chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored more than 30 days in a refrigerator; Vaccine was administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the 30 day BUD) and PRODUCT STORAGE ERROR (Vaccine was stored more than 30 days in a refrigerator) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 33K212A and 027L21A) for COVID-19 prophylaxis.     The patient had no known allergies. It was reported that patient has never been diagnosed or tested positive for COVID-19. It was reported, patient had no acute illness at the time of vaccination and up to one month before.  It was unknown if patient had chronic or long-standing health conditions.    On 22-Apr-2022 at 11:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-May-2022 at 11:00 AM, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored more than 30 days in a refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the 30 day BUD) and PRODUCT STORAGE ERROR (Vaccine was stored more than 30 days in a refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination were reported as unknown.  First dose was stored in refrigerator on 28-Feb-2022 and was administered on 22-Apr-2022 . Second dose was stored in refrigerator on 08-Mar-2022 and was administered on 20-May-2022. The vials did not undergo any temperature excursion. The patients have not reported any symptoms.  No treatment information was provided.
Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 21 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Tinnitus in Left ear after first dose. Constant. Ringing in right ear started after second dose.  Both are constant yet slightly different pitch.
PATIENT CALLED THE NEXT DAY AFTER VACCINATION TO REPORT A SORE ARM WILL SWELLING AT INJECTION SITE AND REDNESS.
This spontaneous report as received from a physician via company representative, and refers to a 4 month old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 06-DEC-2021 the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), dose: 2 milliliters, lot # 1691133, expiration date: 28-NOV-2021 orally as prophylaxis (anatomical location was not provided) (expired product administered). No temperature excursion and no additional information was provided.
Immediately following HPV injection, pt. experienced syncope. Pt. was seated, fell to the to the right side, and struck the right side of her head on the floor. An ammonia capsule was provided for pt. inhalation. Pt. awakened after app. 60 seconds. Carefully moved to sitting position. Ice applied to Rt. head. Pt. alert and oriented. No visible injuries.
Sweet syndrome; This is a literature case, reported by health care professional (physician), initially received on 12-Aug-2019, concerning a 41-year-old, male patient.   The patient had no relevant medical history and drug reactions or allergies.  One day after receiving an influenza vaccination (batch number and expiration date were not reported), the patient's symptoms of painful rash on his left neck and arm began. Physical examination revealed erythematous papules and plaques on the lateral neck and left arm. Laboratory evaluation and chest X-ray were negative. A punch biopsy from the neck demonstrated slight epidermal spongiosis with papillary dermal edema and a diffuse dermal neutrophilic infiltrate. No vasculitis was identified and direct immunofluorescence was negative. The patient was treated with triamcinolone cream, minocycline, and niacinamide. His cutaneous manifestations significantly improved, but his arthralgias were still present. Rheumatology subsequently started him on diclofenac. The patient was diagnosed with Sweet syndrome (acute febrile neutrophilic dermatosis). The pathogenesis of Sweet syndrome remained unknown, but its association with underlying diseases suggested a hypersensitivity reaction. Preceding vaccination had been rarely described as a cause of Sweet syndrome. Only a few cases of influenza vaccine-induced Sweet syndrome had been reported in the literature. The drug-induced form of Sweet syndrome could be due to a variety of culprits, although the strongest association exists with granulocyte-colony stimulating factor. Reporter's Comments: The patient developed acute febrile neutrophilic dermatosis after administrating the suspect product, INN Flu Vaccine. Chronology is plausible. No information regarding medical history or concomitant drugs was provided. Based on this information, causal relationship between the suspect product and event is assessed as related.
This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date of 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 mos p/last dose; titer result was neg;
1/8/21 evening: arm swelling (baseball-size circumference surrounding vaccination site), onset of fatigue 1/9/21 morning: onset of dehydration, worsening of arm soreness (limited ROM) 1/9/21 evening: fever--onset near 10PM (unsure of highest temp. Temp after 400 mg ibuprofen: 99.6 F. Fever broke after 3AM.), body aches (mild-moderate in both arms, all fingers, back, and both knee 1/10/21 evening: shortness of breath/coughing fits (required use of inhaler--3 puffs with symptom onset. Mild shortness of breath for remainder of day w/o need for inhaler), mild altered taste (only lasted approx.2-3 hours) 1/11/21: onset of arm itchiness surrounding site of vaccination, frequent urination (at least every hour) 1/12/21: worsening of arm itchiness (itches from shoulder to elbow), ROM improving at this point but still painful to touch 1/13/21 morning: worsening of dehydration (back pain, headaches, muscle cramps), arm itchiness improving at this point 1/13/21 evening: urination frequency returning to normal, back aches (from dehydration, less severe than morning), headaches continuing (less pain with ibuprofin, but on/off pain still present), nausea improving at this point 1/13-1/14: late start to menstrual cycle 1/14/21: most symptoms improving at this point, headaches and nausea still mild 1/19/21: first full day with no nausea 1/21/21: first full day with no headaches 1/22/21: symptom-free
The patient was administered VARIVAX on 19-JUL-2021. She had a positive pregnancy test at home on 21-JUL-2021; No additional adverse events reported; This spontaneous prospective pregnancy report was received from a nurse prescriber, regarding a 37-year-old female patient.   On an unspecified date (reported as, prior vaccine administration), the patient had an negative urine pregnancy test, negative human chorionic gonadotropin (HCG) test, and an unspecified negative ultrasound; ;also, laboratories were performed, which determined that she was non-immune to varicella but was immune to measles, mumps and rubella (MMR). The reporter stated the patient could had polycystic ovary syndrome (PCOS) for which the patient was started on medication to help with her ovulation as well as prenatal vitamins (not further specified). The patient's drug reactions or allergies were not reported. The patient became pregnant with last menstrual period (LMP) reported as 27-JUN-2021 (and estimated date of delivery (EDD) of 03-APR-2022), based on a pregnancy gestation reported as three weeks (3 weeks) at the time of the report.  On 19-JUL-2021, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T035400, has been verified to be a valid lot number, expiration date reported and established as: 16-OCT-2022) (vaccination scheme frequency, route and anatomical location of administration were not reported) as prophylaxis; however, on 21-JUN-2021, the patient had a home pregnancy test which reported a positive result (exposure during pregnancy). At the time of the report, the pregnancy outcome was pending, the fetal outcome was not provided, and the patient did not experience any additional adverse events.
Initial report received from health care professional on 23 Dec 2009: The reporter stated that a 3 year old child received FLUVIRIN on an unknown date. Outcome was not reported.
Approximately 10 minutes after administration, patient stated that their throat felt tight and that they were having difficulty swallowing.
Nerve tingling in the same area where she originally had shingles.  It is also into her ear lobe and the roof of her mouth.; pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in 2013).   On 4th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th October 2019, less than a day after receiving Shingrix, the patient experienced pain. On 18th October 2019, the patient experienced tingling. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the tingling was not recovered/not resolved.   The reporter considered the pain to be related to Shingrix. It was unknown if the reporter considered the tingling to be related to Shingrix.  Additional details were provided as follows: The patient had no issue with shingles since 2013. 10 days to 2 weeks after receiving Shingrix, the patient experienced nerve tingling in the same area where she originally had shingles. It was also into her ear lobe and the roof of her mouth.  The reporter did not consent to follow-up. The patient wished to remain anonymous.
pt recv vax 1030AM & @ 6PM chest pain started lasting till following day;upon awakening in morning pt had 3" small area of hives;
Parent describes via telephone red bump at injection site on LLE and 99.9 degrees F fever since 8 am (on TYLENOL). Gave parent parameters for calling PCP.
About 5 weeks after my second shot I developed tingling in both arms from the elbow down. At first it felt like mild carpel tunnel but the pain became so severe that I went to the ER at hospital on June 13, 2021. The pain has progressed to severe nerve burning on the left side from my shoulder down and on the right side from my elbow down. It is so severe at night that it prevents me from sleeping.  I have intense joint pain in all the joints of both hands and wrists.
Narrative: COVID infection following COVID vaccine series and after previous COVID infection 07/25, Pfizer, dose #1 (FACILITY) 08/15, Pfizer, dose # 2 (FACILITY) 07/28 COVID swab, result: detected 12/23 COVID swab, result: detected 08/05 ABG: i-pH 7.44, i-PCO2, iPO2 39.0, i-PO2 71, i-HCO2 26.8 08/05 ddimer: 0.26 08/05 CRP: 5.582 08/05 PROCALCITONIN: <0.05 08/05 CXR IMPRESSION: Faint groundglass opacities involving the bilateral lower lobes and left upper lobe. Finding may be consistent with the patient's known positive COVID status. If further characterization is desired, consider chest CT. 08/07 ESR: 57 08/07 FIBRINOGEN: 449 08/07 DDIMER: 0.79 08/05 pt cc: exposure: unknown 08/05 pt admit Medicine cc: Cough, shortness of breath dx: hypoxemia, COVID 19 LOS: 1 day
A non-serious spontaneous report of administration of H1N1, Intranasal to a 60-year-old female was received from a registered nurse. The patient's medical history was not provided. On 05-Nov-2009, the patient received H1N1 vaccine. There was no adverse event associated with this medication error: therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Tinnitus developed in my left ear around 36 hours after the 2nd Pfizer shot. Currently still have the ringing in my ears. Causing a lot of distress.
numbness of the left-sided face, her left arm, left leg, left foot, pain in her left hip, now also pain in her right hip. She has had the symptoms for 3 or 4 weeks. She did have a fever 1 day, that was August 13, none none before or since, and she thinks that was because she had a cold feeling on her all day. She got a Covid test the next day it was negative.  She has no other really concerning symptoms, no visual changes, no focal weakness.  She did not really have any tenderness to suggest polymyalgia, and she does not have much in the way of pain in the smaller joints or fatigue or rash to be very concerned about Lyme disease, but I think we do need to consider these diagnoses and also the possibility of MS if the symptoms continue or worsen in any way.
Have them for almost 3 weeks now I also had the vx; Have them for almost 3 weeks now; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had shingles vaccine and the patient had shingles for almost 3 weeks now  The patient stated that if he/she was grumpy with you just look over me please it was horrible just say a prayer for him/her. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
pt recvd 5th dose of vax & w/in 6 hrs of vax devel area of induration approx 10 cm wide @ the inject site; also exp malaise, nausea, low grade fever & flu-like sx;
Fatigue - onset: 2 pm after 10 am dose, lasting 48 hours Full-body muscle aches - onset: 7 pm after 10 am dose, lasting 15 hours Full-head headache - onset: 5 pm after 10 am dose, lasting 2 hours Hives on toes - onset: 8 am 48 hours after dose, lasting 1 day (still continuing) Itchiness and painful vaccination site - onset: 11 am after 10 am dose, lasting 72 hours
The patient presented to Hospital on 8/3/2021 with chief complaint of chest pain.  He received a second dose of COVID-19 Pfizer vaccine on 7/31/2021.  By that evening he began experiencing migraines, low-grade fever, and alternating hot and cold feeling.  Sunday evening he started feeling a weird sensation in his chest that eventually developed into a pressure that radiated down his left arm. The patient noted a significant family history of heart disease with his father having multiple heart attacks and stents prior to the age of 54.  In the ED high-sensitivity troponin was elevated at 2538.2, and D-Dimer 472.  EKG was without progressive ischemic changes.  In the ED, the patient received Toradol, morphine, and heparin infusion. He was admitted to cardiology service.   Echocardiogram showed mildly reduced LV function with EF 40-45%, mild global hypokinesis. MPI with lexiscan was non-ischemic. Chest pain was felt to be secondary to myocarditis felt most likely secondary to COVID vaccination. He was started on metoprolol and lisinopril. HS-troponin peaked at 8273, downtrending. He was placed on Lasix which was switched to Aldactone. HS trop decreasing 394 at discharge.  Outpatient monitor was placed prior to discharge due to increased risk of arrhythmia related to his myocarditis.   As of 08/19/2021, the patient is feeling well. He denies recurrent chest pain, pressure, or tightness. No exertional dyspnea. He has noted increased fatigue. He has went back to work but has difficulty working a full day due to fatigue. Blood pressures are well controlled. No dizziness, syncope, or near syncope. The patient has been monitoring his sodium and fluid intake closely. Weights are down about 15 pounds since hospitalization.   The patient turned in his cardiac monitor yesterday. He denies palpitations. Heart rate is mildly elevated today which he attributes to walking in from the parking lot and being called back right away.
Information has been received from a pharmacist referring to a patient of unknown age. On 11-NOV-2015 the patient was vaccinated with a dose of improperly stored GARDASIL lot # K011562 (expiration date 08-APR-2017) (Incorrect product storage). No adverse effect reported. The outcome was unknown. Additional information has been requested.
3/17/2022- immediate local reaction of erythema, hives, and pruritis that resolved w/hydrocortisone application and administration of diphenhydramine.  Remained in office for 15 minutes after identification of reaction throughout time of treatment  3/23/2022- mom called office, patient c/o itching to left thigh w/large "rash" to area
Information has been received from a nurse concerning a female who on unknown date was vaccinated with VARIVAX (Merck) (LOT # was not provided) and then experienced a chicken pox outbreak. The patient was given a second dose of VARIVAX (Merck) because the physician's office did not have proper patient history until after the dose was given. The outcome of the patient was unknown. It was also unknown if the patient sought medical attention. Follow-up information has been received that there was not an adverse reaction. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number, date of event, recovery status. This is an amended report. Upon review of the file, the code of "inappropriate schedule of drug administration" was deleted. Follow-up information has been received from the nurse that there was no patient involved and that she was just calling for clarification. This is one of several reports received from the same source. Additional information is not expected.
Gradual onset of constellation of symptoms starting 5/19/16 including weakness, cold chills, poor appetite, worsening dyspnea, myalgias to legs upper arms and neck, splotchy red rash on left upper thigh starting 6/8/16, pt was evaluated 6/10/16 and referred to local ER but pt declined, on 6/19/16 ex-wife called 911 and pt is currently hospitalized with diagnosis of bacterial meningitis and gram-negative bacteremia.
Report involves two products - COVID-19 Moderna vaccine (Moderna) and Invega Trinza (Janssen). Patient is my brother and I am company employee. Patient began Invega sustenna Dec-2016 and transitioned to Invega Trinza 2 years later. Patient has been on same dose of Invega trinza for at least a year. Regimen has been followed per prescribing instructions (per psychiatrist). Patient received first dose of Moderna COVID-10 vaccine at his place of employment on 24-Dec-2020. Last/most current dose of Invega Trinza was 15- Jan-2021. Patient then received 2nd dose of Moderna vaccine AM of 21-JAN-2021 (same location). Patient began severe pain in eyes, chills, myalgia (beginning 01:00 22-Jan-2021) and had to call in sick to work on 22-Jan-2021. Patient went for COVID-19 test on 22-Jan-2021 and result was negative. By 23/24-Jan-2021 patient began displaying symptoms of psychosis to family. Work colleagues noted that week of 25-Jan-2021 he was "not himself". Suicidal ideation (in emails) began 01-Feb-2021, symptoms intensified and currently 04-Feb-2021, patient is missing, endangered and in state of psychosis. Since patient is missing, I will serve as reporter in this case At the time of this report company was notified at 20:53 UTC and Moderna will be notified next after completion of this report.
severe stomach pain; left arm pain; racing heart; breathing felt off; uncontrollable body shakes and back spasm; neck pain; unable to eat; unable to sleep; weakness; lightheadedness; shoulder pain; headaches; 102.1 fever; nausea; weird tired-like-exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off) and TREMOR (uncontrollable body shakes and back spasm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 036AZLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac disease. Concurrent medical conditions included Asthma.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-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 ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off), TREMOR (uncontrollable body shakes and back spasm), NECK PAIN (neck pain), FEEDING DISORDER (unable to eat), INSOMNIA (unable to sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), ARTHRALGIA (shoulder pain), HEADACHE (headaches), PYREXIA (102.1 fever), NAUSEA (nausea) and FATIGUE (weird tired-like-exhaustion). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 4 mg. At the time of the report, ABDOMINAL PAIN UPPER (severe stomach pain), PAIN IN EXTREMITY (left arm pain), PALPITATIONS (racing heart), DYSPNOEA (breathing felt off), TREMOR (uncontrollable body shakes and back spasm), NECK PAIN (neck pain), FEEDING DISORDER (unable to eat), INSOMNIA (unable to sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), ARTHRALGIA (shoulder pain), HEADACHE (headaches), PYREXIA (102.1 fever), NAUSEA (nausea) and FATIGUE (weird tired-like-exhaustion) outcome was unknown.            No concomitant medications were reported.    This case was linked to MOD-2021-051486 (Patient Link).
Patient received 3 immunizations. Upon receipt of 3rd immunization became unresponsive for approx. 30 sec-1 min. T-98, P-74 R-18 B/P-120/52.
C/o swelling & redness to upper L arm after PNUEMOVAX administration. RX for Cephalexin 500mg PO. T QID x 7 days.