chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Clinical Summary Patient is a 67 y.o. female with a history of COPD, tobacco abuse, HFpEF, IDDM, CKD, PAF, and recent admission 12/3-12/8/22 at Hospital with AECOPD +CHF who presented to ER 12/10/22 with SOB. Patient found to have Afib with RVR complicated by COVID infection. Patient transferred to different Hospital 12/10/2022 for further management. Admitted to MICU, hospitalist assumed care.    1. Acute Hypoxic Respiratory Failure: required 6L NC on admission, suspect multifactorial in setting of anemia, Afib with RVR, COVID infection. Admit CT chest with bilateral lower lobe consolidations concerning for PNA. Urine antigens, respiratory PCR and MRSA swab negative. Continued decadron & zosyn through 12/16/22. On RA 12/14/22.  CCM followed. 2. Viral pneumonia: secondary to Covid 19. Test positive on 12/10. Vaccinated X3. Special isolation as per protocol. Continue standard dose of dexamethasone for 10 days.  3. P-Atrial Fibrillation with RVR: Presented HR in the 130-140s. Suspected secondary to multiple other medical problems. Held home coumadin on admission with concern for GI bleed as below. BB held given previous hypotension. Converted to NSR 12/12/22. Resume coumadin 12/18 if hgb stable. 4. Acute blood loss Anemia: Hgb 6.2 on admission with prior baseline ~11-13. Received 3U pRBC since admission, last 12/11/22.  EGD 12/12/22 with oozing cratered duodenal ulcer s/p clips.  GI followed, recommending to continue PPI for 12 weeks and repeat EGD in 3 months. Hold AC for at least 5d from intervention (until 12/18/22)  5. IDDM2 with Hyperglycemia: A1c 10/22 of 6.2. BG 500, pH 7.3, anion gap 24, bicarb 21. non-DKA insulin gtt transitioned to NPH/SSI on 12/13/22. 6. Aortic Valvular Abnormality: TTE 12/12/22 w/ EF 76%, moderate aortic valve sclerosis with mobile echodensity measuring 1cm x 0.5 cm in LVOT, probable Lambl's excrescence but cannot exclude vegetation. Bcx 12/10 negative. Cardiology recommended outpatient TEE.   7. AKI on CKD: baseline Cr ~1.5, Cr 2.01 on admission. Suspected pre-renal. S/p IVF and pRBC. Resolved.  8. Constipation: CT A/P on admission with stool-filled colon and rectum with large amount of formed stool seen within the rectal vault. Bowel regimen in place.  9. CAD: per history. Heart cath 10/2022 with RCA stenosis however small in size therefore medical management recommended at that time. Continued home statin. Resumed home ASA.  10. HFpEF: per history. Admit TTE noted. Held home Lasix on admission with AKI. Resumed with improvement in renal function. 11. COPD: per history with recent exacerbation as above. No signs of acute exacerbation. Continued home inhaler.  12. Chronic Pain Syndrome with Opioid Dependence: per history. Continued home Percocet on admission (Rx reviewed). 13. Pressure ulcer: coccyx, stage II, pt reports present for weeks on 12/13/22.  Continued offloading.  ET RN followed 14. Tobacco Abuse: NRT ordered. Cessation recommended.
This spontaneous report was received from a licensed practical nurse refers to a 1-year-old patient. On 04-FEB-2013 (reported as yesterday) the patient was vaccinated with an expired dose of M-M-R II (lot # (669631/0156AA, expiration date 01-FEB-2013, route not reported). No concomitant medications were reported. No adverse effects reported. No other information provided. Additional information has been requested.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-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 FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-114381 (Patient Link).
When he received the second dose experienced neck and shoulder stiffness which was more intense; When he received the second dose experienced neck and shoulder stiffness which was more intense; When he received the second dose experienced neck and shoulder stiffness which was more intense; This spontaneous case was reported by a patient and describes the occurrence of the first episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense), the second episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011AC1A and 015MCOA) for COVID-19 vaccination.     Patient has no known allergies. Patient was using spray for insect bite.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced the first episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense), the second episode of MUSCULOSKELETAL STIFFNESS (When he received the second dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense). At the time of the report, last episode of MUSCULOSKELETAL STIFFNESS (When he received the last dose experienced neck and shoulder stiffness which was more intense) and CONDITION AGGRAVATED (When he received the second dose experienced neck and shoulder stiffness which was more intense) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) No, the patient has not ever tested positive for covid-19.         Patient had 14 different concomitant medications which didn't specify. Patient received 1st dose of Moderna vaccine and experienced neck and shoulder stiffness. When he received 2nd dose of Moderna vaccine experienced same symptoms with more intensity. Patient wants to know if after the symptoms he experienced he should still get the new bivalent booster. His HCP said it would be okay to get it, but the pharmacist asked to call this number. Treatment medications were not reported.   This case was linked to MOD-2022-645070, MOD-2022-645288 (Patient Link).
Spontaneous coronary artery dissection mild type 2 heart attack; Mild type 2 heart attack; Chest pain; Fever; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CORONARY ARTERY DISSECTION (Spontaneous coronary artery dissection mild type 2 heart attack) and MYOCARDIAL INFARCTION (Mild type 2 heart attack) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 023M2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (body ache) and PYREXIA (Fever). On 28-Mar-2021, the patient experienced CHEST PAIN (Chest pain). On 30-Mar-2021, the patient experienced CORONARY ARTERY DISSECTION (Spontaneous coronary artery dissection mild type 2 heart attack) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (Mild type 2 heart attack) (seriousness criterion hospitalization). The patient was hospitalized from 30-Mar-2021 to 31-Mar-2021 due to CORONARY ARTERY DISSECTION and MYOCARDIAL INFARCTION. At the time of the report, CORONARY ARTERY DISSECTION (Spontaneous coronary artery dissection mild type 2 heart attack), MYOCARDIAL INFARCTION (Mild type 2 heart attack), PAIN (body ache), CHEST PAIN (Chest pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Electrocardiogram: results were fine normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were nor reported. Treatment information included unspecified medication.   This case was linked to MOD-2021-066271 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 41-year-old female patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   On 14th February 2022, the patient received Engerix B. On 14th February 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Engerix B, which led to expired vaccine used. The reporter consented to follow up.
Pt received pfizer vaccines on 03/01/2021, 03/22/2021, and 11/04/2021. Pt presented to the ED on 11/15/21 with complaints of feeling fatigued with SOB. Pt was found to be COVID positive
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2008, the patient was inoculated by a physician with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the female patient was treated by a physician (optometrist) at an eye care facility and was diagnosed with Herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
medication error due to the DTaP/IPV component of PENTACEL being administered without the Hib component (with no reported adverse event); Initial information received on 17-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 month old male patient who had administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]  dtap/ipv component of pentacel without the hib component (with no reported adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 05-Jan-2023, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE for Suspension for injection (lot UJ613AAA, expiry date: 25-FEB-2023, strength not reported) via intramuscular route in the thigh nos for Immunization.  On 05-JAN-2023 the patient was administered the dtap/ipv component of pentacel being without the hib component (with no reported adverse event) (product administration error) ( latency: same day).  No lab data available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.  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.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 31st March 2019, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site erythema to be related to SHINGRIX. Additional case details were reported as follows: The patient received vaccine in the right arm. In the evening on 30th March 2019, the patient had soreness and tenderness at the injection site. Yesterday (from the day of reporting) on 31st March 2019, 1 day after receiving SHINGRIX the patient noticed redness and swelling that was the size of a baseball and extended to the bone going to her neck bone. The patient stated it remains on the reporting date, patient called the pharmacist, who referred her to GlaxoSmithKline. The patient was encouraged to report to physician and treatment inquiry.
Felt dizzy, heart racing. Heaviness in chest. States elevated BP, 911 called - normal EKG - IV, BENADRYL, felt fine by end of the day.
pt recvd vax; devel mild case of chicken pox consisting of a large number of rash marks;NKDA;to MD & dx of chicken pox;no complications, no fever
headache & fever (101.2) x 1 day -- > tylenol headache & fever (99.7) x 1 day -- > tylenol
Covid-19; chills; fever; weakness; heat of the day that evening did not make him feel well; do not want anything to eat; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MALAISE (heat of the day that evening did not make him feel well), DECREASED APPETITE (do not want anything to eat), COVID-19 (Covid-19) and CHILLS (chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced ASTHENIA (weakness), MALAISE (heat of the day that evening did not make him feel well), DECREASED APPETITE (do not want anything to eat), CHILLS (chills) and PYREXIA (fever). On 12-Aug-2021, the patient experienced COVID-19 (Covid-19). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), MALAISE (heat of the day that evening did not make him feel well), DECREASED APPETITE (do not want anything to eat), COVID-19 (Covid-19), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that the heat of the day that evening did not make him feel well  Concomitant product was not provided by the reporter  Treatment information was not provided
Sinus infection; Upper respiratory illness; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) and RESPIRATORY SYMPTOM (Upper respiratory illness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since September 2018, Insulin resistance (due to PCOS) since 2011 and Polycystic ovarian syndrome since 2011. Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) from September 2021 to an unknown date for Birth control pill, LOSARTAN from September 2018 to an unknown date for Blood pressure high, METFORMIN HYDROCHLORIDE (GLUCOPHAGE) from 2011 to an unknown date for Insulin resistance, MULTIVITAMIN FOR WOMEN from September 2019 to an unknown date for Vitamin supplementation, FISH OIL from September 2019 to an unknown date for an unknown indication.   On 21-Apr-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced SINUSITIS (Sinus infection) and RESPIRATORY SYMPTOM (Upper respiratory illness). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) on 11-Jun-2021 at an unspecified dose and frequency. On 11-Oct-2021, SINUSITIS (Sinus infection) and RESPIRATORY SYMPTOM (Upper respiratory illness) had resolved.            Other Concomitant includes Probiotic started  since Sep-2019 and still continuing.   This case was linked to MOD-2021-406383, MOD-2021-410582 (Patient Link).
This vaccine was the PN23  I don't see that listed in the vaccine choices. My right arm still hurts very bad. Sometimes it just aches and other times I can hardly lift my arm  How long is this supposed to last?
This spontaneous report as received from an office manager refers to a male patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # 672962/0025AE, dose and route not reported) on 26-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced local injection site reaction after vaccination with PNEUMOVAX 23. The site was hot, swollen and raised. The treatment was TYLENOL and ice. The patient called to office for medical attention. The outcome of local injection site reaction was unknown. This is one of several reports received from a same source. Additional information is not expected.
Pt develop a reaction to 1st dose of COVID-19 vaccine.  Symptoms described as having fast heartbeat (palpitations).  No V/S, no hospital care provided.   Pt. verbalized feeling better and recovered.
This spontaneous report as received from a physician via the field employee refers to a female patient of unknown age. No medical history, drug allergies and concurrent conditions were reported. On an unknown date in 2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot number were unspecified). No concomitant medications were reported. Approximately six months ago in September 2014, 2 weeks after received the zoster vaccine live, the patient developed shingles. The patient was tender in an unspecified area for 2 weeks after that. Patient sought medical attention and treatment was given for the event with acyclovir. No product quality complaint (PQC) involved. The outcome of events was reported as recovered on an unspecified date. Additional information has been requested.
MOTHER OF PATIENT CALLED THE PHARMACY ON 12/16/2021 INFORMING US THAT HER DAUGHTER DEVELOP A NODULE/LUMP ON THE NECK, ABOVE THE CLAVICLE NEXT DAY AFTER GETTING THE VACCINE.
On 08/24/2021 I felt bad within the hour after getting the COVID-19 1st dose at 3:45 pm; very fatigued and cold. On 08/25/2021 I woke up at 6:30 am and felt bad; nausea, fatigue, and weakness. On 08/25/2021  at 10:00 pm, I started feeling light-headed. I brushed it off and started to get hot, dizzy, at moments I could not hear. I sat there for about 10 minutes and got up to go to bed took about 5 steps, and had to immediately sit back down. After that, I do not remember anything but waking up on the floor and jerking and could not hear anything my fiance was in front of me crying and histairicle. I had no recollection of what just happen. When I came completely too my fiance preceded to tell me what happen he said, "I sat back down and was looking down and suddenly raised my head up and gave him a blank stare and jumped up out of the chair, locked up and started to convulse and fell over and continued to convulse and kick my legs vigorously. I suspect I had a seizure.
In late April 2021, my immune system and gut function went into complete overdrive/dysregulation. I experienced abdominal pain, could not eat much for several weeks (every time I ate, I would be in a lot of stomach pain), experienced severe jaw pain and could not open my mouth on the left-side of my face due to the jaw pain, and severe anxiety emanating from my stomach. I could feel crazy terrible things going on in my intestinal tract, which a doctor listened to on stethoscope, describing it as if "two bears were fighting inside my stomach."  This went on for months on end, with severe anxiety and psychological distress for months on end, eventually starting to improve over time and continuing to improve today. I asked my PCP for an emergency prescription of Klonopin to deal with the anxiety, a drug I have not needed to take for a long time. I still do not feel like I have recovered fully, as this anxiety continues to flare-up a year later always at night after a large meal. I had never experienced anything like this prior to receiving the COVID-19 vaccination. I believe the vaccine severely exacerbated something in my immune system to cause these side effects and possibly had a negative impact on the lining of my gut, causing a cascade of inflammatory responses throughout my body to produce this type of reaction. No doctor has wanted to touch this. I saw some of the top doctors.  You can't test for immune system dysregulation, at least that I know of.
This spontaneous report was received from a nurse via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (dose, frequency were not provided) lot# N021092 and expiration date 11-MAR-2019, for prophylaxis. On an unknown date, the nurse had difficulty opening ROTATEQ tubes and she was using a sterile needle to puncture the dosing tubes, open and administer doses. No adverse effects were reported.