chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 10 hours after receiving dose, woke up in middle of sleep with shivering and muscle aches. Did not yet have a fever. By 10 am on 26th started getting a fever and muscle aches got worse. Temp was 101.1. Few hours later temp was 102.5 and by 9 pm that evening, temp hit 103.2 F. Ibuprofen had been take in the am and throughout the day but temp gradually increased.  Severe headache and muscle aches continued as well. On Wednesday (27th) felt better by noon - where headache not as severe and temperature was less than 100 F and muscle aches gradually subsided except for the injection site as that was and still is sore. I had these reactions with the first dose but not nearly as severe as they were with this second dose. With the first dose in September had the shivering and muscle aches with low grade temp but never more than 100 F.  With the 2nd dose these symptoms were extreme compared to the first dose but the recommendation was that one should still get the 2nd dose if you had any of the named reactions listed above.
A report has been received from physician via medical representative, concerning patients of unknown age and gender. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. Physician reported to her that she has had a lot of breakthrough influenza cases this season with nasal FLUMIST QUADRIVALENT (Intranasal) at her pediatric practice. She vaccinated children with FLUMIST for ages 6months to 5 years. She did not have exact number of breakthrough cases or any information on which patients. The outcome for the events of breakthrough influenza and vaccinates children with FLUMIST for ages 6 months to 5 years was unknown.  The reporter assessed the event of breakthrough influenza to be non-serious. The company physician added the event of vaccinates children with FLUMIST for ages 6 months to 5 years from the source document as non-serious adverse event.
No additional AE/PQC; MMRII with a labeled expiry of 5/29/2022 was administered; This spontaneous report was received from office manager, referring to patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an 15-JUL-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (recombinant human albumin) (M-M-R II) 0.5 milliliter, lot #T018669, expiration date: 29-MAY-2022 (strength, route of administration, and indication were not provided) (Expired product administered). No adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007043: US-009507513-2207USA007049: US-009507513-2207USA007188: US-009507513-2207USA006816: US-009507513-2207USA007049:
This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a registered nurse concerning an 80 year old female with hypertension, hypokalaemia, osteoarthritis, asthma and sulfonamide allergy who on 09-APR-2007 was vaccinated SC with a 0.5 ml dose of Zostavax (Merck) (lot# 656394/0162U). Concomitant therapy included alendronate sodium, hydrochlorothiazide (manufacturer unknown), potassium (unspecified) and lisinopril (manufacturer unknown). On 16-APR-2007, the patient developed a vesicular rash. The rash covered a 5 cm area of the outer lumbar spine and the lesions crossed the midline. There was no pain. The patient questioned the registered nurse if the rash could be shingles. No lab testing was performed. Unspecified medical attention was sought. The patient was recovering. No further information is expected.
The needle came off the syringe and some of the dose went down the patient's arm; The needle came off the syringe and some of the dose went down the patient's arm; The needle came off the syringe and some of the dose went down the patient's arm; A spontaneous report was received from a pharmacist, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and where the needle came off the syringe and some of the dose went down the patient's arm.  The patient's medical history was not provided. Concomitant medications use was not provided.  On an unspecified date, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, while administrating vaccine the needle came off the syringe and some of the dose went down the patient's arm. The reporter was unsure of the dose that was delivered to the patient. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, the needle came off the syringe and some of the dose went down the patient's arm was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of incorrect dose administered, exposure via skin contact and syringe issue for mRNA-1273 (lot # unknown)  with no associated AEs reported.
1st shot- Just a sore arm, no major symptoms 2nd shot- Sore arm, felt headache, very very tired for 2 days. Tiredness continued for several days off and on. On the last Thursday in May, around 10 pm, noticed pain in left arm where shot was administered. Upon looking, it was swollen about the size of a large marble, very tender to the touch, and black and blue, which continued to spread down the shoulder over the next few days. I went to the doc and she had no idea why this happened.  I DID NOT bump my shoulder. I've shown it to several health professionals and no one can give me an idea of what this is. As of today, 6/16/2021, the lump is still there, still sore, and periodically itches. The bruising has subsided.  I can send pics if you want.
Discharge Provider: DO Primary Care Provider at Discharge: MD   Admission Date: 3/19/2023 Discharge Date: 03/23/2023  PRESENTING PROBLEM: Acute pulmonary embolism with acute cor pulmonale, unspecified pulmonary embolism type [I26.09] Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present [I26.99] COVID [U07.1]   HOSPITAL COURSE: Patient is a 86 y.o. female with past medical history significant for Alzheimer's dementia (A&Ox3 at baseline), aortic valve stenosis, hypertension, hyperlipidemia, CKD stage 3, GERD, chronic hypoxic respiratory failure on 2L nasal cannula at night, on room air and saturates 88% during the day who presented for this hospitalization with shortness of breath after a COVID outbreak at her facility, with pulse ox showing 86% on room air. In the ED, she was hypoxic to 88% on room air, improved to 90% on 2L nasal cannula. CMP obtained showed creatinine at 1.41, GFR 36, which is near the patient's baseline.  BNP 971. Troponin was -3 Delta.  Complete blood count with hemoglobin 10.9.  Patient is COVID positive. EKG showed sinus bradycardia at 57, no concern for MI. CTA positive for acute PE with mild RHS, multifocal areas of atelectasis. PERT activation was deferred by IR. Bilateral LE dopplers showed bilateral distal DVTs, no proximal clot in either leg. The patient has been diagnosed with COVID-19 pneumonia, acute on chronic hypoxic respiratory failure, and acute PE. Patient was on heparin gtt and transitioned to Eliquis. She was continued on steroids for total of 10 days. Patient was continued with her home lumbar spinal brace in place except during skin care times. PT/OT recommended SAR. She was recommended to follow up with her PCP. She was discharged to SAR in stable condition
On April 15th 2022, I broke out in a rash that started in the middle of my neck like a bite. It was a red raised itchy small round lump. In the next few days it spread down my neck onto my upper and lower chest, but now it was much more pronounced and in clusters, red and many more bumps. Very itchy! It is now April 21st and It is spreading to mu right shoulder with smaller bumps that are less itchy. The Dr. put me on Claritin, 10mg which I started April 20th.
Hives; Swelling; This is a spontaneous report from a contactable consumer. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  Consumer stated, "I had a reaction to the COVID-19 Shot. I had hives and swelling." The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date, blood test: unknown results on 12Jan2021. Therapeutic measures were taken as a result of hives and swelling included given Benadryl in the emergency room. outcome of events was unknown.    Information on the lot/batch number has been requested.
Missed the deltoid muscle; Redness and swelling at injection site; Swelling at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On 21st September 2020, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site swelling and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the pharmacist missed the deltoid muscle at the time of administration of Shingrix, which led to vaccine administered at inappropriate site. After vaccination with Shingrix, the patient had redness and swelling at injection site. The reporter stated that, the clinic had  photo of the redness and swelling. The reporter did not consent to follow up.
Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes; Dizziness;nausea;fever; This is a spontaneous report from a contactable nurse. This is the maternal report. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 11Jan2021 14:30 at a single dose on right arm for COVID-19 immunization. Medical history included none. No allergies to medications, food, or other products. Concomitant medication included prenatal vitamins. The patient experienced dizziness, nausea, and fever on 12Jan2021 10:00. Treatment was not received for the events. The outcome of the events dizziness, nausea, and fever was recovering. The mother reported she became pregnant while taking bnt162b2 (Pregnant at the time of vaccination?: Yes). The events were assessed as non-serious. The mother was 24 Weeks (gestational period) pregnant at the onset of the event. The mother was due to deliver on 03May2021. Last menstrual date: 24Jul2020. Patient did not receive any other vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Pt recv vax on 3/18/98; on same day pt exp chest pain; pt imp same day
Patient ID: 76 y.o.    Admit Date:  8/2/2022   Discharge Date: 8/6/22   Principal Dx/ Final Dx: Precordial chest pain   Relevant Inpt Dx: Principal Problem:   Precordial chest pain Active Problems:   COVID-19 virus infection   COPD (chronic obstructive pulmonary disease)       HPI:   Hospital Course:   This 76 year old man was admitted with chest pain and covid.   He ruled out for MI.  D-dimer was normal.  He had stress test that showed no ischemia and echo that showed normal LVEF.   He had covid and copd.  He was treated with remdesivir and steroids and nebs.  He has improved.  Today his lungs have no wheezing.  He will complete oral steroids.  He does have home oxygen and will continue this   He did have CT that showed possible right apical lung mass and right renal lesion.  Will arrange repeat imaging in several weeks and follow up with pcp, pulmonary, and urology.  He does have hepatic lesions that have been present since 2017 and this will follow up on those also.             Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO SOCIAL WORK IP CONSULT TO COPD NAVIGATOR       Disposition:  home   Discharge Condition:  fair
He took the shot on September 26 2022 , his right arm was sore / sore arm only last for 2 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (He took the shot on September 26 2022 , his right arm was sore / sore arm only last for 2 days) in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure abnormal.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced PAIN IN EXTREMITY (He took the shot on September 26 2022 , his right arm was sore / sore arm only last for 2 days). On 27-Sep-2022, PAIN IN EXTREMITY (He took the shot on September 26 2022 , his right arm was sore / sore arm only last for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Experienced side effects after the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Experienced side effects after the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Experienced side effects after the second dose). At the time of the report, ADVERSE EVENT (Experienced side effects after the second dose) outcome was unknown. Not Provided          No concomitant medication reported.  Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable.
developed mild to moderate COVID; developed mild to moderate COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "developed mild to moderate COVID". The event "developed mild to moderate covid" and "developed mild to moderate covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: mild to moderate covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200131953 same reporter, drug event and different patient.;US-PFIZER INC-202200203970 same reporter, drug event and different patient.;US-PFIZER INC-202200204043 same reporter, drug event and different patient.;US-PFIZER INC-202200204041 same reporter, drug event and different patient.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender 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 an unknown date, 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant products were not provided. Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
Severe facial swelling for 24 hours, throat swelling for 24 hours. throat still swells from time to time for up to 24 hours, heart palpations that last for a few minutes that continue until this very day, Chest tightness that continues from time to time but doesn't persist.
This case is linked with 2016SA111915 (same patient). Initial unsolicited report received from a consumer (extracted from the medical records) on 30-JUN-2016. This case involves a 35-year-old female patient who was vaccinated with a dose of FLU SHOT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient had a medical history of allergy to flu vaccine, tuberculin/ppd vaccine, bactrim vaccine, Buspar vaccine, Reglan vaccine and pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccination with in four weeks prior to date of vaccination were reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had similar reaction after flu shot and allergy to flu vaccine. It was reported that the patient required ER visit. Lab data and corrective treatment were not reported. The outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: Anaphylactic reaction (similar reaction after flu shot). List of documents held by sender: none. Sender's Comments: The case is very poorly documented. The patient had a significant allergic history to Bactrim (critical), Buspar (Moderate), Reglan (Moderate) and Tuberculin/PPD (critical). Further information on the symptoms the patient experienced after the flu shot, vaccination details, time to onset, data confirming the diagnosis, allergy testing to identify the culprit allergen, etc. will be needed for complete assessment of this case. Based on the information available, a role of the vaccine cannot be ruled out.
Information has been received from a registered nurse concerning a 6 year old female with no known allergies, no prior medical history and no pre-existing medical conditions who on 06/05/1997 was vaccinated with varicella vaccine. On 10/28/2001, the pt developed a fever of 101 deg F. On 10/29/2001, the pt broke out in approximately 25 red, non-raised spots which were described as a "chicken pox rash." The pt had no other symptoms and no diagnostic or lab testing was done. The nurse further reported that the pt's older brother, who had never received a varicella immunization, had chicken pox two weeks prior to the event. The pt sought unspecified medical attention. Additional info is not expected.
Upon waking up, the inoculation site was sore. It is painful that I am very cautious when moving my left arm. At about 7:00AM while at work, I felt pain all over my body and was more sensitive to pain. Headache slowly develop during this time too. At around 3:40PM, I arrived home and checked my temp, it was 100.5. Stomachache/heartburn starting to progress also.  I started to get chills. I slept and rest and woke up around 6PM to eat dinner. I took Tylenol in before going to bed, the next day at around 4AM before going to bed, I checked my temp and it's 99.5, I took another Tylenol and felt better the whole day after.
Expired vaccine administered beyond 12 hours post puncture for booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours post puncture for booster dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson COVID-19 Vaccine (First dose administered using Johnson and Johnson COVID-19 vaccine) on 27-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 Vaccine.   On 27-Oct-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours post puncture for booster dose). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours post puncture for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  The vial was in the refrigerator for 24 hours after punctured and didn't undergo any temperature excursions.
Severe chills, shaking, pain in right hip, ribs, headache, fever 101.3, body aches