. Chronic stomach pain noted for several months. Dr seen 10/24/08 for stomach pain. 3rd GARDASIL shot giving 11/12/08. Chronic stomach pain continues medical involvement continues for stomach pain. Patient seen 5/09 for severe back pain. Stomach pain continues until April 6, 2010 when patient stricken with seizures, hospitalization, blindness.
Patient described slight redness and lump at injection site, and arm feels numb like she has hard time holding onto things.  Can move hand just has weak grip
Swollen face, eyes, lips. Lump in throat. Hives. Respiratory issues
pt recv 2vax 9/18/96 & 10/23/96 & lab eval on 23DEC97 revealed a lack of seroconversion (IgG=less than 10, IgM=less than 10);
2 days after injection, reported dizziness, broke out in an itchy rash on chest, scalp and torso. rash was minimal,  Had Headache, dizziness, and nausea and diarrhea were severe and persisted through Sunday.   Symptoms until Tues (one week later) felt feverish and mild Headache and dizziness and nausea.  By  Thursday 2/3/2 all symptoms gone except for fatigue for another few days.
pt devel a fine rash on 27APR93 starting on rt arm & spreading to back; no itching, temp or change in activity level; seen by MD who dx rash as contact sensitivity & prescribed hydrocortizone cream;