chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 06-JUL-2016 from a Certified Medical Assistant. It was reported that a male patient of unknown age was administered a dose of PROQUAD (lot # M004893, expiration 26-JUL-2017) 0.5 ml on an unknown date (route and injection site not reported), that was improperly stored (details not specified). No adverse effects were reported. No further information was provided. Additional information has been requested.
Severe arm pain; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Severe arm pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 0616M20A) for COVID-19 vaccination.     Concomitant products included BIOTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and SACCHAROMYCES BOULARDII (FLORASTOR KIDS) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain). On 20-Jan-2021, PAIN IN EXTREMITY (Severe arm pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment information was not provided.
5cm area of erythema at site of injection approximately 24 hours after injection. Has arthralgias partially responsive to Ibuprofen.
Pt received shot and within 3 hours his arm blew up and they were numerous bruises. He felt pain all throughout his body. He went to the ER 2 times.
On 10/09 back broke out in slight rash by 10th early evening, back and neck were completely broken out and itching.  Were on cruise ship MD's office was closed.  So went as soon as opened next day, treated hives.
73-year-old male past medical history of hypertension, high cholesterol, non-Hodgkin's lymphoma, CAD recent diagnosis of squamous cell carcinoma of the oropharynx who is here for evaluation of fever, congestion, cough and fatigue noted for last 2 weeks that exacerbated over the last few days.  Patient states that he feels really tired.  Patient denies any chest pain or shortness of breath.  Patient has dry cough.  Patient has been taking Tylenol as needed for fever.  Patient denies any nausea, vomiting, abdominal pain, diarrhea.  Patient requiring 15 L of oxygen nasal cannula
mild swelling and tenderness at the injection site,  small pea-sized lumps in her left armpit
Fever X 1 day; nausea, headache X 1 day and body pain.
04/03/23 presents to ED for "fatigue, fall". PMHx of "cancer, partial gastrectomy, BPH"
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) 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) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information regarding first or second dose were provided. No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as received from a physician refers to a child of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 21-SEP-2016, the patient received a partial dose of PROQUAD (lot number reported as M026879 and expiration date 27-NOV-2017, albumin status therapy type, dose and route of administration were not reported) due to the fact that the parent, who was holding the patient, moved during the injection procedure. The patient did not experience any adverse effects. No product quality complaint (PQC) was involved. Additional information has been requested.
Major take with smallpox vaccine with lymphadenopathy.  Feeling lousy with some dizziness and fatigue.  Recommended quarters for rest of today and tommorrow due to his complaints.  I submit this VAERS due to quarters and not due to unexpected symptoms.
Headache Localized swelling; fatigue, hot flashes Narrative:   Other Relevant History:
Dizzy. BP 96/60, HR - 67; BP 102/59, HR 69; BP 101/61, HR 70.
2wk post vax pt lost vision in both eyes;taken to hosp dx optic neuritis;loss vision 9MAY98;
4/12/21 - After 6 hours - chills Throughout the night - chills, achey, sore arm 4/13/21 - 5:45 am - vomiting phlegm (once) Throughout the day 4/13/21 - chills, achey (I never took my temperature), sick to my stomach all day, was able to resist vomiting. 4/13/21 - 7:00pm:  went to bed with chills, aches.  Slept 12 hours and felt better upon awakening. I haven't had the flu in several years, and after this shot, I felt like I had a bad case of it!
received booster on Monday and would like to report some side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (received booster on Monday and would like to report some side effects) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (received booster on Monday and would like to report some side effects). At the time of the report, IMMUNISATION REACTION (received booster on Monday and would like to report some side effects) outcome was unknown.        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.   No concomitant medication information was reported. No treatment information was reported.   This case was linked to MOD-2021-393473 (Patient Link).
The patient received a third dose of the vaccine because she did not remember receiving any dose of the vaccine when she requested a Moderna COVID-19 Vaccine EUA
Red, raised discrete lesions on neck, chest, shoulders starting 12/20/04.  One "umbilicaled lesion" described 12/21.  Re-evaluation 12/22 showed resolution of most lesions.  No site to sample for lab testing.  Hospitalized overnight for observation. Follow up: Reporter states she consulted with the CDC after pt was discharged. Final diagnosis is generalized rash a form of erythema multiforem and not generalized vaccinia as hospital discharge summary states.
Chest pain; Heart pounding; Difficulty breathing; This spontaneous case was reported by a nurse and describes the occurrence of CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding) and DYSPNOEA (Difficulty breathing) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding) and DYSPNOEA (Difficulty breathing). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain), PALPITATIONS (Heart pounding) and DYSPNOEA (Difficulty breathing) outcome was unknown.        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.   The concomitant medications were not reported. The treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received and had no new information.
Shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date with outcome of unknown. There is a little shingle maybe 4 or 5. Patient went to see the doctor and he gave the patient an antibody for shingles. Patient did not know if it was an antibiotic or it is supposed to be antiviral. Medication is Famciclovir, 500 mg and the doctor wanted the patient to take it 3 times a day for 7 days.  Information on the lot/batch number has been requested.
I didn't have a fever. My temperature was 98.6 consistently. I had a runny nose and was coughing up phlegm. I didn't have any soreness.
Seizure; headache; chills; lethargic; diarrhea; I've had problems with sight; brain fog; I cannot spell words or recall  thing; I cannot spell words or recall  thing; tired; This is a spontaneous report from a non-contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 10:00 (Batch/Lot Number: EN 6206) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:00 (Batch/Lot Number: EN ER9730) as dose 2, single for COVID-19 immunization. Medical history included Hashimoto, allergies to eggs and nuts. Concomitant medications included levothyroxine; ascorbic acid (VIT C); vit d [vitamin d nos] (VIT D); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced seizure (which she never had) headache, chills, lethargic, diarrhea. Since 09Mar2021, she had problems with sight, brain fog, (overnight) she cannot spell words or recall things and was constantly tired. The events occurred on 09Mar2021 18:00. No treatment given. The patient had no prior vaccination and was not tested for COVID post vaccination. Prior vaccination, the patient was not diagnosed with COVID-19. The outcome of the events recovered with sequel/ lasting effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2014US023361, is an initial spontaneous report received from a medical assistant on 19 Nov 2014 and with follow-up information from a medical assistant received on 06 Feb 2015. This report refers to a 12 year old male patient. Historical condition was not reported. No concomitant medication was reported. The patient was inadvertently vaccinated only with the Men-CWY-135 liquid component of MENVEO (batch number: M14068) via intramuscular route into left arm on 19 Nov 2014. The patient was notified to come into clinic for revaccination. No adverse event was reported following this administration error (inappropriate preparation of medication). Follow-up information from a medical assistant received on 06 Feb 2015: Patient's demographics (height and weight) and site of vaccination (left arm) was updated.
w/in second of vax pt became extremely diaphoretic, nauseous & hypotensive (76/38);pt was watched for 25min, color returned, BP rose to 98/60;pt was advised to rest this day, see MD if sx of any kind occurred & warn next hlth provider;
As patient was starting to leave observation area, she became lightheaded and felt dizzy.  She had no SOB, chest pain, rash or other symptoms. She returned to observation area and reclined on cot.  Oxygen started at 4L per NC.  VS: O2 sat 98% P 76 B/P 110/60.  Given water to drink. VS  remained stable.  She drank a bottle of water and final VS at 4:30 B/ P 130/80, P 82, O2 sat 98%.  Patient left ambulating without difficulty. Symptoms completely resolved
This spontaneous report as received from a pharmacist refers to a 65 year old female patient with hypertension. On 07-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot # H016762, expired date 11-DEC-2013) (dose, route and indication were not reported) in the arm. Several days ago, in March 2013 the patient experienced an injection site reaction with itching on the back of arm in which she received the vaccination and the reporter described the rash as faint and "speckly". There was no vesicles. The action taken, outcome and causality were not provided. The patient had contacted pharmacist for medical attention. Additional information is not expected.
I've had hives for about 3 months. If I stop taking any antihistamines, they come back. I went to the dermatologist yesterday and that took a while. I forgot to take Zyrtec, missed the dose, and had hives this morning because I didn't take the Zyrtec. They told me to take Benadryl at night and then Zyrtec during the day. As long as I stay on those, they dissipate. I have to take these to stop the hives and the dermatologist gave me creams and they get stronger as time goes on. They've given me 2 creams and I need to pick up a third. Dermatologist recommended that I try going to an allergist now possibly. Incredibly uncomfortable, very itchy. Located on back and sometimes buttocks. If it's all over my back, I struggle to put some cream on my back. Usually really bad on the back. Sometimes on legs and arms, sometimes on buttocks. Even had them on face, the forehead. Hives tend to move around body. Sometimes on wrists and on forearms and palms of hands. They had talked about giving me epinephrine, but I wasn't able to talk to a dermatologist again about this yet. Possible follow up in 3 weeks. Take 100-300mg Benadryl during the night and multiple doses of Zyrtec throughout the day. If I stop taking either of these medications, hives come back. They didn't appear immediately when I got the booster, it was about a month later. All of my vaccines, the only real issue at the time of the vaccine was a sore arm for a day. I didn't expect anything different, but now I have hives. Dermatologist took a biopsy of one of the locations and it was determined that it was indicative of hives. They wanted to rule out skin form of sarcoidosis. Had stitches in my back for 10 days after. I was looking for something more pronounced, and that was the result. They were able to say it was not in relation to my long standing health condition.
irregular bleeding, shortened menstrual cycle, menstrual cramping throughout cycle period. prior to vaccine, very regular cycles with no intermittent bleeding.
Fever, chills, headache, body aches: started around 9pm after getting the vaccine at about 10:45am.
Patient is a 62 y.o. male patient of, MD with history of ischemic cardiomyopathy s/p ICD, coronary artery disease, severe MR, diabetes, hypertension, hepatitis B infection presented to Hospital with fever, nausea vomiting and diarrhea. Problem based management in the hospital is as follows:    Covid-19 Virus Infection Date of onset of symptoms: 06/28/2023 Symptoms present on admission: Fever, nausea vomiting and diarrhea, confusion and sore throat Date of covid positive test: 07/01/2023 Vaccination status: vaccinated. Two doses Imaging: CT chest showed mild cardiomegaly, trace pericardial effusion, atherosclerotic calcification.  Mild subsegmental dependent atelectasis and bilateral lower lobes were seen.  No acute pulmonary abnormality noted Oxygen requirements on admission: RA Current oxygen requirements: RA Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: 7/10/2023   Acute metabolic encephalopathy, POA, resolved Likely due to sepsis and COVID infection Patient appears at baseline.   He is oriented X3 and able to provide history Monitor   Sepsis, POA, now resolved Likely secondary to above, presenting with fever of 103.2, heart rate 118, blood pressure 169/73.  Respiratory rate 8 Chest x-ray nonacute.  UA unremarkable Received 1 dose of cefepime and vancomycin in the ED Hold antibiotics for now Blood cultures NTD  Physical deconditioning Patient seen by PT/OT, recs consistent with home health care at discharge   Ischemic cardiomyopathy s/p ICD Coronary artery Hypertension Hyperlipidemia Continued home dose metoprolol, Imdur, atorvastatin, aspirin and Plavix BNP mildly elevated at 435 but chest x-ray nonacute/no evidence of pulmonary vascular congestion Continued home dose Lasix   Diabetes mellitus type II with insulin use Resumed Lantus and sliding scale insulin Dose insulin as needed   After 4 days of hospital stay, patient was doing well so he was discharged in stable condition. Advised to f/u with PCP. All questions and concerns were addressed before discharge.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age. On 24-NOV-2015 the patient was vaccinated with an improperly stored dose of oral, ROTATEQ lot # K022993 (Expiration date 20-JUL-2016) (incorrect product storage). No adverse effect reported. This is one of the two cases received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning her 5 year old white son who was a student with asthma, no known drug allergies and no illness at the time of the vaccine who on 24-JUL-2007 at approximately 10:00 was vaccinated subcutaneously in the right arm with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot number 657780/0617U). Concomitant therapy was not reported. On 24-JUL-2007, by 19:00, the patient experienced a warm, swollen area measuring "11 cm x 5-6 cm" of his "entire upper right arm." Subsequently, on an unspecified date, the patient recovered. It was also reported that the patient's sibling experienced "the same reaction, same day" from varicella virus vaccine live (Oka/Merck) (MSD). (WAES# 0806USA00616). This is one of two reports from the same source. Additional information is not expected.
My arm was hurting 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was hurting 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A, 040A21A and 939909) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis and Arthritis (arthritis in left thumb. basil joint issues in left hand).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (My arm was hurting 1st dose). At the time of the report, VACCINATION SITE PAIN (My arm was hurting 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-403846, MOD-2021-403805, MOD-2021-403805 (Patient Link).
act-hib had been reconstituted with Sterile Water for Injection, rather than the diluent that is included with acthib with no reported adverse event; Initial information received on 01-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a Child of unknown gender who was administered HIB (PRP/T) vaccine [ACT-HIB] that had been reconstituted with sterile water for injection, rather than the diluent that is included with ACT-HIB with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Sep-2023 at 1:30 pm, the patient received 0.5 mL dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number; expiry date: not reported) via unknown route in unknown administration site for Immunization that had been reconstituted with sterile water for injection, rather than the diluent that is included with acthib with no reported adverse event (product preparation error) (same day latency).  Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   No further details were available from the reporter.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a third dose of GARDASIL (Lot # not reported). The physician reported that the patient received the complete series of GARDASIL and tested positive for HPV DNA 16 and 18 following cytology testing. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
No additional AE reported.; concomitant administration of PROQUAD and VARIVAX to a patient on 7/28/2022; concomitant administration of PROQUAD and VARIVAX to a patient on 7/28/2022; This spontaneous report was received from a nurse and referred to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUL-2022, the patient was administered concomitantly with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #U028164, expiration date: 09-SEP-2023; dose, strength and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (lot #U028178, expiration date: 08-MAR-2023; dose, strength and route were unknown) for prophylaxis (Overdose; Inappropriate schedule of product administration). No additional AE reported. No product quality compliant (PQC) reported.