chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 and administered on 30-Mar-2022.; Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 and administered on 30-Mar-2022.) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     Patient had not ever been diagnosed or tested positive for COVID-19.  Concurrent medical conditions included Fish allergy.    On 30-Mar-2022 at 11:09 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 11:09 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 and administered on 30-Mar-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Mar-2022 and the vaccine was expired on 19-Mar-2022 and administered on 30-Mar-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The date the vial was initially stored in the refrigerator was on 01-Mar-2022. The nurse (healthcare provider) at a local county health department had inadvertently administered the expired Moderna COVID-19 vaccine on 30-Mar-2022 with expiration date on 19-Mar-2022. No patients had reported any adverse events for now. The adverse event had not caused the patient to seek the medical care. The vial had not undergone any temperature excursions.  No treatment information was provided.
Globus sensation and feeling of throat tightness after injection of h1n1 vaccine.  Treated with epi pen, ambulance took to ED.  Did well, no other signs or symptoms of anaphylaxis.  Planning on allergy testing.
Body aches; Fatigue; Low energy; Right arm pain tingling to fingertips; Right arm pain tingling to fingertips; Under armpit pain; Headache; Hot; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old 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 right on 18Aug2021 at 13:30 as a single dose for COVID-19 immunisation. Medical history included parathyroid gland excision and hypothyroidism. The patient previously took sulfur (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 19Aug2021 at 00:00, the patient experienced right arm pain tingling to fingertips, under armpit pain, headache, hot, body aches, fatigue, low energy. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right arm pain tingling to fingertips, under armpit pain, headache, hot, body aches, fatigue, low energy was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the Pfizer 5-11 dose of vaccine instead of the age appropriate 12+ Pfizer vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had other medication in 2 weeks. Anti-viral product Paxlovid, for Covid-19 treatment from 09Jul2022 and to 13Jul2022. The patient  had rebound Covid 7 days after completing Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
EATING DIFFICULTY; COULDN'T KEEP FOOD DOWN; COULDN'T SLEEP; SORE ACHING BODY; SEVERVELY SICK; CHILLS; BAD HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced eating difficulty. On MAR-2021, the subject experienced couldn't keep food down. On MAR-2021, the subject experienced couldn't sleep. On MAR-2021, the subject experienced sore aching body. On MAR-2021, the subject experienced severvely sick. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the eating difficulty, chills, couldn't keep food down, bad headaches, couldn't sleep, sore aching body and severvely sick was not reported. This report was non-serious.
Patient hospitalized for breakthrough infection from 07/18/21 - 07/26/21. Patient received J&J vaccine on 05/21/21. The below information is copied from the patients discharge summary:    This is a 64-year-old female with past medical history of morbid obesity/arthralgias, presents with lower extremity edema and pain along with shortness of breath after testing positive for COVID-19.  Patient has been vaccinated with J&J vaccine last month. Patient BMI is 38.     Acute hypoxic respiratory failure secondary to COVID 19 Better, tolerating nasal cannula Completed remdesivir.  Continue decadron  Keep PRN albuterol inhlaer Muccinex PRN D/c to SNF   Essential hypertension / NIDDM  Resume outpatient medications   Bilateral lower extremity arthritic pain  Continue p.r.n. pain medications US neg for DVT   Seizure disorder  - stable continue Trileptal
Started 3 hrs, fever 102, nausea and vomiting, arms sore at injection site, joint pain, bilateral hands heavy and tingling, at 6:30 AM x 2 episodes of being incoherent
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. The patient's past medical history included Abdominal pain, Diarrhea and Constipation. Previously administered products included for Abdominal pain: Tylenol (Patient has IBS and sometimes she would have abdominal pain and diarrhea or constipation which would be relieved by Tylenol). Past adverse reactions to the above products included No adverse event with Tylenol. Concurrent medical conditions included Irritable bowel syndrome (Patient has IBS which was diagnosed long before to getting the 1st dose of the vaccine). On 29-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 31-Dec-2021, PAIN IN EXTREMITY (very sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. Patient is scheduled to have her 2nd dose on 26-JAN-2022. This case was linked to MOD-2022-461324 (Patient Link).
Redness around vaccine site traveled down the arm to include the left elbow by 10/29. Also developed red itchy bumps all over his body. Dad presents some photos c/w hives
15MAY95 viral resp & Otitis dx; 8JUN995 check mild URI pt recv vax; 9JUN95 irritable, t99.7, target lesions & purpura; dx anaphylactoid purpura-etiology undetermined
Patient experiencing swelling in palm of hands, patient report being tired. Initial V/S bp 140/80, HR 78, o2 sat 97% room air. Patient was observed for further evaluation, at 4:00 patient felt better and no complaints. Latest V/S is 110/70, o2 sat 97 on room air, P-79.  Patient was able to grip on both hands. Health education provided and instructed to call his PCP for further evaluation.  Patient left the premises with wife.
Patient tested positive to COVID-19 on 03Aug2021.; Patient tested positive to COVID-19 on 03Aug2021.; This is a spontaneous report from a contactable Consumer. A Consumer reported for a 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via Intramuscularly, in Arm Right, on 01Apr2021 at 09:00 AM (age at vaccination: 16 years), as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via Intramuscularly, in Arm Right, on 22Apr2021 at 09:00 AM (age at vaccination: 16 years), as a single dose for COVID-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medication which included birth control within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient tested positive to COVID-19 on 03Aug2021. The patient did not receive any treatment for the events. The patient underwent lab test and producers which included SARS-CoV-2 test (Nasal Swab) on 03Aug2021: positive. Outcome of the events was recovered on an unspecified date in Aug2021.
Chills began 12 hours after shot, lasted through the night.  Upper body aches and low grade headache began at same time, lasted 24+ hours.
tingling in lt arm & hand, achiness, pain @ inj site;seen @ occupational hlth on 11/4/99;
I stood and I tried to walk and I may have made it 30 feet and I was dizzy. Someone helped me to a place to sit, I stayed there for half hour, head was hurting, got nauseous, remained nauseous. I laid on floor but it did not help. I remained there an hour and a half. I was put in wheelchair to go home, I had motion sickness. I remained on my couch for ten days, symptoms remained severe that entire time, could not sit up, could not stand, struggled to make it to bathroom. . Also had loss of appetite the entire time, I could barely drink as well.
Diagnosed with shingles two weeks after second vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported), via an unspecified route of administration on 21May2021 at 12:00 pm at the age of 43-years-old) as single dose for covid-19 immunization. Medical history included autoimmune disease-RA (rheumatoid arthritis), hashimoto's and UCTD (undifferentiated connective tissue disease) but was stable and doing well and ongoing hypothyroidism. Concomitant medications included Acela natural thyroid for hypothyroid (received within two weeks vaccination). Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization and had no reaction. On 05Jun2021, 2 weeks after second vaccine, patient was diagnosed with shingles. Patient received Valetex, and Gabapentin as a treatment for the event. Event was resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age (currently 20 years old, age at the time of event unspecified). Nurse stated that other patient's mother told her that she recently (date unspecified) saw on the internet a news story about 2 women who are sisters, the second of 20 years old. On an unknown date, the patient was vaccinated with GARDASIL series (dose, route, dates not specified) and on an unknown date, the patient experienced early menopause. The outcome of early menopause was unknown. Relatedness was not reported. This is one of several reports from the same source (MARRS # 1311USA009479 sibling, MARRS # 1311USA004306). Additional information has been requested.
Information has been received from a 23 year old female patient with no pertinent medical history and no known drug reactions or allergies who in March 2009, was vaccinated with a dose of GARDASIL (Lot# unknown). Concomitant therapy included albuterol inhaler. The consumer stated that she discovered a lump in her arm that had been there for 1 year (approximately on 02-AUG-2009) and had slightly grown in size since then. She stated that she notified her physician about it but he told her to disregard it and not worry about it. There were no laboratory tests or diagnostic studies performed. Therapy with GARDASIL was discontinued. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Rt. Medial deltoid became paralyzed and patient could not raise arm for 24 hours.  Condition was painful.  Was resolved by soaking in a hot tub and taking pain killers.  Devastating to not be able to use dominant arm.
The patient received a series of Moderna vaccines when she was aged 17 and did not meet the minimum age requirement for this type of vaccine
Initial report received from a healthcare professional on 24 November 2014. A 70-year-old female patient, whose medical history and concomitant medication were not reported, had received a dose of FLUZONE HD, (batch number, dose, route and site of vaccination not reported), on an unspecified date. On an unspecified date, patient's injection site is still red with blue mottling, feels hot, almost looks like bruised. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender: none.
Developed  red  itchy burning sensation area near injection site. Warm to touch slightly swollen - 9 Days after shot. Burning and itching subsided after about 2 days and redness gradually faded- maybe 4-5 days
Information has been received from a nurse referring to unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L003221, expiration date 30-JUL-2016; strength, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT DEVELOPED RASH ON HER CHEST, FELT HER THROAT CLOSING, AND HAD DIFFICULTY BREATHING. AFTER INJECTION WITHIN A TIME SPAN OF 5-7 MINUTES. TREATMENT: GAVE PATIENT 10ML OF BENADRYL AND CALLED AMBULANCE
evening of 26OCT92 exp burning & itching sensation all over; next AM awakened w/red raised rash all over body; some rash remaining 9NOV92;
Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult male 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.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) outcome was unknown.            No concomitant medications were reported. Adult male Patient with an event of non-serious Rheumatoid arthritis flare up in joints with HUMIRA. Patient received booster dose COVID-19 Vaccine  Moderna. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in No treatment information was reported.  Company comment: This spontaneous case concerns a male patient of around 65 years, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of around 65 years, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Per father patient experienced a sore arm. Father reports that he did not administer tylenol or ibuprofen and did not encourage fluids per instructions from nurse at time error occurred.
Pt recieved 1st dose of Shingrix vaccination on 6/17/22.  In the days following her arm was a little red, but not painful and no other concerns. On the 21st, the patient developed a bruise at the injection site and a rash surrounding on her arm that was mildly itchy/painful and spreading out to cover most of her upper arm. I advised patient to try putting OTC hydrocortisone cream on it . Has yet to resolve
Patient developed fever which lasted for 1 day. Patient developed painful tender swelling to the left axilla radiating into the shoulder and chest. Patient received 1 dose ketorolac 30mg IM in clinic and ibuprofen 600mg PO q6 hours for home. Follow up scheduled in 1 week.
About 1 to 1 1/2 hrs post vax pt devel a high pitched cry, tremors of arms & legs, t104.6 & devel spells of breath-stopping; seen in ER;
Severe arm pain; Moderate to severe arm pain extending from the injection site; This is a spontaneous report received from a contactable other health care professional. A 62-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via intramuscular route in the left arm on 09Mar2021 (age at vaccination 62-years-old) as single dose for COVID-19 immunisation. Medical history included kidney transplant 20 years back and patient was on immunosuppressive agents. The concomitant medication included Immunosuppressive agents given after transplant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 09Mar2021following the first vaccination experienced moderate to severe arm pain extending from the injection site in her shoulder down the entire length of her arm. The pain has persisted but is now resolving ten days post. The patient did not received treatment for the reported events. The clinical outcome of events vaccination site pain and severe arm pain was recovering at the time of this reporting.   No follow-up attempts are needed. No further information is expected.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment medication were not reported.
Initial report received from a non-healthcare professional (patient's parent) on 27 August 2012. A 2-month-old male patient, whose had no medical history and concomitant medications were not reported, received first dose of FLUZONE 0.5ml (lot number: unknown, route and site of vaccination not reported) on an 23 August 2012. The patient had also received another vaccine on the same day (lot number, manufacturer, route and site of vaccination not reported). The patient was suffering with Nasal and sinus congestion with green nasal exudate at the time of vaccination. It was reported that the 2-month-old was given FLUZONE that was meant for reporter's 4-year-old son. On 25 August 2012, after 48 hours of vaccination, the patient developed low grade fever 98.9 F. The patient was also moody and irritable and was crying at times. Laboratory investigations were not reported. The patient was administered TYLENOL as the corrective medication. The patient had recovered from the events on an unspecified date. List of documents held by sender: none.
Severe tachycardia (heart rate 190), lightheadedness and nausea. In just a few minutes arrived at ED: hypokalemia; received 40mEq oral potassium and 20mEq IV potassium.