chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.; covid-19; Fever; light cough; like I had a sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (like I had a sinus infection), COUGH (light cough), FEELING ABNORMAL (feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.), COVID-19 (covid-19) and PYREXIA (Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SINUSITIS (like I had a sinus infection). On 22-Jul-2021, the patient experienced COUGH (light cough). On 23-Jul-2021, the patient experienced FEELING ABNORMAL (feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.). 23-Jul-2021, the patient experienced COVID-19 (covid-19). 23-Jul-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD & SINUS) for Sinusitis, at an unspecified dose and frequency; PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED SINUS) for Sinusitis, at an unspecified dose and frequency and SODIUM CHLORIDE (SALINE NASAL MIST) for Sinusitis, at an unspecified dose and frequency. At the time of the report, SINUSITIS (like I had a sinus infection), COUGH (light cough), FEELING ABNORMAL (feeling is "slightly kicking my ass at this point," "all in my head," and "all in the nasal areas.), COVID-19 (covid-19) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, Body temperature: 101 (High) 101. On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient also used steam for relieving symptoms.  No concomitant medication was provided.   This case was linked to MOD-2021-265911 (Patient Link).
04/17/22 presents to ED for "worsening headaches". PMHx of "pancytopenia" "Essential thrombocythemia"
hematochezia, vomiting, lethargy, nonspecific bowel gas pattern 4-5 days after vaccine administration, most likely intussusception even though U/S did not show evidence of intussusception
11/01/2022 morning urine was very cloudy and smelled terrible. Went to urgent care. Urgent care ran a culture test on urine. Prescribed cefalexin. Culture revealed Klebsiella Pneumoniae. After the course of cefalexin, I was placed on sulfameth/trimethoprim and then nitrofurantoin-mono/mac, and then cefuroxime during subsequent returns to doctor as symptoms did not improve. Doctor scheduled participant for abdominal ultrasound, but results are pending.
Problems breathing; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Problems breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Polio.   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 DYSPNOEA (Problems breathing) (seriousness criterion death). The reported cause of death was problems breathing. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided.  Treatment medications was not provided.  Action taken with mRNA-1273 in response to events was not applicable.  As a young child, patient was in an iron lung.  This is a case of fatal Dyspnoea in a male subject with a hx of polio, who died after receiving the second dose of vaccine. Very limited information has been provided at this time.; Sender's Comments: This is a case of fatal Dyspnoea in a male subject with a hx of polio, who died after receiving the second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Problems breathing
swelling of eyes lips; swelling of eyes lips; Rash; itching; Wheezing in lungs; This is a spontaneous report from a contactable other hcp (patient). A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: Ff3590, Expiration Date was not reported), via an unspecified route of administration, administered in the left deltoid on 06Nov2021 12:00 (at the age of 47-years-old), as dose 1, single for COVID-19 immunisation. Medical history included chronic dvt and known allergies: Sulfa. Concomitant medication included influenza vaccine taken for immunization on 15Oct2021 as dose number unknown, single. The patient previously took erythromycin and experienced hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced swelling of eyes lips and rash, itching with wheezing in lungs on 06Nov2021 12:45, 45 minutes after vaccination. Events resulted to Doctor or other healthcare professional office/clinic visit and treatment with Diphenhydramine (BENADRYL), steroids, and script for epinephrine (EPIPEN). The outcome of events as recovered with sequalae on an unspecified date (reported as with lasting effects).; Sender's Comments: Based on temporal association and known safety profile, a causal association between BNT162B2 and the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Within 6 minutes chest tightness left hand tingling then elevated HR and BP. Mild SOB and benadryl givin with approx 5 to 10 minutes
PC from PGM states infant with big knot in leg. Saw PMD - referred to surgeon. Had I and D of abscess per PGM 1/2 inch wide 1 inch in depth that is patched daily and placed on 10 days of antibiotics. To follow-up with surgeon. 1/05/2006 C and S done. See MD notes (attached). Abscess left thigh - I & D on 12/28/2005. Culture Staph A, susceptible to Bactrim.
Arm is still very inflammed; arm was red; arm was hot, still warm; arm was sore; Headache; Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was hot, still warm), PAIN IN EXTREMITY (arm was sore) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The illness lasted for 2 weeks and she did not have any major symptoms from it) in November 2020 and Appendectomy (Emergency appendectomy) on 20-Jun-2021. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was hot, still warm), PAIN IN EXTREMITY (arm was sore), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm is still very inflammed), ERYTHEMA (arm was red) and VACCINATION SITE WARMTH (arm was hot, still warm) had not resolved and PAIN IN EXTREMITY (arm was sore), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included  blood pressure medications and hormone replacement therapy.  Treatment information provided included application of ice on arm.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received and added surgical procedure (emergency appendectomy) and updated reporter's contact information.; Sender's Comments: Based on the current available information which shows a strong temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded.  Headache, low grade fever and fatigue are consistent with the known safety profile of the mRNA-1273.
Three weeks after the injection (dose 2), I woke up in the morning with pain at the injection site and it went down my arm to my fingers., across my chest, front and back, and up into my neck.  I have had 7 massages and 4 acupunctures to relieve the pain. I still have burning sensation between my shoulder to my elbow on my left arm. I still have pain at the back of shoulder and across my neck though it is not as bad as it once was. I was prescribed 800 mg of ibuprofen as needed. My back, legs and pretty much had stiffness over the whole body. The burning in the arm is the worst part and I was weak in that arm and could not fully rotate it. My orthopedist gave me a cortisone shot and I was able to lift up my arm after that. After I has more mobility of the arm, the pain in the arm became worse. The doctor advised me that the pain in my arm was not related to the shoulder. After the initial orthopedic appt, I was referred to a spine doctor who will order another MRI to rule out any spine issues.
Headache, Myalgia, Fever, c/o fatigue,injection site sore and warm to touch, tinnitus Narrative:
Initial unsolicited report received from a pharmacist and consumer on 27-Oct-2017. This case involves a 79-year-old female patient, who was vaccinated with a 0.5 ml of dose of FLUZONE HD intramuscularly once (batch number: UI877AA, expiry date, dose, dose in series, route, and site of administration were not reported) on 25-Oct-2017. The patient's medical history and concomitant medication were unknown. Also reported that patient does not have any chronic illness or allergies. On an unknown day, two days following the vaccination, the patient developed right shoulder pain and cannot lift the arm. Lab data and corrective treatment was not reported. Outcome of all the events were not recovered. List of documents held by sender: none.
HEADACHE; TIRED; NUMBNESS ON THE BODY; TINGLING ON THE BODY; FEVER (A MILD ONE); UNEXPECTED THERAPEUTIC BENEFIT; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma (uses puffers), b-thalassemia, osteoporosis, meningioma (tumor had shrunk since the second Janssen booster shot), sulfites allergy (she also had lot of genetic mutations and she gets tested for every medication), non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage.  The patient previously received Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 1) (form of admin, route of admin not reported, batch number were not reported, expiry: unknown) dose was not reported, administered on 09-FEB-2021 for covid-19 prophylaxis.  On 09-FEB-2021, immediately after the vaccination, the patient experienced anaphylactic reaction and had to go to the hospital (dose number in series 1). The outcome of anaphylactic reaction was not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 18-FEB-2022) dose was not reported, 1 total, administered on 08-AUG-2021 in right arm for covid-19 prophylaxis.  On an unspecified date in 2021, the patient experienced neurotic (in terms of hysteria around the janssen vaccine), tiny achy, little headache, and tiny fever (dose number in series 2). The patient was recovered from neurotic (in terms of hysteria around the janssen vaccine), tiny achy, little headache, and tiny fever on an unspecified date in 2021. The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: unknown) dose was not reported, 1 total, administered on 02-DEC-2021 in right arm for covid-19 prophylaxis which was coded to revaccinated with different covid-19 vaccine (dose number in series 3). Age at time of vaccination 60 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced headache, tired, numbness or tingling on the body and had fever (a mild one) (dose number in series 3). Patient also stated that she was dealing with meningioma and was about to go for a surgery but the scan done after the second booster indicated that the tumor had shrunk and the surgery was currently cancelled (unexpected therapeutic benefit) (dose number in series 3).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, tired, numbness on the body, tingling on the body, fever (a mild one), revaccination with different covid-19 vaccine and unexpected therapeutic benefit was not reported. This report was non-serious. This case, involving the same patient is linked to 20220911774 (dose number in series 1).
Intense itching and redness at area and surrounding injection site; Intense itching and redness at area and surrounding injection site; Urticaria; Underlying rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Intense itching and redness at area and surrounding injection site), VACCINATION SITE ERYTHEMA (Intense itching and redness at area and surrounding injection site), URTICARIA (Urticaria) and RASH (Underlying rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's thyroiditis and Sjogren's. Concomitant products included LEVOTHYROXINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Jan-2021 at 9:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Intense itching and redness at area and surrounding injection site), VACCINATION SITE ERYTHEMA (Intense itching and redness at area and surrounding injection site), URTICARIA (Urticaria) and RASH (Underlying rash). At the time of the report, VACCINATION SITE PRURITUS (Intense itching and redness at area and surrounding injection site), VACCINATION SITE ERYTHEMA (Intense itching and redness at area and surrounding injection site), URTICARIA (Urticaria) and RASH (Underlying rash) 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.
Left upper arm/ biceps with mild redness and swelling below vaccination sites.  Mild tenderness to touch, FROM.
Patients received the 1st dose of a 3 doses series of the Covid-19 vaccine BUD-expiration date. As per Doctor patient needs to repeat the 1st dose of the series. Mother was contacted and is aware. Patient is in good condition and had no symptoms or side effect related to the vaccine. Patient has an appointment for patient to repeat the vaccine on 01/31/2023.
fatigue, body aches, fever, headache, sweats, metallic taste in mouth.
Marked myalgias lower extremities fatigue and mild confusion onset within 24 hours of #3 HPV. Improved on 5/8/2013. Used ibuprofen.
Onset on day 4 after vaccine; Headache (moderate); nausea (mild) Duration: approx. 24 hours
nurse only administered the DTAP and Ipol portions of the vaccine. She did not mix in the ActHIB powder into the vaccine / no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21 months old male patient who received only third dose of 0.5 ml DTap/IPV portions of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) Lot UJ115AAA, DTAP/IPV vial: U6396AB (Expiry date 23-Oct-2020) via intramuscular route in the right thigh on 15-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that nurse only administered the DTAP and Ipol portions of the vaccine. She did not mix in the ActHIB powder into the vaccine)  At a time of reporting no adverse event 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.
RASH ON WHOLE BODY; This spontaneous report received from a patient concerned a 54 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received 2 doses of bnt 162 (Pfizer) (Dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown), dose was not reported, administered for prophylactic vaccination. No adverse events were reported following vaccination with bnt 162 (Pfizer) (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 213021A, expiry: unknown) dose was not reported, 1 total administered on 11-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-DEC-2021, the patient experienced rash on whole body (Dose number in series: 2). On 17-DEC-2021, treatment medications included: prednisone used for rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on whole body. This report was non-serious.
It began with runny nose, slight fever, muscle aches on 10/16; swollen left cheek (sinus), complete nasal stoppage, constant mucous dripping out nostrils and down throat and terrible headache added on 10/17; then constant cough and sore throat added on 10/18; then difficulty breathing by 5AM on 10/19. Rushed to ER at 5:30am on 10/19. Given one dose prednisone. Saw pediatrian on 10/20. Rx: prednisone x 3 days, plus prescribed cough and nasal decongestant. She could hardly sleep and missed school all week due to all the symptoms!
Client requested today on foot team Fluarix, Jynneos vaccinia, Hepatitis A, and Pfizer Bivalent booster COVID 19 vaccine. PHN assessed client and client has no record in the system. Client verbally reported receiving a Janssen COVID 19 vaccine "last summer" at a local pharmacy. Client confirmed she has not received any COVID 19 vaccines since then or in the past 2 months. Client denied history of pericarditis or myocarditis. PHN called Dr. at 10:30 am. Per Dr, client ok to receive all 4 vaccines, prefer to vaccinate with Pfizer bivalent COVID 19 vaccine today. PHN administered Fluarix Lot # 9PG4D in the right arm IM at 10:40 am. PHN administered Pfizer bivalent booster COVID 19 vaccine Lot# GJ5342 in the left arm IM at 10:41 am. PHN administered Havrix Lot# 95DB2 in the left arm IM at 10:42am. PHN administered Jynneos vaccinia in the right forearm ID at 11:43 am while client was sitting in a chair. At 10:54 am client stated she felt dizzy. PHN gave client juice to drink. Vitals taken: 138/82, HR 82 bpm, RR 18. At 10: 56 am client was assisted to lie down on a yoga mat. Ice pack was applied to her forehead. Client alert and oriented to person, place, time, and situation. Skin dry and appropriate color for Ethnicity. Client stated her throat felt "itchy." No rash observed rash or redness/hives was observed by PHN across the neck, chest, or arms. Client's breaths were regular and relaxed. Client has a history of anxiety and is a smoker. Client denied any prescription medication. At 11:00 am client stated "I feel better" when lying down and that her throat "felt fine." Vitals taken at 11:02 am: BP 130/82, HR 76 bpm, RR 16. At 11:03 client was assisted to sit up. Client denied any dizziness and said she "felt better." Client drank 2 sips of juice. Vitals taken at 11:07: BP 132/80, HR 80 bpm, RR 13, SpO2 94%. At 11:10 am client was assisted to stand up and stated she "felt dizzy again" and returned to a sitting position in the chair. Vitals taken at 11:15 am: BP 130/78, HR 71 bpm. RR 16, SpO2 96%. At 11:18 am client was assisted to stand up. Client denied dizziness, headache, or itchiness. Vitals taken while standing: BP 124/90, HR 74 bpm, RR18, SpO2 94%. Client walked away on her down with a steady gait at 11:30 am to the next tent for resources. PHN educated client to follow up with her PMD. PHN educated side effects of the vaccines.
Pt became confused towards the end of tx.  Pt was unable to answer date, time, people and place and keep repeating "I am ok."  BP 137/104, Hr 77, BS 87.  Tx was terminated 26 mins early.  EMS was called and Pt was sent to ER.  Per Pt's husband, Pt had COVID booster on Wed and this is her reaction to the vaccines because she had same reaction to the pervious COVID vaccines.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and product supply issue. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient reported that, it has been past 6 months and she could not locate the 2nd dose due to supply issues. The patient also reported that she needs another dose for her husband as well but did not clarify when he received his first shot (US2018GSK226181 case for husband). The patient reported that after injection, she experienced pain and swelling at the injection site which was resolved.