chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 33 years old female patient. The patient had no medical history or drug allergies. On 27-DEC-2012, the patient was vaccinated at another health care providers office with a dose of VARIVAX (Merck) (lot number, expiry date, route and dose were not reported), Influenza Virus Vaccine (manufacturer unknown) and tetanus toxoid. No concomitant medications were reported. Subsequently, the patient became pregnant with last menstrual period (LMP) of 07-DEC-2012 and an Estimated date of delivery (EDD) of 13-SEP-2013. The patient was exposed to VARIVAX (Merck), Influenza Virus Vaccine (manufacturer unknown) and tetanus toxoid during trimester 1. The nurse reported that the patient's gestation was 7 weeks 6 days as of 31-JAN-2013. No adverse effects reported. The outcome of pregnancy was unknown (outcome pending). Follow-up information has been received from a physician refers to a 33 year old female patient. Last menstrual period (LMP) was on 07-DEC-2012 and estimated date of delivery (EDD) was on 13-SEP-2013. The patient had 3 previous pregnancies and had 2 full-term delivers. No birth defect occurred in any previous pregnancy. A stillbirth or miscarriage occurred in previous pregnancy. Pre-term births were SAB. On 12-FEB-2013 an ultrasound was performed showing 9 week 4 day intrauterine pregnancy (IUP), + cardiac activity. Additional information has been requested.
Body Aches, periods of sharp pain. Weakness, fatigue 11/12/2016: pain continues, sweating profusely, weak.
Pain at injection site after vaccinations. Slowly started to swell that evening.  Fever, COVID like symptoms over the weekend.  Today at examination, injection site swelling, heat, redness.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 11-JAN-2018, the patient was vaccinated with a dose of improperly stored VARIVAX lot number N001527, expiration date 13-JAN-2019 for prophylaxis (frequency and route of administration were not reported). The sterile diluent (MERCK) used for reconstitution was properly stored. On unknown dates, the doses of VARIVAX underwent temperature excursions of 6 degrees Fahrenheit (°F) to 14 °F for 69 hours 2 minutes, 15 °F to 46 °F for 36 hours 14 minutes. A previous temperature excursion of 15 °F to 46 °F for 60 hours was reported. Temperature excursions were detected by the data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1801USA010690: US-009507513-1801USA010882: US-009507513-1802USA004843.
Headache; joint pain; Fatigue; hives the patch of hives is about 5 inches large; Itchiness on stomach; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives the patch of hives is about 5 inches large), PRURITUS (Itchiness on stomach), HEADACHE (Headache), ARTHRALGIA (joint pain) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced URTICARIA (hives the patch of hives is about 5 inches large) and PRURITUS (Itchiness on stomach). On an unknown date, the patient experienced HEADACHE (Headache), ARTHRALGIA (joint pain) and FATIGUE (Fatigue). At the time of the report, URTICARIA (hives the patch of hives is about 5 inches large), PRURITUS (Itchiness on stomach), HEADACHE (Headache), ARTHRALGIA (joint pain) and FATIGUE (Fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Teatment provided included aloe vera, no concomitant medications reported.
Boosted 45 year old; Breakthrough Covid; Breakthrough Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, Dose unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Boosted 45 year old"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The event took place after use of product. Patient was having mild symptoms.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions drug reactions or allergies were not reported. On an unknown date in 2016, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M020521, expiration date 17-NOV-2017, by intramuscular route, (frequency and anatomical location were not provided). No adverse effects were reported. The temperature and time frames were: 24-AUG-2016, 34 Fahrenheit degrees for 14 hours, and, on 29-AUG-2016, 30 Fahrenheit degrees for 14 hours; there no were any previous excursion and digital data logger was not involved. Product quality complain was not involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Right hand brown spots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2022 at 01:00 as dose 1, single (Lot number: FP7150) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies : Pollen" (unspecified if ongoing); "Known allergies : Trees" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 04Oct2022, outcome "not recovered", described as "Right hand brown spots". Therapeutic measures were not taken as a result of skin discolouration.  Additional information: No other medications in two weeks. Known allergies included pollen and trees.
erythema @ site of inj;warmth, erythema & edema of ipsilateral arm;
Localized clear bumps to upper left arm in area of administration of Dtap vaccine. 15 mins before the appearance clear bumps.
red swelling where shot was given;big knot under skin/cry/screaming/no sleep x 24 hr sick to stomach
S+O;WALKIN;CC swelling and redness left upper arm;site of the pneumonia shot ;was given 11/12/08 in clinic. The patient return here 11/13/08 arm feels heavy,is red and itching;ROM  of both elbows and left shoulder WNL; no injury. The patient did scratch because of itching.  There was no CP;no SOB;no GI COMPLAINT. The record temperature 11/12/08 was 98.9 and the temperature record 11/13/08 was 99.1 The patient was treated with Benadryl 25mg bid prn itching 7 day supply qty 14 0 refills and moist heat to the affect shoulder. The patient did not decline admission for observation.
Information has been received from a physician concerning an either 15 or 16 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced an episode of syncope (also reported as continuous episodes of syncope throughout the whole GARDASIL series). Due to the syncope, the second and third doses were not scheduled to be given and she only received the first dose (it was also reported that all 3 doses were given, however no dates were specified). Height and weight were not given. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
administered to a patient this morning after it had been sitting at room temperature since yesterday; administered to a patient this morning after it had been sitting at room temperature since yesterday; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 21Oct2022, outcome "unknown" and all described as "administered to a patient this morning after it had been sitting at room temperature since yesterday". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Additional information: The report was assessed as non-serious. RN, who is working remotely today, is calling about the bivalent gray cap formulation of the vaccine that was administered to a patient this morning after it had been sitting at room temperature since yesterday around 8am and then was punctured this morning.  It was left at room temperature beyond the 12 hour window. RN does not know age and gender of patient, just that they were getting the bivalent Pfizer booster.  It was administered by the medical assistant and she was notified around 10AM.
Moderna Bivalent booster was given on 10/21/22 at another facility and another Moderna bivalent booster given at clinic on 10/28/22
Patient in apparently so ill that she cannot get out of the house for normal activities; Patient in apparently so ill that she cannot get out of the house for normal activities; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered" and all described as "Patient in apparently so ill that she cannot get out of the house for normal activities". It was unknown if therapeutic measures were taken as a result of illness, loss of personal independence in daily activities.  Additional information: Other vaccine in four weeks were reported as unknown. Other medications in two weeks were reported as unknown. Details were obscure. Patient in apparently so ill that she cannot get out of the house for normal activities. Had told others that she was going to sue Pfizer. If COVID prior vaccination reported as unknown. If COVID tested positive vaccination reported as unknown. Known allergies reported as unknown. Other medical history reported as unknown. Device time stamp reported as 27Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fluzone/Influenza vaccine Aventis Lot U1764AA,administered 12/14/2005 by nurse at about 12:30 PM. By 7:00 PM non-productive, hacking cough, bad headache, painful joints and generally seeming like having the flu. Next day stayed home on sick leave, developed an ear ache (R), with very swollen lymph glands on neck, from in front of ears downward to side of neck, with right side still swollen and some tenderness as of 12/20/2005 (six days later). Other symptons have gradually reduced with headache gone after 3 days, general joint pain after 2-3 days, some coughing still continues, and right side of neck and ear tenderness still somewhat of concern.  In the CDC VAERS data review by vaccine type, mfg, lot, the lot for my flu vaccine had 11 entries, and ranked among the 10 lots for all entries. Of note, 4 entries were in uninterrupted sequence, with the remaining 7 in close sequence. I received this dose as a (left-over/remaining dose) late injection because I had been deployed for Hurricane Katrina and had taken other shots for that deployment in early September, and the shots were just made available on a limited basis. I am concerned if this is an allergic reaction that I need to discuss with my physician, a known side effect of the vaccines, or something more specific. Thanks.
Narrative: 80yo patient passed away on 9/25/2021 at grandson's wedding. EMS was called and pt was taken to hospital where he lived for several hours but ultimately passed away from Sudden Cardiac Arrest. Pt had received covid vaccine on 1/22/21 & 2/22/21. Likely this death is not related to covid vaccines given patient's age, cardiac arrest death, and long length of time between date of vaccines and date of death.
injection site swelling; injection site redness; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: not reported) on Friday (date unspecified) via an unspecified route of administration as DOSE 1, single for covid-19 immunisation. Patient medical history and concomitant medication was not reported. On an unspecified date, after the vaccination patient experienced injection site redness and injection site swelling. She wanted to know if this was something that was reported, and how long does this side effect last and if she can use ice to control the symptoms. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Nurse was at facility that said they had done all ook ups prior to the clinic and patients attending were due for their boosters.  Patient was vaccinated without incident. When patient was being entered after the vaccination, it was noted that he had received 2nd shot in primary series on  9/7/21 and was not yet eligible for a booster.  Nursing director at facility.  Process has been changed that all patients are being checked prior to being vaccinated.
pt recvd vax 13OCT95 PM & was started on Duricel for fluid effusion; 1130PM that evening pt was found to be very hot & when picked up began to convuls;febrile sz p/vax
Dose administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and LORATADINE (CLARITIN [LORATADINE]) for Allergy, DOCUSATE SODIUM (COLACE) for Stools abnormal, BUPROPION, UBIDECARENONE (COQ10 [UBIDECARENONE]) and TRAZODONE for an unknown indication.    On 20-Jan-2022 at 2:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022 at 2:45 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 20-Jan-2022 at 2:45 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown. Colace was used as a stool softener.  1 dose was administered from the vial. Use by date was on  21-Jan-2022. On 19-Jan-2022 at 14:10 the vial was first punctured. Post puncture the vial was stored in Fridge. The vial did not undergo any temperature excursions. Just when drawing doses the vial was exposed to room temperature range (8 degree to 25 degree Celsius which is equal to 46 degree to 77 degree F).
patient went to waiting area. patient sat down then he pass out. Fell out of chair onto the floor. patient got up walk over to pharmacy said he passed out
Pt was due for DTaP/DT/Td vaccination but was given DTaP/Hep B/IPV instead.
70 y.o. Caucasian male hx CAD s/p CABG, HFrEF (no echo on file but EF reportedly ~40% in 2010), PVD, dm2, remote hx of afib. Pt reports he was feeling well until last couple days he developed cough, chest congestion. Denies dyspnea or fevers. Denies chest pain. Yesterday he was feeling generally weak and slipped in the bathroom. Uses wheelchair at home at baseline, lives alone. He was too weak to get up. Scraped his extremities, fell onto buttocks, denies any other injuries. Eventually friends checked on him and ems was called. Tells me he was down 4-5 hours, report stated potentially 24 hours. He is alert and oriented for me. In the ER covid positive but not hypoxic. He is vaccinated x4.
I had my booster (5th Pfizer covid booster), so it lowered my white blood cell numbers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety disorder" (unspecified if ongoing), notes: Anxiety disorder, unspecified; "Gluteal tendinitis, right hip" (unspecified if ongoing), notes: Gluteal tendinitis, right hip; "Hyperlipidemia" (unspecified if ongoing); "Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes" (unspecified if ongoing); "Secondary malignant neoplasm of bone" (unspecified if ongoing); "ALLERGIES: Penicillins" (unspecified if ongoing); "Secondary malignant neoplasm of bone marrow" (unspecified if ongoing); "Neoplasm of Uncertain Behavior of Skin" (unspecified if ongoing); "Other bursitis of hip, right hip" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM; LETROZOLE; LIPITOR; OMEPRAZOLE; OXYCODONE HCL; OXYCONTIN; VITAMIN D3; ZOLEDRONIC ACID. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "I had my booster (5th Pfizer covid booster), so it lowered my white blood cell numbers". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that patient was off for 3 weeks all together around the holidays, because patient was traveling and stuff. Patient had her booster (5th Pfizer covid booster), so it lowered white blood cell numbers, and they wanted her to be off it (Ibrance) for an extra week.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Child developed rash to face and chest approximately 5 minutes after vaccine. No lethargy or difficulty breathing noted. VSS Pt sent to emergency room for evaluation.
20-30 min post vaccine developed extreme mucous production and uncontrollable cough; 02 sat 98%; MD administered benadryl and decadron; EMS called to transport patient to ED; patient discharged home after ED visit; no issues reported from patient after follow-up call from MD
Shingles. Valacyclovir pills for 8 days. Ibuprofin and Tylenol or Vicodin for pain. Shooting pains, blisters, swelling, sensitive skin. 6 days after blisters appeared I had a fever of 100.4 Started prescription of Cepalexin for 5 days. Now scabs, still pain and sensitive skin.
Pt states has has pain at injection site since vaccination. States tenderness on deltoid (L) w/arm weakness. States was informed by other MD that indentation could be felt. Ibuprofen and prednisone 10 mg QD x 5 days prescribed on 4/23/12. MD suggests ultrasound and x-ray.
she noted huge hives (3-4 inches) which started at the injection site (left arm); fever; chills; was feeling "fluish"; nauseous; dizzy; vision smoky; light her my eye; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), VISION BLURRED (vision smoky), PHOTOPHOBIA (light her my eye), INFLUENZA LIKE ILLNESS (was feeling "fluish") and NAUSEA (nauseous) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced DIZZINESS (dizzy), VISION BLURRED (vision smoky), PHOTOPHOBIA (light her my eye) and NAUSEA (nauseous). On 11-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (was feeling "fluish"), PYREXIA (fever) and CHILLS (chills). On 16-Aug-2021, the patient experienced VACCINATION SITE URTICARIA (she noted huge hives (3-4 inches) which started at the injection site (left arm)). The patient was treated with PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) for Vaccination site urticaria, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site urticaria, at an unspecified dose and frequency. On 10-Aug-2021, DIZZINESS (dizzy) and NAUSEA (nauseous) outcome was unknown, VISION BLURRED (vision smoky) and PHOTOPHOBIA (light her my eye) had resolved. On 13-Aug-2021, INFLUENZA LIKE ILLNESS (was feeling "fluish"), PYREXIA (fever) and CHILLS (chills) had resolved. On 18-Aug-2021, VACCINATION SITE URTICARIA (she noted huge hives (3-4 inches) which started at the injection site (left arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.