chrisvoncsefalvay/vaers-outcomes huggingface dataset:
missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Declined) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS.    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 PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information listed.   Reporter did not allow further contact
REPORTING ONLY AS RESIDENT EXPIRED ON 1/17/2021 3 DAYS AFTER. S/S HYPOXIA/CONGESTED LUNG SOUNDS
PATIENT GOT MODERNA FOR THE FIRST DOSE AND PFIZER FOR THE SECOND DOSE
Rheumatoid arthritis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4383284-00 (AbbVie).  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since May2019 (Batch/Lot number: unknown) at 40 mg 2x/week (40 mg, 1 in 2 week), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis" possibly related to BNT162b2.  Causality for Humira 40MG/0.4ML (Adalimumab) The reporter's causality for the event(s) of signs and sympytoms of Rheumatoid arthritis was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
pt recv vax & had redness & swelling size of grapefruit where pneumonia shot was giving the day a/ rt arm;also c/o soreness wider the at arm, rt side of neck & throat;instructed pt to go immed to MD;
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Patient administered with the vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered with the vaccine that underwent temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:38 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered with the vaccine that underwent temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered with the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.
Patient was given a 3rd Shingrix vaccination upon request. Discovered it was third dose while documenting the dose.  Patient has reported arm soreness at the site of injection and a minor rash on her cheeks that lasted less than one day.
Fever; Weakness; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, weakness and fatigue. On an unknown date, the outcome of the fever, weakness and fatigue were unknown.   It was unknown if the reporter considered the fever, weakness and fatigue to be related to Shingrix.  Additional case details were provided as follows: The patient reported for himself. The age at vaccination was not reported. The patient experienced fever, weakness and fatigue after receiving Shingrix. The patient declined to provide his contact information.
Vaccine given to a 16 year old.  No noted or reported adverse outcome.  Vaccine clinic was held at clinic. Clinic was asked if any residents or staff was under 18 and they responded no.  Patient turned out to be 16 and a staff worker.  Administering RN did not catch the age and when it was entered in to database it flagged.
09:47 AM given Anthrax #1, Right Deltoid, appr one minute later, while withdrawing a needle from his Left deltoid where I had just administered his #3 Twinrix, he began to have tonic-clonic movements/seizure. Code Blue called. His face turned red, no breathing for 3-4 seconds; seizure stopped began breathing, opened eyes, then eyes rolled back and he began having grand mal seizure type movements again.  This lasted 5-10 seconds.  Code Blue team arrived as he awoke: oriented X4, skin pale. No difficulty breathing, no angioedema, no urticaria. V/S at 09:52 were B/P 90/33, HR 42, RR 14. At 09:53 AM, he was transported via wheelchair to a treatment room accompanied by two physicians and hospital corpsmen. He was placed in Trendelenberg position and given hiflow O2 via Nonrebreather mask. He continued to be awake, alert, and oriented X4.
Itchy after injection around the abdomen; Contracted Covid-19; First dose was taken 01-Dec-2021 and Second dose was taken  20-Dec-2021; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy after injection around the abdomen), COVID-19 (Contracted Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was taken 01-Dec-2021 and Second dose was taken  20-Dec-2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen,40MG/0.4ML. On 20-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was taken 01-Dec-2021 and Second dose was taken  20-Dec-2021). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itchy after injection around the abdomen) and COVID-19 (Contracted Covid-19). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Itchy after injection around the abdomen), COVID-19 (Contracted Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was taken 01-Dec-2021 and Second dose was taken  20-Dec-2021) outcome was unknown.            Concomitant product use was not provided by the reporter. The reporter's causality for the event(s) of Contracted Covid-19 and Itchy after injection around the abdomen with Adalimumab Solution for Injection was Not Provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.
Within 9 hours of administration of vaccine the left upper arm had swelling and redness. Within 11 hours of 12 administration small erythematous rough papules were on cheeks of face. By Saturday 12-16-17 the swollen arm and bumps on face had not gone away and were itchy (no fever, no difficulty breathing, no swollen lips, no hives). Nurse advice line recommended oral diphenhydramine. It helped. By Monday 12-17-17 arm not swollen but face with bumps.
Seen on 7MAR91 as mom requested to have TM's checked; child active & normal 9MAR91 developed sl. fever & rhinorrhea was well except for fever @ 0222 10MAR91 parents heard him in crib 0730 10MAR91; Found dead @ 11AM 10MAR91;
Dizziness and feeling faint . Pale. Numbness in face and both arms. Severe chest and throat pain and tightness. Audible wheezing with shortness of breath. Tachycardia with heart rate 150s. Elevated blood pressure, SBP 140-150s, DBP 100-110.  The following days experienced brain fog with significant vertigo, pins and needles pain and decreased sensation in both legs, neuropathy with burning sensation in both feet. Continue to have vertigo with neuropathy in feet in legs making it difficult to drive and ambulate.
Lethargic, limp, unresponsive to external stimuli, developed rash and inflammation behind both ears, staring spells, lost alll language, lost all gained milestones, resorted back to crawling, developed allergies, immune dysregulation. Diagnosed with brain damage and autism soon after.
Migraine; Fever; Headache; Body ache; Chills; Blood pressure high; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 44-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0177, Expiration Date: 31Aug2021), via an unspecified route of administration in arm on 07Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history included thyroid disorder, coeliac disease, blood clotting disorder. Concomitant medication included levothyroxine taken for thyroid disorder. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, LOT#EW0182, Expiration date: 21Aug2021), via an unspecified route of administration on 14May2021 as single dose for COVID-19 immunization and no reaction was experienced. On 07Jun2021, the patient experienced migraine, fever, headache, body ache, chills, blood pressure high. Patient stated, he just wanted to report the side effect. Patient reported that "I received the second vaccine on 07Jun2021 and I had Migraine, 12 hours after the (second shot) shot, it started with fever, headache, body ache, chills for 2 days and then after the 2 days headaches did not go away and had just got progressively worst, he went to my Primary Care Doctor and he gave to me the Migraine medication. Patient added, I never had Migraines. This was the first time I have ever had. That was also a side effect my blood pressure was high right now but Doctor said it was because of the headache". Therapeutic measures were taken as a result of migraine. The outcome of the events fever, body ache, chills was recovered on 09Jun2021, outcome of events headache, blood pressure high was not recovered and unknown for other events.  Information on Lot/Batch number was available. Additional information has been requested.
9 days of left upper quadrant abdominal pain and fever (starting 6/7/21), and splenic infarctions visualized on CT abdomen/pelvis on 6/14
Irritability. Wont eat, no fever, no pain focus, no site irritation.  Reasure parent.
After the second vaccination.. within 24 hours or less I started violently shaking and was unable to perform simple tasks such as hold my phone. I could not control the severe almost convulsive like movements. This continued to happen spontaneously for 2 months after the 2nd dose. I have not had one now since around 8-12-2021. I am not sure if they are gone for good now.
1 week after Tdap, he developed pain in bilateral hamstrings which then extended up back gradually all way to neck. These symptoms resolved after 7 days but malaise has continued (which also started 7 days after injection).
Patient with 3 COVID vaccinations who admitted with dyspnea and tested detected for COVID.  Provider d/c note:  "86 YO male with h/o COPD on 2L O2, HTN, AS s/p TAVR, CKD III, hypothyroidism presenting to the ED for evaluation of shortness of breath.  Patient states he has chronic shortness of breath/DOE/nonproductive cough however much worse, had to crank up his O2 up to 5L without significant improvement.  He was found to be COVID positive.  He was started on treatment for COPD exacerbation likely due to COVID infection.  Shortness of breath improved and he was brought back down to his home O2 requirements.  Pt was stable on discharge.  "
swelling; hives; lost feeling on her arm; This case was reported by a nurse via call center representative and described the occurrence of swelling in a 16-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 724K2, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included stevens johnson syndrome.   In August 2020, the patient received Fluarix Tetra 2020-2021 season. In August 2021, the patient started Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, between 1 and 3 months after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced swelling, hives and loss of sensation. On an unknown date, the outcome of the swelling, hives and loss of sensation were unknown.   It was unknown if the reporter considered the swelling, hives and loss of sensation to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details provided were as follows: The case was reported by patient's mother. The nurse reported that the patient received Fluarix dose last year from the date of reporting and she started with hives, swelling and she lost feeling in her arm.  They were working with the patient´s doctor to see which component affected and cause this bad reaction to the patient. The reporter consented to follow up by email.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 24, 136 and 56 hours, with the lowest recorded temperature of 34, 31 and 30 degrees Fahrenheit, respectively. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pain at injection site that lingers, minor but noticeable loss of rotational ability in upper left arm
About two days after the vaccine, started to feel shortness of breath, heart palpitations and elevated pulse.
pain left upper arm since injection, can't sleep on that side because of pain.  Throbbing.  No position helps.  Tingles in fingers if picks things up.  Can't put hand in hip pocket because it hurts to move arm back that far.  Patient states he feels like there's a knot under left shoulder blade.  Felt dehydrated when had lab draw 2 weeks ago (1 week after shot).  Grip strength right 94.6lb, left 24.6lb, "makes it throb" when grasping.
Client was administered  0.5mg of monovalent Moderna for a 1st dose, yet it was a blue top (which came out originally for 'boosters only' prior to bivalent being made).  No adverse S & S had been noted nor reported to my knowledge.
Positive reaction: Red blotchy patches on face later developing on torso 5 days post vaccine. Client on Meds during administration of vaccine. Treatment with steroid injection.
The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022; No adverse event; erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022).    No concomitant medications were reported.  The Beyond use date (BUD) (refrigerator) was reported as 01-Jul-2022. It was reported that 10 days past expiry date the patient received the vaccine. Vial size was reported as 5.5 ml. Vial did not undergo any temperature excursion.   No treatment medications were reported.
Vomiting, weak, unable to walk without assistance, headaches, fatigue, and blurry vision.
Received the PNEUMOVAX 23 vaccine and the next day experience hives and bruise at the injection site.; Received the PNEUMOVAX 23 vaccine and the next day experience hives and bruise at the injection site.; This spontaneous report has been received from a company representative referring a male patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided).  On an unknown date, husband and wife both received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the next day experience hives (vaccination site urticaria) and bruise (vaccination site bruising) at the injection site. At time of reporting, the events where improving (recovering).   The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA002883:
Site: Pain at Injection Site-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Seizure-Mild
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. The medical assistant reported that on 18-DEC-2017 the patient received an improperly stored dose of GARDASIL 9 lot number: N017697 (expiration date: 21-JAN-2020), for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: 47 F to 77 F for 30 minutes. - Previous temperature excursion: at or above 32 F to 35 F for 7 hours. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA004525: US-009507513-1801USA005371: US-009507513-1801USA005373:
This spontaneous report as received from a health worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of GARDASIL (lot #, dose, route, not reported) that underwent a temperature excursion on an unknown date. Concomitant therapy was not reported. No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
After 20 minutes of recieving shot, had itching and rash on scalp, neck, shoulder and left wrist and hand. Within 48 hours the back and scalp and hands had developed papules covering entire areas. ER trip was diagnosed with rash and given steroid creme and antibiotics. Few weeks later family doctor visit resulted in severe rash and gave steroid shot and prednisone pack. Dermatologist appointment scheduled for January 28th. After disease coverage spread and eventually covered from head to toe, Dr performed a biopsy in 2 places and sent them off for diagnosis which 12/17/2021 it was confirmed by pathologist that it was LICHENOID DERMATITIS. Since I have been awaiting the dermatologist appointment and continuing to use lotions, steroid creme and watching diet.
Information has been received from a licensed practical nurse concerning a patient (age and gender not specified), who on an unknown date was vaccinated with a dose pneumococcal 23v polysaccharide vaccine, and then developed a reaction area that was extremely red and warm to touch. The outcome of the event was not specified. No further details were provided. This is one of 2 reports from the same source. Additional information has been requested.
Red, swollen, painful welt from shoulder to elbow. Tx: BENADRYL and cold compress