chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PROPRANOLOL, ROSUVASTATIN and MINERALS for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm). At the time of the report, INJECTION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported for this event.
i had a severe reaction to my first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (i had a severe reaction to my first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (i had a severe reaction to my first dose). At the time of the report, VACCINATION COMPLICATION (i had a severe reaction to my first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Initial unsolicited report received from non-healthcare professional (office staff) on 17 April 2015. A female patient, whose age, medical history and concomitant medication were not reported, had received a dose of ADACEL (batch number: U5081AA, expiration date: 25 June 2017, dose, dose cycle, route and site of administration were not reported) on an unspecified date. On unspecified date, 2 hours after vaccination patient had experienced slurred speech, jerky reflexes, and shortness of breath. It was reported that, patient's parents took the patient to the emergency room (ER) for follow up. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of the event were unknown. List of the document held by sender: None. Follow up report received from non-healthcare professional (office staff) on 27 July 2015. No new information reported. Documents held by sender: none.
This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and circumstance or information capable of leading to medication error were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received only adjuvant portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the box of 10 doses had one vial of powder remaining, so it was possible that the patient only received vial of liquid only, which led to circumstance or information capable of leading to medication error. The reporter did not determine which patient might have been impacted at this point so did not have any patient details to share yet. The reporter consented to follow up.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, muscle spasm, pain, injection site tenderness, back pain and neck pain. The patient was treated with ADVIL, TYLENOL and muscle relaxants. On an unknown date, the outcome of the injection site erythema, muscle spasm, pain, injection site tenderness, back pain and neck pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, muscle spasm, pain, injection site tenderness, back pain and neck pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient experienced redness and tenderness at the injection site. The patient's neck and back were aching, along with excruciating pain. The patient had muscle spasms all around the neck, back and her shoulder. She went back to the clinic on 18th August 2018 and she was prescribed muscle relaxant medication. The physician advised her to take ADVIL and TYLENOL every 6 hours. Later on the same day she also contacted her physician. It lasted for total of 14 days and then she recovered. The patient gave permission to contact her health care provider. No further details were provided.
Approximately 15 minutes after receiving the Covid-19 vaccine, I started to feel a tingling in my throat. It prompted me to repeatedly try to clear my throat. I then felt a sensation of my throat getting tight mildly restricting my airflow. Next my throat became sore. I experienced pain when swallowing.  I then became hoarse and lost my voice for about 8 hours. Currently (19 hours after receiving  vaccine), I am still experiencing a sore throat, but all other adverse effects have since resolved.
01/06/22 presents to Birth Center Triage for "IOL for FGR". PMHx of  "seizure disorder on Keppra" "positive chlamydia in pregnancy" "Anemia during pregnancy"
After 15 minutes rest period, Employee states she went back to work and became dizzy and had a pounding headache.  Employee sat down and ate and 2 hours later the headache is going away and dizziness has gone away.
suspected vaccination failure; got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter knew the patient who got shingles even though he/she received Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This case had been linked with case US2021AMR188220, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188220:same reporter
This spontaneous report was received from a 66 year old male patient. with no drug reactions or allergies, who was reporting on himself. The patient had no pertinent medical history. On 01-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX 1 time immunization (dose, lot # and expiration date were not provided) for shingles prevention. On the same day, the patient received a dose of PNEUMOVAX23 (reported as "pneumonia vaccine (unspecified)"; dose, route, lot # and expiration date were not provided). Concomitant therapies included lisinopril (unknown manufacturer) and atorvastatin. On 01-DEC-2016 (reported as "immediately afterwards"), the patient experienced swelling and puffiness in his left armpit, accompanied by a slight fever. As time progressed, the feeling became very painful, like "pins and needles", and he began to notice red dots as well. The patient sought medical attention and received an unspecified treatment for the events. The outcome of the events was unknown at the time of the report. The relatedness between the events and suspect vaccines was not reported. Additional information is not expected, as there was no consent to contact the patient's physician.
arm & fingers went numb for a couple of hrs;next day felt strange;had prev 3 dose series a few yrs ago
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments:  US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
first COVID vaccine was on15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric,; first COVID vaccine was on15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric,; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN: LRN4535447, 7793-2123331565.  A 39-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EUPHORIC MOOD (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "first COVID vaccine was on15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric,". Additional information:  it was reported that patient experienced: No immune response to COVID vaccine, first COVID vaccine was on15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
big knot,  swelling, redness and fever at site of injection.  Patient in a lot of pain.
Slight redness and itching at injection site after recieving a Zostavax injection.  Upon follow up an hour later redness had mostly resolved and itching had subsided.
slight nausea; liquid diarrhea; This is a spontaneous report received from a contactable reporter (other healthcare professional, nurse). The reporter is the patient. A 59-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in arm right, administration date 22Dec2020 03:15 (Lot number: EK5730) at the age of 59 years as dose 1, single for COVID-19 immunisation. Family history included: "psoriasis" (unspecified if ongoing), notes: treated with biologic; "lymphocytis colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 22Dec2020 03:15, outcome "recovered", described as "slight nausea"; DIARRHOEA (non-serious) with onset 22Dec2020 03:15, outcome "recovered", described as "liquid diarrhea". Therapeutic measures were not taken as a result of nausea, diarrhoea. Additional information: The patient was not admitted to the hospital and not deceased. No follow-up attempts are possible. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA.  About ten minutes after receiving her first covid-19 vaccine, pt experience dizziness, weakness and nausea while in observation area.  Pt was observed for an additional 15 min (a total of 30min) and reported feeling better.  At 30 mins pt still reported dizziness.  We offered to call an ambulance and pt refused.  Pt had a family member pick her up from pharmacy as to not drive.  Counseled pt to be aware of any additional symptoms and to have family member continue monitoring her as needed depending on symptoms.  Pt was also told if got worse or symptoms related to anaphylaxis developed to call 911
Temp up to at least 104,  SEVERE Muscle Aches, Nausea, Vomiting, Headache
Delayed dizziness; fatigue; Brain fog; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 30Mar2021 at 14:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had nil known allergies to medications, food, or other products. Concomitant medications included creatine monohydrate 5 mg (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 05Apr2021 at 07:00, 6 days after first dose of vaccine, the patient experienced symptoms of delayed dizziness, fatigue, brain fog and nausea. Therapeutic measures were taken as a result of the event which included treatment with anti nausea drug and unspecified intravenous drug. On 07Apr2021, the patient underwent nasal swab test and the result was negative. The events resulted in emergency room/department visit or urgent care. The clinical outcome of the event dizziness, fatigue, brain fog and nausea was resolved with lasting effects on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
After vaccines administered pt started coughing, stated throat itched, developed hives to left arm where Varicella vaccine was given, single papule to (R) side of neck, and 2 to forehead, 25 mg BENADRYL was given and pt observed for 30 minutes. Breath sounds improved. EPIPEN sent to pharmacy. Instructed to call if any worsening symptoms or go to ER.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: severe hives from neck to knees, front and back of body. Went to emergency room and got a steroid shot as well as a medrol dosepak. Still experiencing hives/itching after steroid shot as well as start of dosepak. Delayed reaction - started the next day.
administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication details reported.
COVID+ 10/26/22.  Vaccination status - moderna x4 BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider: NP Admission Date: 10/26/2022 Discharge Date: Oct 28, 2022   Active Hospital Problems   Diagnosis Date Noted POA ? COVID-19 10/26/2022 Unknown ? Fever 10/26/2022 Unknown ? Bilateral Lung Transplant, 10/11/19 10/11/2019 Yes ? Type 2 diabetes mellitus, with long-term current use of insulin (HCC) 07/23/2019 Yes   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Other complications of lung transplant (HCC) [T86.818] COVID-19 [U07.1]   HOSPITAL COURSE:  Pt is a 75 y.o. male who presented 10/26 with fever, fatigue, lethargy in the setting of COVID Infection diagnosed on 10/10. He received MAB shortly after positive test and felt a little better. About a week ago reported still feeling fatigued, fevers at home, and mild SOB/DOE. Due to worsening symptoms and neutropenia his MMF was held. He was direct admitted for a bronch and BAL. Significant vocal cord edema was noted on bronch so ENT was consulted and decadron x2 was given. ENT felt edema was likely from viral process and didn't feel treatment was indicated. Decadron was stopped and he was reduced back to home 5mg pred dose. BAL culture prelim was consistent with normal respiratory flora. Given improvement on abx though, will complete 5d course and follow-up final cultures as outpatient. Patient has been afebrile, ambulating without difficulty, and without shortness of breath. He will be discharged today to follow-up in clinic.
Patient stated that arm is unevenly swollen. He stated it looked like he "worked out" with one arm.
Information has been received from a consumer concerning an immunosuppressed patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX. It was reported that the patient developed shingles after vaccination. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
anaphylaxis, asthma attack, heart racing, dizziness, severe headache, pain in left side from shoulder to waist, numbness in both hands, pain in right arm from shoulder to hand with numbness and tingling sensation. Inabiltiy to walk or stand, red eyes, swollen faces, shortness of breath, weakness in legs, rise in blood sugar levels,  feeling light headness, fever, sore throat, chills.
Discomfort in chest, rapid irregular pulse on carrying bags of groceries up flight of steps Thursday evening (3/13).  BP 150/110, P 150, not relieved by rest.  At local ED around 7 or 8 pm that same evening, CPK MB and Troponin I rose, and EKG showed changes consistent with a subendocardial MI and Atrial Fibrillation, with AF resolving after treatment. Echocardiogram and catheterization results pending.  Impression: Myocardial infarction due to longstanding serious cardiac risk factors of hypertension, elevated lipid levels, and Type II AODM. No fever, no leukocytosis.
Pt. states that after receiving the 1st dose of J&J 04/10/2021, started experiencing symptoms 04/13/2021 of abdominal pain, Emergency Room visit 04/16/2021 * (160) Blood Clots located in the Abdomen area. Cat-Scan, Ultrasound, Blood Work done. Loss of weight, clots located in bowel movements. Still continuing to experience symptoms, no Follow-Up with Treating Physicians.
Two weeks after dose 3, I experienced a flare up of my arthritis, pain and numbness in my left leg that progressed up my leg from below my knee to above my hip, and I could not stand any pressure on it and was bedridden. I went from being very active to being bedbound unable to walk due the pain. I was bedridden for about 10 days until I could see an orthopedic specialist. I was diagnosed with trochanteric tendonitis and bursitis and I was experiencing nerve pain as well. I have received a cortisone injection to my hip on 5/5/2022, was x-rayed to confirm diagnosis and given exercises to perform at home. This has also effected the way I walk, and I feel that I am a fall risk.
Warm, reddish, itchy area around injection site beginning about 36 hrs. after injection.  Could be described as "covid arm" type rash, but no raised area.  Reaction was only after 2nd Moderna  booster.
RINGING IN EARS; MUSCLE TIGHTNESS; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (RINGING IN EARS) and MUSCLE TIGHTNESS (MUSCLE TIGHTNESS) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21H) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (allergic to many antibiotics).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced TINNITUS (RINGING IN EARS) and MUSCLE TIGHTNESS (MUSCLE TIGHTNESS). At the time of the report, TINNITUS (RINGING IN EARS) and MUSCLE TIGHTNESS (MUSCLE TIGHTNESS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided