chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; vaccine dose number= 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hi blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "stress" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EXTRA DOSE ADMINISTERED (non-serious) with onset 25Feb2022, outcome "unknown", described as "vaccine dose number= 5"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical course: The patient received Paxlovid treatment from 16May2022 to 20May2022 for covid-19 treatment. After taking the Paxlovid Patient felt exhausted, short tempered, dizzy, lethargic. Felt better prior to taking the medication. Patient lost taste and generally did not feel good at all.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash/hives all over body x2 weeks since injection - 1-2 days after injection.
Within several hours developed soreness, hardness at injection site.  By late afternoon/early evening I began feeling very tired.  Developed headache and muscle soreness by 7 p.m.  As evening progressed became increasingly tired, headache worsened (sinus back of head).  Felt weak.  Began shivering (fever).  My wife took my temperature several times and it was 100.4. Overnight I was miserable with the headache, muscle soreness (everywhere) and by morning still had the fever (100.2).  As the day (Saturday) progressed began to feel somewhat better. The headache had mostly subsided, some  soreness persisted, felt stronger.  By Sunday morning felt much better.  No specific treatment for the symptoms other than fluids.
Severe swelling of arm from shoulder to elbow. Redness and itching.  Given prescription of Prednisone at an urgent care facility.
Patient woke up with mumps of which was between 16 to 18 days incubation period after the shot was administered, right saliva gland swollen with ear hurting.
This spontaneous report was received from a pharmacist refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were inadvertently vaccinated with improperly stored doses of PROQUAD (Merck), lot # K008870, expiration date: 19-DEC-2015, (dosage and route were not reported). No adverse effects were reported. Concomitant therapy was not reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected because there is not permission to contact physician.
June 16, 2021, my BP was elevated, I had elevated BP 138/99.  September 2, 2021, my BP was 147/101 when I went in for surgery for my right thyroid removed.  This elevated BP continued till 09/27/2021 and doctor put me on a BP medication and cholesterol.  I went back to my Doctor today and it is now 128/80. So my doctor feels that medication is working.
Provider ordered DTAP and pt is 7 years old. DTAP can only be under age 7. MA administered DTAP. Re educated MA about age indications. Handouts given on vaccine age limits. Provider also informed
Within 24 hours post vax, the pt developed a high pitched cry fore a duration of 4 hours. No fever present, no redness or swelling, and no evidence of site involvement. Pt treated with acetaminophen.
This spontaneous report was received from a physician via a company representative concerning a currently 20 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient received the third dose of GARDASIL 9 intramuscularly (dose, lot number and expiration date were not reported) for prevention of human papillomavirus (prophylaxis). Another suspect therapy included TRUMENBA. On an unknown date, the patient fainted. On an unspecified date, the patient sought medical attention. At the time of reporting, the outcome of the event was recovered. The causal relationship between the event and GARDASIL 9 was not reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA002569.
I developed fever and fatigued the following day after I received the vaccine .I had an online appointment with Dr. and he ordered bloodwork at that visit. My kidneys aren't functioning right I have more bloodwork scheduled for 10/7/21 not sure if its related to vaccine or not.
Dizziness and lightheaded ness with and without rest. Has continued daily since flu injection. Have never experienced this before having the shot. I haven't seen a doctor as of today but will make a appointment if continues. It's been a week now with no relief.
cardiac issues; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 03Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "cardiac issues".  Additional information: Question: "EUA vs Comirnaty does the FDA approved Comirnaty have any liability, if there are complications, for me to say to Pfizer I am having xyz problems from your vaccine. Just like any other FDA approved drug?" The caller received her Pfizer vaccine 2nd dose on 03Feb2021 still having cardiac issues. She had to deal with ever single day. Her job was making me get the booster dose.  Response: Spoke to the caller from the attached document. Provided the caller with the following information and resource website.  Question: Please continue to pass along our frustrations with this situation, the inability of the frontline agents to tell consumers if they receive a Comirnaty vaccine and it is labeled EUA, is Pfizer still possibly liable for damages like any other FDA approved drug? I am not an antivaxer. I am just trying to look out for my health and we feel like puppets on a string.  Response: Spoke to caller from vaccine injury program  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around 10 am I received the flu vaccine. Immediately after I was nauseated and started having hot flashes. About 30-40 minutes later I started dry heaving and became extremely dizzy. I tried standing up and fell back down so I immediately got my boss and told her something was wrong and I needed to go to the ER. The room was spinning and I could barely lift my head up. A little while later the back of my neck and down my spine started hurting almost like a muscle ache. The nurses at hospital took me over to the ER where I was seen immediately. I loss consciousness twice while they gave me my IV. The doctors gave me benedryl mixed with a medicine that I cannot remember but it was copazine or something like that. I was there for about 2 hours then was discharged after I started to feel better and was able to stand.
2 days after injections (L) thigh increased erythema & swelling without fevers. Pt with pain but ambulates with ease (L) thigh 60 % erythema & edematous warm & TTP nonfluctuant.
A non-serious spontaneous case of double dose of FluMist was received from a registered nurse concerning a 38-month-old male patient. The patient received the first dose of FluMist on 14-Oct-2009 and the 15-Oct-2009, a second dose of FluMist was given. The reporter last saw that on 16-Oct-2009 at which time he was doing fine, running around, and playing. There was no adverse event associated with the vaccination error therefore, treatment and causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.
Severe Pain in Left Shoulder radiating down through the upper arm region. Sharp and throbbing with decreased range of motion and mobility. Increasing pain daily.
Initial solicited report on 08 March 2017 and follow up information received on 13 March 2017 from an investigator in the trial. A 23 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 03 August 2016. On 14 August 2016, 11 days after vaccination the subject was diagnosed with I40.8 Other acute myocarditis/I51.4 Myocarditis, unspecified. The subject's lab data included, ECG was normal done on 14 August 2016, Echocardiogram was normal and Troponin I result, highest value 0.54 ng/Ml was abnormal done on 15 August 2016. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 23-year-old male who developed acute myocarditis with favorable temporal association post vaccination with ACAM2000. Myocarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be myocardial infarction, pulmonary edema and coronary artery vasospasm. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Patient reports arm hurt more than normal during administration. By 5:30 am, next morning, had no feeling on left leg; it took 30 minutes to wear off. Patient did not go to doctor. Occasionally takes some BENADRYL to go to sleep; and experienced a similar episode. This time it passed quickly. Patient has not used BENADRYL since. Patient not sure whether to take next SHINGRIX dose because afraid of similar symptoms. Except for supplements patient has not taken any TYLENOL/ALEVE since. Patient will mention incident to doctor during next visit. In terms of recovery, patient not sure if episode will repeat again.
pt devel; 10 1/2 x 9cm area of redness;swelling @ inj site probably cellulitis & low grade temp;pt required treatment w/ATB;
About 5 days after the immunization was given the patient developed welts and blisters on her upper arms and upper back. She also experienced itching.
This spontaneous report as received from a nurse refers to a 14 month old male patient. The patient pertinent medical history was none and no known drug allergies. On 10-FEB-2015 the patient was received a partial dose of M-M-R II (dose and frequency were unspecified) (lot # K008625 and expiry date: 16-JUN-2016) subcutaneous in the left leg because the needle was not correctly attached to the syringe. Concomitant medications were none. On 10-FEB-2015, the patient subsequently developed hives at the injection site on the patient's thigh within 30 seconds of receiving the partial dose. The patient was immediately treated with BENADRYL. No lab tests were performed. The outcome of hives at the injection site was reported as recovering/resolving. The causality of hives was not reported. No product quality complaint (PQC) was reported for (M-M-R II). Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's coexisting conditions included rheumatoid arthritis with an unspecified onset. No other information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 06-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # L035686, expiration date 16-FEB-2017 (dose and anatomical location were not provided). On approximately 06-JUN-2016 (reported as immediately after receiving the PNEUMOVAX 23, the patient experienced a reaction described as: swelling, muscle pain, headache, neck ache, injection site swollen to size of orange (diagnosed as symptoms of cellulitis). The nurse reported that the patient sought medical attention by calling nurse practitioner office on 09-JUN-2016 but was not seen by the nurse practitioner until 10-JUN-2016 (also reported as today). The treatment note was not completed at the time of the call (reported as the patient was given the treatment). During infusion of REMICADE for rheumatoid arthritis on an unspecified date in June 2016, the unspecified staff member noticed that the patient had a hard area which was bruised and tender where the PNEUMOVAX 23 was administered. The patient did not have lab diagnostic studies performed. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
After vaccine administration, he felt hot, faint, said his hearing and vision went in and out for a few minutes. He sat, drank water, and left without further incident. He had a driver and was much improved in 10 minutes.
patient received FLUZONE QIV NP vaccine that expired on 30JUN2021 with no AE; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a nurse via Agency (under reference:00814554).  This case involves a 30-year-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] vaccine that expired on 30-Jun-2021 (expired product administered).   The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 14-Oct-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5mL, once, Total, lot UT7108MA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual case of medication error due to expired vaccine used (latency: same day).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine. See inquiries associated with this contact for additional patient information. This information is regarding the seventh of 12 patients that received expired FLUZONE QIV NP."  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After 3rd shot- 10 days after, hives all over body, dermatographia, hot flashes, low grade fever. On December 23, I had an allergy specialist appointment . Same symptoms from November 14-present
Got 2nd vaccine on Monday morning. On Tues  (2/23) I had extreme fatigue about 4:30 PM.  By the time I went to bed ,  all my bones and muscles ached and I had a headache.  I had a very slight fever that Tylenol took care of .Wed. morning I was OK but it happened again Wed. afternoon.
Hives on left arm, left thigh, right leg , right side of stomach. Took benadryl and zrytec and didn't solve problem. Dr prescribe itch cream and pills.
8/26/21: Bilateral sandpaper rash around knees at night. 8/27: Rash on entire legs, below buttocks; 8/28 Rash included buttocks and swollen, painful lymph nodes in inguinal area.  Skin felt inflamed, but not itchy. Started Zyrtec 10mg daily. That night rash started on hands. 8/29 AM, rash was on arms up to the shoulder. 8/29 Rash started on lower trunk area, itching started. Singulair 10 mg nightly started. 8/30 Rash covered trunk area from below the chest in front and below the shoulder blades in back. 8/31 Top of breasts. 9/2, rash started to wane, inguinal pain started to diminish. By 9/5 pain in the inguinal area was gone. 9/10 small patchy areas behind the knee and at elbows. 9/13 rash completely resolved.
P. reported chest pressure, sweating, shortness of breath, dizziness, throat a little tight, jaw and neck pain. EMS evaluated patient. Pt. was informed to seek Provider Medical Treatment. Pt. observed for approximately one hour and a half. Released to family member.
ill; minor reactions; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) and IMMUNISATION REACTION (minor reactions) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for an unknown indication.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (ill) and IMMUNISATION REACTION (minor reactions). At the time of the report, ILLNESS (ill) and IMMUNISATION REACTION (minor reactions) outcome was unknown. Not Provided      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743464, MOD-2023-743565 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743464:Master Case MOD-2023-743565:Patient 2
leg swelled; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from Non-HCP (Sales Representative).  This case involves a 4 years old patient who experienced leg swelled, while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious leg swelled (peripheral swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant test was not reported.  Final diagnosis was leg swelled.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for leg swelled.  Information on the batch number was requested.
Pt vaxed on 11NOV91 & on 14NOV devel a spot on the leg which was itchy & raised; this disappeared but has had an itchy spot come & go each day x 5 days on various areas of the body;
weakness was so severe; could not get out of bed and could not walk; Polymyalgia Rheumatica; muscle pain in her arms and biceps; This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 cases of shingles in her life).   On 16th August 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. In August 2021, less than a week after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant) and muscle pain. On an unknown date, the patient experienced weakness and mobility decreased. On an unknown date, the outcome of the polymyalgia rheumatica, muscle pain, weakness and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the polymyalgia rheumatica, muscle pain, weakness and mobility decreased to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient received Shingrix vaccine into her left deltoid at her physician's office. Four to 5 days later, she reported muscle pain in her arms and biceps. The patient also mentioned in the first 4 weeks after the vaccine, she also reported that she had 2 separate episodes in which her weakness was so severe that she could not get out of bed and could not walk. The patient had never reported these symptoms prior to getting the Shingrix vaccine. The patient had blood tests done, which came back normal, but she was diagnosed with polymyalgia rheumatica.  The patient reported symptoms was currently unresolved. The reporter consented to follow up.
livedo reticularis; This spontaneous case was reported by a consumer and describes the occurrence of LIVEDO RETICULARIS (livedo reticularis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No past medical history was reported.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced LIVEDO RETICULARIS (livedo reticularis). At the time of the report, LIVEDO RETICULARIS (livedo reticularis) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received.  No product concomitant was reported.