chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced HEADACHE (headache). 19-Jan-2021, the patient experienced NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received 0.25 mL of Bivalent dose instead of 0.5 mL; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL) 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 ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL).    No concomitant medications were reported.  It was reported that, the nurses had no standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, that was they were administering 0.25 mL instead of 0.5 mL to uncompromised adults.  No treatment medications were reported.
Had TDAP 10/08/14. Had local reaction with itch within 15 min of injection. Now warm and local swelling D = 3 3/8" Red and swollen.
Patient experienced pain and numbness in left arm after administration. Numbness and pain were reported in lower arm extremity. Patient evaluated over the course of 30 minutes. During that course patient reported pain and numbness travelling down to wrist and fingers. She also reported a pounding headache once felt on forhead. Patient did report that it was getting better than worse over the course of observation. Mother was advised to contact pediatrician for further assistance if it progresses to worst.
Moderna vaccine given to a 16 year old. Patient came in after 28 days for the second shot.  It was identified at this time the patient received Moderna not indicated for her age. There were no adverse reactions reported. Event immediately disclosed to mother, child, medical director and chief medical officer.
large red spot at site of injection.  red spot remained for several days and did not show up until more than a week after my shot.  warm to the touch, slightly raised.  Not painful.  slightly itchy.
This is a spontaneous report received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 12Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included oesophageal carcinoma (Esophageal cancer and undergoing radiation therapy (5 times a week), chemotherapy (once a week)). The patient's concomitant medications were not reported. The patient experienced pain on the injection site of the vaccine on unspecified date in Mar2021. Therapeutic measures were taken as a result of event. The outcome of the event was unknown. Follow-up attempts completed. No further information expected.
9/06/2021:  pain on the arm where got the shot,  tiredness 9/08/2021 until today:  Feel very tired, tie chest and short breath sometimes.   Joint pain all the times, specially on the neck, left and right ankle and ball pain the most 9/11/2021 : upper left ankle area start swelling 9/12/2021: instep on left foot is swelling Ankle feel pain more after lay down and get up no matter how long do i lay down. Pain the most after get up in the morning
I administered a 2nd Pfizer booster to this client  but she was not eligible (not yet 50 years old.  Error was discovered after the booster was given.  She did not report any adverse effects after the booster before leaving the clinic site.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. The patients were vaccinated with doses of VARIVAX (Merck) (doses, routes, lot numbers not reported) which were reconstituted with expired sterile water diluent (expiration date May 2012). The nurse noted that 1 or 2 doses were administered on 01-AUG-2012 and approximately 9 other doses were administered on unspecified days. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 13-NOV-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 24-OCT-2016, the patient received his second dose with GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported). On 06-JUL-2018, the patient received the third dose with GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Pins and needles in my limbs/hands/feet, burning sensations, deep joint pain in my hands, joint pain all over, headaches, rapid heart rate, chest pain, costochondritis, constant left side neck and trapezius pain, left shoulder pain, muscle spasms daily, involuntary muscle jerking a couple of times, strong internal vibrations, body aches, occasional tinnitus, brain fog but that has cleared for the most part.
fast heartrate; weakness; swelling; felt her arm itchy; rash at the vaccination site; a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartrate), ASTHENIA (weakness), SWELLING (swelling), VACCINATION SITE PRURITUS (felt her arm itchy) and VACCINATION SITE RASH (rash at the vaccination site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DENOSUMAB (PROLIA), AMLODIPINE, LOSARTAN, METOPROLOL, PRAVASTATIN, RALOXIFENE, LEVOTHYROXINE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (a sore arm at the injection site). On 22-Jan-2021, the patient experienced HEART RATE INCREASED (fast heartrate), ASTHENIA (weakness), SWELLING (swelling), VACCINATION SITE PRURITUS (felt her arm itchy) and VACCINATION SITE RASH (rash at the vaccination site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (fast heartrate), ASTHENIA (weakness), SWELLING (swelling), VACCINATION SITE PRURITUS (felt her arm itchy), VACCINATION SITE RASH (rash at the vaccination site) and VACCINATION SITE PAIN (a sore arm at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient had received DTAP upper right 4/1/08. Mother brought child into clinic. Right upper arm red, swollen, warm. Mother informed to use ice. Ring was drawn around area to make reaction decreases.
adult patient received a pediatric dose; adult patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number unknown, expiry date 17th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-September-2022 Reporter's comment: This case was reported by nurse. The nurse reported that an adult patient received a pediatric dose of Engerix-B. Reporter consented to follow up. Additional supportive information: As patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
PT PRESENTED TO OFFICE ON 12-24-08 WITH C/O SORE THROAT, COUGH AND FEVER.  STREP SCREEN PERFORMED, RESULTS NEGATIVE.  DR. DX'D PT WITH POSSIBLE FLUMIST SIDE EFFECT.
pt began crying & screaming about 230PM & it cont about 2 1/2 hrs; rt thigh was edematous & red; this lasted a total of 2 days; mom states crying was unusual & high pitched; mom called MD to inform of reaction; MD felt only have pt have DT
Allergic rash; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic rash) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On 17-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DERMATITIS ALLERGIC (Allergic rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DERMATITIS ALLERGIC (Allergic rash) had resolved with sequelae.            Concomitant medication of the patient was not reported.  Formulation of Humira (adalimumab) was reported as solution for injection in pre-filled pen.  Causality for Humira (adalimumab): The reporter's causality for the event of allergic rash with Humira (adalimumab) was a reasonable possibility (probable).  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.
Myalgia & Fever Narrative:  MISSED DAY OFF WORK DUE TO SYMPTOMS  Other Relevant History:
This spontaneous report as received from a CMA (certified medical assistant) regards an unknown number of patients (no demographic details were provided). The medical history of the patients was unknown. The reporter stated that an unknown number of patients many have received VAQTA, RECOMBIVAX HB, (merck) VARIVAX, PEDVAXHIB and GARDASIL that was improperly stored. This report concerns PEDVAX HIB. No details were provided regarding the administration dates, dosing regimen or lot number. No adverse event was reported. This report is linked to the cases with MARRS ID 1305USA003372, 1305USA007106, 1306USA007107 and 1306USA007109 which concern VAQTA, RECOMBIVAX HB, (merck) VARIVAX and GARDASIL respectively. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, chills Narrative: The day after he received the vaccine, the patient reported experiencing body aches, headache, diarrhea, a "fever (100.1 F), and chills. He took one dose of ibuprofen 600mg and took acetaminophen 650mg every 6 hours for one day.
Extreme redness, swelling and pain at injection site the following morning; feeling of total exhaustion; swelling and pain continues three days later.
Physician Discharge Summary: Patient ID: "PRIVATE"- 66 y.o. female- DOB: 7/11/1956. Admit Date: 7/12/2022 -Discharge Date: 7/15/2022. Discharge Diagnosis: Principal Problem: Right sided numbness. Active Problems: Essential hypertension; Atypical chest pain; COVID-19. Hospital Course: 66 year old female was admitted for right side numbness with stroke alert. Symptoms resolved spontaneously. MRI showed no acute infarct. MRV brain showed no occlusion. Carotid duplex did not show stenosis. Bubble study was normal. She was discharged in stable condition on ASA and statin. Patient educated on appropriate level of care post-discharge. Follow up with Primary Care Doctor in 5-7 days. Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 98.6 °F (37 °C) Heart Rate (Monitor): 72- Pulse: 64- BP: 135/72- Respirations: 14- SpO2: 99 %- O2 Flow Rate (l/min): 0 l/min. General Appearance: no distress; Eyes: PERRLA; ENT: moist mucus membranes, no adenopathy; Lungs: clear to auscultation bilaterally; Heart: regular rate and rhythm; Abdomen: soft, non-tender; Skin: No rashes or lesions; Extremities: full ROM; Neuro: alert, normal strength and tone. Consults: IP CONSULT TO NEUROLOGY; IP CONSULT TO NEUROLOGY; IP CONSULT TO STROKE NURSE NAVIGATOR. Significant Diagnostic Studies: MRI head, MRV brain, bubble study, carotid US, CT head, CT C spine. Operations: none; Disposition: Home; Discharge Condition: Fair.
Outbreak of pruritic small papules on thighs, trunk, arms, face, beginning about two days after Varicella vaccine; no fever or malaise
In march I started becoming SOB and it continued to progress.  It became so bad that I could only walk about 5-10 feed before becoming totally exhausted, needing to sit down for a few minutes.  My heart rate remained sinus-tach running up to 120's.  On March 4, 2021 I had an appointment with Dr.   He sent me to the Hospital to have a CTA.  The test was positive for a MASSIVE bilateral PE.  Doppler studies of my lower extremities showed a partially occluded Palpitate vein in my right leg.  I was admitted to the hospital and started on Heparin IV.  I was also taken to the Cath- lab where I underwent a Thrombectomy of my right lung.  The Cath-lab quit working so the procedure was stoped and the left lung was not treated.  On admission to the hospital my O2 sat was 97%.  After the thrombectomy my O2 sat went to 83%.  I was placed on Hiigh-flow O2 via nasal cannual.  On March 8th I was started on Lovenox SQ for 30 day and discharged from the hospital on March 9th.  I am now on Eliquis 5 mg bid and doing much better.
5 hours after getting vaccination, developed chills, fever, light headed with some nausea.  High fever continued, reported 103-104, for 36 hours, then went to an Urgent Care clinic.  Fever, low grade, and headache persisted for 72 hours.
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # M018957 with expiration date 22-NOV-2017, dose was unknown), orally for prophylaxis. The vaccine was exposed under temperature of 1.46 degree centigrade for 1hour 30 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
sore arm, up neck and chest swollen lymph nodes. Still has one swollen lymph node as of 2/5/2021
He got covid the next day after taking the vaccine; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable male consumer of an unspecified age reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/ Lot number: unknown), via an unspecified route of administration on 22Apr2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was scheduled to take his second dose tomorrow. He got his first dose 3 weeks ago on 22Apr2021. However, he got covid the next day after taking the vaccine. He wanted to know if he can still take the second dose tomorrow or not. The patient underwent lab tests and procedures which included sars-cov-2 test results positive on 23Apr2021. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 11-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
hardening of tissue below injection site; Initial information received on 02-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 57 years old male patient who experienced hardening of tissue below injection site (vaccination site induration), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  On 02-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and Expiry date unknown) via intramuscular route in right arm.  On 02-Nov-2019, the patient developed a non-serious hardening of tissue below injection site (vaccination site induration) 2-3 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was hardening of tissue below injection site.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Recovering for hardening of tissue below injection site.
Local Pharmacy administered the wrong vaccine. It should have been the seasonal flu vaccine according to the VAERS  and consent form and instead the Pfizer COVID-19 booster was given. The patient suffered headaches, body aches, nausea, and pain as a result.
She should have received the bivalent version for this dose but received the original Moderna instead. She had no adverse effects. We will give the appropriate version in 2 months.
Information has been received from a registered nurse concerning a 64 year old patient who on 03-MAR-2009 was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot# not provided) instead of with a dose of ZOSTAVAX (Merck) (lot# not provided) due to human error. No adverse effect reported. Additional information has been requested.
After 1st dose had bronchitis, is better now but the symptoms of bronchitis lingered; Patient did not get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (After 1st dose had bronchitis, is better now but the symptoms of bronchitis lingered) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (After 1st dose had bronchitis, is better now but the symptoms of bronchitis lingered) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the 2nd dose). At the time of the report, BRONCHITIS (After 1st dose had bronchitis, is better now but the symptoms of bronchitis lingered) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided   Reporter did not allow further contact
Information has been received from a medical assistant concerning a 17 year old female who on 12-FEB-2007 was vaccinated with the first dose of Gardasil, (lot#654510/0962F), IM. Concomitant therapy included desogestrel/ethinyl estradiol (APRI). On approximately 12-MAR-2007 ("a month after first dose"), the patient experienced stomach aches and nausea. The patient sought unspecified medical attention. The patient experienced the symptoms off and on and if the problem persists the physician may decide to discontinue further series of Gardasil. The patient's stomach aches and nausea persisted. The causality of the events was not reported. Additional information has been requested.
Diagnosed by Dr, Guillain - Barre Syndrome.  11/12/09 Neurological consultation received service dates 10/29/2009 to 11/4/2009. Assessment: Generalized demyelinating polyneuropathy. Findings consistant with Guillain-Barre' Sundrome. Patient presents with weakness and sensory loss in the lower extremities. Ascending paresthesias. Absent deep tendon reflexes. Loss of position sense bilaterally, vibratory sense reduced in feet. Uses walker.
PER MOTHER PATIENT HAD SUDDEN ONSET OF VOMITING WITHOUT FEVER OR DIARRHEA ON 6/20/08, WHICH LASTED THROUGH 6/24/08, AT WHICH TIME SHE BROUGHT HIM TO OUR OFFICE TO BE EVALUATED.  COINCIDENTALLY, MOM ALSO HAD A FEBRILE ILLNESS THAT BEGAN ON THE SAME DATE.  SHE IS PRIMARILY NURSING.  SIBLING BECAME ILL WITHIN THE NEXT 24 HOURS WITH DIARRHEA ONLY. ALL FAMILY MEMBERS RECOVERED WITHOUT FURTHER SEQUELAE.  OF NOTE:  MOTHER HAS HISTORY OF REFUSING PEDIARIX, DTAP, HEP B, IPV VACCINES UNTIL AN ALUMINUM-FREE OR LOW ALUMINUM DTAP VACCINE CAN BE GIVEN TO PATIENT.