chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIZZINESS/SUNLIGHT MAKES FEEL DIZZIER; ITCHY; ARM HURTS AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm hurts at injection site. On 08-APR-2021, the subject experienced dizziness/sunlight makes feel dizzier. On 08-APR-2021, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm hurts at injection site, and itchy, and had not recovered from dizziness/sunlight makes feel dizzier. This report was non-serious.
Patient's son went to visit this patient at her assisted living facility. Patient's son found patient alert but glassy eyed and not following commands. Patient gradually regained consciousness and became more communicative and complained of a headache. BP was checked at the assisted living facility, which was 91/61 and later BP became elevated with a reading of 170/70. Patient received the Pfizer vaccine booster 2 days prior to this event. Since her booster vaccine, patient was experiencing malaise and fatigue. Facility and son state that over the last 2 weeks patient has becoming increasing confused. Patient was sent the emergency department for evaluation.   Patient had an EKG which showed A. fib. (patient already had this diagnosis prior) with minimal ST depression and minimal LVH otherwise unremarkable compared to prior EKG.  Chest x-ray showed small left pleural effusion with associated atelectasis. Head CT showed no intracranial hemorrhage infarct. Initial labs were unremarkable except for an elevated Prolactin of 25. Patient was admitted tot he hospital for observation for further evaluation.  Neurology was consulted; they recommended an EEG. EEG was attempted but patient could not tolerate test due to mental status/confusion. Neurology felt her symptoms were mostly likely due to her Parkinson's. Patient was stable for discharge with VNA nursing services back to her ALF.
Left arm was sore; Left arm was red; Fever; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028A21A and 025A21A) for COVID-19 prophylaxis.     The patient's past medical history included Heart block (80 percent blockage of the heart). Concurrent medical conditions included Emphysema (had a medical history significant for Emphysema, COPD), COPD (had a medical history significant for Emphysema, COPD) and White blood cell count high (Chronic high white blood cell count). Concomitant products included CLOPIDOGREL, BUDESONIDE, IPRATROPIUM, LEVOSALBUTAMOL HYDROCHLORIDE (LEVALBUTEROL [LEVOSALBUTAMOL HYDROCHLORIDE]) and AZITHROMYCIN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills). In April 2021, VACCINATION SITE PAIN (Left arm was sore), VACCINATION SITE ERYTHEMA (Left arm was red), PYREXIA (Fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high.         On 30-Oct-2021, the patient received first booster dose of Moderna COVID-19 vaccine.  After receiving both the second dose and first booster dose of Moderna Covid-19 vaccine, the patient experienced redness and soreness in left arm, fever and chills, that lasted for 2 to 3 days.  The patient was receiving budesonide, ipratropium and levalbuterol nebulizers.  No treatment medications were reported.   This case was linked to MOD-2022-657268, MOD-2022-657182 (Patient Link).
Employee administering vaccine documented the following statement: "Syringe came apart while administering COVID vaccine. Needle was in patient's arm and I was pushing down on the plunger when the needle separated from the syringe shaft and some vaccine sprayed out. Some vaccine was administered but not the whole dose. Needle stayed in patients arm separate from syringe shaft, was removed easily. Explained to patient what had happened, notified clinic manager.
17 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter.
This spontaneous report was received from literature: Axillary Adenopathy after COVID-19 Vaccine: No Reason to Delay Screening Mammogram. This report concerned multiple patients. The objective of the study was to determine the outcomes of axillary lymphadenopathy after COVID-19 vaccination on breast imaging examinations. The patients height, and weight were not reported. The patients concurrent conditions included: lung cancer (one patient). The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced axillary lymphadenopathy, lymphoma and metastatic lung cancer, metastatic to axillary lymph node and four patients was diagnosed with metastatic breast cancer. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) had benign results and malignant results. Four patients were diagnosed with metastatic breast cancer, Mammogram (NR: not provided) lymphadenopathy, decreased lymph node size (follow-up examinations within 12 weeks, 25% were given Breast Imaging Reporting and Data System or BI-RADS, category 3 recommendations. No patients in the follow-up group were diagnosed with a subsequent malignancy), No malignancy, Mammogram (NR: not provided) lymphadenopathy, decreased lymph node size (15.7 weeks after the initial examinations, decreased lymph node size and were assessed as benign), No malignancy, Mammogram (NR: not provided) lymphadenopathy, decreased lymph node size, and Sonogram (NR: not provided) lymphadenopathy (identified lymphadenopathy and the average node measured as 1.8 cm (range, 0.54.2 cm). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the axillary lymphadenopathy, metastatic breast cancer, lymphoma, lung cancer metastatic and metastatic to axillary lymph node was not reported. The authors emphasized on there should be no delay in screening mammograms due to recent vaccination and there is variable time to resolution of reactive lymphadenopathy. Lymphadenopathy should be interpreted in the context of patient risk factors with vigilance in patients with concurrent suspicious mammographic findings in the ipsilateral breast. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220458141-COVID-19 VACCINE AD26.COV2.S-lung cancer metastatic, metastatic to axillary lymph node. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. (Confounding factor as pre-existing medical history) 20220458141-COVID-19 VACCINE AD26.COV2.S-metastatic breast cancer, lymphoma. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
UTI; This is a spontaneous report from a contactable 66-year-old male consumer (patient) or other non-health care professional from Pfizer-sponsored program, Support (NCSP: 159558). A 66-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL9264, Expiry date: unknown), via an unspecified route of administration in the right arm on 05Feb2021 and second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EN9809, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 26Feb2021 (at the age of 66-year-old) both as a single dose for covid-19 immunization. Patient switched vaccination arms purposely. Medical history included prostate issues. Concomitant medications included finasteride 5 mg for prostate (ongoing) and morniflumate (FLOMAX) 4 mg for prostate (ongoing). On 17Sep2021, the patient experienced UTI (urinary tract infection). He has shrunk of two inches because his age. He did not have a prescribing doctor. Therapeutic measures taken as a result of the events included antibiotic Cefdinir (manufacturer: Unspecified, Lot number: unknown, Expiry date: unknown) 300 mg to treat UTI. Patient wanted to get his third dose and asking if he can get his third dose 7 months after his second dose. He also wanted to know if it will impact the effectivity of the vaccine as he was on antibiotic, Cefdinir. He heard in Israel they were given the third dose 6 months after the second dose. He was inquiring about getting the third dose after seven months. He knows was given the third dose after 8 months. The clinical outcome of the event UTI was not resolved.  No follow up attempts are needed. No further information is expected.
Swelling of the entire left arm with pain 1 day after receiving Tdap and MENACTRA vaccines. IV Nafcillin and clindamycin; BENADRYL.
Patient felt lightheaded after both vaccines. Responded well to supine positioning in reclining chair. Eating crackers and peanut butter because patient has not had breakfast. Bp 120/70 and HR=70. Patient complains of feeling "foggy". Dr. called to evaluate patient. Complains of "prickly face feeling". Ordered Cetirizine HCL tablet 10 mgm, p.o. VS stable. Discharged at 1047.
Site iswarm, swollen, red;  reaction area is below site, appears to be a flacid fluid filled area approximately 3 X 4 inches.  Some itching.
Fevers as high as 103 Body aches chills Metallic taste in mouth  Nausea vomiting  Lasted 3 days
This spontaneous report as received from a nurse refers to an unspecified number of patients of unkonwn age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with unspecified number of improperly stored doses of PROQUAD (Merck) lot # L007230, expiration date 03-SEP-2016 (strength, route unspecified). No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; numbness in extremities; numbness and tingling in extremities, tingling in extremities more so in left upper extremity then left foot, then right hand; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration (Left arm) on 27Dec2020 14:30 at single dose for Covid-19 immunization. The patient's medical history included connective tissue undifferentiated (disorder), cervical radiculopathy, and Covid-19. No known allergies. Concomitant medications were unspecified; the patient received other medications within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported numbness and tingling in extremities more so in left upper extremity then left foot, then right hand on 27Dec2020 (16:00). The patient also noticed slightly on day of injection then on day 3 (30Dec2020) after injection the patient had severe pain in left arm, weakness, and unable to raise arm at shoulder. The adverse events resulted in Emergency room/department or urgent care. The patient was treated with prednisone. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Patient came to ED with runny nose, sore throat, and wheezing.  Patient was admitted to hospital with Covid pneumonia and treated with remdesivir.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No pertinent medical history drug reactions or allergies and concomitant medications were reported. On 30-JUN-2015, the patient was vaccinated with an expired dose of M-M-R II, dose: 0.5 ml, once, subcutaneously, expiration date: 14-JUN-2015 (lot # not reported). No adverse effect was reported. Additional information has been requested.
Information has been received from a registered nurse, who is a public health nurse concerning a female nurse colleague, who in January 2004, was vaccinated with a second dose of hepatitis A virus vaccine inactivated (lot #645022/0065N). The registered nurse reported the female colleague had a needle stick injury. On 04-Mar-204 the nurse colleague had blood drawn for a laboratory study of hepatitis A immunoglobulin M antibody and now she is IGM positive for hepatitis A. The registered nurse reporter stated it was unknown if the needle stick mishap was with a patient who had hepatitis A or not. It was unknown whether treatment was required for the adverse event. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Dizziness, Myalgia, Fever, NauseaVomiting, 102.3 temp Narrative:  Other Relevant History:
COVID positive; COVID positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 at 08:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High BP" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: TEGRETOL; MONTELUKAST; BENICAR HCT.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID positive". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a female patient of unknown age referring to herself, who was not pregnant. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 03-OCT-2016, the patient received a dose of PNEUMOVAX 23 injection (lot#, expiration date, dose and route were unknown). A few hours later, the patient began to experience severe pain at the injection site. The pain continued throughout the night and she was awakened by the pain. The patient contacted her physician by phone but did not receive any treatment. The outcome of the events was reported as not recovered/not resolved. The causality assessment between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
8 days after injections 3x5 cm area of redness and induration at injection site, requiring oral antibiotic for possible infection. HIB and HEP A given at this site on 9/28, VARIVAX given nearby (left thigh).
Approximately 3 months after immunizations, irregular heartbeat,pain down left arm with high salava being produced, blackouts, and severe stomach cramps began. This only accured about once a month. Didn't know what was going on and it didn't seem frequent enough to have checked out. These signs started to appear more often until 9 months later, an EEG was done by family doctor. Nothing was found, but signs continued. 1 year after the EEG, legs cramped up and was taken to emergency room where high sugar levels were found. Family doctor tried for 6 weeks to get sugar levels under control by oral meds. Was diagnosted as type 2 diabetic. By end of the 6 weeks, sugar levels were over 900 and was diagnosted as type 1 diabetic. Was told that the pancreas not producing insulin could have caused all of the signs above, which could have been caused by the immunizations given. No family history of diabetes on either side of family, and patient is not over weight. Is very active.  11/7/08 Reviewed hospital medical records of 11/27-11/30/2007. FINAL DX: no d/c summary dictated. Admitted for hyperglycemia & new onset type 1 diabetes. Records reveal patient experienced new onset DM approx 3 weeks prior when developed severe leg cramps while playing sports & seen in outlying ER w/very high blood sugar.  Unable to control BS at home on oral agent, ranging from 400-600mg/dl along w/blurry vision, HA, lethargy, weakness, nausea polyuria.  BS in current ER was 600, tx w/IVF & decreased only to 386, neg ketones.  Tx w/sliding scale insulin, oral agent d/c, additional IVF & meds.  Referred to Endocrine clinic & started on routine insulin.  11/14/08 Reviewed PCP medical records of 4/24/06-11/01/2007. FINAL DX: new type II DM Records reveal patient experienced facial poison ivy 4/06.  Seen in ER & treated w/steroid taper.  RTC 9/06 w/rapid heart beat, nausea, left arm numbness, dizziness.  EKG at that time revealed HR 58.  Referred for echocardiogram & Holter monitor.  RTC 10/2007 s/p ER visit for severe leg cramps while playing sport, polyuria, polydipsia.  BS in ER was 250 & tx w/insulin.  Started on oral agent & additional labs ordered.  RTC 11/2007 w/consistently high but improving  blood sugars.  Meds were adjusted.    11/18/08 Reviewed ER medical records of 10/17/2007. FINAL DX: leg cramps, hyperglycemia. Records reveal patient experienced leg cramps lasting approx 2 hours s/p physical activity.  Reported occ visual blurring, excessive thirstiness & excessive voiding.  Exam revealed anxiety, tachycardia, calf cramps.  Tx w/meds, improved & d/c to home to f/u w/PCP re diabetic control. 1/28/2010 Patient still has type 1 Diabetes-having to give insulin 5 times a day is having some kidney problems right now.
LAD of the L axillary area; fever; chills; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 22Dec2020 18:50 at the age of 37-year-old (Lot Number: EJ1685; Expiration Date: Mar2021) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient provided information to the physician regarding the reported adverse events with the use of BNT162B2. The physician considered the BNT162B2 had a causal effect to the events. The patient experienced LAD of L axillary area, fever and chills on 26Dec2020 23:00. The patient was not admitted to hospital. No emergency  or physician office done, no treatment for the events given. It was reported that there was a reasonable possibility that the event is related to BNT162B2. The events recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a 23-year-old female patient. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 09-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 (dose, strength, route of administration, lot # and expiration date were not provided) for vaccination. On 18-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 (dose, strength, route of administration, lot # and expiration date were not provided) for vaccination. On 18-JUL-2018, the patient was feeling lightheaded. The outcome of feeling lightheaded was unknown. The relatedness between GARDASIL 9 and feeling lightheaded was not reported.
This spontaneous report was received from a 65 year old male patient regarding himself. The patient has diabetes. The patient had no drug allergies and reactions. On 30-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant therapies included Metformin. On 01-SEP-2013, the patient developed injections site itching 2 days after receiving ZOSTAVAX. The outcome of injection site itching was reported as not recovered. The patient lab tests included routine blood work. The patient did not seek medical attention. Additional information has been requested.
Fever of 104.2 at highest, chills, body aches, nausea, diarrhea. Body aches began 13 hours after shot given, chills started 15 hours after shot given,  at around 10 a.m. that same morning began taking my temperature because teeth were chattering , fever went from 100.6 to 104.2 in 30 minutes. Called doctor, but did not receive call back so called ambulance when temp reached 104.2.  Ambulance crew came but fever dropped to 101.4 and after consulting with doctor and emergency room decided not to transport. Continued with body aches, fever, chill, nausea until 10:00 p.m.. Next morning had some residual body aches particularly in both arms and intense fatigue.
Shortly after the injection, I began to experience tinnitus and dizziness.  It was mild but enough to notice.  I did notice the same after the 2nd shot but it was more severe and I wasn't sure if it wasn't certain of the cause at that time.  After the 2nd dose, the ringing and dizziness lasted for several months but recently went away.  Several hours after the 3rd, and the ringing and dizziness returned but as mentioned earlier, is more mild than after the 2nd dose