chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.  No Medical History information was reported.  On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day use by date) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.   Beyond use date of the vaccine was 16-Jan-2022. Date the vial was initially stored in the refrigerator was 17-Dec-2021 and the vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
I have severe pain in my left and right shoulder since the vaccine. I have difficulty lifting my arms, I have difficulty sleeping because of the pain.
Rash all over hands, arms, stomach, and chest. Small red bumps that are slightly raised and itchy. I was told by my doctor to take 10 mg od xertec in the morning and 20 mg of pepcid at night.
Got the Moderna COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got the Moderna COVID-19 vaccine while pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025620A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Jun-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got the Moderna COVID-19 vaccine while pregnant). On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got the Moderna COVID-19 vaccine while pregnant) had resolved.            No treatment information was provided.  No concomitant medication was provided.   Action taken with suspect product was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Follow up received: No additional information updated. On 10-Feb-2021: Internal review on 20JUL2021 resulted in updates to pregnancy details.
Information has been received from a registered nurse (RN) concerning an 8-year-old white female who on 19-OCT-1998 was vaccinated with a dose of Varivax (lot# 627875/1245H). Subsequently the patient experienced a generalized rash of less than 50 lesions. Medical attention was sought and the patient was seen by a physician. No hospitalization was required. No outcome was reported. Additional information has been received from a woman who reported that no further information is available on this patient.
Myalgia, Rash, ErythemaMultiform, UrticariaPruritus, Injection site pain Narrative  Patient reported that they were on Bactrim for eczema (x30days, BID) when they received Covid-19 vaccine
The patient began feeling light-headed and diaphoretic immediately after vaccine administration. He was taken by wheelchair to a medical exam table to recline, with feet elevated on pillows. He stated he had not had anything to eat that morning or the evening prior. He was offered juice, and would take sips if it was held to his mouth, however did not want to eat any crackers. He was not verbal, answering questions by shaking his head yes or now only. Unsure if he remained oriented. He was also noted to have a brief syncopal episode. He was noted to be shaky and anxious. He complained of lethargy and was unable to bear weight/walk.  His vitals upon arriving at the exam table were: BP 110/64 HR 45 SpO2 97% It was determined by RN that he may be hypoglycemic. No glucometer was available. She stated he was not able to tell them if he was diabetic. She decided to administer 1mg glucagon subcutaneously. He also continued sipping on apple juice. His vitals were repeated five minutes later and at that time were: 110/82 HR 84 SpO2 96% Ten minutes after this: 122/80 HR 74 SpO2 95%.  This was now 1045. He was complaining of his head spinning when he tried to sit up and remained shaky. He was unable to stand or walk independently. At this time it was recommended that he go to the emergency room or urgent care. He denied an ambulance, but stated his mother could come pick him up and take him to the emergency room. She was contacted, arrived at 1105.  His last set of vitals remained within normal limits at 1106. He was taken by wheelchair to his mother's car.
Within 15-minutes of vaccination, the patient reported feeling lightheaded and nauseous. Patient was found to hypertensive (170/88) compared to baseline hypotension. Patient was evaluated for 20-minutes and her vitals and mentation returned to normal. The patient refused transport and was able to ambulate to her daughter's car.
Severe shaking; This case was reported by a consumer via interactive digital media and described the occurrence of tremor in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 24 hrs after receiving Shingles vaccine, the patient experienced tremor. On an unknown date, the outcome of the tremor was unknown.   It was unknown if the reporter considered the tremor to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: This case was reported by a patient via  interactive digital media. The patient received a dose of Shingles vaccine and 24 hours after experienced severe shaking. Additional Supportive Information: Follow-up would not possible as no contact details were available.
pt recvd vax;devel rash approx 2 mon following varicella vax;
felt crummy; very tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Nov-2021 and was forwarded to Moderna on 01-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL and FATIGUE in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL and FATIGUE. At the time of the report, FEELING ABNORMAL and FATIGUE outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
mom called 24APR97 pt had 102, bad h/a, very agitated, stomach pain & glassy eyed;pt cried for many hr during the noc;APAP was given about 12MN;
Headache, Myalgia, NauseVomiting, Chills Narrative:
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353459USA. A male patient between the ages of 19-24 years, who experienced poisoning by unspecified drug or medicinal substance (Serious, since 11-May-2012, until 11-May-2012) while enrolled in a Teva study. The patient was an active recruit. Adenovirus vaccine was administered on 04-May-2012. Adverse events within 42 days of vaccination: Cold pak (since 07-Jun-2012, until 07-Jun-2012) treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, outcome, severity and seriousness were not assessed; otitis media (since 15-Jun-2012, until 15-Jun-2012) treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, outcome, severity and seriousness were not assessed. Concomitant medications within 42 days of vaccination: Acetaminophen (since 11-May-2012, until 16-May-2012), (500mg, Q6H, PO) right hip pain radiates to leg; penicillin G (since 10-May-2012, until 09-Jun-2012), (600,000 mL, once, IM) prophylaxis; Acetaminophen (since 12-Jun-2012, until 17-Jun-2012), (325mg, Q6H, PO) unknown indication; pseudoephedrine Acetaminophen (since 15-May-2012, until 18-May-2012), (30mg, QID, PO) unknown indication; dexamethasone and guaifenesin (since 15-Jun-2012, until 15-Jun-2012), (20mg/20mg, QID, PO), unknown indication; amoxicillin/potassium (since 15-Jun-2012, until 25-Jun-2012), (875-125mg, BID, PO), unknown indication. At the time of the report the outcome of the AEs were: poisoning by unspecified drug or medicinal substance : not recovered/not resolved. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. The patient's concomitant medication included DTP (since 04-May-2012); Meningococcal Vaccine (since 04-May-2012); IPV (since 04-May-2012); Influenza Vaccine (since 04-May-2012). The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus Vaccine - Not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as Not Assessable to the Adenovirus Vaccine.
Localized induration with tenderness to palpation, erythema and warmth. Patient has generalized malaise. Headache and chest pressure.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 1, single (Lot number: ew0170), in left arm and on 13May2021 as dose 2, single (Lot number: ew0182) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 03Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 069f21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022 at 02:00, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Negative; (01Jun2022) Negative; (05Jun2022) Negative; (06Jun2022) Positive, notes: evening; (unspecified date) Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient did not receive any medication in 2 weeks. Patient had no known allergies. Adverse event: negative antigen test 22May. Negative antigen test 01Jun. Negative antigen test 05Jun. Positive antigen test 06Jun evening. Took evening test because patient felt achy similar to how felt with covid. So 15 days covid negative then positive. The patient received Paxlovid as a treatment for COVID-19 from 19May2022 to 23Jun2022.
GERD; burning sensation; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 40 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Jul2021 14:17 (Lot number: EW0171) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Time: 11:02 AM, Anatomical site of injection: Deltoid, Route of administration: Intramuscular, Batch/Lot number: EW0171), administration date: 29Apr2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "Rash", "fatigue", "Chills", "extreme body heat", "Dry skin", "burning sensation in my arms and feet". The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 29Jul2021, outcome "unknown", described as "GERD"; BURNING SENSATION (non-serious) with onset 29Jul2021, outcome "unknown", described as "burning sensation". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had not received any other vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
my daughter was given her first Guardisil vaccine.  within 2 minutes of injection she began to ask me if it was normal....when she collapsed and fainted.  her eyes rolled back into her head and she began to shake almose as if she were on the edge of a seizure.  within 45 seconds to one minute she awoke wondering what had happened to her.  we are very concerned about the safety of this vacccine and do not intend to continue treatment
patient complained of itching to throat and roof of mouth and tingling to tongue. Also had rash to chest and neck and itching. Patient complained of symptoms becoming worse and having to constantly clear throat, epi pen was used and patient transported to the ED via wheelchair.
Fever as high as 101 degrees. Redness, swelling, warmth at injection site.
FEVER; WEAKNESS; DIZZINESS; DIFFICULTY BREATHING; VOMITING; HEART RATE INCREASED; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included renal insufficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm at approx 13:45 -14:15. No concomitant medications were reported. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced heart rate increased. On 15-MAR-2021 04:30, the subject experienced dizziness. On 15-MAR-2021 04:30, the subject experienced weakness. On 15-MAR-2021 04:30, the subject experienced difficulty breathing. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from dizziness, weakness, difficulty breathing, vomiting, and heart rate increased. This report was non-serious.
Severe joint pain since taking the vaccine. Not able to work out due to pain all over, affecting job and daily living. Was put on anti inflammatory, diclofenac.
Diagnosis by Doctor - HSP vasculitis pityriasis.  Two days after covid vaccination (second dose) child develops fever of 101 for one night. Child is lethargic and uncomfortable. After fever child develops small spot red rash on feet and hands and inflammation. Rash is extremely itchy and painful - child screams in pain for three nights. After 2-3 days rash has spread other body areas. Rash is largest on lymph nodes in armpits, groin and behind knees. Swelling and darkness in eyelids and under eyes.  Child continues to lose energy and the rash persists for 5-7 weeks at it's most affected.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced classic chickenpox on the face, front, arms and back of body consisting of not much more than 50 lesions. The pt also experienced mild fever and fatigue. It was reported that a sibling vaccinated on the same day never had any symptoms.
J&J vaccine around 8:40am Saturday. By 3pm, I was feeling significant fatigue. By 5pm, chills and low fever (99). Chills and fever intensified, and fever rose to 103  by 10pm, with headache and body aches (mainly legs). I had very mild nausea & loss of appetite. Over the course of the night, I tried to stay hydrated with water and apple juice. By about 11pm, I took 200mg of Advil. I took another 200mg Advil several hours later. Throughout the next day, Sunday, my fever subsided gradually, significant fatigue persisted as did loss of appetite. By Monday, I was left feeling mostly weak and worn out, but on the road to recovery. By Tuesday morning (now), I feel that the I will be recovered by tomorrow.
Pt was nervous before the vaccine (visibly shaking legs), counted down injection as requested by patient. Asked if it was done without realizing vaccine was complete. Pt was sturdy upon standing and said she felt well. She made it to the chair in the designated area in front of the pharmacy. Approximately 3-5 minutes later patient raised her arm to get the attention of the staff. Said she felt funny. Vaccinating pharmacist went out to determine what was wrong. Patient said she felt faint and dizzy as well as felt nauseous. Patient spit up clear saliva inbetween dry heaving. We were able to give her paper towels and some water after her episode of spitting up. Approximately 5 to 7 minutes later she said she felt better but still had some faintness and a tingling sensation in her arms and fingers. Had patient stay for 20 minutes after she said she was feeling better. No more shaking, nausea, or faintness. She felt her normal self after the 20 minutes and her mother was with her to drive her home. Explained to patient that VAERS report would be submitted.
Moderna Booster after 2 inital doses of Pfizer administered within the recommend time frame per CDC and manufacturer Patient reported Left Axillary swelling after receiving vaccine , patient was examined by PCP with no noted mass affect or lymphadenopathy. Diagnostic imaging and testing also reported as stable and WNL. Patient reports having continued intermittent pain, swelling, and numbness in L axilla. Also reported rash and fever 48 hours after receiving vaccine.
Received booster dose of COVID vaccine (Note that dose 1 and dose 2 were Pfizer vaccine, but this dose 3 booster was Moderna vaccine).  About 48 hours after booster dose received the patient developed suddenly more short of breath with a productive cough, and a sensation of tightness in the chest, and also noted it was difficult to lay reclined so had to sit up to sleep due to symptoms.  Patient presented to  Medical Center ED 12/5/21 at 1221 and was noted to have mildly elevated blood pressure, negative COVID-19 antigent test, moderately elevated D-dimer (0.65) and miild leukocytosis and initial troponin elevated at 0.068 with subssequent troponins of 0.087 and 0.089. Patient had CT imaging that indicated likely CAP, and with elevated troponoin and shortness of breath the provider decided to admit the patient to the hospital.  A echocardiogram returned without any evidence of abnormality. The troponin level remained mildly elevated but downtrending. The patient was discharged 12/9/21 at 1200.
Information has been received from a pharmacist concerning a 59 year old female with allergy to "everything" and a history of lupus who on 16-NOV-2007 was vaccinated SC with a single dose of ZOSTAVAX (lot # 658602/1080U). There was no concomitant medication. On 16-NOV-2007, after vaccination the patient developed injection site reaction. It was reported that the redness at the injection site was initially the size of "teacup saucer", but it subsided to the size of baseball. At the time of report the patient was recovering. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
Beginning at approximately 9pm on 04/03/21, spasm like pain under back right ribs, radiating around under ribs and up into right shoulder and right arm.  Diagnosis in 4/7 was acute pulmonary embolism in right lung.
Headache, Myalgia, Fever INJECTION SITE PAIN, HEADACHE, CHILLS,  FEVER, INSOMNIA  Narrative:
Narrative:  77 year old male admitted on August 4 2022 with fever, delirium, and hypoxia.. He had received Moderna vaccine x 3 on January 28 2021, February 25 2021, September 28 2021. He was treated with remdesivir 200 mg x 1 then 100 mg IV daily x 3 days and dexamethasone 6 mg daily x 4 days.. He symptomatically improved and was discharged home on August 7 2022.
within 24 hours of second Moderna dose, I experienced nausea, chills and flu like symptoms. In addition to these expected symptoms, I also experienced GI upset for 4-5 days after my second dose- I was nauseous and had diarrhea.
lt anterior thigh w/induration appears as fat necrosis initially fever & pain x 1-2 days;
On Sunday 3/28, I developed a lump on the left side of my neck - presumably the lymph node.  It hurts to the touch and is about a marble in size.  As of Tuesday even (3/30) it is still there.  Some soreness around the lump in my neck area as well.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient did not receive other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
PNEUMOVAX reaction (MERCK & CO Lot # R000579) temperature to 100.2, body aches, myalgias. Red swollen arm hot and painful from top of shoulder down to elbow. Headache.
My left arm was sore.  My whole body felt sore.  I had diarrhea.  Developed a tooth abscess.  The tooth had to be pulled.  I have a video exam with my doctor.  She gave me antibiotics and over-the-counter medicine for the diarrhea.
Patient developed hand & feet swelling, pruritic rash with urticaria over limbs and torso.  She was treated with PO prednisone and PO hydroxyzine.
Flu shot received on 10/7/14 about 1600 - at 10 pm I had chills - and sore throat -this am (about 0700) my (Rt) side of my face became tingly and swelling of the (Rt) side of my lips.
Vaccine stored under refrigeration beyond 30 days. Modera Case ID CEA-2628 result: lot number 056M21A maintained the activity necessary to protect against the SARSCoV-2 (COVID-19) virus at time of administration. Did not contact patient per no action required.