chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; Moderna (previously Pfizer); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Sep2022, outcome "unknown", described as "Moderna (previously Pfizer)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: previously testing negative; (24Oct2022) Positive, notes: Positive test after previously testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications in 2 weeks, Patient was treated with Product Paxlovid from 13Oct2022 to 17Oct2022 for COVID 19 Treatment, Positive test after previously testing negative, 8 days after finishing Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Excessive yawn; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of YAWNING (Excessive yawn) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced YAWNING (Excessive yawn).   At the time of the report, YAWNING (Excessive yawn) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
He had stiffness in shoulder after injection for 4 weeks that resulted in shoulder impingement syndrome and frozen shoulder with inability to raise arm above shoulder height.  Treating with PT exercises and formal PT consultation to mobilize shoulder and motrin.
rt red, swollen, hot to touch from rt deltoid; mom states DTP given in rt arm;
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 18-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Death within 60 days of COVID vaccine administration.  Dose 1 on 12/23/2020 Dose 2 on 01/13/2021
Patient complained of being tired and weak with increasing back pain in late December 2010. Weakness continued and slight sore throat developed in January 2011. Sore throat got worse and leg and arm pain developed and she sought treatment Feb. 2, 2011. Doctor suspected strep, but did not test and prescribed antibodies. Feb. 4th went to ER. After extensive tests, doctor thought it might be Vertigo and prescribed medicine. Patient was partially paralyzed by Feb. 6 and went back to ER. ER doctor suspected Guillain-Barre Syndrome, admitted her and neurologist diagnosed GBS and began treatment Feb. 6 afternoon. She was in hospital, including their rehab center, for 34 days. She then went for more rehab before returning home April 16.  She has not fully recovered but her stamina and strength are at about 65-75 percent of her pre GBS level.
PATIENT REPORTED TO PHARMACY FOR 1ST COVID VACCINE. PATIENT REPORTED NKDA & NO PRIOR ADVERSE EVENTS WITH VACCINE. PATIENT STAYED FOR MONITORING AND PASSED OUT WITHIN 15 MINUTES OF VACCINE ADMINISTRATION. PATIENT WAS FOUND LYING FACE DOWN. EMERGENCY PERSONNEL WERE CONTACTED IMMEDIATELY. PATIENT WAS ABLE TO BE ROUSED QUICKLY. EMTS EVALUATED PATIENT ON ARRIVAL AND PATIENT DECLINED FURTHER MEDICAL CARE. PHARMACY OFFERED TO CALL FAMILY FOR THE PATIENT AND TO ESCORT THE PATIENT OUT. PATIENT DECLINED.
Pt had received a covid vaccine and had a reaction. Pt had dizziness, visual changes, nausea. Per pt, it had happened before when she received other vaccines. Pt was transferred from the vaccination site to the observation area where pt was further evaluated and observed. Pt was laid down on the gurney to rest. Then, she was given crackers and orange juice. After, 30 mins in the observation area. Pt stated that she felt much better and able to go. V/S: 109/71, 100, 20, 02 100%RA. Pt was stable when she left the clinic.  Time: 1340-1415
The patient reported intense dizziness as well as some shortness of breath several  hours after receiving  their first dose of the Pfizer vaccine. According to the patient, these symptoms lasted for 24 hours approximately.
The last week in January I noticed a swelling in my left clavicle. I called my oncologist and made an appointment just because of my past breast cancer diagnosis in my right breast. The oncologist ordered a PET scan. On my way home from where I had the pet scan done asking which arm I had my COVID vaccination in. When I got the report, the report stated the swelling in my clavicle was "most likely due to COVID  19 vaccine". Since then I have developed an ache in my left shoulder. The ache is still there.
After injection arm became very swollen (3 inches in diameter) and red.  Swelling subsided but then an aching pain in my upper left arm started that has now progressed to my upper left back ( shoulder). It is a cronic pain that won't go away. As of 12/1/2009 I went to my doctor.  I still have a hard spot where shot was injected.  They are prescribing antibiotic and 800 mg of motring.  Also I am scheduled to get an ultra sound of the area.
sick; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY), administration date 31Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (ongoing), notes: she has a lot of other health problems., Onset Date: Approx 2015, Stop Date: Ongoing , Pertinent Details: L2 L3 hemicolectomy 8-19; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: LEFLUNOMIDE taken for rheumatoid arthritis (ongoing); PRAVASTATIN (ongoing); AMITRIPTYLINE (ongoing). The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; VERTIGO (non-serious), outcome "unknown", described as "vertigo".   Additional information: She suffered from vertigo and got sick even when she puts on her eyeglasses. She did not indicate whether these health issues began before or after getting Comirnaty. Use of medications that suppress the immune system (e.g., high-dose of corticosteroids, cyclosporine, methotrexate, azathioprine, and biologic therapies like rituximab and etanercept). she wanted to get a fourth dose of the vaccine, but she heard there may be another formulation coming out in Mar2022 that specifically targets the Omicron variant. Caller asked if this was true and if the vaccine had a specific lot number that she can ask about at the pharmacy or doctor's office when she goes to get the shot. Vaccine was not administered at military Facility. There was no prior vaccinations within four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On the 10th of March, I remember the spot where the vaccine was administered was itchy.  This was not a prolonged itch.  On the 11th, I noticed a 1 and a half inch by 2 inch jagged red oval at the injection site.  The area is warm to the touch and it appears to slightly swollen.  My only reaction at the time of the shot was just soreness that lasted a day.
No adverse event; Pharmacist states that they had patient dosed with the bivalent vaccine which was administered one and two days beyond the BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had patient dosed with the bivalent vaccine which was administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had patient dosed with the bivalent vaccine which was administered one and two days beyond the BUD.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had patient dosed with the bivalent vaccine which was administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had patient dosed with the bivalent vaccine which was administered one and two days beyond the BUD.).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that the vial was pulled out of the freezer on 24-Apr-2023 and 4 doses were administered on 25-May-2023 and 2 doses on 26-May-2023. Treatment medications were not provided.  This case was reported for patient 6 out of 6.   This case was linked to US-MODERNATX, INC.-MOD-2023-726797 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726797:Patient 1
felt heart start to beat very fast/felt heart accelerating; chest pain; muscle tension; This spontaneous case was reported by a health care professional and describes the occurrence of TACHYCARDIA (felt heart start to beat very fast/felt heart accelerating), CHEST PAIN (chest pain) and MUSCLE TIGHTNESS (muscle tension) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TACHYCARDIA (felt heart start to beat very fast/felt heart accelerating), CHEST PAIN (chest pain) and MUSCLE TIGHTNESS (muscle tension). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (felt heart start to beat very fast/felt heart accelerating), CHEST PAIN (chest pain) and MUSCLE TIGHTNESS (muscle tension) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
PT reported feeling dizzy, warm, shaky, and tachycardic after shot. moved to med obs 1 via wc. vitals monitored  1730 LYING - BP: 144/82 (through shirt), HR: 75, o2: 100 1737 Standing - BP: 116/83, HR: 74, o2: 100
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Sep2023 as dose 1, single (Lot number: HG4629) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 6, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 5, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 4, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Oct2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Oct2023, outcome "unknown", described as "COVID-19 ". Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Nausea, dizziness, itchy eyes, pain on arms, legs, toes and fingers. Poor appetite. And intense burning sensation all over the body.
Extreme fatigue and sore throat for 10 days. Swollen lymph nodes all over my body. Most affected lymph node was under my right arm pit. I ended up getting an ultrasound to rule out cancer.
Flu vaccine given to left deltoid. Pt's arm started bleeding. Alcohol pad used to wipe blood off pt's arm. Saw that arm had swollen and turned blue/brown where injection had been given instantly. Also complained of dizziness. Vitals monitored: pt had irregular heart beat.
Brief Summary of Hospital Stay: Patient is a 56 year old female with a history of cerebral palsy, asthma, hypertension, scoliosis, and seizures and is a resident of local AFC who presents to the ED with cough as well as an episode of vomiting (witnessed aspiration) associated with hypoxia.  Hypoxia quickly resolved.  Patient during hospitalization treated with a full 5 day course of doxycycline and ceftriaxone for aspiration event pneumonia.  Patient also testing positive for COVID and initially treated 3 day course of remdesivir although with development of hypoxia changed over to dexamethasone although hypoxia resolved by 4/11.  Patient to continue dexamethasone however to complete 10 day course with 7 more doses.  Of note patient had transient epistaxis episode which did not recur during hospitalization.  Patient discharged back to AFC on 04/12 and was stable at time of discharge although continued to have upper respiratory breath sounds but maintain saturations and did not appear to be in respiratory distress.  Dietitian manage tube feeds during hospitalization and change tube feeds to Jevity 1.5 on carton 3 times a day with 30 mL flush of water before and after each feeding as well as 250 mL of fluid 2 hours after each feeding (spaced out to diminish residuals and decrease chance of vomiting).   Wound care nurse evaluated right antecubital wound and give the following recommendations:  Right AC: Cleanse with normal saline. Pat dry. Cover with optifoam gentle. Change 3 times weekly and PRN loose or soiled.  Place interdry in Right elbow fold.    Skin care to Left AC: Cleanse with warm wet wash cloth and Remedy cleanser and moisturizer. Pat dry. Apply caldesene powder and dust off excess. Place interdry in left elbow fold. Perform every shift and PRN incontinence or excessive moisture.
Pt called in the morning after receiving vaccine to inquire about effects of vaccine. She stated that upon waking she experienced extreme soreness (unable to raise arm above head), redness, swelling, and inflammation from just below shoulder down to elbow. She marked the boarders w/ a pen. Around 3:30, she stated she was a little better and the reaction had not spread any. She did not take any antihistamine as recommended.
p/vax pt exp flatter varicella like lesions, moderate case, predominantly on the trunk & face, a low grade fever & a pruritic rash;
No adverse symptoms after first vaccine After second vaccination (4/27) - apx 17 hours later; severe headache, body aches, chills, nausea, exhaustion  lasted apx 24 hours - most symptoms subsided by 4/29 - fatigue 4/29 and 4/30
Patient was given 0.25mcg Moderna Bivalent Booster not 0.5mcg. Wrong dose given.
Neurosarcoidosis (auto-immune disease), tarted to effect the arm the injection was given in also across the back of the neck into the base of the skull.  A MRI was done and they found a mass from C2 to C5 on my spine I was hospitalized right away.  At the onset of this reaction I had intense pain and sensitivity also felt like electric shocks going across my body. Total numbness in both feet, both legs, from waist down also both hands are numb with tingling.  My feet and legs get intensely cold and achy.  They found that I had extremely high inflammation in my body.
Narrative: Patient received influenza vaccine on 12/11/21 and presented with a rash localized to the injection site on 12/13/21. Patient prescribed prednisone 5mg dosepak for the rash.
BODY ACHES; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, headache, and nausea on APR-2021. This report was non-serious.
priorix vaccine may have been reconstituted with a Merck sterile water diluent; This non-serious case was reported by a physician via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: priorix vaccine may have been reconstituted with a Merck sterile water diluent).  The outcome of the wrong solution used in drug reconstitution was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 19 Sep 2023 The physician had a vial of priorix vaccine that might have been reconstituted with a Merck sterile water diluent (he had a pfs of priorix diluent left and no more vaccine)  The reporter asked would he need do a patient recall? The reporter consented to follow up. The patient received priorix vaccine might have been reconstituted with a Merck sterile water diluent which led to wrong solution used in drug reconstitution.
Fatigue; Sweating; Pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN (Pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. I00B21A) for COVID-19 vaccination.     The patient's past medical history included Transient ischemic attacks in 2004, Nerve block (Nerve block on back) on 01-Mar-2021, Knee replacement (Left knee replacement), Arthroplasty of knee in 2018 and Brain operation (brain surgery aneurysm) in 1991. Concurrent medical conditions included Fibromyalgia, Hypertension, Arthritis and COPD.   On 22-Mar-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) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN (Pain), CHILLS (Chills) and PYREXIA (Fever). On 30-Mar-2021, the patient experienced FATIGUE (Fatigue). On 01-Apr-2021, HYPERHIDROSIS (Sweating), PAIN (Pain), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 99.1 (High) Unknown.         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
10:42: Patient complained of scratchy throat and mild anxiety and claims to have history of anaphylaxis with penicillin and Aleve allergy. Patient's initial blood pressure at 148/91, 98% O2 sat, 74 HR, RR 16. Patient requested and was given 25 mg/1 tab of benadryl PO.  Patient with no labored breathing or respiratory distress and no swelling at vaccine left upper arm injection site.   10:57: Vitals retaken. BP 136/84, hr 70, 96% RR 18. At this time, patient decided to go AMA. Risks and benefits explained. AMA form signed by patient. Pt in stable condition with steady GAIT and able to exit facility with no issues.
G3P2002, due date 9/23/21, pregnancy complicated by hyperemesis gravidium, received first dose vaccine Moderna march 19th. Starting 2-3 weeks later, she has progressive rash that initially improves with steroids but after rapid taper of steroids in early June progresses to include fevers, body aches, fatigue, joint pain, headache. She is admitted to the hospital, found to have bilateral infiltrates on imaging, oxygen requirement, thrombocytopenia, mild transaminitis. Extensive infectious and rheum eval neg. Skin biopsy positive for eosinophila. Represents to hospital beginning of July with nearly identical symptoms, which never fully improved from first hospitalization. ICU stay, multiple consultants involved. Diagnosed with DRESS (drug reaction with eosinophilic systemic symptoms). Based on medication list and timing, this is vaccine induced.
In mid-October 2022 I began to have, what I thought was acid reflux.  When I have had reflux in the past it would last about a day or two.  This time it lasted almost three weeks. But the pain went away, and I just continued to have a cough.  The cough just persisted.  The doctor is now treating this as asthma.  I have an appointment in January for a doctor to listen to my lungs.  The cough happens less if I am standing up or walking.  When I sit for a long time, it is worse.  When I try to lay down and sleep it gets even worse.  I take Nyquil to help with sleep.  My throat is also sore and if the substance is too spicy or too cold, I begin to cough severely.
Shortly after the patient got his immunization, he felt nausea and like he was going to throw up and was sweaty. He was nervous and had thrown up before coming to the immunization appointment. He stated it is normal for him. He had to lay down and felt better after a couple minutes.
Itching skin and eyes, swollen eyes, throat tightness, sob, dizziness began 8 hours after injection. Progressed x 2 days. Tx with Advil, no relief. Second night took Benadryl with relief next morning.