chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Medical assistant calling to report administered vaccine temperature excursion on multiple patients. Per caller vaccines went out of range yesterday and it was not discovered until this morning when checking the data logger. Multiple AE's filed. See; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-JUN-2022, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot # U0326586, expiry date 21-OCT-2023) (strength, and route of administration were not provided) administered for prophylaxis (Product storage error). Lot number U0326586 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  Administered dose of vaccine experienced the temperature excursion. It was reported that the vaccine went out of range on 13-JUN-2022 (reported as "yesterday") and it was not discovered until the morning on 14-JUN-2022 when checking the data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA004154: US-009507513-2206USA004187: US-009507513-2206USA004337: US-009507513-2206USA004511: US-009507513-2206USA004506: US-009507513-2206USA004557:
could barely move/ down for the count.; joints ached; no appetite; itchy; AWFUL; sick; Fever; This case was reported by a consumer via interactive digital media  and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced sickness, fever, mobility decreased, joint pain, appetite absent, pruritus and feels awful. On an unknown date, the outcome of the sickness, mobility decreased, joint pain, appetite absent, pruritus and feels awful were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the sickness, fever, mobility decreased, joint pain, appetite absent, pruritus and feels awful to be related to Shingles vaccine.Additional details were provided as follows:  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the shingles shot and was so deathly sick. The patient had fever for three days, the patient could barely move, joints ached severely, no appetite, itchy beyond belief, and down for the count. The patient received only the first of the series of two shots. The patient supposed to go back in October to get second one. The physician said that his/her immune system was working.  The patient did not need the 2nd shot and did not want to go through that ever again. It was awful.
Patient describes feeling of drainage and complete numbness of the right ear. Consulted with ENT. As of June 21 2021 still feeling slight numbness.
Patient received immunization at work place clinic, so actual formulation (brand), manufacturer and Lot Number is unknown.  Reaction was swelling/redness/discomfort at site of injection approximately 48 hours later.  Patient treated with antibiotics for possible cellulitis at injection site
WOKE UP NEXT DAY NAUSEOUS AND UPSET STOMACH, FOLLOWED BY DRY HEAVES NEXT DAY, DAY 3 TOOK TO ER AS I WAS CONCERNED ABOUT DEHYDRATION. BECAME DISORIENTED, DELIRIOUS, BREATHING COMPROMISED, INTUBATED, AMONIA LEVEL 188, UNCONSCIOUS FOR 5 DAYS ON VENTILATOR.
Day of vaccination; Joint pain started about 6pm Quick onset of Extreme chills, uncontrollable teeth chattering, muscle spasms 10-10:15pm Excessive urination Midnight- 5am, got up hourly with need to urinate. Muscle and joint pain subsided by about 9am next morning (8/29). No medical treatment sought.
Case number PHEH2012US006673 is an initial spontaneous report received from a nurse on 20 Mar 2012. This case refers to a patient (age and gender not reported). The patient was vaccinated with 0.5ml intramuscular dose of MENVEO (batch number: M100062) intramuscularly on 20 Mar 2012, that had been exposed to temperature up to 53 F for up to 4 hours. Vaccine was not reconstituted during excursion. No adverse event had occurred following vaccination.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 09-FEB-2015, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly, lot # K008213, expiration date 17-DEC-2016. On 08-MAY-2015, the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly, lot # K014191, expiration date 10-MAY-2017. On 24-JUL-2015, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, intramuscularly, lot # K023432, expiration date 18-JUN-2016. No adverse effects were reported. Additional information has been requested.
This case was reported by a pharmacist via other manufacturer and described the occurrence of hives in a female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX and BENADRYL, the patient experienced hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to BOOSTRIX. Additional details were provided as follows: This case was previously not reported to food and drug association. This case was reported by a registered pharmacist. The age at vaccination was not reported. The patient experienced hives after receiving the whooping cough vaccine or BOOSTRIX. The patient recovered fully from adverse reactions. No additional information was provided. This case has been linked with the case US2016GSK141283, reported by the same reporter for the same patient.
a couple of days after the vaccine i started to spit up blood and had a cough. at this time i did not go to a doctor. this continued untill early august when my feet started swelling. i then went to urgent care and they immediatly sent me to  hospital . i stayed in the hospital for three days . upon discharge i was sent to a pulmanary doctor and under went ct scans etc showing i had serious leisons in my lungs and an infection. for the infection i was sent to doctor. he gave me strong antibiotics which caused me not to eat for a few months. i then started having problems with vertigo and my balance. i went to see a nurologist dr . he said i had a spot on my brain which is causing my tremors , vertigo and loss of balance.   i have not been able to work since i was hospitalized on Aug 13,2021 and i am not getting better.    i had not had any symptoms or health issues untill i recieved the vaccine.
Not requiring emergency care Concerned about second dose Irritation bronchial tube, pain and decreased function joints of knees Sore throat, general nausea, unable to take deep breath, needing to sit to rest long term,heavy flu-like symptoms incontinence lasting 40 hours inability to use abdominal muscles to defecate lasting 40 hours Difficulty rising to standing position Extreme fatigue compounding that from having Covid in 04/20 which never cleared BP 100/70 for 40 hours (usual 135/78 on Amlodipine) No treatment/ contacted physician office
Per mom pt not eating or walking, has fever; Nurse left message w/mom to take pt to clinic; Family phoned & said pt on get anti-febrile meds; Pt is alert, but weak on legs-poss due to lack of appetite;
(L) arm posterior area of erythema 10 x 15 cm. Central 5 x 5 area painful to touch. Noted at visit 6/9/10 9:15am. Prescribed KEFLEX 500mg BID x 10d.
After about 5 minutes I got extreme burning on left arm,   Then my throat felt restricted, difficulty breathing and rapid heartbeat. My left arm had hives with mild redness. My blood pressure shot up to 138/85. I walked back in from waiting in my car and taken into clinic to be observed for about 30-40 minutes. My symptoms did calm down and mostly resolve after 30 minutes. Due to reaction my 2nd dose scheduled for 4/9/2021 was declined as it was in a non-clinical setting. Was advised to go to a hospital for 2nd dose since doctor was concerned I may get a stronger anaphylactic reaction. I am getting seen by my PCP since I have been having dizziness and heart palpitations since the 1st dose. However not sire if related or not. I do want more information whether I should even get the 2nd dose or not.
Large localized, swollen, reddened area at injection site, followed by a generalized rash on abd, trunk, back and arms. Started approximately 12 hrs post injection. Treated with Benadryl.
He had his shots on Thursday. He was fine Thursday and Friday. He was fussy during Friday night. He woke up early Saturday. He was fussy. I checked his temperature around 7:30am, no fever. I went to work. Picked him up at 12:15pm and he was warm and clingy. Went home and took his temperature and it was 102. Gave him 5ml of MOTRIN. I went and changed his diaper. Then I started to rock him, before I put him down to nap. He was fussy at first and then he closed his eyes to sleep. He then started having a seizure in my arms. I ran with him to get my phone and called 911. They had me put him on his left side. His tongue was hanging out of his mouth. He stopped breathing and turned blue. The 911 operator to me to start CPR. I started chest compressions. He started breathing. The EMT showed up. He was hospitalized overnight.
This spontaneous report was received from a medical assistant and refers to an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours), 26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour); and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours), 25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 03-JAN-2018. This is one of several cases reported by the same reporter. Sender's Comments: US-009507513-1801USA006569: Original Case: 1801USA006569.
Approx 36h after administration and improving after 18 hours-sudden onset achy joints, stiff neck, "bad" leg cramping, fever. Patient improved with Ibuprofen.
After first dose, sever stomach cramping and nausea which lasted 4 days.  Was diagnosed with appendicitis 26 days after 2nd vaccine dose
Gray dot on right thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number FY4E9, expiry date unknown) for prophylaxis.   On 5th July 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, less than 4 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171095   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: The reporter reported that the patient experienced gray dots on right leg after received Pediarix and Hiberix vaccine. The reporter stated that the mark was observed on 28th October 2022 visit prior to receiving the additional vaccines. The reporter did consent to follow up. Additional supportive information: for the tolerance of the 2nd dose, refer linked case US2022AMR171095, reported by same reporter. Note: As per the case was created for first doses of Pediarix and Hiberix the event onset date was not captured.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR148961: US-GSK-US2022AMR149561:
12/16 - onset of fatigue and runny nose followed by headache and body aches. As of 12/23 he has a mild headache not requiring any medication for relief. He missed a day of work on 12/22. He did not seek medical attention. Treatment dugs:
Fever and congestion beginning on 5/17 and still ongoing as of 5/19 (high of 103.4 degrees Fahrenheit via rectal thermometer while on Tylenol and Advil). Will go to doctor tomorrow if his fever is not improved by then.
ZOSTAVAX vaccine was administer 2:30 pm. Pt fainted 10 minutes later. 911 was called and pt was driven to hospital b/c pt was complaining of dizziness.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/12/2022,  3/5/2023,  1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Developed a fibroidenoma in left breast. Core needle biopsy showed benign growth.
I got really loud ringing in my ears; I had this problem more 10 years. After the shot it got really loud even now after 3 weeks. Louder than it has ever did before. Sore arm, tired for a couple of days and went away. General checkup 11 Aug 2021 get extra rest and consider not getting the 2nd shot.
off balance; tension headaches; diagnosed with vestibular migranes; heart rate slightly elevated; blood pressure slightly elevated; States not getting enough sleep; vertigo; dizziness; Episodes of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (off balance), TENSION HEADACHE (tension headaches), VESTIBULAR MIGRAINE (diagnosed with vestibular migranes), HEART RATE INCREASED (heart rate slightly elevated) and BLOOD PRESSURE INCREASED (blood pressure slightly elevated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (off balance), TENSION HEADACHE (tension headaches), VESTIBULAR MIGRAINE (diagnosed with vestibular migranes), HEART RATE INCREASED (heart rate slightly elevated), BLOOD PRESSURE INCREASED (blood pressure slightly elevated), INSOMNIA (States not getting enough sleep), VERTIGO (vertigo), DIZZINESS (dizziness) and FATIGUE (Episodes of fatigue). The patient was treated with LORAZEPAM (ATIVAN) ongoing since an unknown date at an unspecified dose and frequency and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) ongoing since an unknown date at a dose of 75 mg then to raise to 150mg after 1 month. At the time of the report, BALANCE DISORDER (off balance), TENSION HEADACHE (tension headaches), VESTIBULAR MIGRAINE (diagnosed with vestibular migranes), HEART RATE INCREASED (heart rate slightly elevated), BLOOD PRESSURE INCREASED (blood pressure slightly elevated), INSOMNIA (States not getting enough sleep), VERTIGO (vertigo), DIZZINESS (dizziness) and FATIGUE (Episodes of fatigue) outcome was unknown.            The patient reported heart rate and blood pressure slightly elevated but not as bad as after the 1st dose. Further he went to physical therapist to rule out vertigo and went to ENT doctor. The Sunlight Triger  the headache event.  the Ativan medication was taken 15 min prior to receiving 2nd dose. The treatment was for 6 months. The patient has no COVID-19 infection previously.   This case was linked to MOD-2022-467546 (Patient Link).
I was administered a TDAP (tetanus) vaccine (Sanofi Pasteur, Lot# U6964AA) intramuscularly to my left deltoid following a severe bicycle injury on 6/28/21 by NP at Urgent Care. The days following my visit, I experienced muscle soreness and tenderness around the injection site in the left arm which seemed typical.    However, the symptoms have since worsened, expanded to left side of neck. Left shoulder is now immobilized and I am experiencing excruciating pain and discomfort that inhibits function and use of my left arm. I am unable to lift my arm more than 45 degrees in any direction and trying to lift it above my head results in extreme pain. I have since visited a local orthopedic urgent care facility (7/9/21) and received X-rays (4 projections of left shoulder) - no evidence of displaced fracture or dislocation (due to bike injury) was noted. Additional comments were: 'Joint spaces are grossly preserved. Mineralization is unremarkable for the patient's age. Nonspecific subtle sub-centimeter lytic lesions seen in the left proximal femoral diaphysis, nonaggressive appearing. Regional soft tissues are grossly unremarkable'. Current understanding is that I am having a severe local reaction to the TDAP (tetanus) vaccine (Sanofi Pasteur, Lot# U6964AA) I received on 6/28/21.   I wanted to report this incident  as an adverse event as this seems an atypical reaction to a common TDAP vaccine.
Sluggishness; Fever; Body aches and pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness), PYREXIA (Fever) and MYALGIA (Body aches and pains) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggishness), PYREXIA (Fever) and MYALGIA (Body aches and pains). At the time of the report, SLUGGISHNESS (Sluggishness), PYREXIA (Fever) and MYALGIA (Body aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment medication information was provided    This case was linked to MOD21-035014, MOD21-10588, MOD21-086365, MOD21-086368 (E2B Linked Report). This case was linked to MOD-2021-104083 (Patient Link).; Sender's Comments:  MOD21-035014: MOD21-10588: MOD21-086365: MOD21-086368:
8yo female with history of allergy to cats (has multiple at home) and no other significant past medical history. About 10 minutes after receiving her COVID Pfizer 5-11yo Vaccine, she reported feeling some itchiness to the right side of her jaw. Physical exam WNL, including a patent airway. HR ~80-90. Heart/lungs clear to auscultation. No signs of respiratory distress or compromise. Pt and mom agreed to taking Cetirine 5mg PO along with water. About 10 minutes after taking Cetirizine, pt reported feeling much better. All VSS, and exam WNL. Mom agreed to bring pt in for medical attention if any symptoms worsened or for any other concerns. On phone follow up mom reported pt was doing completely fine at home.
Redness and swelling at the site greater than 1 inch in diameter. Hot to touch.
No adverse event; Dose administered after 12 hours post first puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post first puncture) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post first puncture.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post first puncture.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post first puncture.).    No concomitant products were reported by the reporter.  It was unknown if patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. Patient received first dose on 07-Apr-2021, second dose on 05-May-2021 and first booster on 29-Dec-2021 all from Moderna. Patient was administered with vaccine after 12 hours post puncture. Patient did not reported any side effects.  No treatment medication reported by the reporter.