chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Choking; Loss of consciousness; Ageusia; Anosmia; Decreased appetite; Drooling; Feeling abnormal; Fatigue; Pyrexia; Chills; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CHOKING (Choking) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included High cholesterol. Concurrent medical conditions included Prostate cancer (Hormone shot taken 02-APR-2021 for prostate cancer) and Blood pressure high. Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CHOKING (Choking) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills). At the time of the report, CHOKING (Choking), LOSS OF CONSCIOUSNESS (Loss of consciousness), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 65 year old male patient with diabetes and high cholesterol. No drug reactions or allergies were reported. On 14-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot# L032397, expiration date 26-NOV-2016) 0.65 ml, subcutaneously in an unspecified arm. There was no information about the patient's concomitant medications reported. On an unknown date in March 2016, the patient experienced numbness and an intermittent shooting and burning feeling on the left outer thigh. No treatment was given and none lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The patient sought medical attention and spoke with the reporting pharmacist. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected, as there was no consent for follow up.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 28-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
tends to have blood clots; This is a spontaneous report from a Pfizer-sponsored program, patient. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was scheduled to get the second shot this afternoon (02Mar2021), on a blood thinner and tends to have blood clots. Outcome of the event was unknown.    Information on Lot/Batch number has been requested.
Fever; Chills; Unwell; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced fever, chills and unwell. On an unknown date, the outcome of the fever, chills and unwell were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills and unwell to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left arm. The pharmacist on the line reporting she gave Shingrix to a patient who was reporting a bad reaction.  The patient had fever, chills, and was feeling really unwell.    The symptoms started either Tuesday night or early Wednesday.
some weakness in my arms and legs for several seconds; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 10:30 (Lot number: EL3247) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tree" (unspecified if ongoing); "Known allergies: grass pollens" (unspecified if ongoing); "Known allergies: dust mites" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 09Mar2021 10:40, outcome "recovered" (Mar2021), described as "some weakness in my arms and legs for several seconds"; VACCINATION SITE PAIN (non-serious) with onset 09Mar2021, outcome "recovered" (10Mar2021), described as "Injection site pain". Therapeutic measures were not taken as a result of muscular weakness, vaccination site pain. clinical course:  Additional information: The Patient did not receive any other vaccine in four weeks. Patient received Other Medications in two weeks was vitamin D 2000IU daily. About 10 minutes after injection, I felt some weakness in my arms and legs for several seconds. Injection site pain that lasted about a day. The patient did not had covid prior vaccination and not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient's friend called an hour after patient left the pharmacy to report that he was having facial swelling and arm numbness. He received vaccine at 230pm and called the pharmacy back at 335pm. I recommended Benadryl and medical attention if needed. She was going to administer Benadryl  and seek medical attention if his symptoms stayed the same or worsened.
Patient initially presented with generalized body aches and was admitted by medicine service.  She had paresthesias and numbness from the wrist down.  she also had problems with urinary retention, bowel movements and difficulty standing.  she was worked up by neurology and thought to have some sort of Guillian-Barre Syndrome related to receiving a Flu Vaccine.  10/24/08 Reviewed hospita medical records of 11/28-12/06/2007. FINAL DX: transverse myelitis& urinary retention secondary to flu vacccine Records reveal patient experienced generalized body aching esp from lower torso up to mid back, chills, urinary retention, difficulty standing, abnormal gait, constipation, worsening numbness & tingling from waist down. Neuro & uro consults done.  Tx w/IV steroids & I/O caths.
Left axillary lymph node swollen . Sleep paralysis. Tired. Dizzy, hungry thirsty.
Woke complaining of a severe headache, stabbing pain behind right eye, had a 103.3F fever, began vomiting the next morning and could not hold any fluid or food down in any quantity, took to the ER Monday morning, treated for dehydration, discovered ear infection in right ear, pediatrician came down and saw him, did some preliminary neuro tests and was "concerned" with weakness, lethargy, heart rate dropped into 40s on multiple occasions in a 10 minute period. Admitted to the pediatric floor Monday afternoon. Had a brain CT, was normal, Lumbar puncture down that afternoon, originally suspected meningitis. Had immediate relief of headache after LP, started to suspect pseudo tumor cerebri, Had a MRI with contrast, negative, Started on Vancomycin, and rocephin pending culture results. CSF was clear, changed possible diagnosis to encephalitis, started on Diamox to relieve pressure behind eye, was hospitalized for 5 days, vomiting and headaches continued throughout visit. Discharged Friday with no clear diagnosis, plan is to follow up with ophthalmologist to explore pseudo tumor but still have possible diagnosis of encephalitis. All CSF cultures, respiratory cultures were negative. Discharged on Diamox and Zofran with continued vomiting and headache as well as back pain.
Narrative:  84yo patient died at home on 8/24/21.  Pt was admitted to home hospice on 6/29/21. He had received covid vaccines on 1/11/21 & 2/8/21.Hospice DX: Idiopathic pulmonary fibrosis ICD10). Death not related to vaccinations.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 19-SEP-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (dose, dose # and route not reported) (Lot # reported as G007814, Exp. Date: 10-AUG-2013). No adverse effects were reported. The outcome and action taken were unknown. No PQC (product quality complaint) involved. Additional information has been requested.
02/23/2021, first vaccine.  I got covid on march 5,2021. On march 8 I tested for positive for Covid. On march 16 got my second vaccine.  I had mild symptoms to my second vaccine but probably due to covid.  I took Tylenol for three days 03-05 to 03-07-2021. No symptoms today, only have kidney problems where lower back hurts me and do not know if it is because of Covid or something else.
Patient states he received notice to return for 2nd dose. Given dose and then patient made a comment regarding how it didn't hurt like the first one. Discovered that client had received first Pfizer dose on  March 3.  Agency suspects that client had registered twice for clinics and actually he received another first dose clinic notice rather than the appropriate 2nd dose clinic notice.  He states he had no adverse effects and did not seek medical care.
Patient was given (orange cap) Pediatric Pfizer 0.2 mL of vaccine as her second dose. Patient should have been given Pfizer 0.3 mL dosing as her second dose to complete her primary series. Per CDC Covid 19 vaccine errors. Pfizer-BioNTech 5?11 formulation (orange cap)administered to a person age 12 through 17years does NOT need to be repeated.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 13-AUG-2013, the patient was vaccinated with a dose of M-M-R II (Lot number was reported as H017430, expiry date was 20-SEP-2014, route and dose were not reported) that was exposed to 14 C for 30 hours, which was unsupported by in-house stability data. No adverse effect was reported. Additional information has been requested.
The site of the shot is swollen; The site of the shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received his/her Shingles vaccine on Sunday at 11:00 am.  The patient stated that, the site of the shot, left upper arm, was swollen and hurting.  The reporter wanted to know anything he/she could do.  The reporter asked that he/she should be worried. Additional Supportive Information: The follow up would not possible as no contact details were available.
Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 75-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of  a 75-year-old, male patient who  was administered a vaccine that has been refrozen for mRNA-1273, lot # 025J20-2A. There were no reported adverse events associated with this case of administered a vaccine that has been refrozen.
Patient is late for the second dose / First dose was / on January 2020.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   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 for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was late for the second dose of Shingrix. No adverse events were reported. The details regarding patient's identifiers, vaccine lot number and expiration date and vaccination date were not provided. The reporter consented to follow up. This case has been linked with US2021034680, reported by same rporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021034680:Same reporter.
Information has been received from a physician concerning a 13 year old male with asthma an no allergies who in the early afternoon of 09/20/2004, was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included fluticasone propionate + salmeterol xinafoate (ADVAIR) and levalbuterol HCl (Xenopenex). The physician reported that on 09/20/2004, the pt developed local papules at the injection site. On that same day, at 10:00 the pt developed tremors ans was taken to the ER. Subsequently, in 09/04, the pt recovered from the injection site papules. At the time of this report, the outcome of the tremors was unknown. The reporting physician felt that the pt's recovery may not be related to the varicella virus vaccine live. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 12-MAR-2014 the patient was vaccinated with GARDASIL (lot number, dose and frequency not provided), intramuscular. The patient received the vaccine which was exposed to 49 degrees F for 1 hour. No known adverse effects. Additional information has been requested.
Went to er on March 3rd around 2am with discoloration on body with confusion and pain. Was told possible ttp. Condition quickly declined and was transferred to hospital main campus around 12pm. Condition continued to rapidly decline and passed away on March 4th at 11am.  There is much more to tell about this. To much to write down. I have called several times no one has called me back.
Patient brought to ED by son for severe weakness and dizziness x 9 days which he attributed to the Moderna booster received 9 days prior. Had also been confused and stopped eating. Weakness was the point where he was unable to ambulate and had to be carried to the restroom. While in triage the patient had seizure like activity with repeated convulsions that stopped. Patient was awake and alert and answering question but appeared fatigued and weak. Patient was given 2mg of Ativan and started on NS fluid bolus, shortly afterwards while labs being drawn, he again began to have convulsion-type activity and became unresponsive and pulseless. Code blue called. Patient was initially in v-tach, defibrillated 7 times-unsuccessfully and while code was ongoing, Hgb was 3.6. He went from Vtach to PEA. 2U of blood were given after which ROSC was achieved, and additional 2U were given.  Patient admitted to IC with blood loss anemia suspected GIB, anoxic encephalopathy, pancreatic head mass suspected malignancy, sever metabolic acidosis, AKI, transaminitis and UTI. Patient has partial gaze paralysis. EEG showed mod to sever cerebral dysfunction. Patient no progress and later passed after patient family made the patient CMO.
Left side of face started to droop; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received their second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported), via an unspecified route of administration on the left arm on 02Feb2021 14:25 at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported) via an unspecified route of administration on the left arm on 14Jan2021 at 0.3 mL, single for COVID-19 immunization.  The patient reported that when at work on Sunday 07Feb2021, the left side of his face started to droop at 23:00. No treatment was received for the event. The patient did not recover from the event.
R arm deltoid posterior area is red, raised, hard and warm to the touch, circumference about 4 inches. There is some pink, irritated area also wrapping toward the armpit. Patient's temperature is 98.8. Chills reported the night before.
Info has been received from a licensed practical nurse concerning a 32-year-old male volunteer firefighter with no known allergies and no known medical conditions who on 12/02/2002 at 19:00 was vaccinated intramuscularly in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). The dose was "given with a 25 guage, 1" needle". There was no concomitant medication. There was no illness at the time of vaccination and no symptoms following prior vaccinations with the pt or his siblings. It was noted that 2 hours after the vaccine was given, he spent 20 hours at a fire scene and was engaged at times in "heavy physical labor". On 12/03/2003 at 21:00, he developed pain and "induration from elbow to shoulder", but did not require medical care as a result of this. It was also noted that the nurse suspected the "activity played a major role in their reactions". The pt recovered on 12/06/2002, after 48 hours. The also reported on 9 other pts that were vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M) and developed induration (WAES #0212USA01192, 0212USA01193, 0212USA00729, 0304USA00825, 0304USA02075, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081. No further info is expected.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) and (batch number 5942P, expiry date 30th January 2020. On an unknown date, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain and fever. On an unknown date, the outcome of the injection site pain and fever were recovered/resolved. The reporter considered the injection site pain and fever to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient had injection site pain for three days and also said the patient had a fever but did not take an actual temperature. The lot for SHINGRIX diluent was 5942P and has the same expiration date as provided above.
Representative from a Pharmacy came to my place of work to do the Flu clinic. I was the first one that day that the representative injected. The representative never "Landmarked" my arm for proper injection site and I truly believe he went to high.. When he began to administer the flu shot I felt immediate pain as he injected. The pain was nothing like I ever felt with ANY injection. I figured it would be the "usual" 2-3 day sore arm but it never got better but instead got worse. I am not sleeping well at night, trouble lifting , pain in upper arm and shoulder. Seen by Dr. on November 24th 2020 and she gave me tapering steroids. Steroids are done and pain persist.
Headache, severe dizziness starting 2-3 hours after injection, lasting about 12 hours. Fatigue, full body aches and pains starting within 12 hours of injection, lasting about 48 hours. Fever, chills starting within 12 hours of injection, lasting about 36 hours. Mild lightheadedness and diarrhea starting about 64 hours after injection, still ongoing as of  6/15/20
fever of over 102.4, body aches, extreme fatigue, no appetite, unable to do anything but lay in bed for about 2 days.
Pt reports that she took a flu shots and twelve hours later developed hives and a rash over her body.  Pt taking Benadryl with no relief.
Fever Migraine headache Vomiting Diaerea  Horrible body aches Neck especially can?t move injection arm Red cheeks as res as Santa Claus suit. Felt great yesterday up to 15 hours after no horrible
Patient received 2nd dose of Moderna COVID vaccine . While waiting 15 minutes post vaccine in waiting room, patient became dizzy, diaphoretic, and weak. Had brief episode of unresponsiveness, but awakened independently and answered questions appropriately. Oriented to person, place, and time. Noted to have bilateral hand tremors, but does have diagnosis of Parkinson's Disease. Was evaluated in Urgent Care briefly, and ultimately sent home in stable condition.
APPROXIMATELY 3" BELOW INJECTION SITE, ROUND RED AREA WARM, SWELLING + PAIN. SLIGHTLY ITCHY. STARTED DAY OF FLU VACCINE. TREATED WITH BENADRYL, THEN DIAGNOSED AS CELLULITUS TX WITH AMOXICILLIN.
Onset of rash 4/17/13. Scaly. Began over right shoulder. Seen today 4/24/13 and diagnosed by pityriasis rosea. Began triamcinolone cream.