chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough COVID infection; positive test with NO symptoms; Breakthrough COVID infection; positive test with NO symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant), outcome "recovered" and all described as "Breakthrough COVID infection; positive test with NO symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rapid test, positive test with NO Symptoms; Negative, notes: The PCR test was negative.  Clinical course: Breakthrough COVID infection in fully vaccinated patient; positive test with NO symptoms. Patient's mother thinks the rapid test may have produced a false positive and was taking him to get a PCR test this morning (07Jun2022). The PCR test was negative, so patient's mother suspects the original rapid was a false positive. Event took place after use of the product.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a male patient of unknown age reporting on himself without medical history, drug reactions and allergies. On an unknown date the patient was vaccinated with ZOSTAVAX lot # J013451, Expiration ate: 25-JAN-2015, 0.65 ml in the back of the upper arm for prevention of shingles (route of administration was not reported). There was not concomitant medication. Couple of months ago the patient developed headache and ringing in the ear late the day or the next day he received ZOSTAVAX. He reported that it felt like a hangover. Patient did not receive any treatment for the adverse event. He did not seek medical attention. There were not laboratories diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
INJECTION SITE RASH AT SITE OF INJECTION ON RIGHT ARM APPROX 2.5 INCHES IN DIAMETER.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested positive for Covid again after four days of testing negative; (2023) Positive, notes: Tested positive for Covid again after four days of testing negative; (Jul2023) Positive, notes: Tested +10 days after first initial test of positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with paxlovid from 03Jul2023 to 07Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further informaton is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250384 Same reporter/patient, different drug/AE.;
Community member stated had "left arm weakness."  stated she usually had left arm weakness in the past after her "brain surgery in 2017."  At 1600 community member stated she felt better and wanted to go home. Observer RN noted weakness to left lower extremity as well and called Rapid Response Team at 1607.  Community member remained responsive and alert and oriented x4, followed commands.
This spontaneous report has received from a physician referring to an unspecified number of patients with unknown ages and genders. On an unknown date the patients were vaccinated with improperly stored (OKA/MERCK) VARIVAX (route, lot#, dose and frequency unknown). No adverse effects reported. It was not specified if the patients sought for medical attention. Additional information has been requested.
Has what appears to be a scabbed over chicken pox at site of varicella injection. Also had one possible pox on abdomen per mother. Mother states he ran a fever 100-101 off and on x 2 weeks.
Headache; Muscle aches; upset stomach; doesn't have any appetite; feels like sleeping all the time; doesn't feel right; does not have any energy at all; Redness; she felt more achy around left side of her chest under left breast; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), RASH (Rash), BREAST PAIN (she felt more achy around left side of her chest under left breast), HEADACHE (Headache) and MYALGIA (Muscle aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history is provided and concomitant drugs are provided.     On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced RASH (Rash). On 04-Apr-2021, the patient experienced ERYTHEMA (Redness) and BREAST PAIN (she felt more achy around left side of her chest under left breast). On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Muscle aches), ABDOMINAL DISCOMFORT (upset stomach), DECREASED APPETITE (doesn't have any appetite), SOMNOLENCE (feels like sleeping all the time), FEELING ABNORMAL (doesn't feel right) and ASTHENIA (does not have any energy at all). At the time of the report, ERYTHEMA (Redness), RASH (Rash), BREAST PAIN (she felt more achy around left side of her chest under left breast), HEADACHE (Headache), MYALGIA (Muscle aches), ABDOMINAL DISCOMFORT (upset stomach), DECREASED APPETITE (doesn't have any appetite), SOMNOLENCE (feels like sleeping all the time), FEELING ABNORMAL (doesn't feel right) and ASTHENIA (does not have any energy at all) outcome was unknown. Not Provided          Treatment: acetaminophen (Tylenol) and Heat
I am 22 weeks pregnant. My due date is July 27th, 2021. The evening I received the shot around 9pm, I started to feel nauseous and dizzy. Soon after I started having chills and body aches. It also felt like I was given a shot of adrenaline and was wide away until 3:30am. After a couple hours of sleep, I woke up and had a loss of appetite, chills, body aches, and no energy. I took some Tylenol for relief and stayed in bed all day. On Wednesday morning I work up with no symptoms and my appetite returned.
Client had chills, fever, headache and was throwing up after the 1st dose of the Pfizer vaccine.  She was sick most of the day after the vaccine was administered.
she feels off; arm was hot; arm was sore; fatigue/felt tired/extreme fatigue; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she feels off), INJECTION SITE WARMTH (arm was hot), PAIN IN EXTREMITY (arm was sore), FATIGUE (fatigue/felt tired/extreme fatigue) and PYREXIA (Feverish) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002CZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IUD                                                            Birth control for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FATIGUE (fatigue/felt tired/extreme fatigue) and PYREXIA (Feverish). On 27-Apr-2021, the patient experienced INJECTION SITE WARMTH (arm was hot) and PAIN IN EXTREMITY (arm was sore). On 11-May-2021, the patient experienced FEELING ABNORMAL (she feels off). At the time of the report, FEELING ABNORMAL (she feels off), INJECTION SITE WARMTH (arm was hot), PAIN IN EXTREMITY (arm was sore), FATIGUE (fatigue/felt tired/extreme fatigue) and PYREXIA (Feverish) 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.   No treatment medications were reported.
Extremely sore arm, fever, chills, headache, body aches, nausea, dizziness
Narrative: 88YOM with PMH GERD, AF, coronary arteriosclerosis, carotid atherosclerosis, carcinoma of colon died while admitted to the MICU on 6/24/2021 due to shock. Patient only received one dose of COVD vaccine on 1/29/21. Post-first dose, patient was admitted for 5 days due to weakness and chest pain. Upon arrival for 2nd dose, pt reported feeling weak since admission. Decision was made by nurse and pharmacist to hold second dose until pt's strength returned. 2nd dose was never rescheduled by patient or given. Death appears unrelated to vaccine.
Pt admitted to hospital  72 yo male patient with PMH of asthma, SSS S/p pacemaker, Parkinson's disease, Barret's esophagus, recent hospitalization for syncope, was brought by his wife to the ED, stating pt mental status has change becoming more sluggish after he was discharge from the hospital last Friday. She reported pt started presenting urinary incontinence for the past 2 days and referred this is the first time it happens. Pt's wife expressed he has been laying in bed for the last 2 days which she described is unsual on him. No fever, abdominal pain, dysuria reported. Pt denies syncope episodes.    In the ED, lab workup pertinent to LDH: 241, CRP: 15.07, Glucose:117, Ferritin:334, CBC remarkable for Neutrophilia:88.1. ESR: 51.  UA remarkable for pyuria, WBC:21-50. RBC: 51-100, blood:1+, protein UA: 2+ Ketone:1+, bacteria: trace. Chest xray unremarkable, pt has a pacemaker.   Pertinent Summary of prior admission(s)/Care everywhere/ED visit/Clinic visit:  Pt was discharged on 8/6/21 after being evaluated and treated for Syncope.
Reports approx 10 pm the night she had the injection she began having cold chills, fever, H/A, pain in legs and sore all over, in bed for 2 days. Took ASA and Night Quil poked right with nail no Sun 4/2/06.
Fractured her left foot; Accident; Swelling (left foot); Pain (left foot); This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, in 2021, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient would be getting her second Pfizer COVID-19 shot in 2 days. In 2021, the patient had an accident and now was taking medications. In 2021, the patient fractured her left foot and she was taking naproxen 500 mg for the swelling and the pain. The patient wanted to be sure that it wouldn't be an issue to get her shot as she read online that anti-inflammatories can reduce the effectiveness. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.
Pt noticed increased reddness to palms of hands and fingers, VS taken q 15 minutes (WNL) and monitored for 1 hour. Redness decreased but still visable.  Pt stable and ok to go home. pt called while at home at 3:30 pm and was resting with decreased symptoms.
Covid19 vaccine Pfizer: mild itching (L) forearm, benadryl 25mg given PO at 1400, pt observed until 1430, pt reported resolution of symptoms at 1430 and d/c'd from vaccine clinic; advised to f/u with PCP if any further questions/concerns
Fatigue during the first two days(so far). Starting to experience asthma conditions (wheezing, and some shortness of breath). Muscles and arm where shot was administered tender still and hurts to the touch or motion.
suspected vaccination failure; still got the shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient reported that he/she got the shots and still got shingles for 4 months and it was harable worst thing in life. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Pt developed a ring rash around neck the day after COVID-19 Moderna Vaccine. pt also had on a scarf that she thinks caused this. no itching
Information has been received from a vaccine nurse concerning 6 or 7 kids who were vaccinated with GARDASIL (lot # not provided).  Subsequently the patients experienced seizure.  The patients sought for unspecified medical attention.  Upon internal review, "seizure" was considered to be an other important medical event.  Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Fever blisters; This case was reported by a consumer and described the occurrence of fever blister in a adult 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 fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient asked could fever blisters be side effect of Shingrix shot.
First and second nights after second vaccine dose I had severe chills and on the third night I awoke with  profuse sweating. First day to second day after second infection I slept all but 7 hours. On the second day after the injection I developed an itchy rash at the injection site, approx. 3 inch circumference. Today 4/10/21, the rash is fading and less itchy, but still noticeable. On day 4 I had mild discomfort from inflamed lymph nodes under left arm. Both the first and second injections I had moderate discomfort at the injection site.
This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 31-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014706:
Itchy rash appeared on my bra line and within hours spread to my arms and stomach. Later in the night spread lower to my belly and groin and head/scalp. By the next day was all over my body, legs, and back in addition to the above. Red raised bumps and swelling, extremely itchy!! At this time it has been  3 days and no improvement. Saw a doctor he prescribed 3 days of prednisone and Benadryl. I have been taking both, no improvement. Have been soothing with oatmeal baths, have tried anti itch cream (doesn?t work), applying coconut oil with a couple drops of tea tree oil to help soothe itching.
Tested positive for COVID-19; Chills; Aches; lingering cough; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (Aches), COUGH (lingering cough), PYREXIA (fever) and COVID-19 (Tested positive for COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced CHILLS (Chills), PAIN (Aches), COUGH (lingering cough) and PYREXIA (fever). On 16-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with BENZONATATE at a dose of 1 dosage form. At the time of the report, CHILLS (Chills), PAIN (Aches), COUGH (lingering cough), PYREXIA (fever) and COVID-19 (Tested positive for COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Blood pressure medications. Treatment medication also included cough syrup at night to help sleep and inhaler.
Erythema at injection site the following day, then a pruritic rash developed over the next 3 days, then lessened with benadryl per Dr  (patient's PCP).
History of Present Illness: Pt c/o of rash on L bicep as a reaction to a Td shot she recieved 1 wk ago. States rash is itchy and coarse. Urticarial reaction on upper outer arm. Past Medical History: Reviewed history from 05/12/2009 and no changes required: Current Problems: CML HYPERTENSION, BENIGN (ICD-401.1), ATYPICAL DUCTAL HYPERPLASIA LEFT BREAST (ICD-238.3), P  PLANTAR FASCIITIS (ICD-728.71), OBESITY (ICD-278.00), OSTEOPOROSIS (ICD-733.00), REACTIVE AIRWAY DISEASE (ICD-493.90), DYSPNEA ON EXERTION (ICD-786.09), HIP PAIN, RIGHT (ICD-719.45), SLEEP APNEA (ICD-780.57), GERD (ICD-530.81), CHEST PAIN (ICD-786.50), HYPERLIPIDEMIA (ICD-272.4), CATARACT (ICD-366.9), MUSCLE SPASM (ICD-728.85) Family History: Reviewed history from 10/16/2007 and no changes required: FH Asthma, FH Colon CA, FH Coronary disease, FH Diabetes, FH Hyperlipidemia, FH Hypertension, FH Thyroid disease, FH Multiple Myeloma Social History: Reviewed history from 10/16/2007 and no changes required: Married Vital Signs: Patient Profile: 73 Year Old Female Height: 64.5 inches (163.83 cm) Weight: 172 pounds (78.18 kg) BMI: 29.17 Temp: 98 degrees F (36.67 degrees C) oral Pulse rate: 72 / minute Pulse rhythm: regular BP sitting: 118 / 78  (right arm) Cuff size: regular  Physical Exam General: alert and in no apparent distress;  Skin: urticarial region on L outer arm. No evidence of cellulitis Impression & Recommendations: Problem # 1:  Minor dx of URTICARIA (ICD-708.9) Return if not resolved 3-4 d Orders: 99213 Exp (CPT-99213) Patient Instructions: 1)  Return to clinic as needed. Precautions given regarding worsening or nonresolving symptoms.  Prescriptions: HYDROXYZINE HCL 25 MG TABS (HYDROXYZINE HCL) 1 by mouth 4 times a day as needed for itching  #60 x 0 New Asthma Problem: Minor dx of URTICARIA (ICD-708.9)
Dysfunctional uterine bleeding. Work up has been ordered to r/o other causes.
migraine symptoms: headache, nausea, dizzy, loss of appetite, sensitivity to sound, smell, light.
Had a reaction after the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a reaction after the second shot) 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 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 VACCINATION COMPLICATION (Had a reaction after the second shot). At the time of the report, VACCINATION COMPLICATION (Had a reaction after the second shot) outcome was unknown.            No concomitant medications provided No treatment medications provided
Patient became increasingly lethargic while waiting in post-vaccination observation area.  Patient became less responsive and paramedics were called.  Patient was conscious and breathing but unresponsive to stimuli when paramedics arrived.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: About 5 min after giving vaccine pt started to feel nausea, dizzy, sweaty and light headed. She stated she had not eaten since yesterday. She did not lose consciousness. 1st BP reading at 5:55pm (85/68 & HR 87), 2nd BP reading at 6:15pm (99/78 & HR 76). Pt was given water and a damp towel to help with symptoms. After an additional 30min of monitoring pt felt better and was able to leave.
Injection site broken out and puffy, Itchy, red dots, warm to the touch, swelling from left shoulder to elbow.
Patient was given Vaxelis and Hib on the same day. Patient had no adverse reaction or side effects.  Dr. did speak with patient's mother regarding the event.
On going Uncontrollable body convulsions. Tightness in the chest,behind the knees and calves. Low body tempature 95.8 during episode. Seems to only happen when I lay down or change in room tempature. Feel the need to wrap myself in several blankets. Not a seizure I am fully conscious during episode. Episodes last 10-30 minutes once a day when going to sleep or laying down.
Itching upper back and chest and face/mouth. No shortness of breath but some tightness in throat. Faint red rash on upper chest and upper back.
This spontaneous report as received from a healthcare worker refers to a 5 year old female patient. The patient's medical history included pneumonia, eczema and itching of her skin. No known drug allergies. On 04-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K018528, expiry date: 14-APR-2016, 0.5 ml, subcutaneously for her low titer level. Concomitant therapies included fluticasone, hydroxyzine hydrochloride, montelukast sodium (manufacturer unknown), hydrocortisone (manufacturer unknown) and mometasone furoate (manufacturer unknown). On 05-JUN-2015, the patient experienced fever of 104 Fahrenheit and cellulitis and the patient was taken to emergency room. The patient was then treated with cephalexin 4 times daily. The patient sought medical attention. Action taken with the suspect drug was not applicable. The patient was recovering from the events on therapy. Causality was not reported. No product quality complaint reported. Additional information has been requested.