chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease stage 3a" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive, notes: Took PCR Covid test on 07Jun222 and tested POSITIVE on 08Jun2022; (31May2022) Positive; (04Jun2022) Positive; (06Jun2022) Negative, notes: On 06Jun2022 no temp, and rapid test shows Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 31May2022 to 05Jun2022.  Clinical information: Reported as, the patient did not receive other medication in two weeks. Symptoms began 28May2022, thought it was allergy. Rapid test positive on 31May2022, and started Paxlovid with an evening dose for the treatment of COVID-19. Took all five doses, still had congestion and mild temperature. Retested with rapid test on 04Jun2022, results Positive, congestion and intermittent mild fever. The patient stopped Paxlovid on 05Jun2022. On 06Jun2022, no temp, and rapid test shows Negative. Took PCR Covid test on 07Jun2022 and tested positive on 08Jun2022. The patient was still congested and messed up sleep patterns, some loose bowels.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever. Hypoglycemia-Hospitalized with IVF- D10. 1/31/2008 MR received for DOS 1/16-22/2008 with chief complaint of Fever (no D/C DX on D/C Summary). Pt had apparently had some blood sugars below 80 at home 2' to fever and was admitted for supportive care.  Txd with D10 IV.
1st case of shingles confirmed in May 2022, lasting through July 2022. 2nd case of shingles confirmed by doctor on 3/8/2023.
Has been unable to receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose (0.5 ml) received intramuscularly on unknown deltoid 2 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient self-reported this case. The patient had been unable to receive her 2nd dose till the time of reporting (resolution unknown), which led to incomplete course of vaccination. The reporter did not consent to follow up.
Patient reports that she received the injection "high up" on her shoulder and she thinks that the injection may have gone in to the joint. She had excruciating pain for 48 hours, especially if she tried to move it. It was better after 4 days, but still is uncomfortable 4 weeks later, when she reported this to us. She reports that she will go to her PCP if the pain does not resolve totally. She has been doing ROM excerises that her cousin who is a PT has recommended for her.
After the shot I had arm pain and redness, kind of like a bump. It went away in a few days, but about a week later my arm started inching and the big red/swollen spot came back.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and Unknown) for COVID-19 vaccination.     No medical history was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On 01-MAY-2014, the patient was vaccinated with GARDASIL (dose and route of administration were not provided)(reported lot # was illegible, expiration date: 28-SEP-2014) dose 1 in the left deltoid. The GARDASIL was out of range temperature. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Hospitalized 11/24/2021; COVID-19 positive 11/24/2021; fully vaccinated  BRIEF OVERVIEW:  Admission Date: 11/24/2021 Discharge Date: 11/26/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] Hypoxia, sleep related [G47.34] Fall, initial encounter [W19.XXXA] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is an 85 year old female with a history of OSA, Meniere's disease, chronic kidney disease, and deafness in the right ear who presented to the ER on 11/24 with weakness and fall after 4 days of sinus congestion and cough.   The patient has an abrasion posterior lateral to her left eye as a result of the fall.  The patient had an oxygen desaturation to 87% in ER and was stable on 2 liters supplemental oxygen per NC. Other vital signs were stable except for an occasional high blood pressure read. Lab work showed kidney function at patient's baseline, indeterminate but stable troponins, and a positive covid test. The patient has received 2 doses of Pfizer Covid vaccine. CT head showed no acute intracranial abnormality. Chest x-ray showed patchy opacities in the left base. The patient was weaned to room air prior to getting to her inpatient room. She was admitted for weakness and falls likely related to Covid infection for further work up and monitoring.   The patient continued on room air while in the hospital.  A home oxygen evaluation showed she maintained 92% saturation with activity on room air; she does not need supplemental oxygen. She was offered MAB therapy but declined at this time.  She did receive two doses of Remdesivir and decadron while inpatient.  She was evaluated by PT and OT. PT recommended home with home health care.  The patient currently has the assistive devices she needs in the home.  She was discharged in stable condition with HHC and recommended follow up with PCP. She was also encouraged to get some sort of alert device incase she falls or is in need of help at home but can't get to the phone. She agreed and will do the research to find the communication aid that fits her needs
I started shivering and felt really cold around 10-11pm. By 1am I had 102.5 fever and could not sleep. Fever is still lasting through the next day (14h after fever onset time) although it went slightly down to 101.1 My left arm hurts at the injection site
9FEB91 generalized aching; 10FEB91 nausea, vomiting, diarrhea, temp 101, 11FEB91 hospitalized BP 90/60 - nausea, vomiting, diarrhea, temp continued, MD reported "looked like had a sunburn from head to toe"  IV - re hydration
SIRVA - Shoulder injury related to vaccine administration.  Left shoulder began having severe pain the day after the vaccine and every day after that.  It is worse at night.  It appears to be bursitis related to improper injection location.  Severe restriction of arm movement.  Severe pain.  No history of pain in shoulder in entire lifetime.
This spontaneous report was received from a healthcare worker and refers to an approximately 57 years old female patient. The patient's concurrent conditions included unspecified allergies. On 21-JUL-2013 the patient was vaccinated with ZOSTAVAX (strength, dose frequency and route were not reported). Concomitant medications included unspecified eye drops and unspecified antihistamines. The reporter stated that on an unspecified date in the beginning of October 2015 the patient was diagnosed with a case of shingles. Patient sought medical attention by visiting to the office. The outcome of herpes zoster was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Weakness, fatigue, headache, eye pain, arm pain 10/10 & swelling, short of breath, feeling heart racing when not laying down
The vial was iniially stored in refrigerator on 18-Mar-2023 and was administered to patient on 19-Apr-2023; No adverse event; Patient received Moderna Bivalent vaccine 2 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine 2 days after beyond use date), PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 18-Mar-2023 and was administered to patient on 19-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an 81-year-old 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. 065H22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 17-Mar-2021 and MODERNA COVID-19 VACCINE in April 2021; for Product used for unknown indication: COVID-19 VACCINE on 20-Dec-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, MODERNA COVID-19 VACCINE and Moderna COVID-19 Vaccine.    On 19-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine 2 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 18-Mar-2023 and was administered to patient on 19-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine 2 days after beyond use date), PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 18-Mar-2023 and was administered to patient on 19-Apr-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine 2 days after beyond use date) and PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 18-Mar-2023 and was administered to patient on 19-Apr-2023).    Concomitant drugs were not reported.  It was reported that 1 dose from 1 vial was not exposed to temperature excursion. Patient was not contacted by reported for any side effect.  Treatment medications were not provided.
40 minutes after injection she described a funny feeling in her throat.  O2 sat was 100% and she was swallowing with no problem.   15 minutes later she began to cough and we took her to the ED.
Right upper arm has pink discoloration around 6" of site of injection. Swelling and tenderness.
Pt on hospice in facility for severe cardiomyopathy unable to perform interventions received vaccine without adverse sequelae died 5 days later. Reporting as required. Narrative:  Reporting as required patient death 5 days after immunization with Pfizer vaccine. However, no adverse sequelae were noted to the vaccine in the 15minute observation period, nor in the days following the immunization related to the vaccine. The patient denied any prior severe reaction to this vaccine or its components, and the patient gave verbal consent to receive the vaccine. Patient had been in the facility on hospice since 11/18/20 for severe decompensated HF and newly diagnosed cardiomyopathy, unable to perform interventions, also LE ischemic wounds with very poor potential to heal due to advanced PVD.
One day post vax, the pt experienced a fever up to 104, redness to arm and tightness to the site with minimal swelling. Complained of dizziness, stiff neck, achiness, hallucinations, head "tight". The pt was advised to see physician. ER administered IV for dehydration and the pt was told is "allergic to vaccine". No further symptoms.
Information has been received from a registered nurse concerning herself, an 80 year old female with asthma and allergies to codeine and sulfa who was vaccinated with the first dose of PNEUMOVAX 23 (lot number, route and site not reported) within the last 10 years. Concomitant therapy included PREMARIN and thyroid medication. After receiving PNEUMOVAX 23, the patient developed pneumonia. The patient had fluid present in both lower lobes. She was hospitalized during the end of January of 2009 to 06-FEB-2009 for pneumonia. The patient's oxygen level was 87. The patient was given oxygen. "She was in and out of consciousness." The X-rays were performed, but the result was not reported. The patient recovered on an unspecified date. A second dose of PNEUMOVAX 23 (lot number, route and site not reported) was administered March or April of 2009. Pneumonia and "in and out of consciousness" were considered to be disabling, immediately life-threatening and an other important medical event by reporter. Additional information has been requested.
Pt recv vax on unknown day; post vax pt exp vax site swelling; dx=arthritis or rheumatoid arthritis
I contracted had nausea and a fever the 24 hours after my vaccine and then developed shingles (which i have never had) 72 hours later
PT RECIEVED THE PFIZER VACCINE FIRST DOSE AND MODERNA FOR THE SECOND DOSE
Information has been received from a 77 year old female with allergies to cefaclor (CECLOR) and relafan, and a history of shoulder replacement in 1997, who on 10-Nov-2006 was vaccinated in her arm with a first dose of varicella-zoster virus vaccine live. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) (manufacturer unknown) and a dose of pneumococcal 23v polysaccharide (manufacturer unknown). Concomitant therapy included metoprolol succiante (TOPROL XL TABLETS), simvastatin, escitalopram oxalate (LEXAPRO), aspirin, esomeprazole magnesium (NEXIUM) and minerals (unspecified) (+) vitamins (unspecified) (CENTRUM). On 15-Nov-2006 the patient developed little red itchy bumps all over her body. The patient "thinks it's chicken pox". It was reported that the bumps "kept building up and gradually got worse" starting on 18-Nov-2006. She reported that some of th bumps were turning into scabs. She was putting triancinoioneacetonide ointment on them. Medical attention was not sought though the patient stated that she was going to call her physician and make an appointment. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was available. Additional information has been requested. 6/17/10 Additional informatin from the nurse practioner indicated that on 20-NOV-2006 she examined the patient in the office and the patient had about 6 lesions, 4 mm in size. No other information was available.
underneath the shot I got a fire burning sensation that doesn't go away its warm  red rash thats spreading down my arm puffy  swallon hard
Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: 911 called. Patient evaluated by paramedics. Patient recovered and felt well enough to drive home. Patient refused hospital visit
2 seizures less than 8 hours after. My son seized for about 2 minutes, stopped breathing, and fever spiked to 102 degrees. 2nd seizure less than 45 minutes after 1st while in hospital. Again stopped breathing, full body seizure, fever at 102 degrees.
Grandmother verbally reported to that pt. "fell and fainted".  When staff looked up at pt., she was returning to a sitting position from leaning to the left in the chair.  No fall or fainting witness by the staff.  When I approached pt., she was sitting in the chair.  Pt. verbally reported that her head was hurting on the right side of her head and that her arm was hurting on the right side where she received the vaccine.  Temperature taken and was 97.3, B/P 107/73 on left arm, RR 20 and HR 80.  Staff translated in other language with the grandmother and she reported that pt. never had a reaction to vaccines in the past and that pt. had eaten breakfast. Pt. was encouraged to continue to drink fluids.  Pt. was reassessed every 5 minutes and verbally reported that she was feeling better, head and arm was hurting less and that she felt back to normal.  After the 30 minutes of observation, pt. was able to stand, lift arms above head, and she ambulated around the chairs in the post vac area without any signs of dizziness and no verbal complaints.  Patient left the post vacc area without ambulating independently and verbally stating that she felt back to normal.  Post vacc instructions translated to the grandmother from staff.
Patient received 1st dose on 9/24/21 and reported a sore arm afterward but then awoke 9/27 to AICD firing and fired multiple times enroute to ED and in the hospital. Found to have multiple electrolyte abnormalities (K 3.1, Mag < 0.5); placed on amiodarone and lidocaine drips, started mexilitine 200mg q12. Single chamber AICD upgraded to dual chamber AICD on 10/4/21. Recurrent VTach on 10/8/21 - multiple AICD defibs - paced out and started again on amiodarone and lidocaine. Continued issue - required intubation and sedation on 10/8 due to on-going runs of Vtach and AICD defibrillations. At the time of this report, remains on Amiodarone at 1mg/min, Lidocaine at 1mg/min, Mexiletine 200mg PO q12h and is still intubated and sedated.   Note - hospital course has now been further complicated by new LLE DVT and B-PEs on 10/9. Unclear if also associated with vaccine or a complication of hospitalization / arrhythmia. This has been treated with 50mg IV alteplase and he is currently on a heparin drip.
no adverse event; Dose administered after Manufacturer Date of Expiry/Expiration date: 29May2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry/Expiration date: 29May2023) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-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 30-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry/Expiration date: 29May2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry/Expiration date: 29May2023) 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 (Dose administered after Manufacturer Date of Expiry/Expiration date: 29May2023).    Concomitant medication not reported. Treatment medication not reported.
Vaccine adm in left deltoid on Wed 13 Nov 2013, pt woke up on 14 Nov 2013 and arm was numb from injection site down to fingers. Symptoms continued to Friday and she was advised to seek medical attention.
Pt received Varivax #1 in L thigh on 4/11/03. She subsequently developed redness and swelling at site of injection. Was seen at MC ED on 4/12/03 and put on 10 days of Keflex and Benadryl.
Strep pneumococcal sepsis fever, hypertension and lethargy 11/6/07-records received for DOS 5/14-5/21/07-DC DX: Status post streptococcus pneumoniae sepsis. Chief complaint, cough and fever with 2 day history of fever and headache. Ten days prior to admission had diagnosis of GAS pharyngitis and did not complete the antibiotic treatment. PE: decreased right sided breath sounds, mild pain in neck with flexion. Temp 97.8 in ED. Hospital course hypotensive, required intubation, moderate right sided pleural effusion required chest tube and subsequently extubated.
This spontaneous report was received from a registered nurse and refers to a 4 years and 10 months old male patient. There were no historical conditions, concurrent conditions and concomitant therapies. On 11-FEB-2015, the patient was vaccinated with the first dose of varicella Oka/Merck VARIVAX, subcutaneously, lot # K006136, expiration date on 29-APR-2016, for prophylaxis. It was stated that on an unspecified date in June 2018 (reported as "last week"), the patient was exposed to an unspecified child with chicken pox. Subsequently, on an unspecified date in 2018 (reported as over the weekend), the patient developed chicken pox (varicella). Therefore, the patient's mother called to the physician's office and was recommended unspecified doses of TYLENOL for fever, BENADRYL and Calamine lotion for rash. Also it was recommended oatmeal bath for rash and the patient's mother was advised to return to physician office if the patient developed high fever. There were no laboratories performed. The registered nurse stated that the patient was due for second dose of Oka/Merck VARIVAX on an unspecified date "before kindergarten". The outcome of varicella was reported as not recovered. The reporter did not provide causality assessment between Oka/Merck VARIVAX.