chrisvoncsefalvay/vaers-outcomes huggingface dataset:
spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis; sleeping was problem; spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis; had covid vaccine in left arm and it hurt; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), SPONDYLITIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis), SLEEP DISORDER (sleeping was problem), LUMBAR SPINAL STENOSIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis) and VACCINATION SITE PAIN (had covid vaccine in left arm and it hurt) in a 70-year-old 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.    No Medical History information was reported.   In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In December 2020, the patient experienced COVID-19 (COVID-19). In February 2021, the patient experienced VACCINATION SITE PAIN (had covid vaccine in left arm and it hurt). On an unknown date, the patient experienced SPONDYLITIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis), SLEEP DISORDER (sleeping was problem) and LUMBAR SPINAL STENOSIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis). At the time of the report, COVID-19 (COVID-19), SPONDYLITIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis), SLEEP DISORDER (sleeping was problem), LUMBAR SPINAL STENOSIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis) and VACCINATION SITE PAIN (had covid vaccine in left arm and it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  The concomitant medication was not reported.  The causality for the Humira was reported as Not reported.   The treatment medication was not provided.
Slight difficulty with exhalation.  Denies difficulty with inhalation, swelling of face or throat, palpitations, rash, or dizziness and weakness. Advised to continue to monitor. Strict UC/ER precautions advised.
sinus problems; was diagnosed with positive COVID test / few months later has been diagnosed with COVID; was diagnosed with positive COVID test / few months later has been diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Mar2021 as dose 2, single, patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Mar2021 as dose 1, single both for covid-19 immunisation. Medical history included high blood pressure and diagnosed with small renal cell carcinoma in Feb2021. The patient concomitant medications were not reported. On 10Aug2021, the patient was diagnosed with positive covid test, Rapid PCR was performed. On unspecified date patient experienced headache, fever, cough, wheezing, sinus problems. Patient was diagnosed with small renal cell carcinoma in Feb2021 and had right nephrectomy in Apr2021. The vaccine was recommended before surgery and patient got it before procedure. Now a few months later has been diagnosed with COVID. The patient underwent lab tests and procedures which included PCR sars-cov-2 test: positive on 10Aug2021. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Patient developed COVID-19 with complaints of increased cough on 4/6.  Was found to be COVID positive on 4/12.  Recieved combo Bamlanivimab/etesevimab treatment for infusion on 4/14.  Patient had initial recovery to baseline period on 4/22.  Rapidly declined shortly after and died 4/25.
Irritation in her eyes; Some of the VAQTA squirted into her eyes; The plastic syringe broke and some of the VAQTA squirted into her eyes; Drew up the VAQTA into a plastic syringe; This spontaneous report was received from a pharmacist concerning herself, a 47 year old female patient. The patient had no concomitant medications or pertinent medical history. The patient's drug reactions/allergies included NSAIDS (nonsteroidal anti-inflammatory drugs), the reaction was welts, hives, throat, tightening, watery eyes, and fever which occurred over 10 years ago.  On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated(VAQTA) lot # S001360 with expiration date of 06-MAR-2020) for prophylaxis (dose, frequency, route of administration and anatomical location were not provided).   On 24-JUN-2019, the pharmacist prepared a dose of hepatitis a vaccine, inactivated(VAQTA) and drew up the hepatitis a vaccine, inactivated(VAQTA) into a plastic syringe. After this, the plastic syringe broke and some of the hepatitis a vaccine, inactivated(VAQTA) squirted into her eyes. She flushed her eyes with water and then went to an unspecified emergency room where her eyes were flushed further. While at the emergency room, she also developed irritation in her eyes, so she was given moxifloxacin (VIGAMOX). No laboratory diagnostics or studies were performed. At the reporting time, she was recovering from eyes irritation. The reporter did not provide any causality assessment between therapy with hepatitis a vaccine, inactivated(VAQTA) and the aforementioned event.
Patient stated that within 24 hours he was coughing and throwing up blood. Patient stated that this lasted for about a few hours. Patient also stated that he had sore arm.
I started developing red rashes looks like hives on my neck 2 days after the vaccine. And a day after the vaccine I was really itchy. I have never experienced this prior the vaccine.
Patient was given monovalent Moderna as second booster dose.  Attempted to call and follow-up with patient but had to leave a voicemail
Needle on BD integra syringe malfunctioned and vaccine did not enter patient's arm.  Vaccine dripped out and pt did not feel syringe enter arm.  Went ahead and redosed patient with a new needle and vaccine.
Patient complained second subcutaneous injection was more painful.; first dose was administered in her deltoid (intramuscular).; Patient complained of soreness on first VARIVAX dose; This spontaneous report was received from a pharmacist referring to a 39 years old female patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was reported as none. The patent was not pregnant.   On 20-OCT-2019, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# R018141, expiration date 25-JUN-2020; strength and dose were not reported) intramuscularly in her deltoid (incorrect route of product administration) for prophylaxis.  The patient complained of soreness on first varicella virus vaccine live (oka/merck) (VARIVAX) dose injection (onset date: unknown date in 2019). On 20-NOV-2019, the patient was vaccinated with second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# R018141, expiration date 25-JUN-2020; strength and dose were not reported) subcutaneously for prophylaxis. The patient complained second subcutaneous injection was more painful. Both vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, lot# and expiration date were not reported). The patient didn't seek any medical attention and no treatment or intervention was given for the events. The outcome of first dose injection soreness and second dose injection more painful was recovered. The causality between the events and varicella virus vaccine live (Oka/Merck)(VARIVAX), sterile diluent(MERCK STERILE DILUENT) was not provided.
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 16-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004516: US-009507513-1704USA004517.
Muscle ache; Extreme fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle ache) and FATIGUE (Extreme fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle ache) and FATIGUE (Extreme fatigue). At the time of the report, MYALGIA (Muscle ache) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication product use was not provided by the reporter. No treatment information was provided. The patient first shot was a week and a half ago.   Reporter did not allow further contact
p/vax pt c/o not feeling well; just thought it was fatigue from traveling;low grade T102 & c/o h/a; liver enzyme check & they were sl abn; feeling bad; slept all day; arm @inj site red & swollen & tender;also had chills & dizziness;MD seen
Presented to ED today with complaint of right-sided CP onset yesterday. Patient has history of renal cell carcinoma with metastatic disease to the liver.  He has had recurrent pleural effusions involving the right lung.  Has worsened pain with breathing. Had a R tube placed due to pleural effusion and last week when the tape was taken off it pulled and caused pain. Endorses SOB. No significant cardiac history. No h/o DVT, PE. Has renal CA and had L kidney removed. Patient admitted. Pulmonary/critical care was consulted regarding Pleurx catheter.  It is felt that his pleural effusion had decreased in size, and the catheter was likely contributing to his right-sided pleuritic chest pain.  Catheter is removed with good results of his pain.  Patient however did have recurrent fevers.  Empirically placed on Rocephin.  With this, he did improve. He was discharged in stable condition.
no additional AE; temperature excursion; This non-valid spontaneous report was received from a registered medical assistant and refers to an unknown patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were unknown.   On an unknown date in 2020, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, injection, lot # T028093, expiration date 24-APR-2022 (exact dose, anatomical location and route of administration were not reported) for prophylaxis (storage error). The administered dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) experienced a temperature excursion of 46.6 degrees Fahrenheit (F) for 45 minutes. Previous temperature excursions included 46.4 degrees F for 15 minutes on 29-SEP-2020 and 47.4 degrees F on 02-NOV-2020. The temperatures were captured with the use of a digital data logger. There were no additional adverse events reported.  This report was considered to be non-valid due to lack of patient identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028093; expirationdate: 24-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
10 days after receiving the first dose, pain an inflammation of an axillary node on the left side began, which I attributed to the immunological reaction of the vaccine.  3 days later, the ipsilateral breast doubled in size. My neddle was normal and was not discharge or  I suspect a probable breast cancer and perform a mammogram like previus BIRADS 2 findings.   Inflamation decrease and desapear within the next week. It was normal at the time of the second dose.  This event was repeated 48 hours after receiving the second dose.
An irregular shaped 5inx5in bright red mark appeared about 1 inch below injection site and lasted three days.  It was warm to the touch, looked a little swollen, and felt slightly itchy.  Under the marking, one part of the skin/muscle felt firmer and more dense (hard to describe).  It was not painful.  The skin was not raised at all.  This side effect only happened with 2nd shot in the series (first shot was also in the right arm).
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 52 year old male. Initial information was processed along with additional information received on 16-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: tree nut allergy. The patient previously received covid-19 vaccine ad26.cov2.s 9 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: unknown) dose was not reported, 1 total, administered on 08-MAR-2021 in right arm for prophylactic vaccination. Age at time of vaccination 51 years old. Concomitant medications included ibuprofen (advil), paracetamol (Tylenol) and Hammer Nutrition Tissue Rejuvenator and Race Cap. On an unspecified date in 2022, the patient experienced confirmed clinical vaccination failure (Dose number in series 1). The patient received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin was not reported, batch number: 071F21A, expiry: unknown) dose was not reported, administered on 09-NOV-2021 in right arm for prophylactic vaccination.  The patient reported that he tested negative for covid-19 after 10 days (date unspecified). Treatment medications for covid-19 included: ritonavir (Paxlovid) from 20-APR-2022 to 25-APR-2022. On 01-MAY-2022, patient reported more severe symptoms reoccurred (coded to confirmed covid-19 infection) (Dose number in series 2). Patient reported that he assumed the symptoms were something else and infected his partner as he was no longer isolating. Patient tested positive again on day 16 (date unspecified).  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable.  The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000231245; Sender's Comments: V0:20220530373-COVID-19 VACCINE Ad26.COV2.S-confirmed clinical vaccination failure  The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
child received a bivalent COVID immunization vaccine clinic. The dose received was not correct and may not adequately protect against COVID.  No adverse event reported.
Fever, chill, difficulty sleeping, fatigue, flu like symptoms, injection site soreness, severe muscle soreness
Patient called reported that had vaccine on 12/08/2022 and 2 days later went to ER was diagnosed with  DVT in right upper leg.
Patient woke up 9-3-08 with redness and swelling of her left thigh.  Continued to get larger in size - swelling and red area - warm to the touch.  Brought in for appointment 10:40AM 9-4-08.
pt recv vax 5DEC96  & thigh became dark red w/lt leg @ site of MMR w/raised area-dime size;MD order DPH;to ER if redness, edema cont or inc;
Face broke out with rash. Spread down to neck/trunk. Small dots all over face around eyes. Dr. Px: Hydrocortisone 1% cream.
blood clotting issues in his feet,clots on his legs; red places on both of his hands; bumps on legs/appeared as a raised portion on his leg; see the veins and blood in his feet; discoloration; veins more prominent in his feet and legs; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL for Heart disorder, FAMOTIDINE, MULTIVITAMINS [VITAMINS NOS] and SERENOA REPENS FRUIT (SAW PALMETTO PROSTATE COMFORT) for an unknown indication.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (headache). On 27-May-2021, the patient experienced VARICOSE VEIN (veins more prominent in his feet and legs). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) (seriousness criterion medically significant), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration). On 28-May-2021, VARICOSE VEIN (veins more prominent in his feet and legs) was resolving. At the time of the report, DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration) outcome was unknown and HEADACHE (headache) had resolved.            Treatment information included the patient using compression hose. After the vaccination the patient experienced a headache for a day.The patient's legs and feet looked much better on 28-MAY-2021. The patient reported he was not on any blood thinners.  Company Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
I received the vaccine on April 6. At the time of receiving the vaccine I began to feel numbness in the tip of the tongue, lips and central incisors, on April 7, the day after receiving the vaccine I began to feel numbness in the small fingers of both hands. Today, April 8, the numbness of the lips and the numbness and tingling still persist in all the fingers of the hands, especially the little fingers
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm"; MIGRAINE (non-serious) with onset Mar2021, outcome "unknown", described as "migraine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
InjectionSitePain,InjectionSite Swelling Narrative: Injection site itchy, whelped, red area has gotten bigger. Took Benadryl.
23OCT98 redness around inj site, warm to touch, soreness, then turned into splotches which were warm to touch;Friday splotches spread to bilat legs & patches on posterior back area;
By the next day I felt like someone had hit me in the arm with a baseball bat. It felt like my arm was asleep all the way down to my hand. I contacted the doctor and went in for a visit. The doctor did not have any recommendation for treating the symptoms. They lasted in total for about 2 weeks. I had already waited a while to see the doctor. I completely recovered from these symptoms.
Headache, Myalgia, Arthralgia, Injection site pain, Fatigue Narrative: Patient experienced symptoms for three days following vaccination
rash all over body started on evening of 10/05/2023, no treatment was necessary as rash did get better
Headache, nausea, Earache, sore throat, eye pain, severe Body aches.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. The registered nurse reported that since 25-NOV-2015, the patients have been vaccinated with unspecified doses of PROQUAD (Merck) which were exposed to temperatures outside of the recommended range (Lot #L031601, expiration date 18-FEB-2017; Lot# L033696, expiration date 28-FEB-2017) (strength and route were not provided). Concomitant medication was not reported. This is one of several reports from the same source. Additional information has been requested.