chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of BRONCHITIS (Bronchitis), COVID-19 (COVID-19 infection/ result was positive) and DRUG INEFFECTIVE (Lack of Drug effect) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 042L20A) for COVID-19 vaccination. The patient's past medical history included Flu (She used the inhalers in the past when she had the flu). On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced COVID-19 (COVID-19 infection/ result was positive) and DRUG INEFFECTIVE (Lack of Drug effect). On an unknown date, the patient experienced BRONCHITIS (Bronchitis). The patient was treated with CEFTRIAXONE SODIUM (ROCEPHIN) for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE for Adverse event, at a dose of for 7 days; FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Adverse event, at an unspecified dose and frequency; CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE - CODEINE [CODEINE PHOSPHATE;PROMETHAZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) for Adverse event, at an unspecified dose and frequency. On 24-Dec-2021, COVID-19 (COVID-19 infection/ result was positive) had resolved. At the time of the report, BRONCHITIS (Bronchitis) had resolved and DRUG INEFFECTIVE (Lack of Drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. On 24-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Chest X-ray: bronchitis (abnormal) bronchitis. On an unknown date, Oxygen saturation: normal (normal) Oxygen saturation level was fine. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Drug details were reported. It was reported it has been about 2 weeks since the recovery. Company comment: This case of drug ineffective concerns a 42-year-old female patient with no relevant medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 10 months after the 2nd dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case of drug ineffective concerns a 42-year-old female patient with no relevant medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 10 months after the 2nd dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
12 days after receiving my booster I developed a rash/dermatographia. The rash both itches and stings. I have tried antihistamines, oral and topical steroids, and cromolyn. So far nothing has aliviated it. It is VERY uncomfortable and concerning.
10th day generalized macular rash, napping for 3 hours never done before, cranky, clingy, PE molar teething.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported.
Rash, erythema multiforme. Tx: Prednisone tapes, Zyrtec, Zantac
p/vax pt was sleepy & hyporesponsive;also clammy, pale skin;sx improved then returned over next several days;4-5 days p/shot;devel stuffy nose;intermittent high pitched cry;
Frequent tiredness, lethargic, hair loss, huge flakes of skin flaking off my hair scalp.. itchy skin all over.. intense chest pains in my breastbone/chest bone. My periods have not came back.. at all since 2nd dose of vaccine. Before I had any covid vaccinations , I was experiencing a light monthly periods..very light spotting.. after having COVID-19 the second time, my periods have been very light and not consistent.. I have not had a period at all since both COVID-19 vaccines.  I have had a lot of  random falls, almost like an unexpected twitch in nerve and I fall immediately with no warnings.. this last fall I had, just walking and I fell in bushes and rocks and my ribs were extremely sore and I had a lot of bruising on my skin rib cage areas on my back., went to ER had scans done, and found unusual bone Spurs in my joints and ligaments and arthritis and bruised bones. The doctor said it was advanced for someone my age..
What started as anxiety attack progressed to syncope. Patient temporarily fell asleep, suibsequently losing consciousness. Came to alert after i removed her from chair and was beginning to place her flat on her back.
wound up with the shingles/suspected vaccination failure; wound up with the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient got the shingles vaccine and patient still wound up with the shingles. The vaccine did not 100% prevent.  This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation were not given. This case has been linked with the case US2020AMR164915 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR164915:same reporter US-GLAXOSMITHKLINE-US2020AMR164914:same reporter
Site: Itching at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe
pt recvd vax & began crying uncontrollably, loss of color & began shaking w/sz; exp episodic szs hospitalized; tests run; phenobarb given;
Moderate fatigue and extreme arm pain 24 hours after shot. Arm pain subsided after 3 days but swelling and redness still present as of 1/7/2021. Very mild itching at injection site as of 1/1/2021
Started feeling the arm really hot, and harder the area where the vaccine was received around 4:30pm. Then started having a fever of 100.9 and a headache (tried to keep it under control with ice packs) thru the afternoon onwards till today(Saturday) still have a fever and the arm is really sore.
pt states after he got the covid vax he had pain in his right arm.  Pt still has pain in left arm from 1st dose and now has pain in right arm from 2nd dose.  Has had these symptoms since vaccinations.  Pt has not contacted a doctor regarding this symptom at this time.
Swelling left arm, malaise and difficulty breathing. Onset 1-2 hours, post vax.
flu like symptoms-  chills, goosebumps, upset stomach, feeling cold.  Symptoms started somewhat on 10/6- with a bloody nose, however the flu-like symptoms started today on 10/7.  Pt plans to see doctor on 10/8
No adverse event; Health Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Health Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 07-Apr-2023, 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 07-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Health Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Health Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Health Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023).    No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live follow up received included non-significant information- patient name updated.
3-4 weeks after her Gardasil shot (#1) She began exhibiting a rash which escalated over the next 5-6 weeks until she was covered with psoriasis and eczema on her arms (upper and lower), her legs (upper and lower), tops of her feet and hands, her neck, and slightly on her torso, body and face.
Since shot 2 has had more outbreaks/suspected Vaccination failure; after shot 1 had 1 outbreak on ankle/ 2 more shingles outbreaks; first ever shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Additional patient notes included never had a shingles outbreak in the past.   In September 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and shingles. The patient was treated with medication unknown (Pill (Medication Unknown)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the shingles was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The reporter considered the shingles to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR174105   Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comments:  The reporter was the patient and was 67 years old.  The patient said that right after receiving 1st dose he had his first ever shingles outbreak.  Since receiving Shingrix 2nd shot (about 2 months prior to the reporting) he had 2 more shingles outbreaks.  The outbreaks were the same intensity or even worse than the intensity of the first outbreak.  All of the outbreaks occurred on his left ankle.  He jokingly or sarcastically said that he now wanted to get his left leg amputated to cure the shingles. The reporter provided limited information.  He did not want to answer any further questions therefore he did not have his street address or email address or date of birth or MD contact.  The reporter ended call abruptly.  He said, his doctor prescribed pill for shingles.  The patient took the pills for 7 days. The pills did not help resolve the shingles.  They were big pills taken 3 times a day.  The reporter tried to get him to look on his pill bottle to confirm if the pills were brand name Valtrex  or another other antiviral pill but he indicated that he would have to call his doctor to find out the name of the pills and he was unwilling to did any research or any work for GSK because Shingrix did not work. The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2022AMR174105:same patient
10 days post vaccine, developed papular rash upper back and posterior neck, only 3 pustules developed
Patient received first dose of his Moderna COVID 19  vaccine and was seated in the waiting area around 11:45am. Around 11:49am patient had fainted and fallen to the floor slumped over onto the adjacent chair. 911 was called, and patient regained consciousness after a minute and was responsive and stated no issues other than dizziness. Patients BP was checked and documented, EMS arrived and also did a thorough exam of the patient and found him stable. Patient stayed in seating area to wait for spouse who came to escort him home around 12:40.
Pt was given PCV13 at pharmacy Pt came in 3 days later w/fever, body aches and rash at injection site.
Had Td immunizations 2/23/06. Client states on 2/24/06 lightheaded and dizzy. 2/25/06 client complained of L arm was sore and ache. Late afternoon got dry heaves. Sharp pain shot down his arm from site of injections to his knuckles. Went to bed. Got up next day no problem. No problem with arm since. Did not see PMD. Just red around injection site.
Day after vaccine I began to have tachycardia upon standing and walking. Heart rates are in the 140-170s when walking a normal pace. Resting heart rate is much higher than normal at around 100. When climbing stairs, heart rate gets into the high 170s. Shortness of breath and dizziness accompany standing, walking and climbing stairs. These symptoms still persist - have been ongoing from 11/12/21 - 11/22/21.
Tested positive for Covid virus after the first dose of vaccine; Tested positive for Covid virus after the first dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received her first single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration on 29Apr2021 (lot number not provided), at age of 27-year-old, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid at some point after her first dose of the vaccine. She then tested negative for Covid on 14May2021. Her second dose is due 20May2021. She wanted to know if she needed to wait to get the second dose of the vaccine or can she proceed with the second dose as scheduled. The outcome of the event was unknown.  Information about lot/batch number is requested.
Pt recvd 3 doses of Engerix-B & exp no medical problems or reactions; titer test results indicated no antibody;
Nausea, vomiting, fever of 101°, chills/shaking, headache
General aches and pain, nausea, severe abdominal pain, chills, diarrhea
really really sick; extremely high fever; joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really really sick), PYREXIA (extremely high fever), ARTHRALGIA (joint pain) and HEADACHE (Headache) in a male patient of an unknown age 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, the patient experienced VACCINATION COMPLICATION (really really sick), PYREXIA (extremely high fever), ARTHRALGIA (joint pain) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (really really sick), PYREXIA (extremely high fever), ARTHRALGIA (joint pain) and HEADACHE (Headache) outcome was unknown.            The  concomitant medications on use were not provided.  No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
This spontaneous report was received from a male patient of unknown age, reporting on himself.   No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. In approximately 2016 (reported as "the year before last"), the patient received a dose of PREVNAR 13. In 2017 the patient was vaccinated with a first dose of PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) and again in 2018 he received another dose of PNEUMOVAX 23 dose for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (frequency reported as "1 dose each year for the past 2 years") (inappropriate schedule of drug administration). The patient stated that he experienced "some kind of reaction" after getting the last PNEUMOVAX 23 vaccination (adverse reaction). The patient also said he did not know why he received revaccinations of the product and did not know if he was in the "high risk" category required to receive revaccination. The outcome of the adverse reaction and the causal relationship between the event and therapy with PNEUMOVAX 23 were not reported.
rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; muscle aches; swelling on left side of body including facial, arm pit, and arm down toward elbow, upper back under shoulder blade; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), intramuscular on 12Jan2021, at 13:00 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN). On 12Jan2021, at 15:00, the patient experienced fatigue, headache, muscle aches, swelling on left side of body including facial, arm pit, and arm down toward elbow, and upper back under shoulder blade, rash on chest and upper back, sore throat, and muscle twitching around left eye. The patient had no treatment for the events. The patient had no other vaccine in 4 weeks; and patient was not Covid tested post vaccination. Outcome of the events was not recovered.
CC: Received Smallpox vaccination August 26, 2004, approximately 10-14 days later developed shortness of breath, palpitations, and diagnosed with myopericarditis following September 2004 admission.   History of Present Illness:    Immunization: Smallpox  Vaccine Date: August 26, 2004 Onset date: September 5, 2004 Symptoms: This healthy 21 year old received his first Smallpox vaccination on August 26, 2004.  Approximately day 7 he began to notice some midsternal chest pain 3-4/10 scale with shortness of breath at rest. By day 10-14 his discomfort had worsened and he sought medical attention with a medical physician at base clinic. He stated his pain worsened when lying flat easing sitting up and forward. He was placed on 50 mg Indocin and light duty and referred to a cardiologist.  The doctor consulted another doctor who gave a differential diagnosis of "suspected pericarditis". He was subsequently admitted to a hospital. According to this service member, an echocardiogram confirmed a diagnosis of "myopericarditis". His records indicate a normal EKG and a sonosite limited echo as normal with IRBB (QRS 110) and 2 degree type 1 AVB. His labs showed elevation of CK at 1384, MB 298 --> 14 within 6-8 hours. (records unavailable). He was released one week later on Indocin to light duty for 6-8 weeks being transferred from warehouse work to a desk job typing and driving. His follow up exam with the doctor about week nine included a repeat echocardiogram, stress test and labs that showed no further evidence of myopericarditis and he was cleared for full duty two weeks later. As of this interview (May 5, 2005) he continues to complain of periodic "sharp aches" occurring 4-5 times a week lasting for a few seconds with spontaneous resolution since his return in February 2005. He denies any other complaints including no shortness of breath, nausea, vomiting, radiating pain, weakness, cough or recent illness. He was seen by a doctor on May 5, 2005 for this discomfort after voicing concerns to his supervisor. The doctor referred him to cardiology with an EKG showing NSR with first degree AV Block. His echocardiogram on May 5, 2005 was normal.  He is scheduled for a six weeks cruise the end of May and then deployment.   His initial referral contact with the Vaccine Healthcare Center was from physicians in theater in September 2004.  Attempts in December 2004 continued to be unsuccessful in contacting this member. As of July 18, 2005 no further contact has been made; nor has he responded to email correspondence.  There are no medical records available at this time pending return of medical release forms.  He was indecisive about participating in this study.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 06Jul2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 32 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (13Sep2022) Negative; (16Sep2022) Positive, notes: tested, immediately positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included anti-viral Paxlovid from 07Sep2022 to 12Sep2022. Took Paxlovid, felt great, tested negative 13Sep2022, 16Sep2022 felt horrible, tested, immediately positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a Register Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 31-DEC-2015, the patient was vaccinated with an expired dose of ROTATEQ lot # K001196, expiration date 22-OCT-2015, oral, (dose was not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
bloody streaks with mucous in stools for just one day that began the day after the vaccines were administered and resolved by the following day.
Flu like symptoms, swollen arm, ached all over. Pt still aches all over.