chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blurry vision; Throat tightened; Could not sleep; Throat hurt; Shakes; brain spazzing; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), THROAT TIGHTNESS (Throat tightened), INSOMNIA (Could not sleep), OROPHARYNGEAL PAIN (Throat hurt) and TREMOR (Shakes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine, Brain tumor (Benign brain tumor.) and Consciousness loss (2 concussions.).    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry vision), THROAT TIGHTNESS (Throat tightened), INSOMNIA (Could not sleep), OROPHARYNGEAL PAIN (Throat hurt), TREMOR (Shakes), CEREBRAL DISORDER (brain spazzing) and HEADACHE (headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (BABY ASPIRIN) at a dose of 1 dosage form. At the time of the report, VISION BLURRED (Blurry vision), THROAT TIGHTNESS (Throat tightened), INSOMNIA (Could not sleep), OROPHARYNGEAL PAIN (Throat hurt), TREMOR (Shakes), CEREBRAL DISORDER (brain spazzing) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 100 (High) over 100 and is normally 65.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant drugs provided. Other treatment drug is steroids.; Sender's Comments: This case concerns a 65 year old female with significant medial history of Concussions time two, Migraines and Benign brain tumor who experienced the unlisted events of Blurry vision, Oropharyngeal pain, Throat tightness, Tremor, Cerebral disorder and listed event of Headache. The event occurred the same day as the first dose of Moderna COVID-19 vaccine and a re-challenge has not be noted. The medical history of Brain tumor, Concussions and Migraines remain confounders. The benefit-risk relationship is not affected by this report.
This spontaneous report was received from a supervisor, referring to a currently 15 months old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 11-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000680; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000684; US-009507513-1903USA000685.
She had a bad reaction fever; chills; tired; She still feels tired and headache; She also experiences still shortness of breath; With each shot, she gets her symptoms are worst; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization, reaction(s): "With each shot, she gets her symptoms are worst"; Bnt162b2 (Dose number: 2), for COVID-19 immunization, reaction(s): "With each shot, she gets her symptoms are worst". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "She had a bad reaction fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "not recovered", described as "tired"; HEADACHE (non-serious), outcome "not recovered", described as "She still feels tired and headache"; DYSPNOEA (non-serious), outcome "not recovered", described as "She also experiences still shortness of breath"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "With each shot, she gets her symptoms are worst". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Phone-Out 09:17 AM, 1st attempt by phone to consumer to obtain contact information. Call answered by consumer who stated "She had a bad reaction fever, chills, and tired after her 3rd shoot. She still feels tired and headache. No doctor. She also experiences still shortness of breath for a long time and is not recovering. With each shot, she gets her symptoms are worst. She just wants to know if it will go away eventually." Medical team number was given, but stated she already call them and no information was provided. No more information to provide.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a physician refers to a 98 year old female patient with oxycodone allergy and cardizem allergy. The patient's medical history included hypertension. On 17-DEC-2007, the patient was vaccinated with a dose of ZOSTAVAX (lot # 658396/0967U, expiry: 25-DEC-2008), 0.5 ml (reported as 0.5 cc) in the left arm. Concomitant therapies included COREG 1.25 mg twice a day (bid) and isradipine 5 mg once daily (qd). On 10-JUN-2013, the patient experienced herpes zoster-dermatome CN-5th. Other systemic symptoms included headache. Patient had no recent exposure to chickenpox or shingles. The outcome of herpes zoster was unknown. Additional information has been requested.
Client incorrectly given bivalent dose of Pfizer 5-11 COVID vaccine instead of monovalent dose, for first ever COVID vaccine. Clinician reported the vials looked exactly the same, besides the small bivalent/monovalent printed difference, making it hard to tell vials apart.
Trigeminal Neuralgia, MED-Carbamazephone 200 mg, twice daily
Headache, Myalgia, Fever, Diarrhea & NauseaVomiting Narrative:
About 10 days post vaccine I went into to ER with stomach pains so severe and not like my normal IBS pains, My gallbladder was infected and ruptured and I had surgery and recovered from it. My IBS has been out of control since the vaccine. I also developed anxiety out of the blue. I would have sudden episodes of weakness and my legs would give out, no obvious reason and I was extremely fatigued. I still was working full time, I have a stressful job and I started experiencing brain fog and it took me a lot longer. I was treated for low iron after my vaccine and I had a few infusions for that. The iron infusions helped a little bit, I still have been exhausted.
This spontaneous report was received from a other health professional refers to an unspecified patients of unknown age and gender. On 02-AUG-2014, doses of RECOMBIVAX HB were exposed to an unsupported temperature excursion of -1C for "5 to 16 hours". On an unspecified dates since 02-AUG-2014, RECOMBIVAX HB (lot # J012567; expiration date: 30-JAN-2016) (dose and route were not reported) were administered to unspecified patients. No adverse effect has been observed or reported. Follow up has been received from a pharmacist on 14-OCT-2014 concerning 12 patients. For the 7 patients demographics was updated. This is one of several report received from the same reporter. Follow up has been received from a pharmacist on 20-OCT-2014 concerning a patient of an unknown age and gender. The reporter provided another RECOMBIVAX HB lot number J012520, expiration date: 30-JAN-2016 that was improperly stored and would have been included in the original report. Additional information has been requested.
Pt received MMR, VZV, Hep A & Prev 13 at well check on 8/9/11. Developed localized swelling & knot at PREVNAR site. Rec. Ibup every 6-8 hours & warm compresses.
Case number PHEH2014US002598 is am initial spontaneous report from the consumer received on 04 Feb 2014. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination she felt nauseous and light headed. The outcome of the events was not reported.
Knees were swollen, red, warm to the touch, rash with raised bumps, she would flinch and cry in pain when you touched it. She was limping on her right leg and walking on her toes. Took her to the ER. They did blood tests and xrays. Blood tests came back normal and her xrays looked good. Gave her an antibiotic shot and told us to follow up with pediatrician in the morning. Knees looked better this morning, but her left ankle was swollen and red. Pediatrician is thinking it is a viral reaction to the flu shot she received with her 15 month shots.
Felt numbness, and tingling Left toes Left fingers approximately 4-5 hours after injection went to ER for evaluation 10/21/2009 - early am - saw PCP next day, ongoing evaluation.
Patient c/o left arm feeling numb. Then felt dizzy and heart racing.  Patient appeared to faint for 4 seconds, lowered to the floor x 8 minutes.  Responded immediately approperately, drank water.  B/P 120/74, pulse 84, resp 20.  The sat up in the chair and had a conversation with the nurse and her mother on the phone.  Then c/o feeling dizzy again and she was lowered to the floor where she recovered immediately and rested x 20 min, B/P 120/76, pulse 84 and resp 20.  Then she sat up and continued to talk to staff.  Staff called mother and advised family to drive patient home and for patient to eat something.  Patient has not eaten anything today.  Mother came to health department @ 12:40 PM to pick up patient.
Information has been received from a health care professional concerning a 12 month old white male who was vaccinated IM in the arm with a 1st dose of MMR. On 3/8/99, the pt experienced fever with generalalized rash on his face and body, and way dx'd with measles. Laboratory test showed an EIA value of 0.49 for rubella virus IgG antibody. According to the reporter, the pt had no record of allergy or medical history. Subsequently, the pt's epidsodes subsided after 3 days. The pt sought unspecified medical attention. No further details were provided.
Patient received FLUMIST on 2 November at approximately 1130. Mom reports patient saw family practice provider off base after that and was put on steroids for a pressure problem in his ear. Patient had been unable to clear his ear since airplane flight on 9/1/10. Physician started patient on course of steroids that mom reports was initiated around 1430. That evening patient developed rash at approximately 2000. Mom had follow up appointments with Dr and child was diagnosed with Henoch Scholein Purpura. Provider said etiology unknown as  patient had FLUMIST, steroids, could have been exposed to virus, and mom reports that due to close proximity to Halloween her soon had consumed more candy than normal with the artificial colorings and dyes.
2 blisters appeared @ injection site, each approximately 5mm diameter and about 3mm between each other. c/o itchiness @ site, but no other itchiness. Clear fluid appeared in blisters.
shivering; After the 4th shot the dose was given with a longer 23 needle than a 25 inch needle; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (shivering) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (After the 4th shot the dose was given with a longer 23 needle than a 25 inch needle) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A and 939909) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Nurse told the Agent that she has a history of a clotting disorder and that she does have a Cardiologist. Nurse did not want to provide any additional information about her Medical History. Nurse did not provide permission for Safety to follow up with her.  The patient's past medical history included Clotting disorder (she is consulting a cardiologist).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced CHILLS (shivering) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (After the 4th shot the dose was given with a longer 23 needle than a 25 inch needle). On 18-May-2022, CHILLS (shivering) had resolved. At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (After the 4th shot the dose was given with a longer 23 needle than a 25 inch needle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient did not have any adverse events after the first, second and third dose of vaccines. The patient feels that the deeper injection into her muscle may have contributed to her Adverse Reaction. It was reported that she had shivering for and a half hours after 4th dose. No treatment medications were reported.   Reporter did not allow further contact
Intussusception requiring reduction.  Repeat intussusception needing second procedure.  12/21/07 Reviewed vax record which confirms dose & lot #s as reported.  12/28/07 Reviewed hospital medical records which reveal patient experienced vomiting, bloody stool, reduced oral intake, irritability & lethargy.  Admitted 11/16-11/17/2007.  Enema successfully reduced IS.  Admitted for overnight observation.  Did well & was d/c to home.  Readmitted 11/19-11/20/2007 for recurrence of vomiting & bloody stools.  2nd abdominal US (+) for IS & was successfully reduced w/air contrast enema.  Kept overnight for observation.  Did well & d/c to home. FINAL DX: Recurrent ileocolic intussusception at hepatic flexure, enema reduced x 2.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-SEP-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
The patient's medical history and concomitant medications were not reported. It was reported that the patient got the first dose last 06Apr2021 and tested positive of Covid 19 last 18Apr2021. Second dose was on 16May (more than 21 days). The outcome of event was unknown.  No follow-up attempts are needed. Information related to batch/lot number could not be requested.
Vaccine fluzone QV given in pregnancy with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of vaccine fluzone qv given in pregnancy with no reported adverse event.   Data regarding this pregnancy were received retrospectively, i.e. after pregnancy outcome was known. The reported Vaccine fluzone QV given in pregnancy with no reported adverse event occurred at 7 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 7 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 26-Jul-2022. The estimated due date is 02-May-2023. The actual date of delivery is 30-Apr-2022. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 31-Aug-2022, the patient received a 1 unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation was unknown, lot uT7682KA and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  On 31-Aug-2022 the patient developed a non-serious event of vaccine fluzone qv given in pregnancy with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken : not applicable.  Outcome: Unknown.  Additionally, at time of reporting, the patient delivered a baby at unknown weeks of gestation on 30-Apr-22.  Outcome of the pregnancy was reported as unknown and fetal outcome was reported as unknown.
Patient received the vaccination and after going out to eat and after a couple more hours started to feel ill. She experienced nausea and vomiting and perceived the vaccination as the cause.
Pt complained of pain that whole night he had the shot done and the next day. About 24 hours after he had the shot he said it felt like someone stepped on his arm. I looked and he had a big, raised patch of hives just below the injection site and fire red about the size of a baseball area on his arm and the area felt very firm and was a little swollen. I put Benadryl gel on the area. The area continued to hurt and was red that same size still until yesterday morning (1/16/2020) and by then the pain had subsided. When I looked last night (1/16/2020) it was no longer red but you could still see in light pink the area that size that had been red.
pt recv vax & w/in 24hr pt devel tongue swelling, SOB & bronchospasm;
That evening after I got my first Pfizer shot I experienced many blood clots in my menstrual bleeding. One was larger than a golf ball. They continued for two days and there were hundreds. It was very alarming I made an appointment to see my doctor I went the next day and had an ultrasound done they had seen no reason or cause for all the blood clots and she told me it was from the vaccine.
Nausea after booster; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea after booster) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 18-Apr-2021.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced NAUSEA (Nausea after booster). At the time of the report, NAUSEA (Nausea after booster) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2022-508309, MOD-2022-508339 (Patient Link).   Reporter did not allow further contact
Approximately 24 hours after receiving AVA dose #2 patient developed swelling of right arm from elbow to shoulder with itching.  Denies pain.  Full range of motion present.  Patient advised to take Benadryl and/or NSAIDS for relief.
PATIENT EXPIRED ON 09/28/2021; PREVIOUSLY COVID POSITIVE 11/30/2020.
No known adverse events. Nurse not aware that monovalent vaccine should no longer be used as a COVID booster Dose.
Patient was vaccinated and there was no internet connection for team to check and to verify that patient had not been previously vaccinated with other COVID19 vaccine. Previous had Pfizer vaccine in January 2021 and then received J&J.
Numbness, tingling, swelling of lower lip. Patient is going to ice the area and take BENADRYL. If no relief she will contact her MD.
Quarter size red area at the injection site with larger reddened area surrounding. Erythema, painful to touch, swollen, painful when moving arm. Started on Keflex today.
1 day p/vax pt was difficult to arose from nap & would not open eyes;pt arched back & remained rigid for 1min;mouth was open & would not take a breath but let out intermittent cry;
This spontaneous report was received from a licensed practical nurse regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since unspecified dates starting on or after 05-MAY-2016, the patients were vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported, lot #K011325 with expiration date 05-APR-2017 or lot# reported as K010125 with expiration date 05-MAY-2017). The temperature was 11 Fahrenheit degrees during 11 days (digital data logger). There was no previous temperature excursion. There was no adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, fever x 1 day temp to 101.3, nasal congestion symptoms started 10/17/10.
Pt received her second dose Moderna shot.  Had complaint of slight tightness in her throat.  Pt was able to speak in full and unlabored sentences .  Pt has history of high blood pressure but denies any history of adverse reactions to medications and had no reaction to her first vaccine.   Offered PT diphenhydramine to assist with symptoms. 1545 administered 2.5ml and monitored PT.