chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Batch/Lot number: unknown), on 03Feb2021 as dose 2, single (Batch/Lot number: unknown), on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 12May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid (orally) from 11Aug2022 to 16Aug2022 for Covid-19 treatment. Patient had no Known allergies  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure, covid-19 and suspect drug BNT162B2 cannot be excluded.
Patient passed out 5-10 minutes within receiving vaccine.  Unresponsive for a minute or two. Vomited soon after waking up. Paramedics arrived soon after patient stopped vomiting. Transported to  in . RPh talked to patient several days later. Patient stated "needle thing" was thought to be cause. Patient stated she had passed out previously when giving blood, but her administration and consent form said no previous history of serious reaction after receiving a vaccine.
This spontaneous report was received from a registered nurse and refers to an approximately 9 days old neonate of unknown gender. No pertinent medical history or concurrent conditions were reported. On 10-AUG-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K024552, 0.5 ml, intramuscular. No adverse effects were reported. This report was linked to case 1509USA012522 as it was received from the same source. Additional information has been requested.
There was an excursion from the freezer,vaccine administered to 118 patients; There was an excursion from the freezer,vaccine administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and POOR QUALITY PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and POOR QUALITY PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and POOR QUALITY PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported  no treatment medication were reported
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 84-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment with the State currently. Also reported that no adverse reactions were experienced by any patients.
Few hrs after VARIVAX shot- mom noticed him stiffening in his high chair and turning of head to 1 side for brief sec. Occurred 2x again after 30-60 min from 1st episode. Patient was awake and stopped the stiffening when mom got him out of the high chair.
Rapid and irregular heartbeat Taken to hospital emergency room Treated Remained 8 hours until heart stabilized
swollen lymph nodes in armpit, fever, hot and cold sweats, fatigue, swelling and redness at injection site
Side effects of the vaccine were elevated and lasted longer than usual. Injection site swelled for ~5 days to a raised, red bump ~2 inches in diameter and was very hot. Pain/heaviness of arm continued for a few days after swelling resolved.
WITHIN 6HRS OF INJECTION: VERTIGO/SYNCOPE, FEVER, EXTREME CHILLS/SHIVERS, NAUSEA, SIGNIFICANT SWELLING AT INJECTION SITE, HEADACHE, MUSCLE SPASM/WEAKNESS. TX'D WITH 800MG IBUPROFEN Q4-6H PRN PAIN/FEVER. WARM COMPRESS TO INJECTION SITE, PUSHED FLUIDS AS TOLERATED TILL NAUSEA SUBSIDED. VERTIGO/SYCOPE - 48HRS CHILLS/SHIVERS/FEVER - 72HRS MUSCLE SPASM/WEAKNESS - 48 HRS NAUSEA - 48 HRS SWELLING AT INJECTION SITE - 72 HRS PAIN AT INJECTION SITE - 96 HRS AND STILL PAINFUL HEADACHES - 96HRS AND STILL PAINFUL
Swelling at injection site, pain in the shoulder/neck area on side where the injection was given
Patient experiencing nausea anxiety SOB.  On-site emergency response performed assessment.  Vital signs all within normal limits; patient and husband advised to continue monitoring for life-threatening signs and symptoms; further medical transportation and treatment not advised; patient advised to hydrate and wait additional time. no transportation utilized  RN
Complained of off and on pain in left arm since he received a flu shot on 12/6/06.
COVID breakthrough first dose 3/15/2021 EL9266, second 4/5/2021 EL 9269.  COVID pos respiratory PCR 6/1/2022.  73-year-old female who presented to the emergency room today with complaints of shortness of breath which she developed over the last the 48 hours.  Patient states that has been tested at the assisted level of care facility where she resides for COVID yesterday and it was reported as negative.  Unfortunately, her respiratory distress has persisted, and worsened over the night and she decided to present to the emergency room.  She was diagnosed by PCR method with COVID-19 infection.  She had difficulty breathing, with increased secretions
Myalgia, Fever, NauseaVomiting,  fatigue, site swollen sore
w/in 2wk of vax pt began having episodes of eye fluttering & cessation of activity for brief periods several times a day, EEG shows probable petit mal sz activity
supposed to get the second dose on 17 Feb 2021, but were not able due to climate conditions/received second dose on 01 Mar 2021; A spontaneous report was received from consumer, who was also a 76-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was supposed to get the second dose on 17 Feb 2021, but were not able due to climate conditions/received second dose on 01 Mar 2021 (inappropriate schedule of product administration).  The patient's medical history was not provided. Concomitant product use was not provided.   On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  The patient reported that he was supposed to get the second dose on 17 Feb 2021, but was not able due to climate conditions.     On 01 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Immunization given 11/1/02. Rash on torso, legs, face started 11/10/02. Tylenol and Benadryl started 11/12/02. Rash fading 11/14/02.
pins and needles in right leg.  Leg then went numb.   Started toes and increased up leg.  Called Doctor and she said to come into office.
Inguinal lymphadenopathy - both sides, swollen, 1/2 diameter fever - 101-104 degrees F.
Pt. received her second dose Moderna Vaccine and upon discharge from the observation area, she started feeling tightness in the  throat and neck area as well as experiencing an itchy throat sensation. Pt was immediately  brought to the ER room, assessed and monitored closely by NP?s. Pt remained alert and oriented x3 and coherent, v/s were 117/68 pulse 89, o2 sat 99% room air. NP administered 50 mg Benadryl  PO and Pt was observed for an additional 45 mins. Airway and buccal mucosa appeared to be intact, no swelling, no erythema noted. Pt given hydration and a snack, pt. was able to tolerate the snack, and drank 8oz of fluid without any difficulty. Pt denied having any difficulty swallowing. Pt verbalized that  she felt better and the itchy and tightness sensation subsided. Once Pt was stable, and verbalized no further complaints of symptoms, she was discharged from ER observation accompanied.
tested positive for covid on 2/15/22 shortness of breath, fatigue for 3 days, hypotensive, febrile and hypoxic, w cough . Dialysis patient.
I have Lupus which has been pretty controlled, and I have never missed work. I have had some vision loss in the past. The vision loss has been controlled since 2017. The last time I had gotten a checkup was November of 2019. I saw my Ophthalmologist just before the second dose of the vaccine and there was some vision loss in my right eye. There was no change on the left. I went back to the eye specialist five weeks later. 05/03/2021 and 5/25/2021. I have had a flare up of Arthritis in my hip which started two weeks after the second dose of the vaccine. I was also diagnosed with Hypertension at the same time as my Arthritis flared up. I am supposed to walk with a cane now and I have been unable to work sometimes because appointments and my hip pain. I am having fatigue, difficulty concentrating which may be somewhat related to the medication for pain. I have had some medication changes to control my Lupus. Solumedrol and Cytoxan infusion therapy. I am getting Bactrim to offset the infusion therapy. Procardia and Prednisone increase and my Myfortic is discontinued. I also Simerinva eye drops for my eyes. I am getting Bactrim to offset the infusion therapy. It has been over ninety days now and My condition is still mostly the same.
Patient states that she has been having trouble moving her arm after the flu shot. She is going to be seen by urgent care.
Patient fainted, slight jerking, arm and face tingling, then difficulty breathing, that lead to coughing, some airway obstruction.
FEELING WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-AUG-2021, the patient experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling weak was not reported. This report was non-serious.
Completely lost hearing in my right ear. Previously had some hearing loss but now I have complete loss in right ear. Happened within 2 weeks of first dose.
Patient is a 63 y.o. female with a history of IDDM2 on U-500, Afib on Eliquis, chronic systolic CHF, ESRD on HD, and multiple recent hospital admists 8/11-8/21/23 for acute CHF and started on HD, 8/23-9/2/23 for R ankle fracture s/p ORIF and 9/15-9/20/23 for hypoglycemia and discharged home with HHC. She presented to hospital 9/23/2023 with 1 day history of fever, dyspnea and cough and was found to have COVID 19. Course complicated by Bifidobacterium bacteremia.    1. COVID 19: 1 day history of fever, productive cough and shortness of breath.  COVID-19 positive on admit.  Chest x-ray on admit nonacute.  Patient on baseline oxygen requirement.  ID followed, remdesivir thru 9/29/23.  2. Bifidobacterium bacteremia: 1/2 bottle from 9/23/23. Started on unasyn 9/25/23. Repeat blood cx 9/25/23, negative so far. ID followed, recommended CT Ab/pelvis which was non acute, and Unasyn continued thru 9/29/23. 3. Nausea, diarrhea, Bloody stools: C diff neg. Eliquis held, restarted 9/29/23. Zofran, PPI ordered. GI followed, OP colonoscopy.  4. Thrombocytopenia: Platelets normal at baseline.  Platelets 142 on admit.  Likely due to above.  monitored, stable. 5. Demand ischemia, Elevated troponin: Troponin 69 on admit.  Repeat troponin stable.  EKG on admit nonacute.  No further work-up 6. COPD with chronic respiratory failure: On 2 to 3 L nasal cannula at baseline.  No evidence of exacerbation.  Continue home inhalers.  Continue home oxygen 7. ESRD: Follows with Dr. (nephrology).  On HD Monday Wednesday and Friday.  Consulted nephrology for ESRD while inpatient 8. Chronic systolic CHF: Follows with Dr. (MC).  TTE 3/23 with EF of 40%.  Volume management per HD. 9. Paroxysmal atrial fibrillation: Eliquis held dt bloody BM, restarted. no longer on beta-blocker due to hypotension 10. IDDM2: Follows with Dr. (endocrinology).  On U-500 at home.  Recent hospitalization for hypoglycemia and insulin adjusted.  Continued home U-500.  Endocrine followed, adjusted regimen as below.  11. Anemia of chronic disease: Baseline hemoglobin 8-9.  Hemoglobin 7.9 on admit. Stable.  12. Chronic liver disease: Follows with Dr. (GI).  S/p biopsy 5/20/2022 with perisinusoidal fibrosis.  Continue home lactulose and Xifaxan. 13. Recent right ankle fracture: S/p ORIF 8/24/2023 by Dr. (ortho). 14. Chronic pain: NaRx reviewed on admit.  Continued home medications 15. Obesity: BMI 37
Started as a mild upper stomach pain increased to a horrific pain that would not allow me to function cause of the amount of constant pain and tightness in my upper stomach.  Had no appetite got sick for first 3 days. Couldnt bend over or twist or put any pressure on my stomach without folding over in pain. No fever other then pain I felt ok.
vax given almost under arm & shortly p/vax pt exp severe stinging sensation on way home & by the time got home, arm was swollen to the bend of the elbow;Vicodin taken;pt cont to swell to 3X nl size w/pitting edema;elbow green w/red streaks;
Information has been received from a physician concerning a male with no past medical history, who on 19-SEP-2007 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  On 21-SEP-2007 the patient experienced multiple seizures.  The patient was taken to the emergency room and admitted to the hospital.  It was mentioned that the patient was hypothermic.  Unspecified medications were administered to the patient.  Laboratory tests included a full blood and spinal cultures that were negative, "enteral viral and HSB test" that were negative.  No product quality complaint was involved.  Additional information has been requested.
Had shot 11/11/21, more than recommended 6 months; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 11th November 2021).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 31-May-2022 Reporter's Comments: The patient had a Shingrix shot of 11th November 2022 and at the time of reporting on 31st May 2022. That was more than the recommended 6 months lag between shots. The patient was asking would the second shot be effective. Also asked do he/ she need to take both shots again. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
patient received QUADRACEL vaccine who was 3 year old having 9 days short of turning 4 years old/ NO AE; Initial information received on 30-Apr-2021 regarding an unsolicited valid  non-serious case received from a consumer or non-healthcare professional (administrative assistant of a physician's office) via email through sales representative.  This case involves a 3 year old patient who was 9 days short of turning 4 year old (unknown gender) who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number and expiry date not reported) before 4-year of age (product administered to patient of inappropriate age) on 06-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  Reporter would that vaccine need to be repeated.  At the time of reporting, no adverse event was reported.  No additional information was provided.  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 by Regulatory Authority. 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.  There will be no information available on the batch number for this case.
Severe anxiety and what we think was a significant panic attack.  Began with tingling hands, light headedness and fatigue.  Turned to chest pains and nausea.  Lasted from 8:30 PM to 11:00 PM
Parent called nurse triage line patient's R leg is very sore and limping. Patient is very upset about the pain. Parent will watch if S/sx of cellulitis to come in.  To treat with Tylenol/ice PRN.
Area of injection red the size of a half dollar, red and warm to touch.  Benadryl 25 mg Po one time given
This case was reported by a physician and described the occurence of photophobia in an 11-year-old male subject who was vaccinated with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular pertussis vaccine, adsorbed (Tdap) (Boostrix) for prophylaxis.  The physican is the mother of the subject.  There were no concurrent medications.  On 18 August 2005 the subject received a booster dose of Boostrix (lot number not specified) to the left arm.  At an unspecified time after vaccination with Boostrix, on 18 August 2005, the subject experienced photophobia, fever greater than 104 degrees Farenheit, nausea and pain in extremities (arm and foot).  At the time of reporting the events were unresolved.  The physician considered the events were probably related to vaccination with Boostrix.
No Adverse Event; HCP called in to report patient was administered expired dose of VAQTA and wanted to know about revaccination for the patient. . No Additional AE/PQC.; This spontaneous report was received from a other health professional refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2023, the patient was vaccinated with one dose of hepatitis a vaccine, inactivated (VAQTA) lot# U004366, expiration date: 01-OCT-2022, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
pt recvd vax & the day p/dose 3 exp one-joint arthritis (knee) which has not subsided;
On 01/22/2021, small dot started to itch and was red. the redness continued to increase and almost had appearance of a "bullseye". One 01/25/2021, took an oral dose of diphenhydramine and by 01/26/2021 seems to be better.