chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BRIEF OVERVIEW: Admission Date: 9/5/2023 Discharge Date:  09/08/2023 Discharge Disposition:  home health care svc  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE:   Patient is a 78 year old female with past pertinent medical history of chronic respiratory failure (2-3L on home oxygen after CABG 2015), paroxysmal Afib (s/p left atrial appendage), CAD (s/p 3vCABG 2015), CHF, type 2 DM, anemia of chronic disease, hypothyroidism, morbid obesity, and GERD who presented with chief complaint of chest pressure and signs of flu infection. On 8/31, patient developed fever, chills, sore throat, shortness of breath, and light-headedness. Her chest pressure and shortness of breath gradually increased with exertion. Due to these symptoms, she was transported to the ED via EMS on 9/5. Patient presented to the ED afebrile (37), bradycardic (HR 59), hypertensive (174/38), and 97% SaO2 on 2L nasal cannula. Patient desatted to 88% with ambulation. Viral PCR was positive for COVID-19. Physical exam was notable for diminished right lung sounds and 3+ pitting edema on the bilateral lower extremities. Chest x-ray showed right midlung opacity and middle lobe nodular opacity. CMP, troponin, EKG, BNP, and procalcitonin were unremarkable. Strep and Legionella urine ag were negative. CBC was only notable for normocytic anemia (9.7 mg/dL, baseline 9-11 for last 10 years). D-dimer was elevated (570 ng/mL). LE ultrasound showed no DVT. She was given one dose of  ceftriaxone (1 g) and azithromycin (0.5 g). She was started on dexamethasone (6 mg IV initial, 6 mg PO daily 10 doses) and remdesivir (100 mg daily) regiment for confirmed COVID-19 respiratory infection. During hospitalization, patient improved in symptomology. Pitting edema has resolved.  She did not require more than 3 L oxygen which is her baseline.  Patient required rest after 30 ft walk (baseline 50).  On discharge, patient had improved ambulation. PT recommended skilled home PT. Remdesivir and prednisone were stopped.  Patient also benefited from adult care program.
Pt states had t100-102 on 2JUL91; On 3JUL91 t100; Injection site red, painful & warm to touch;
I developed a fever, and my arm was very sore, later in the evening after the vaccine. I then progressively became more ill and feverish.  The next day I was COVID tested it was negative. My symptoms continued  for several more days, I was thinking that this was a reaction because my arm still hurt and I was having fevers with a cough.
I had nervous sweats, I felt that my throat was closing. Once I got home, I had body aches, fever, and chills. It lasted about three days. I took Dayquil and nightquil
This case involves a 4-month-old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] 6 days earlier than due date (inappropriate schedule of product administration). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. On 06-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (injection, lot number: UJ494AA and expiry date: 09-Jul-2021) via an intramuscular route at an unknown administration site. On 28-Oct-2021 she also received a 0.5 mL dose of the same vaccine (injection, lot number: UJ494AA and expiry date: 09-Jul-2021) via a subcutaneous route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day). It was reported "Caller states that a patient received a dose of PENTACEL 6 days earlier than they were due, and would like to know what they should do next?" At the time of reporting, no adverse event was reported. 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 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.
Initial report received on 24 October 2011 from a health care professional via the company's web site. A male patient had received a dose of FLUZONE (lot number not reported) on an unspecified date and at an unspecified amount of time later had an anaphylactic response to the injection. The patient had no egg allergies. Recovery status was not reported. No further information was provided. Documents held by sender: none.
Product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions; Administration after 45 hours excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions) and EXPIRED PRODUCT ADMINISTERED (Administration after 45 hours excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration after 45 hours excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions) and EXPIRED PRODUCT ADMINISTERED (Administration after 45 hours excursion) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that the product was administered after having been exposed to 45 hours of out-of-range temps reaching a max of 13.4 C.  The date the vial was initially stored in the refrigerator was reported as unknown.  It was reported that provider removed vials from freezer as needed, stored in the refrigerator and did not mark BUD date or keep vaccine tracking records.  It was reported that freezer was exposed to excursions but the provider contacted and indicated the vaccine was considered viable.  Treatment information was not provided.   This case was linked to MOD-2022-583131 (E2B Linked Report).; Sender's Comments:  MOD-2022-583131:MOD-2022-583493 (same reporter case)
Patient received expired 2nd dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose of the Moderna vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose of the Moderna vaccine). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided.  Expired doses of the Moderna vaccine were administered to three patients.
contracted COVID-19/got vaccinated still tested positive for covid19 afterwards; contracted COVID-19/got vaccinated still tested positive for covid19 afterwards; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the parent.  A 7-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 1, single (Lot number: FK5127, Expiration Date: 03Dec2021), on 23Nov2021 as dose 2, single (Lot number: FK5127, Expiration Date: 03Dec2021) and on 23May2022 as dose 3 (booster), single (Lot number: FL0007) at the age of 7 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "not recovered" and all described as "contracted COVID-19/got vaccinated still tested positive for covid19 afterwards". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: vaccinated still tested positive for covid19 afterwards: tested positive on 05Jul2022. Clinical information: The reporter stated that, the reporter was mother of 4 and part time acute care speech language pathologist. The reporter and her family (husband and 4 children (Ages 5,5 (twins), 7, and 9)) were vaccinated and twice boosted to lessen severe illness from a COVID-19 infection. The family contracted COVID-19, likely July3. Only one of the five-year-old has remained negative via at home antigen testing. The reporter asked if there were any studies that they could participate in and assist. There were no other products. There were no additional vaccines administered on same date. No prior vaccinations (within 4 weeks). No AE(s) following prior vaccinations. The reporter assessed the event as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200021017 Same reporter/vaccine/event, different patient.;
lost sense of smell; lost voice; sore throat; sleeping 14-16 hours a day; Was coughing so hard that she was peeing her self; headache; coughing up a lot of  thick mucus; fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing up a lot of  thick mucus), ANOSMIA (lost sense of smell), APHONIA (lost voice), OROPHARYNGEAL PAIN (sore throat) and SOMNOLENCE (sleeping 14-16 hours a day) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had COVID-19 in January). Concomitant products included CLONAZEPAM for an unknown indication.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced COUGH (coughing up a lot of  thick mucus) and PYREXIA (fever). On an unknown date, the patient experienced ANOSMIA (lost sense of smell), APHONIA (lost voice), OROPHARYNGEAL PAIN (sore throat), SOMNOLENCE (sleeping 14-16 hours a day), URINARY INCONTINENCE (Was coughing so hard that she was peeing her self) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date for Fever, at a dose of 1 UNK. At the time of the report, COUGH (coughing up a lot of  thick mucus), ANOSMIA (lost sense of smell), APHONIA (lost voice), OROPHARYNGEAL PAIN (sore throat), SOMNOLENCE (sleeping 14-16 hours a day), URINARY INCONTINENCE (Was coughing so hard that she was peeing her self), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Body temperature: 101 (High) had a fever of 101 and was coughing up a lot of thick mucus. On 02-Aug-2021, Body temperature: 102 (High) still had a fever of 101/102. On 04-Aug-2021, Body temperature: 101.1 (High) had a fever of 100.1..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .
Information has been received from a pharmacist concerning a 1 day old male infant who on 19-NOV-2008 was inadvertently vaccinated SQ with RECOMBIVAX HB.  It was noted that the patient was intended to be administered LIDOCAINE as a nerve block, but was inadvertently administered an unspecified amount of ROCOMBIVAX HB subcutaneously in the groin area prior to circumcision.  There were no adverse symptoms reported.  At the time of the report, the patient's status was unknown.  The pharmacist confirmed that this was human error and not product confusion.  Follow-up information has been received from the pharmacist who confirmed that a male patient was inadvertently vaccinated with ROCOMBIVAX HB.  The pharmacist mentioned that a nurse had pulled a vial of ROCOMBIVAX HB early because she had some students that day.  The nurse attached the vial to the front of the chart and told the nurse that was going to be present for the circumcision that the vial had been pulled.  At the time of circumcision the doctor asked the nurse for the LIDOCAINE and the nurse pulled the vial off the chart without looking at the vial and drew up the syringe and handed it to the doctor.  The pharmacist confirmed that this was not a case of product confusion, but a nursing error.  The pharmacist stated that the vials don't look the same.  Additional information has been requested.
No additional AE reported; an unknown amount of vaccine was injected to the patient and theyare not sure how much vaccine leaked out ofthe syringe; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On 19-APR-2022 (also reported as today), the patient was vaccinated with a partial dose of vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), at a dose of 0.5 milliliter, lot number U013278, expiration date: 26-OCT-2023, administered for prophylaxis (strength, frequency, route of administration and anatomical location  were not provided) due to a non-Merck syringe leaking during administration and the nurse was not sure how much vaccine leaked out of the syringe (incorrect dose administered by product) and how much amount of vaccine was injected to the patient. No adverse event was reported.
Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of Recombivax HB (manufacturer unknown), DTaP, poliovirus vaccine, PedvaxHIB (manufacturer unknown).  Subsequently, the patient experienced alleged injuries and died. The cause of death was unknown.  No additional information is available.
administered the shingrix vaccine/ subcutaneous; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that she administered the shingrix vaccine to a female patient subcutaneously, which led to intramuscular formulation administered by other route.  The patient did not reported any symptoms to the health care professional.  No other information was reported The reporter did not consent to follow up.
SIDE EFFECTS POST-INJECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced side effects post-injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects post-injection was not reported. This report was non-serious.
Severe headache, chills and slight nausea and  severe diarrhea (causing me to lose 2 lbs.).
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Left should still in pain one week after injection. No swelling, no redness. Seen by doctor today for follow up. Unable to lift arm completely.
Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The pharmacist thought that the vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022.  No adverse events were reported.  The vial did not undergo any temperature excursions.   No treatment medications were provided.
fever; headache; flu like symptom; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom), PYREXIA (fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL), ACETYLSALICYLIC ACID (ASPRIN), ROSUVASTATIN and PROGESTERONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom). On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (Inconclusive) 99. On an unknown date, Influenza B virus test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. Patient was tested positive for flu B and COVID-19. Patient was taking low dose blood pressure medication and thyroid medication as concomitant medication.; Sender's Comments: 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.
SARS-CoV-2 (COVID-19) Ag [Presence] in Respiratory specimen by Rapid immunoassay~SARS-CoV-2 (COVID-19) Ag [Presence] in Respiratory specimen by Rapid immunoassay performed on 7/26/21. Came back detected. Case investigation interview with patient has not been conducted as of the time of this note.
X 2 says after immunizations we noticed a swollen gland after a week kept getting bigger and redder; Doctor gave her antibiotics for 10 days and it got worse so he cut it open and today it is getting back to normal; (noted on screen history of runny nose)
user attempted to administer, adjuvant leaked from the sides of the vial.; Pharmaceutical product complaint; This case was reported by a consumer and described the occurrence of intercepted drug administration error in a patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug administration error and pharmaceutical product complaint. On an unknown date, the outcome of the intercepted drug administration error and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient attempted to administer a dose of shingrix, adjuvant leaked from the sides of the vial, which led to intercepted drug administration error and pharmaceutical product complaint.
About 10 minutes post injection, started feeling a tickle in my tongue and tightness in the neck. Difficulty speaking but was able to breathe unobstructed. feeling of hand gripping neck lasted about 45 minutes and subsided on its own with rest.
Received DTaP on 04/24/2004- now 04/23/2004. Pt presents with redness and swelling on upper right thigh (3" swelling)
pt recvd vax; found dead by his wife approx 2 hrs p/ vax;
pt recvd flu vax 16NOV93 & pt felt hot in the waiting room p/vax; pt seen in ER-MD felt pt had bad react to the flu vax; pt shaky; pt exp difficulty walking, pounding head, hot sensation & shakiness;
Persistent, deep cough, heavy mucous in lungs and sinuses, headache, fatigue. Treatment: Zinc and cough suppressant.
I started experiencing mild chest pains that would occur throughout the day or wake me up at night. I went to the doctor, and they advised that I had high cholesterol and high blood pressure through a blood test on November 30, 2022. They ran heart test and referred me to a cardiologist who prescribed Rosuvastatin. The cardiologist ran more test, and they prescribed Amlodipine Desolate. My condition has improved. I rarely have the chest pain and my blood pressure is normal.
swelling, tenderness, erythema below inj site rednee is 7" x 6" football shape;s&s began Wednesday 4OCT95;avised pt to apply moist head to lt arm & to f/u to family MD;10OCT95 seen by MD sxs cleared up