chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lupus flare up; condition aggravated; felt worse than flu; low grade fever of 100; body aches; extreme fatigue (down and out); injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) and CONDITION AGGRAVATED (condition aggravated) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus. Concomitant products included MESALAZINE (DELZICOL), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated) (seriousness criterion medically significant), FEELING ABNORMAL (felt worse than flu), PYREXIA (low grade fever of 100), MYALGIA (body aches), FATIGUE (extreme fatigue (down and out)) and VACCINATION SITE PAIN (injection site pain). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 800 milligram and PREDNISONE ongoing since an unknown date for SLE flare, at an unspecified dose and frequency. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown and FEELING ABNORMAL (felt worse than flu), PYREXIA (low grade fever of 100), MYALGIA (body aches), FATIGUE (extreme fatigue (down and out)) and VACCINATION SITE PAIN (injection site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 100 (abnormal) low grade fever of 100.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Ibuprofen for vaccine related adverse events and Prednisolone for lupus flare up are the treatment medication reported by reporter.  Patient states that adverse events lasted 3-4 days.  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.   This case was linked to MOD-2021-285120 (Patient Link).; 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.
having arthritic kind of joint pain in both hands, in my left arm; some other joints in my body too but eventually it went away in rest of my body; I still occasionally have kind of arthritic joint pain; I had gotten the shot in the left arm and that was the arm in the hand that the pain was the strongest; arthritic kind of joint pain in both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8730), administration date: 01Apr2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "I had the initial series of two shots, no problem"; BNT162b2 (DOSE 2, SINGLE), administration date: 22Apr2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "I had the initial series of two shots, no problem"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FD0809), administration date: 23Nov2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Apr2022, outcome "unknown", described as "arthritic kind of joint pain in both hands"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "having arthritic kind of joint pain in both hands, in my left arm"; PAIN (non-serious), outcome "not recovered", described as "some other joints in my body too but eventually it went away in rest of my body"; ARTHRALGIA (non-serious), outcome "not recovered", described as "I still occasionally have kind of arthritic joint pain"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "I had gotten the shot in the left arm and that was the arm in the hand that the pain was the strongest". Therapeutic measures were taken as a result of pain in extremity, pain in extremity, pain, arthralgia, vaccination site pain.  Additional information: It was reported that, patient started having arthritic kind of joint pain in both hands, in her left arm and then over the next couple months, The patient had a considerable joint pain, some other joints in her body too but eventually it went away in rest of her body, in her right arm, left arm but she still occasionally have kind of arthritic joint pain that she never had before. Treatment included over the counter like Ibuprofen for the arthritis thing. Prior to vaccination, the patient was not diagnosed with COVID.  Follow-up (19Oct2022): Follow-up attempts are completed. No further information is expected.
pt lt leg was red & swollen from hip to the knee; pt was listless for 24 hrs leg remain sore for 2-4 wks; seen by MD 3x;
Patient started having tremor in left hand about 2 weeks after injection of GARDASIL 9 vaccine. Arm that was injected has been hurting. Tremors in both hands - always had tremor in the right hand; a few days ago, legs started to have tremors - was waking him from sleep. Arm that got injected started feeling tingly. Tremor in the hand if drawing - thumb/index finger. Lifelong slight tremor in right hand. Mother had essential tremor. Seeing Neurologist: Complete Neurological Care.
Patient developed a reaction and had to go to the ER where she was told that both shots flu and pneumonia should not be given same time.
Patient in for immunizations on 5/28/2009. Child received DTAP, HPAC, IPV & MMR. Mother telephoned this morning & stated that child began to break out in hives yesterday afternoon-mother stated that the health department was closed-she called the hospital & was instructed to give patient BENEDRYL. Mother stated that patient had no wheezing or problems breathing. Mother stated that patient went to sleep & woke up this morning with hives on her back. Advised mother to give BENEDRYL as directed & to try to manage itching-mother stated child had no respiratory problems this morning. Telephoned healthcare professional, immunization program coordinator & informed of the above. healthcare professional stated that child may have reacted to a component in the vaccine, healthcare professional stated that she will send a list of all components in the immunizations that child received yesterday-advised that mother take the list of components to primary MD & let MD decide if patient should receive additional immunizations. Telephoned mother back & informed of the above. Mother verbalized understanding & stated she will come by clinic to pick up the list. Advised to monitor child for respiratory problems & continue with BENEDRYL & continue with BENEDRYL & comfort measures.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 44-year-old male. Neither medical history nor concomitant medications were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication error that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Complaint investigation results.
12 hours after vaccinations I got a  fever and chills, Severe Fatigue, Joint aches, Headache, Swollen Lymph Nodes, Sore Throat, my ears hurt, Anxiety-I was put on an Anxiety Medication.
No adverse outcomes or side effects were reported or observed by the patients who received the administered doses by an experienced HCP; HCP (nurse) called to report TE for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 11-May-2023 and was administered on 15-Jun-2023; This spontaneous report was received from a nurse, concerning a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-MAY-2023, varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot number W031813 was verified to be valid, expiration date reported and confirmed as 05-OCT-2024) suffered a temperature excursion (TE). On 15-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot number W031813, expiration date 05-OCT-2024), administered as prophylaxis (route of administration and anatomical location were not provided) (Product storage error). The reporter made aware of the by the Vaccines Program until 26-JUN-2023 (reported as "today"). The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with a supported stability evaluation, and there were not any previous excursions and 8 doses total were administered. No adverse outcomes or side effects were reported or observed by the patient who received the administered dose by an experienced HCP.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA012318: US-009507513-2306USA012351: US-009507513-2306USA012355: US-009507513-2306USA012362: US-009507513-2306USA012702: US-009507513-2306USA012732: US-009507513-2306USA012753:
From telephone contact from reporting physician stated that a 74-year-old female patient received a TD Adult vaccination on 6/27/01. Reportedly eight hours after vaccination the patient developed general malaise and body aches mainly in shoulder girth. Patient was seen and treated in physician's office. From additional correspondence received from 9/5/01 it was reported that the patient recovered from this experience. This case is closed.
pt had a positive COVID test on 8/10/21; 8/17/21 pt admitted to hosp with increasing SOB; COVID pneumonia; given Decadron and ABX; required intubation; cardiac arrest - CPR and ACLS protocol; went into Ventricular Fibrillation; 6 shocks with meds and never achieved ROSC; pt passed away in the hospital
Headache; queasy stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Aug2021 16:00 (Lot number: FC3180) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, left arm, around 1600), administration date: 08Jul2021, when the patient was 60 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 07Aug2021, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 07Aug2021, outcome "recovering", described as "queasy stomach". The events "headache" and "queasy stomach" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional information: No emergency Room. The patient went to Physician Office chiropractor. None aside from first dose with in 4 weeks Prior Vaccinations.  No follow-up attempts are possible. No further information is expected.
Doctor's diagnosis: Herpesviral vesicular dermatitis (cold sore) Multiple cold sores appeared on my daughter?s mouth, both on the upper and lower lips, a day after her first dose of vaccination. We visited an urgent care clinic on Dec/8/2021. The doctor prescribed her acyclovir 10 mL suspension. It's been 9 days since the vaccination and the mouth sores are still slowly healing.
This literature report concerns a 52-year-old female patient. In her past medical history she had been passing bloody mucus intermittently for 3 years before a diagnosis of ulcerative proctitis was made at colonoscopy. She improved on sulfasalazine and hydrocortisone enemas, but after stopping medication she had recurrent rectal bleeding and coincident uveitis. She was then treated with oral prednisone and the sulfasalazine was restarted. Sigmoidoscopy showed more extensive friability and exudate and she was hospitalized for intravenous hydrocortisone. The patient was also started on 6-MP at 50 mg/day. She improved quickly and was discharged on sulfasalazine, tapering doses of prednisone, and an increase in 6-MP to 100 mg/day. The sigmoidoscopic appearance had been normal for 4 months when symptoms worsened, with loosening of the stools and reappearance of blood per rectum. On flexible sigmoidoscopy, mucosal friability and edema were again found in the rectum and rectosigmoid. After 3 more months on 6-MP during which the dose was reduced to 50 mg/day because of leukopenia, she was much improved, having formed stools with normal mucosa throughout at colonoscopy. On an unknown date, after 9 months of 6-MP and while in remission, the patient received a subcutaneous injection of influenza vaccine (manufacturer unknown). That night the patient developed abdominal pain and bloody diarrhea and was hospitalized. On examination she had very active UC with friability, ulceration, and exudate. She stated that her earlier exacerbation had also followed a flu shot. She also had recurrence of bilateral uveitis. She was hospitalized and treated with intravenous adrenocorticotropin hormone (ACTH) followed by tapering doses of prednisone. Again she improved, but incompletely. The 6-MP was increased to 150 mg/day and she required larger doses of steroids, becoming very cushingoid. One year after the diagnosis of UC (ulcerative colitis) was established the chronicity of her illness and the complications of steroids warranted surgical intervention. She underwent a total colectomy with establishment of an ileoanal pouch anastomosis. Pathology confirmed the presence of a universal UC and there was no involvement of the terminal ileum. After 1 year with intermittent pouchitis, the pouch and the ileum looked normal. Reporters comment: We acknowledge that the case presented here is probably 1 out of many inflammatory bowel disease patients on 6-MP who received the flu vaccine. Perhaps it was an IgE-mediated reaction (egg allergy). However, we suggest that this case not be ignored since the outcome is a sobering reality.
Fever; Migraine; Overheating; Fatigue; Loss of appetite; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever, migraine, overheating, fatigue, loss of appetite on an unspecified date. The clinical outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt received the vaccine after visit to the cardiologist. He was stable that day and was diagnosed with: HF with recovered LVEF, NYHA Class II, previously 25% , mos recent LVEF of 50-55% HTN - had an exacerbation last week; nose bleed, uncontrolled HTN, OSA on CPAP, controlled HLD, controlled DM.  2 days after the visit and the vaccine, he was found death on the bathroom floor in his home.
The needle was placed in the muscle and when the plunger was pushed the needle retracted before the full 0.2 cc was administered and vaccine ended up on the skin on the arm.  Due to an in complete dose being administered a second vaccination in the opposite arm on 0.2 cc 10 mcg was given.
Flushing of the face and generalized urticaria in 5 minutes after giving the vaccine.
no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 8 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the left deltoid at a dose of 0.5 milliliters (ml), once (lot number: W011626, which was verified to be valid, with an expiration date: 06-APR-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Fainted immediately following shot. Laid chest down and elevated feet. Regained consciousness within 10 seconds. Watch in office for 10 min. Walked out of office.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 10th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th February 2019, 10 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX into the left deltoid.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates on or after 11-MAY-2015, the patients were vaccinated with the improperly stored doses of LIQUID PEDVAXHIB (dose and route of administration were not reported) for prophylaxis. The excursion details were as follows: lot # L014426, expiration date 08-MAR-2018 - 31F or colder (20F) for 156 hours, 32F to 35F for 119 hours lot # reported as K0110778, expiration date 31-MAR-2017 - 32F to 35F for 16 hours lot # K019700, expiration date 16-JUL-2017 - 31F or colder (20F) for 85 hours, 32F to 35F for 169 hours lot # K025006, expiration date 22-JUL-2017 - 31F or colder (30F) for 111 hours, 32F to 35F for 170 hours, 47F to 77F for 7 hours lot # L004740, expiration date 16-NOV-2017 - 32F to 35F for 16 hours The nurse confirmed that all the vaccines were administered prior to their expiration dates. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006088: US-009507513-1707USA008729: US-009507513-1707USA008730: US-009507513-1707USA008731.
Information has been received from a physician concerning an 11 year old patient who "at a younger age" was vaccinated with a dose of Varivax. Subsequently the patient developed full blown varicella and was completely covered with lesions. It was reported that the patient also had a slight fever. Subsequently, the patient recovered. Additional information has been requested.
Received DTAP/Comvax/IPV/Prevnar on 09/26/2003.  On 09/27/2003 in AM, child developed rash all over body.
11 days after the vaccine, site became red, hard, hot and bumpy. Redness grew slightly within 24 hours. Another 24 hours later, rash remains the same. Applied Benydryl cream.
patient received second dose on day 20 instead of day 28; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (patient received second dose on day 20 instead of day 28) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced OFF LABEL USE (patient received second dose on day 20 instead of day 28). At the time of the report, OFF LABEL USE (patient received second dose on day 20 instead of day 28) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
Flu like symptoms; felt off/dazed; low grade temp; chills; Was sick for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick for a day and a half), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (felt off/dazed), PYREXIA (low grade temp) and CHILLS (chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IDELALISIB tablet for Mantle cell lymphoma.    Concurrent medical conditions included Mantle cell lymphoma.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient started IDELALISIB (Oral) 100 mg twice a day. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was sick for a day and a half), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (felt off/dazed), PYREXIA (low grade temp) and CHILLS (chills). At the time of the report, ILLNESS (Was sick for a day and a half) had resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (felt off/dazed), PYREXIA (low grade temp) and CHILLS (chills) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up contains no new information
I work up the next am with a black spot size of a size above my eye and below my eye brow bruise and redness. The next week or two it spread, it was all around my eye and then it went to the other eye under the skin and it didnt hurt. It started with the right eye.   I sent to the pictures to my doctor and they replied to let monitor and let them know   In March2021 went for a regular check and she asked to report it to Agency.