chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date the unspecified number of patients were vaccinated with ZOSTAVAX (subcutaneous, dose reported as single dose). On an unknown date the patients experienced brief discomfort at the injection site after administration of ZOSTAVAX. The reporter states that discomfort resolved quickly without requiring medical attention. No lab tests were performed. The outcome of brief discomfort at the injection site was reported as recovered/resolved. The causality was unknown. Additional information has been requested.
Vaccine diluted with 0.8ml of diluent rather than required 1.8ml
Flu like symptoms (severe cough, shortness of breath, congestion, sore throat, aches and pains, high temperature, excessive mucus production) beginning 48 hours following injection. Initially slight cough only.  Symptoms persist and continue to become more apparent 7 days following injection.
Minor adverse reaction with early cellulitis. (Redness, warmth and swelling at injection site)
Light headed / Dizzy; Jittery; Mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed / Dizzy), FEELING JITTERY (Jittery) and FATIGUE (Mild fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headed / Dizzy), FEELING JITTERY (Jittery) and FATIGUE (Mild fatigue). At the time of the report, DIZZINESS (Light headed / Dizzy), FEELING JITTERY (Jittery) and FATIGUE (Mild fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Hospitalized 12/15/2021; COVID-19 positive 12/16/2021; fully vaccinated  BRIEF OVERVIEW: Admission Date: 12/15/2021 Discharge Date: 12/17/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia [J18.9] Community acquired pneumonia, unspecified laterality [J18.9] HOSPITAL COURSE: Patient is a 63 y.o. female  who presents to hospital emergency department with cough and shortness of breath.  Patient states that she has a history of chronic obstructive pulmonary disease but does not have oxygen at home.  She denies fevers but does states that she has had chills some nausea intermittent diarrhea.  She also has a large amount of sputum that she coughs often chokes on.   patient complained of hemoptysis.  CT angiogram of the chest was performed, at facility which showed no evidence of blood clots or PEs but does show a right upper lobe pneumonia.  Patient's O2 sat drops to 86-84% with oxygen when ambulating.  Additionally at rest O2 sats 91% on 2 L. Patient was admitted to hospital and was started on IV Rocephin and azithromycin for right upper lobe pneumonia.  COVID-19 PCR was negative.  However film array was positive for COVID-19 pneumonia.  Patient was started on dexamethasone and remdesivir.  Patient was quickly able to be weaned off of supplemental oxygen to room air and she remained stable on room air.  Patient performed walking pulse oximetry with respiratory therapist and was found to require no supplemental oxygen on ambulation and at rest.  She was discharged home in stable condition on oral azithromycin for 2 days to complete a total course of 5 days for community-acquired pneumonia.  Patient did not require any continuation of COVID-19 pneumonia treatment
This case was received from a health professional. A 41-year-old female patient, with a history of asthma, received an intramuscular left deltoid third dose of IMOVAX (lot number A0259-3) on 31 March 2008. The patient had received initial doses of IMOVAX, IMOGAM, and tetanus vaccine (lot number and manufacturer not provided) in the emergency room on 24 March 2008, after being exposed to raccoon saliva on a cat. She received an intramuscular left deltoid second dose of IMOVAX (lot number A0259-3) on 27 March 2008, and no adverse reactions were reported at that time. In the evening of 31 March 2008, following her third dose of IMOVAX, she experienced a generalized rash, headache, sore throat, swollen lymph nodes, and a bloody nose. Treatment included BENADRYL and TYLENOL, and at the time of the report the events had not yet recovered.
large red area (softball size) on lt thigh which started out quarter size approx 24hr p/vax;no pain or other sx;cold compresses to area
NUMBNESS IN ELBOW DOWN, FOREARM, HANDS AND FEET; TINGLING SENSATION FROM ELBOW DOWN FOREARM,HANDS AND FEET/PRICKLY FEELING AFTER GET FROM STANDING ON FEET FOR LONG TIME BUT FEELING FROM THE ELBOW DOWN; FEELS ACHY; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known drug allergies and did not had any history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced numbness in elbow down, forearm, hands and feet. On JUL-2021, the subject experienced tingling sensation from elbow down forearm, hands and feet/prickly feeling after get from standing on feet for long time but feeling from the elbow down. On JUL-2021, the subject experienced feels achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in elbow down, forearm, hands and feet, tingling sensation from elbow down forearm,hands and feet/prickly feeling after get from standing on feet for long time but feeling from the elbow down and feels achy was not reported. This report was non-serious.
PT TAKEN TO EMERGENCY ROOM  07/12/19 FOR DIARRHEA X5 DAYS. GASTROENTERITIS PCR PANEL COLLECTED TO IDENTIFY SOURCE AND PT WAS POSITIVE FOR ROTAVIRUS A.
This spontaneous report as received from a other health professional refers to an unspecified number of patients (sex and age unknown). The reporter saw on the CDC website that there was a publication MMWR from 30-NOV-2001. It reference a study in children. On an unknown date, the children had received VARIVAX (Merck) (dose, strength, frequency and route of administration unknown) and MMR II concomitantly. No concomitant medication was reported. On an unknown date unspecified number of children had developed chickenpox. Outcome of the event was unknown. The causality of the event with VARIVAX (Merck) and MMR II was unknown. The case is linked with MARRS # 1402USA006201 and MARRS # 1402USA006288 via same reporter link. Additional information has been requested.
Pt recvd 2nd dose of vax & exp pressure sensation in chest & claimed to have felt pulse in chest; also exp palpitations & bilateral pain, h/a;
I was playing tennis from 11AM to 1PM. I came home ate lunch and took a shower. I noticed my heart rate was still above 150 beats per minute. At about 4PM I called an ambulance. They took an EKG and noticed a problem. I was taken to the emergency room. They were able to diagnose atrial flutters. The rapid heart rate is resolved but I am scheduled for surgery to fix it.
Erythema/induration - tenderness at injection site, no fever, TAC 0.1% oint, KEFLEX 250mg/5mL 1 1/2 tsp po BID x 10 days.
No adverse event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    No concomitant medications were reported. It was reported that, the patient received vaccine after the beyond use-by date. No treatment medications were reported.
Six weeks after injection painful soreness in right upper arm persists. Limits range of motion for right arm when reaching up or back and for carrying moderately heavy things or raising out of bed.
11/21/2018 at 10:30 at Urgent Care: Chills, cellulitis in left arm and painful urination which was an error - I just couldn't pee a sample. 11/22/2018 at 1900 at Emergency Room:  I triggered a code red. Diagnoses of diabetic ketoacidosis, blood sugar out of control, sepsis, white blood cell count 22,000, TIA (Transient  Ischemic Attack) and cellulitis. I was told at some point that I had liver damage but that it had repaired itself by the time I left the hospital around 1400 on 11/26/2018. Pneumonia was talked about constantly throughout the ER and hospital notes but not specifically diagnosed. My daughter was told I had fluid in my lungs at the ER. Dr. whose specialty is infectious disease, saw me.
Unbearable itchiness of the left breast and nipple. Tattoo in area raised and inflamed. Redness and pain from scratching uncontrollably.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 12-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 20-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 11-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
temp body aches; slept several hours; temperature; This case was reported by a consumer via  interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain, sleep excessive and body temperature. On an unknown date, the outcome of the general body pain, sleep excessive and body temperature were recovered/resolved.   It was unknown if the reporter considered the general body pain, sleep excessive and body temperature to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingrix and experienced temperature, body aches and slept several hours. The patient was fine the next day. The follow up would not be possible as no contact details were available.
Patient received COVID Vaccine #1 and reported that about 20 minutes later had onset of left sided facial tingling. No oral or facial swelling noted. No SOB or wheezing. Hx of anaphylaxis + has Epi pen at home. Felt like she had some difficult swallowing but this is her baseline + her mouth was very dry. She was monitored for 60 minutes with improvement of her symptoms. Benadryl + Zyrtec provided but patient did not take them at the time of observation.
10/31/21 pt in nursing home; nurse entered room and pt was non-responsive to verbal stimuli and lethargic; breathing was labored and shallow; 92% on RA; rapid COVID test was positive; COVID protocol initiated; pt found later that morning with no pulse, no BP and no respirations;
The COVID-19 vaccine administered through vaccine administrator, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790). Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
After the first dose, during the night I had fever until the morning. The next day, the fever was gone (probably also because I took advil). My arm swallowed for about two to three days and the part of the vaccine felt hot all the time (like when someone has an infection).
1 hour after vaccination at home, patient reported to mother that he felt extremely dizzy and had fast breathing/panic attack-like symptoms. Felt hot and cold but afebrile. Told to go to bed and rest and later woke up complaining of feeling ringing in ears then no sound for about 30 seconds then back to normal. The next day still felt dizzy and fatigued. Limited appetite, no rash, no vomiting, no fevers. Left arm aching. Seems to be improving.
LEUCINE-RICH GLIOMA-INACTIVATED PROTEIN (LGI1) ANTIBODY ENCEPHALITIS; This spontaneous report was received from physician via literature. The objective of this article was to describe a case of suspected post-vaccine autoimmune encephalitis associated with leucine-rich glioma-inactivated protein (LGI1) antibodies with significant clinical improvement after initiation of immunotherapy nearly a year after symptom onset. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was previously healthy and highly independent.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 9 decade old. No concomitant medications were reported.  On an unspecified date, the patient experienced abnormal posture and spasm of the right shoulder 2 to 3 weeks after vaccination. The abnormal movements progressed to involve the right side of patient face and were refractory to multiple ASMs (Anti-seizure medication). EEG (Electroencephalogram) captured multiple events without epileptiform correlate. Several months later patient had developed paranoia, delusions, and hallucinations. Autoimmune encephalopathy panel returned positive for the LGI1-antibody (leucine-rich glioma-inactivated protein) around nine months after the onset of FBDS (Faciobrachial Dystonic Seizures). The patient had a fluctuating level of arousal, impaired recall of recent events, and was tangential in conversation. There were frequent, brief, repetitive, dystonic movements of the right side of the face consistent with FBDS. Admission was arranged for immunotherapy (intravenous methylprednisolone and intravenous immunoglobulin). Upon follow-up four weeks later, there was significant improvement in patient arousal and concentration with resolution of FBDS and delusions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leucine-rich glioma-inactivated protein (lgi1) antibody encephalitis. The authors concluded that case highlights a classic case of LGI1 encephalitis after vaccination presenting with FBDS and progressive cognitive changes. Despite immunotherapy being delayed, there was marked clinical improvement. It was important to recognize this entity and that it typically had a favorable outcome. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231129709-leucine-rich glioma-inactivated protein (lgi1) antibody encephalitis. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
patient had a loss in range of motion in right arm; The muscle in my right arm is still hurting; sluggish; flu-like symptoms; Pateint was feeling blah; This spontaneous case was reported by an other health care professional and describes the occurrence of JOINT RANGE OF MOTION DECREASED (patient had a loss in range of motion in right arm), SLUGGISHNESS (sluggish), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (Pateint was feeling blah) and MYALGIA (The muscle in my right arm is still hurting) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Flu vaccination.    Patient did not have COVID positive test or diagnosis.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced SLUGGISHNESS (sluggish), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FEELING ABNORMAL (Pateint was feeling blah). On 22-Sep-2022, the patient experienced JOINT RANGE OF MOTION DECREASED (patient had a loss in range of motion in right arm) and MYALGIA (The muscle in my right arm is still hurting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, JOINT RANGE OF MOTION DECREASED (patient had a loss in range of motion in right arm) and MYALGIA (The muscle in my right arm is still hurting) had not resolved and SLUGGISHNESS (sluggish), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FEELING ABNORMAL (Pateint was feeling blah) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  On 04-JAN-2021, patient received First dose of Moderna COVID-19 Vaccine with batch number 039K20A. On 02-FEB-2021, patient received Second dose of Moderna COVID-19 Vaccine with batch number 028L20A. On 23-AUG-2021, patient received First booster dose of Moderna COVID-19 Vaccine with batch number 053E21A. On 30-MAR-2022, Patient received Second booster dose  Moderna COVID-19 Vaccine with batch number 066K21A.  It was reported that Advil works better than the Tylenol.
fast heart beat; my blood pressure swings up; feeling dizzy; stumbling while walking; shortness of breath; throat swells up; tingling feeling on my left hand; numb feeling on my left hand; a rash on my back; Fever; pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (fast heart beat), HYPERTENSION (my blood pressure swings up), DIZZINESS (feeling dizzy), GAIT DISTURBANCE (stumbling while walking) and DYSPNOEA (shortness of breath) in a 66-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.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, METOPROLOL, EMPAGLIFLOZIN (JARDIANCE), GLIPIZIDE, METFORMIN and CLOPIDOGREL for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PALPITATIONS (fast heart beat), HYPERTENSION (my blood pressure swings up), DIZZINESS (feeling dizzy), GAIT DISTURBANCE (stumbling while walking), DYSPNOEA (shortness of breath), PHARYNGEAL SWELLING (throat swells up), PARAESTHESIA (tingling feeling on my left hand), HYPOAESTHESIA (numb feeling on my left hand), RASH (a rash on my back), PYREXIA (Fever) and INJECTION SITE PAIN (pain on the injection site). On 07-Jun-2021, INJECTION SITE PAIN (pain on the injection site) had resolved. At the time of the report, PALPITATIONS (fast heart beat), HYPERTENSION (my blood pressure swings up), DIZZINESS (feeling dizzy), GAIT DISTURBANCE (stumbling while walking), DYSPNOEA (shortness of breath), PHARYNGEAL SWELLING (throat swells up), PARAESTHESIA (tingling feeling on my left hand), HYPOAESTHESIA (numb feeling on my left hand), RASH (a rash on my back) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.
Clusters of headaches; This spontaneous case was reported by a consumer and describes the occurrence of CLUSTER HEADACHE (Clusters of headaches) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic headaches since 2013. Concomitant products included VERAPAMIL, VALPROATE SEMISODIUM (DIVALPROEX) and FROVATRIPTAN for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced CLUSTER HEADACHE (Clusters of headaches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. At the time of the report, CLUSTER HEADACHE (Clusters of headaches) had not resolved.            As per report, patient had been suffering from headaches for about eight years, which had worsened after receiving the second dose of the Moderna covid-19 vaccine. He stated that his preventive medications were no longer effective in controlling the headaches. The patient had made a neurology consultation appointment for 13-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant follow up (Concomitant medication added)
pt with erythematous, firm, hot rash at left deltoid, itchy  started 7 days after the injection.  rash is on side ipsilateral to the vaccine
Fever 100.5, body aches and tachycardia 105 bpm.  Soreness at the site of injection.
Pt presented with tongue and throat swelling associated with scattered hives.  Pt was treated for anaphylaxis and responded to IM epinephrine x1. He was observed in the emergency department and then discharged safely.