chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received first dose of covid vaccine and got covid; received first dose of covid vaccine and got covid; This is a spontaneous report from a program. A male patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. on an unspecified date, patient who received first dose of COVID vaccine and got COVID. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from the doctor's office manager refers to a 16 years old male patient. On approximately 17-JUL-2012 ("Tuesday or Wednesday of last week") the patient was vaccinated with a dose of 0.5 GARDASIL (Lot # and route not reported). Concomitant medications included: MENACTRA. The patient came to see doctor for this AE. About 10 minutes after the vaccination, the patient experienced heart palpitations, anxiety and pacing. No treatment was given. At the time of reporting, the outcomes were not reported. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021 at 9:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 9:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 72.98.  Concomitant products were not provided.  On 12-Feb-2021 the excursion time was 9 AM, 10AM and 11 AM, temperature was 29 and 35 total doses given for the day was 55, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 12-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Initial information has been received from a physician concerning a several adult patients with an unspecified age, gender, pertinent medical history or drug reactions / allergies. On an unspecified date, the patients was vaccinated with a 1.3 ml or 1.5 dose of RECOMBIVAX HB, obtained from 2 pediatric doses of RECOMBIVAX HB (lot number was not reported). No other co-suspect medications were reported. No concomitant medications were reported. No adverse effect were reported. No treatment information was reported. The patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Participant fell off chair  on his right side at 11:04 AM. He hit his right temple area.  He fainted without warning. He has an abrasion  on his right temple and left knee. Syncope episode lasted between 15 seconds.  He responded to voice. Vital  signs were taken immediately and were stable 118/60 pulse 80 respirations 18 chest clear temperature 97, O2 sat was 98% at 11:04 AM. Participant was accompanied by his partner. He denies blurry vision headache or nausea vomiting his skin was clammy and cool pale in color he has a history of fainting. He denied other health conditions. His blood pressure at 11:24 was 120/90 pulse 71 respirations 16 breast sounds clear temperature 97.3  and O2 sat was 99%   His vital signs at 11:39 were 119/75 pulse 72 respirations 16 breath sounds clear 97.5 temperature.   he was alert and oriented once he recovered from his fainting. We placed a participant flat on the ground allowed him to rest until he felt able to sit up.  We dressed his  abrasions in right temple and left knee, monitored his vital signs which were stable.   participant drank water and Powerade.  he declined a snack he rested in cot when able to be moved.   we informed to notify his primary care doctor of the fall and inform to tell vaccinator he has a history of fainting when he comes back for vaccine number two.  he was accompanied By his partner off the premises once he felt better was able to ambulate safely his partner will drive him home his vital signs were stable
102 degree fever, chills, nausea, body aches, headache, exhaustion. Called OB due to fever and chills at 36 weeks pregnant, and sent me to hospital for Labor & Delivery for monitoring and labs.
Fuzzy, itchy tongue, high BP. Antihistamine taken. Observed vitals: BP, O2, HR for 1 hour
rapid heartbeat - 120 bpm/resting -- 24 hours restless legs and arms -- 12 hours tingling in arm where vaccination occurred -- continuing blurred vision --continuing decreased fine motor coordination -- continuing  fatigue -- continuing
given a 3rd shot instead of Tetanus; Shingrix given instead of Tetanus; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: given a 3rd shot instead of Tetanus) and wrong vaccine administered (Verbatim: Shingrix given instead of Tetanus). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 28-MAR-2023/29-MAR-2023 The reporter was retired pharmacist (patient's friend). The reporter clarified verbally that the patient had received the first two doses in accordance with the label, but then about a year later was inadvertently given a third dose. The patient went to the pharmacy to get a Tetanus vaccine recently, but was inadvertently given a third Shingrix dose. The pharmacist granted permission for safety to follow up at the following updated mailing address. No further details provided. The patient was given by mistake Shingrix(3rd dose) instead of Tetanus, which led to extra dose administered and wrong vaccine administered.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 05-DEC-2016 the patient received an expired dose of M-M-R II (lot # K020188, therapy type rHA, expiration date 22-OCT-2016) 0.5 ml subcutaneously for prophylaxis. The nurse reported the vaccine was reconstituted with Sterile Diluent (lot # M023896, expiration date 18-JAN-2018). There were no prior temperature excursions with the vaccine. No adverse effects were reported. Additional information has been requested.
Blisters with erythema at site of injection and oozing still 5 days later. Dr. prescribed him Cephalexin 500 mg two twice daily number 40.
Noticed a softball size lump at the injection site.  Was painful to the touch.  No other symptoms.
3X1.5inch RED, RAISED, WARM, HARD AREA AT SITE OF INJECTION. ADVISED ICE AND ANTIHISTAMINES.
Approximately a few hours after my vaccination I experienced the following: Fever, Chills, Fatigue and this lasted for about 72 hours. I took TYLENOL to suppress the symptoms and I felt better the next day.
No additional adverse events; Caller reported VARIVAX administered after temperature excursion; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 13-MAY-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose of 0.5 ml, subcutaneously, lot # U022321 confirmed to be valid with an expiration date: 15-JUL-2023 (anatomical location was not reported) for prophylaxis. The vaccine underwent a temperature excursion of 6 degrees Fahrenheit for 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Right-sided face swelling, throat swelling , difficulty swallowing, shortness of breath, nausea.  Symptoms lasted approximately 20 minutes.   25 mg benadryl was taken.  did not use an epi pen.
Transverse Myelitis; This is a literature report for the following literature source(s):  A 76-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 12Jan2021 at 00:20, outcome "unknown", described as "Transverse Myelitis". The patient underwent the following laboratory tests and procedures: CSF test: showed 6-8 oligoclonal bands, notes: IgG index pending; Diagnostic procedure: probable MS; Magnetic resonance imaging head: showed global atrophy with nonspecific white, notes: matter T2/FLAIR hyperintensities c/w chronic microvascular ischemic disease; Magnetic resonance imaging spinal: No intramedullary or cauda equina abnormalities. Therapeutic measures were taken as a result of myelitis transverse. Clinical courses: Dizziness and nausea 20 minutes after first vaccination, progressing to severe left upper and lower extremity weakness with inability to walk after two days. Sensation intact. Urinary retention, hyperreflexia and left Babinski sign. Treated with intravenous methylprednisolone. Diagnosis: probable MS.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the event is related to the vaccine administration 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
High fever over 102 degrees. Per exerted temporal thermometer, multiple readings over 102, with a high of 102.7 before we started ibuprofen.
This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (felt burning on the side of my face like a hot iron), HYPOAESTHESIA (experienced facial numbness, numbness was sporadic, have occasional numbness and weakness in hands), MUSCULAR WEAKNESS (occasional numbness and weakness in hands), PARAESTHESIA ORAL (feeling tingling at the tip and top of his tongue) and PARAESTHESIA (tingling) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 036821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ROSUVASTATIN CALCIUM (CRESTOR) and HYDROCHLOROTHIAZIDE for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced BURNING SENSATION (felt burning on the side of my face like a hot iron), HYPOAESTHESIA (experienced facial numbness, numbness was sporadic, have occasional numbness and weakness in hands), MUSCULAR WEAKNESS (occasional numbness and weakness in hands), PARAESTHESIA ORAL (feeling tingling at the tip and top of his tongue), PARAESTHESIA (tingling) and HEADACHE (headaches for six weeks). At the time of the report, BURNING SENSATION (felt burning on the side of my face like a hot iron), HYPOAESTHESIA (experienced facial numbness, numbness was sporadic, have occasional numbness and weakness in hands), MUSCULAR WEAKNESS (occasional numbness and weakness in hands), PARAESTHESIA ORAL (feeling tingling at the tip and top of his tongue), PARAESTHESIA (tingling) and HEADACHE (headaches for six weeks) had not resolved. The patient had CAT scans, blood tests and an MRI while also feeling tingling at the tip and top of his tongue. He claimed that his health care provider could not determine the cause and was not sure how to treat him. Treatment information was not provided.
Autoimmune Hepatitis Flare; This is a literature report for the following literature source(s): A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Mycophenolate mofetil for autoimmune hepatitis. The following information was reported: HEPATITIS (hospitalization, medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered", described as "Autoimmune Hepatitis Flare". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1450; Aspartate aminotransferase: 830; Blood bilirubin: 7.6; Enzyme level test: elevated; normalized within a month.; lab: autoimmune hepatitis. Therapeutic measures were taken as a result of hepatitis.  Clinical course: A 62-year-old male presented to the clinic with right upper quadrant pain associated with elevated liver enzymes. This patient's lab and liver biopsy results were consistent with autoimmune hepatitis. He remained stable on mycophenolate mofetil (MMF) for nine years without any acute flares. However, two weeks after receiving the first COVID Pfizer vaccine, the patient presented with jaundice and severely elevated liver enzymes - AST: 830, ALT: 1,450, and total bilirubin: 7.6. He was subsequently hospitalized and required IV solumedrol for seven days. The patient was transitioned to oral steroids and his liver enzymes normalized within a month. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (Autoimmune Hepatitis) and BNT162B2. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300199136 Same article/ drug/event and different patient;US-PFIZER INC-202300199135 Same article/ drug/event and different patient;
Patient began with fever, excessive crying, elevated white count at 24.6. Received ROCEPHIN IM following AUGMENTIN x 10 days.
Case number PHEH2014US025129, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 83-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
Left arm, left leg, left groin, left side of neck , face and chin tingling/ pins and needles; lips and under tongue tingling; Neck felt like it was on fire; Painful; This is a spontaneous report from a contactable nurse. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm left on 12Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish and avocado. Concomitant medications include prenatal medication, birth control medication, plantago ovata (METAMUCIL), ibuprofen (MOTRIN) and paracetamol (TYLENOL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021, 30 mins after the vaccine the patient felt left arm, left leg, left groin, left side of neck and the face tingling. Then 45 mins after the vaccine the patient's neck felt like it was on fire. It was reported that the last 24 days (at the time of this report) the patient still had burning, tingling in neck, face, chin, lips and under tongue in mouth. It happened almost every day sometimes twice a day and felt like painful, burns and also felt like pins and needles. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events left arm, left leg, left groin, left side of neck, face, chin, lips and under tongue was tingling, felt like pins and needles, neck felt like it was on fire and painful was recovered with sequelae on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
w/in 10seconds of HIB vax, pt had sz lasted approx 1min;pt was given 02;pt transported by EMS to hosp
Hives, red raised bumps very itchy. Medrol Dose pack prescribed by physician.
She got a sore arm; Headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She got a sore arm), HEADACHE (Headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She got a sore arm), HEADACHE (Headache) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (She got a sore arm), HEADACHE (Headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported Treatment received in response to the event was not reported.
First initial symptom was a rapid heartbeat, I knew it because my smart watch told me so. My heart rate was running 106 and 108 while inactive this was 11:00AM. I was just sitting still. I called my doctor via tele-medicine. I decided to take an at home COVID-19 test and it was positive. I also went to the urgent care for a PCR it was also positive. I had come in for an EKG. There was no concern other than the rate itself. The next day I had a sore throat and sines congestion. I was given PAXLOVID, which I took and my symptoms abated in a few days. My heart rate had been normal by the 7th. By the 11th I was testing negative. By that afternoon of the 12th, my heart was racing again it was in the mid 90's. I tested again on the 14th and I was positive again. I knew I had rebound. I was negative on the 21st. Since then my heart has popped up once or twice. on February 3rd, 5th, and the 19th, and March 5th. Since then I had no episodes. I actually wore a heart monitor for a week and everything came back normal.
Confusion to the point of hospitalization; A spontaneous report was received from a consumer concerning her mother, an 82 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Confusion to the point of hospitalization/Confusional state.  The patient's current condition includes Blood pressure, Arrhythmia, Arthritis pain. Concomitant medications includes water pills, Blood pressure pills, Heart medicines for Arrhythmia, Arthritis pain pills.  On 18 Mar 2021, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (batch number: 006B21A) via unknown route for prophylaxis of COVID-19 infection.  On 19 Mar 2021, the patient developed extreme confusion to the point where she was admitted. She was still in the hospital on Admission today 23Mar2021. No Treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, confusion to the point of hospitalization was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.