chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sluggish; 3rd dose without doctor recommendation; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (sluggish) and EXTRA DOSE ADMINISTERED (3rd dose without doctor recommendation) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (sluggish) and EXTRA DOSE ADMINISTERED (3rd dose without doctor recommendation). At the time of the report, SLUGGISHNESS (sluggish) had not resolved and EXTRA DOSE ADMINISTERED (3rd dose without doctor recommendation) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-291730 (Patient Link).
Vaccinee rec'd 1st vax on 28APR91 & the same day experienced allergic rxn, SOB, premature ventricular contractions, rash; Seen in ER;
Patient had swelling & redness below injection site. Complained of pain when trying to raise arm. Area sensitive to touch. Patient given Keflex 500mg q 12hrs x 10 days for cellulitis. Outcome pending
Pt developed throat constriction/pressure about 20 minutes after vaccine #2 of the COVID-19 series. He had no symptoms after the first dose. He denied any other symptoms. Denies SOB, cough, throat/tongue/lip swelling. Physical exam and initial vitals were normal. At 1100, he was given Benadryl 25mg po x1 dose. He reported symptoms were improving shortly after. At 1110, repeat vitals were still normal and physical exam was unchanged. Pt reported feeling better. He was discharged back to work in stable condition at 115.
Pain on right side in my arm near injection site, neck, and goes down my back near shoulder blade; when I move my arm I get a very sharp pain in my arm, neck, and back so I try to keep it still; the injection site also hurts when touched  Also, very tired and drained; the day of vaccine, day after, and today I have no energy so I just sleep.
He felt lightheaded and sweating within 15 minutes around 11am, did not have issue breathing or shortness of breath, he felt fine after resting 15 minutes more and giving him water
Information has been received on 26-MAY-2017 from a lawyer and a male patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 05-JUN-2012 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-DEC-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient has been prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Groin pain\ somewhat tender; Groin swelling\ groin area in the junction of my leg and torso on right side was swollen; Swelling arm; Unusal taste; Armpit pain; Itchy red circular rash where I received my shot; Vaccination site rash; Itchy red circular rash where I received my shot; lymph node swollen; swollen and sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (Groin pain\ somewhat tender), SWELLING (Groin swelling\ groin area in the junction of my leg and torso on right side was swollen), PERIPHERAL SWELLING (Swelling arm), TASTE DISORDER (Unusal taste) and AXILLARY PAIN (Armpit pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (Groin pain\ somewhat tender), SWELLING (Groin swelling\ groin area in the junction of my leg and torso on right side was swollen), PERIPHERAL SWELLING (Swelling arm), TASTE DISORDER (Unusal taste), AXILLARY PAIN (Armpit pain), VACCINATION SITE PRURITUS (Itchy red circular rash where I received my shot), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Itchy red circular rash where I received my shot), LYMPHADENOPATHY (lymph node swollen) and LYMPH NODE PAIN (swollen and sore to touch). At the time of the report, GROIN PAIN (Groin pain\ somewhat tender), SWELLING (Groin swelling\ groin area in the junction of my leg and torso on right side was swollen), PERIPHERAL SWELLING (Swelling arm), TASTE DISORDER (Unusal taste), AXILLARY PAIN (Armpit pain), VACCINATION SITE PRURITUS (Itchy red circular rash where I received my shot), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Itchy red circular rash where I received my shot), LYMPHADENOPATHY (lymph node swollen) and LYMPH NODE PAIN (swollen and sore to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not reported .  Concomitant medication were not reported .   This case was linked to MOD-2021-243638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Contains no new information On 30-Jun-2021: targeted questionnaire
Info has been received from a health professional concerning a 6 year old female with no known medical history or allergies who on 12/5/00 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 12/27/05, the pt experienced an itchy rash and was feeling ill. She felt warm, no temp was taken. On 12/29/05, the pt was seen for a rash which started on 12/28/05. She had approximately 40 red papules, some vesicles on her face, neck trunk and arms. She was treated with Aveeno bath and Benadryl as needed for the itching. There was no product quality complaint involved. Follow-up info indicated that the pt recovered on 12/31/05. No further info is available.
Really painful at injection time, progressively worse, by third day she couldn't lift her arm. As of 10/7/16, had seen a chiropractor and was using ALEVE and a sling. Advised to see MD 10/7. Saw MD 10/8. Flexeril 5mg TID prn and Prednisone 10 taper. See ortho if not improved.
Lt upper arm swollen & erythematous; seen @ ER on 5MAY93;
Toes were tingling on July 3rd, spread rapidly. Diagnosed with Guillain Barre July 17th.
Information has been received from a registered nurse concerning a female patient who in September 2010, was vaccinated with her first dose of GARDASIL (Lot# not reported). The nurse stated that since the patient received GARDASIL, she had not gotten a menstrual period. At the time of the report the patient's outcome was not recovered. The patient did not seek medical attention. No further information is available.
Sore arm, headache, nausea, very tired,  lasted 3 days
Fever of 101.6, severe joint pain, dizziness, loss of vision, nausea, severe headache.
Initial unsolicited report received from a consumer (patient's mother) on 11 October 2015. This case involves a five-year-old female patient who was vaccinated with a dose of Meningococcal vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient was crying, asking to make her head stop hurting. Then patient started throwing up, and it looked like coffee grounds (meant blood). The patient also experienced slight hearing loss. On an unspecified date, the patient was diagnosed with bacterial meningitis. On an unspecified date, the patient was hospitalized. It was reported that, the patient had been given the vaccine because of an outbreak in county. She never got the rash. During hospitalization they wouldn't tell patient parent for 3 days if she would survive. Thankfully, aside from slight hearing loss, she is a grown woman now with two children. People need to know all the signs. Had we waited, she wouldn't be with us. Laboratory investigation includes spinal tap which confirmed bacterial meningitis. Corrective treatment was not reported. On an unspecified date, the patient was recovered from bacterial meningitis, throwing up, and it looked like coffee grounds, make her head stop hurting, crying and rash. The patient was recovered with sequelae from event slight hearing loss. On an unspecified date, 10 days after hospitalization, the patient got discharge. List of documents held by sender: none.
PAINS IN NECK; LOW BODY TEMPERATURE; COUGHING; SCAR LIKE NEXT TO VACCINE SITE; SORE ARM; FEVER; EXTREME SHORTNESS OF BREATH; NAUSEA; This spontaneous report received from a patient concerned a 54 year old female. 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced extreme shortness of breath. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced pains in neck. On 11-APR-2021, the subject experienced low body temperature. On 11-APR-2021, the subject experienced coughing. On 11-APR-2021, the subject experienced scar like next to vaccine site. Laboratory data included: Body temperature decreased (NR: not provided) 94-95 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, was recovering from low body temperature, had not recovered from extreme shortness of breath, nausea, pains in neck, sore arm, and coughing, and the outcome of scar like next to vaccine site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425534 and 20210423876.
This was an error on the part of our pharmacy for not catching this individual's age prior to vaccine administration. All of our information and website is very clear about Pfizer being the only vaccine indicated under the age of 18 at this time, yet the parent signed this individual up for Moderna. The rest of the fault falls on our pharmacy for not catching the date of birth prior to administration as we just starting vaccinating individuals under the age of 18 last week.
Narrative: 83yo male self-presented to emergency facility on 1/4/22 to Hospital. Chief complaint: Ascites Reporter informed pt died on 1/15/2022. Location & cause of death unknown. Pt had received covid vaccines on 2/22/21 & 3/1/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration. Pt's problem list below:  PROBLEM LAST MOD PROVIDER Liver mass 09/17/2021 History of adenomatous polyp of colon 2006; 3/2011- 1 polyp; 10/16- 2 polyps Male hypogonadism Cervical radiculopathy; Herpes Zoster * Retinal Detachment, Onset 06/22/2010 06/22/2010 Right eye; Type 2 diabetes mellitus 11/10/2015 without complication; Essential hypertension; Hyperlipidemia
Within 48 hrs of receiving the shot, began experiencing; redness at the site, swelling, fever, abcess occured at site and had to be cut and drained by ER doctor. Later, after we left the hospital, began experiencing bulging of the fontanel area, sweating, and had a chemical strange odor to him.  Went back to ER, was admitted to hospital. 5/8/06 Received medical records from hospital which reveal patient was admitted 2/12/06 w/dx left thigh cellulitis & r/o meningitis 2 d s/p DTap.  I&D done 2/11 in ER & sent home.  No c/s done on pus.  Returned to ER w/increased irritability & bulging fontanelle.  ID consult done & suggested adverse reaction to DTaP.  Wound c/s done at that time revealed no growth.  Neuro consult done.
soreness at injection site, fever and body aches Narrative: employee states: soreness at injection sire started midafternoon. took tylenol fever & body aches started around midnight took tylenol feeling ok to come to work fever & aches started again around 8am, took more tylenol and better in about an hour (plan to go to bed after work)
Temperature of 103 on day 5/7/02. Temperature of 94 degrees at 23:00 on 5/7/02; felt cold all over. Went to ER, temp of 96; BP 71/35 at 00:55 on 5/8/02. At 05:00, Temp of 98; BP 104/51 on floor.
She got her vaccine, her neck was stiff with sharp shooting pains and it radiated down her right side of her neck to the right side of her arm.   Right at the collarbone it hurt and had a huge knot form.  It wasn't like a lymph node note but it was extremely tender.  She had some chest pains, and a lot of different stuff, sharp, sharp chest pains with radiating shooting type pains.  The knot was visible to see, could barely touch it.  She asked some people that she was with and asked if they could see it and they told her that they could see that it was real swollen in that area and red.  She took some Tylenol and did not go the doctor.  The knot went away after about 4-5 days.  She had gotten the same reaction with the 2nd COVID vaccine that was Pfizer but only lasted a couple of hours and was concerned as it was there for days.  This was in August when she had that reaction.  She is ok now.    She talked to the pharmacist who felt it was an inflammatory response, and did talk to a NP who said it was an inflammatory response as well and that the knot was probably a lymph node.
Patient states she has had soreness in the arm the vaccine was administered in when she moves it that has persisted for over 2 months now.
Information has been received from a nurse via a company representative referring to a female patient of unknown age. Concomitant medication included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as Tdap) and meningitis vaccine. Information regarding medical history and drug reactions/allergies were not reported. On 26-JUL-2016, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route were unknown). On an unknown date in July 2016, when the patient was leaving the office, she fainted and got a seizure. The patient sought medical attention. It was unknown if treatment was given for the events or if lab diagnostics studies were performed. The outcome of the events was unknown. The causality was not reported. Upon internal review, the event seizure was considered to be medically significant. Additional information has been requested.
felt achy; chills; fever (100.8); dose number: 5; dose number: 5; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 77 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "OA in several joints" (unspecified if ongoing), notes: OA in several joints; "known allergies: Sulfonamides" (unspecified if ongoing). The patient took concomitant medications. 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; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4; Manufacturer unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "dose number: 5"; CHILLS (non-serious) with onset 03Oct2022, outcome "recovered" (04Oct2022); PAIN (non-serious) with onset 03Oct2022, outcome "recovered" (04Oct2022), described as "felt achy"; PYREXIA (non-serious) with onset 03Oct2022, outcome "recovered" (04Oct2022), described as "fever (100.8)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, chills, pyrexia.  Additional information: On 03Oct2022, the patient felt achy and had chills and fever (100.8). the next morning (04Oct2022), the patient felt fine.
Numbness on right side of the body; Coughing; Extreme pain in right arm and shoulder still persisting; Muscle soreness; Joint pain; fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A. and 030L20A) for COVID-19 vaccination and experienced COUGH (coughing), PYREXIA (fever of 101F), MYALGIA (muscle soreness) and PAIN IN EXTREMITY (extreme pain in right arm and shoulder still persisting). On 31-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on right side of the body).    The patient's past medical history included No adverse event. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Cough.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient experienced extreme fatigue after receiving the first dose lasting for almost five days.  On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Mar-2021, the patient experienced COUGH (coughing), PYREXIA (fever of 101F), MYALGIA (muscle soreness) and ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (extreme pain in right arm and shoulder still persisting). On 31-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on right side of the body).   On 31-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on right side of the body). The patient visited the hospital, was admitted and sent home the same day with oral treatment for pain.  At the time of the report, COUGH (coughing), PYREXIA (fever of 101F), MYALGIA (muscle soreness), ARTHRALGIA (Joint pain), and HYPOAESTHESIA (numbness on right side of the body) outcome was unknown.  The event of PAIN IN EXTREMITY (extreme pain in right arm and shoulder still persisting) was ongoing at the time of the report.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the events, included paracetamol and provided gabapentin at the hospital   This case was linked to US-MODERNATX, INC.-MOD-2021-067218 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-067218:Crosslinked with dose 1
Red, swollen at site. Chills, fever, and body aches starting 8 hours after and continued for 24 hours.
syncope; patient was given water and was okay after.  she fainted in her chair. not hurt, no damage.
24 hr after 2nd dose im having severe back pain os that normal; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (24 hr after 2nd dose im having severe back pain os that normal) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (24 hr after 2nd dose im having severe back pain os that normal). At the time of the report, BACK PAIN (24 hr after 2nd dose im having severe back pain os that normal) outcome was unknown.            No relevant Concomitant medications were reported. No Treatment information Provided.
Pt devel a vasculitis synd 1 day p/receiving Influenza vax; sx included rash on both arms & a purple rash on both legs & swelling of ankles; p/progression over the 1st 48 to 60 hrs, rash slowly began to subside; pt seen by specialist;
Syncopal episodes within seconds of administering HPV #1; lasted about 15 sec. Had blood work done a few minutes prior to vaccine administration; fell off bed.
Left upper extremity swelling, erythema.  Treated with Keflex 125mg by mouth three times a day for 10 days.  07/14/2003.
Patient noticed 3 areas of bruises on her lower administrating arm. She also complained of numbness on her right hand.
COVID AFTER RECEIVING THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 44 year old female. 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: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid after receiving the janssen covid-19 vaccine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Had covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after receiving the janssen covid-19 vaccine was not reported. This report was associated with product quality complaint (PQC): 90000210584 This report was non-serious The suspected product quality complaint has been confirmed to be the reported allegation could not be determined a manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.
Patient complained of swelling and fever in the arm..says it did not happen right away. Several days later?? She seemed unsure of onset. Had trouble lifting arm for a few days. Talked to patient on 3/6/2017. Reported adverse event to pharmacist on duty Sat. March 4.
Pain left arm, weakness left arm, numbness and tingling and winging of left scapula.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient got shingles from Shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Hives on arms, shoulders & face; temp 101F; no local rxn; No prior rxn w/injects;