chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unable to speak; A spontaneous report was received from a nurse concerning an eighty-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the event unable to speak (aphasia).  The patient's ongoing medical conditions included congestive heart failure (CHF), hypertension, hyperlipidemia, diverticulitis, asthma, osteoarthritis, allergy to prednisone and allergy to tape.   Relevant concomitant medications included acetaminophen, amlodipine, cetirizine, colace with senna, fish oil, furosemide, gabapentin, glucosamine, meloxicam, hydrocodone/acetaminophen, metaxalone, montelukast, multivitamin, occuvite, omeprazole, sertraline and trazodone.  On 06-Feb-2021, approximately two days prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Batch# 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07-Feb-2021, the patient stated they were fine.  On 08-Feb-2021, the patient was found by their daughter in the evening unable to speak.  The patient was brought to the ED (emergency department) where they were later admitted for one day. The patient underwent a CT(computerized tomogram) scan on 08-FEB-2021 which showed no evidence of bleed  On 09-FEB-2021, the patient had an MRA (magnetic resonance angiogram) done which showed no aneurysm, dissection or stenosis. An MRI done on 09-Feb-2021 showed multiple areas of acute ischemia in a left MCA distribution and no hemorrhagic transformation.  Lab work performed yielded no significant findings. The reported stated the patient may be transferred to a higher level of care.  No further treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, unable to speak, was not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
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. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 3 Patients in the exposed cohort experienced Acute infective polyneuritis, while 2 of the unexposed cohort experienced Acute infective polyneuritis. Of the 3 patients in the exposed group age: 3 were in age group 19-24. Sex: 1 female, 2 male. Of the 2 in the unexposed group age: 2 were in the 19-24 age group. Sex: 0 female, 2 male.
A report has been received from a Pharmacist concerning a 25 year old, Female subject, who had been received FLUMIST QUADRIVALENT (intranasal). FLUMIST started on 26-Dec-2013. The patient was inadvertently given expired dose of FLUMIST which started on 26-Dec-2013. The outcome of the event of inadvertently gave expired dose of FLUMIST is unknown. The report was considered to be non-serious.
101.5 fever the day and night flowing vaccination. Chills, head flu, nausea. Cleared up two days after.
Red welt over injection site, slowly growing bigger every few hours. It?s hot, sore and itchy. Just started showing as of 1/29/2021...as of now it is the size of a  kiwi.  When vaccine was administered, doctor must of hit a blood vessel. I bled down my arm.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 16 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:patient 16
the patient came to the pharmacy asking for shingle shot, we administer the vaccine while we were reporting we noticed that he is fully immunized so the 3rd dose that we gave was not necessarily
3 pm: returned to office. Right thigh swollen and red. Approximately 3"x2".
Seizure; This case was received via VAERS (Reference number: 1151220) 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 SEIZURE (Seizure) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) 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.   There was no treatment medication reported. There was no concomitant medication reported.  The patient had a seizure about 10 minutes after the vaccine was given.  She had reported to us ahead of time that she has a seizure disorder.  Very limited information regarding this event has been provided at this time. 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. However, patient's underlying condition of seizure disorder remains a confounder. Further information can't be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. 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. However, patient's underlying condition of seizure disorder remains a confounder. Further information can't be requested.
Left Shoulder hurting; left thigh burning; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Left Shoulder hurting) and PAIN IN EXTREMITY (left thigh burning) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETAMINOPHEN and DICLOFENAC POTASSIUM (VOLTAREN ACTI) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Left Shoulder hurting) and PAIN IN EXTREMITY (left thigh burning). At the time of the report, ARTHRALGIA (Left Shoulder hurting) and PAIN IN EXTREMITY (left thigh burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Rec'd ZOSTAVAX on 5/20/10. On 5/21/10 pt. had vertigo decrease hearing loss in Rt ear. His MD said a "virus probably killed the nerves in inner ear". Vertigo better now but hearing loss in Rt. ear continues.
felt like the flu; aching joints; aching muscles; headache; chills; nausea; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms, joint pain, muscle pain, headache, chills and nausea. On an unknown date, the outcome of the influenza-like symptoms, joint pain, muscle pain, headache, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, joint pain, muscle pain, headache, chills and nausea to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and had side effects included it felt like the flu, aching joints and muscles, headache, chills, nausea for two days. The patient thought he/she had caught Covid. The patient stated that nonetheless, still better than getting shingles. The follow-up would not possible as no contact details were available.
fever of 102 degrees, elevated heartrate (resting ~85), severe aches and pains all over body, long-lasting migraine, unable to perform usual daily tasks for two days
I was having shortness of breath, tightness in my chest, heart palpitations like flutters, I had an EKG at an urgent care and it was normal. I saw another doctor and he put me on a heart monitor and next Friday I will have a stress test. Doctor prescribe metformin for my prediabetic state on 3/21/23.
My event started with a sore arm hours after the injection on Thursday.  at 11 p.m. on Friday night I had SEVERE arm pain and a red area that was 4X5 inches, severe headache and CHILLS.  I had frequent urination AND inflammation of every joint and organ in my body and teeth.  My hands and feet were bright red and muscle stiffness.  I took some aspirin.  The chills ended after 3 hours but all other symptoms and fatigue continued.  They all lessened in Saturday and by Sunday except  for my arm which was not as painful but is still a swollen area of irritation measuing 4X5.  I continue to have a sore arm and  sore teeth on Monday at noon.
disoriented; unsteady; very sick to my stomach; Headache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number EW0162 and expiry date not reported), via an unspecified route of administration, administered in Arm Left in May2021 (also reported as 14May2021 at 11:00 (pending clarification)) (at the age of  62-year-old), as dose 1, single for covid-19 immunisation. Patient had no medical history. The patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELEBREX) and lisinopril. The patient had no other vaccine in four weeks. The patient has not been tested for COVID-19 prior to vaccination and post vaccination. Patient had no known allergies. In May2021 (also reported as 04May2021 at 12:00 (pending clarification)), approximate 12 hours after the first dose, the patient became disoriented, unsteady, had bad headache and the patient felt very sick to her stomach. It was reported that bad headache persisted for days and it was notified to the Doctor. The patient visited physician office and therapeutic measures were taken as a result of the events. The outcome for the events was not recovered.
24 hrs, post immun, 1 of 4 pt's exp h/a, swelling & pain @ inject site, inability to move arm, & fever of 101-103 for 3 days; Tx APAP for pain & fever;
I became tired already about 15-30 minutes after the IM injection, and then had to lie down and sleep, for 3-4 hours, immediately after my 15 minute drive home from the Dr. visit.  I developed a fever, up to 102 degrees, that evening and the next day.  I was tired, weak, and lost appetite for the next 24 hours. A rash developed and covered my right upper arm (see photo), centered on the injection site. I had a mild headache. At 48 hours after the vaccination, I started feeling a little better, and on the 4th day after the vaccination I could take a short walk outside the house. The skin rash disappeared after 4-5 days.
He is not feeling well; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. He has been participating in the clinical trial for the COVID-19 vaccine and he has been calling his clinical trial site since Tuesday with no response. The patient was not feeling well on an unspecified date. Therapeutic measure was taken as a result of the event and included treatment with ibuprofen (ADVIL). Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
On May 30th I experienced a scratchy throat, similar to my allergic reaction to cut flowers. On June 2 at 9:00 PM I had fever and tested positive for COVID. I called my primary physician, Dr. He prescribed Paxlovid that I started the next morning, Jume 3rd. After 2 doses I felt better. I tested negative for COVID by the end of the prescription.
Patient received vaccinations at 11:30am.  Mother returned to health department at 2:00pm with patient with welts, redness, and itching.  Mother states noticed redness and scratching by patient at 12:00pm.  Cough developed while at health department.  No difficulty breathing noted.  911 called at 2:00pm.  Blood pressure at 2:00pm 118/68.  Heart rate at 2:00pm 120.  Benadryl 6.25mg given at 2:05pm.  EMS arrived at 2:15pm to transport patient to Hospital.  Mother followed patient to hospital.  Patient arrived at hospital.
mom states on 21MAR95 that pt had high pitched  scary cry w/vax;
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine received post its 30 days Expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 10:09 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 10:09 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) 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.  Vaccine administration time was given as 02-Apr-2022 10:09:10.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
pt recv vax;p/ 3rd vax,exp pain & mild tenderness at inject site,lasted approx 6-7 days;a nodule devel at inject site;nodule more tender & more painful than the original inject caused;MD intended to treat current condition w/ physical the;
HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 12-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
(L) arm pain, red & hot at injection site started the evening after having injection. Pt c/o fevers, h/a & body aches day after injection. Injection site measured 4 cm red & indurated 2 days after shot. Arm pain resolving.
About 30 hours after vaccine given, child had episode consistent with brief myoclonic seizure: would extend help for around 10 seconds and did this 3-4 times x 15-20" period. During episodes, eyes would consistently roll back. On 2nd day after injections, he has about 10 episodes upon awakening. Looks normal in clinic. No 20C with episodes. No episodes in clinic today (two days after vaccine given). No Treatment indicated.
Felt very cold, mild body aches started 12 hours after shot. Body aches increased throughout the north, continued to feel cold. Took ibuprofen and body aches went back to mild and woke up sweaty. Body aches continued to be mild throughout the following day.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: having tested negative the previous day; Positive, notes: tested positive 3.5 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Adverse event: I started having symptoms and tested positive 3.5 days after finishing Paxlovid. I tested positive (after having tested negative the previous day).  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.
After my second vaccine I had a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (After my second vaccine I had a headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced HEADACHE (After my second vaccine I had a headache). At the time of the report, HEADACHE (After my second vaccine I had a headache) outcome was unknown.            No Treatment medications were provided No  Concomitant medications were provided patient would like to know where to go to receive her booster dose   This case was linked to MOD-2021-404082 (Patient Link).
Pfizer Dose 1 2/8/21 (EL1283) Pfizer Dose 2 3/2/21 (EN6203) Pfizer Dose 3 10/4/21 (lot NA) COVID Positive 1/27/22  1/27/22: Patient is a 79-year-old male with past medical history of advanced Parkinson's disease with intermittent hallucinations, history of frequent falls, hypertension presented to the emergency department for multiple falls. Patient is a poor historian history primarily obtained from ED provider sign-out on chart review.  Reportedly wife is caretaker patient at home has had Parkinson's for 19 years and over the last 3 years has had increased confusion/hallucinations.  Reportedly had close contact/exposure with possible COVID-19 positive case earlier this week and was noted over last 3 days patient was more restless had not slept as well, had multiple falls this week.  Has had history of reported "brain bleed" reportedly was seen restless and writing in chair so was brought into the emergency department today for further evaluation.  Blood work demonstrated no significant abnormality in Chem panel, mild CK elevation blood gases without acute derangement, no significant leukocytosis or anemia, UA with elevated spec graft.  D-dimer was elevated and rapid COVID was positive.  CT head and CT PA were done in ED and initial results reportedly were negative. Patient was reoriented in ED and did not require any medication for agitation or confusion.  However with recurrent falls request was made to admit to medical service for further evaluation therapy evaluation and possible placement.  At bedside patient is lying comfortably in bed he is awake however cannot provide history, social history or medication history.  He denies any lightheadedness, dizziness, chills, fever, nausea, vomiting, diarrhea, chest pain, palpitations, abdominal pain.  Family history could not be obtained.  2/9/22: Pt w severe Parkinson's disease presented with delirium, acute hypoxic respiratory failure secondary to COVID-19 pneumonitis and aspiration pneumonia.  Pt condition continued to decline and family elected hospice, patient remained in the hospital due to poor condition he remains in the hospital until he passed away in February 9th at 00:20.
Patient may have inadvertently been given 1cc of Moderna COVID vaccine instead of 0.5cc Patient was notified. State was notified