chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Periods every two weeks; Heavy bleeding; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on 09Mar2021 at 02:45 (at the age of 27-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 30Mar2021 at 14:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On an unknown date in 2021, the patient experienced periods every two weeks and heavy bleeding. The clinical outcome of the events periods every two weeks and heavy bleeding were unknown at the time of this report.    No follow-up attempts are needed. No further information is expected.
Redness/hotness at injection site. Large red area noted to right upper arm. Size measured at 6cm x 6cm. No pain or discomfort. No temperature. Patient treated with a 15mg dose of prednisolone syrup.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75 years old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE and again 0.5 mL dose of it (Batch number: UI981AB, expiration date: 16-Mar-2019, unknown route, in left deltoid, both doses on 27-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due extra dose administered (reported that the patient who accidentally received 2 doses of the High Dose flu shot on the same day). It was reported that the patient had received FLUZONE HD in previous seasons and it was discovered today that he had already received a FLUZONE HD immunization elsewhere this season. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
14 year old patient receiving a dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old patient receiving a dose of the Moderna COVID19 vaccine) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old patient receiving a dose of the Moderna COVID19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old patient receiving a dose of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  HCP mentioned that a 14 year old patient received a 1st dose of the Moderna COVID19 vaccine outside  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Follow up received contain Non-significant information.
pt recv vax & approx 6hr later seen in ER for SOB, wheezing, cough, chest tightness progressively worse over past 2hr;had facial puffiness on admission to ER;02 sat 100% on room air;given epi, solumedrol, albuterol & DPH;dx allerg rxn;
BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a health care professional concerned an elderly male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On MAY-2021, the subject experienced body aches. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache and body aches was not reported. This report was non-serious.
Extreme erythema and cellulitis that extended entire span of upper arm and elbow. Received injection on 9/26/04 (4th dose). Symptoms persisted through 9/30/04.
Adverse affects to second dose of Shingrix vaccine. About six hours after dosage., sudden onset of chills. About 12 hours after. Sudden leg cramping and overactive kidneys. Peeing out at least double the fluid intake for next 12 hour's resulting in partial dehydration. Pee was clear the entire time. Severe headache and slight fever not controlled by OTC medication. Also fatigue and decrease in balance. Finally, moderate hip & pelvis aching with painful & swollen lymph nodes inside thighs at groin. This started at six hour mark and dissipated suddenly, along with peeing at about 30 hour point. At forty hours. Now have just slight fatigue and hip discomfort
This spontaneous report was received from a 73 year old female consumer referring to herself. The patient's concurrent conditions included drug hypersensitivity to morphine and DILAUDID. The patient's medical history included knee and hip arthroplasty on 2010, and thrombosis. On 25-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # and expiry date was not reported). Concomitant therapies included valsartan, diltiazem, sertraline hydrochloride, ascorbic acid, dexpanthenol, ergocalciferol, niacinamide, pyridoxine hydrochloride, riboflavin 5'-phosphate sodium, thiamine hydrochloride, vitamin a palmitate, vitamin e acetate (MVI), omega-3 marine triglycerides, baby aspirin and omeprazole. On 25-OCT-2017, at 11 pm, the patient experienced from her arm to the side of her neck and collarbone were swollen and painful to the touch. She had trouble sleeping that night because of the pain. The next day on 26-OCT-2017, in addition to this symptoms she also experienced feeling dizzy and lightheaded. The patient called her physician to report the symptoms however she was unable to drive to the physician's office due to the dizziness and instead went to a local Urgent Care facility. There, the patient was sent to the emergency room where they ran all kind of tests. The patient reported that while at the emergency room she did undergo a chest X-ray, bloodwork and EKG. The patient reported that she was told to take TYLENOL and to apply ice to the painful areas. The patient reported that as of yesterday 29-OCT-2017, the swelling had reduced significantly but that she was still experiencing pain and some swelling. The outcome of peripheral swelling was reported as recovering/resolving. The outcome of pain in extremity was reported as not recovered/not resolved. The outcome of poor quality sleep and dizziness was unknown. No causality assessment between the events and the therapy was provided by the reporter.
Broke clavicle bone; Fell; This is a solicited report based on the information received by Pfizer from company (manufacture control number: 21K-163-4152477-00). A contactable consumer (patient) reported that a 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Apr2021 (Batch/Lot number was not reported) as dose 1, single and intramuscularly on 30Apr2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; Age at vaccination was at 64-year-old. Medical history included COVID-19 from Jan2021 to an unknown date, moderate to severe rheumatoid arthritis and psoriatic arthritis. The patient's concomitant medications were not reported. On 2021, the patient fell and broke her clavicle bone. She underwent surgery and bone graft. It was unknown if she was enrolled in a COVID-19 vaccine trial. The action taken in response to the events for adalimumab was unknown. Outcome of events was recovering. Causality for Humira(Adalimumab): The reporter's causality for the events of Broke Clavicle Bone, Fell and Covid 19 was not provided. Company's opinion is that there is no reasonable possibility that the events of Broke Clavicle Bone, Fell and Covid 19 are related to Humira(Adalimumab). Causality for Drug/vaccine per reporter and the events Clavicle fracture and Fall was possible while for COVID-19 was not reported.  No follow-up attempts are needed; information about lot/batch number of BNT162B2 cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - fall, clavicle fracture, and the suspect drug "BNT162B2" cannot be completely 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.
This spontaneous report was received from a registered pharmacist refers to a 70-year-old female patient. Current conditions included hypertension, hypercholesterolemia, hypothyroidism, penicillin allergy and sulfonamides allergy. On 06-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H013023, expiration date 09-OCT-2013) subcutaneously in the right arm. No concomitant medications were reported. The pharmacist reported that the patient developed redness at the injection site. The patient came to the pharmacy on 13-NOV-2012, and was found to have "a red spot" at the injection site without pain, swelling, or itching. No further information provided. Treatment was not given for the events. No lab studies were performed for the event. The patient did not recover from the events at the time of this report. The patient sought medical attention for the event. Additional information has been requested.
I tested positive for on COVID-19 in 04/12/2022. It started with cold like symptoms. I had a bad congestion, sore throat, fatigue and dizziness. I had to miss work for a few days. I like feverish but I didn't take my temp. I was tracking my oxygen level, but it stated normal. My symptoms were very mild. They prescribe me the anti-viral medication.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
shaking violently; felt so cold; felt so tired; right shoulder was very sore; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking violently), FEELING COLD (felt so cold), FATIGUE (felt so tired), ARTHRALGIA (right shoulder was very sore) and NAUSEA (nausea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced TREMOR (shaking violently), FEELING COLD (felt so cold), FATIGUE (felt so tired), ARTHRALGIA (right shoulder was very sore) and NAUSEA (nausea). On 22-Mar-2021, TREMOR (shaking violently), FEELING COLD (felt so cold), FATIGUE (felt so tired), ARTHRALGIA (right shoulder was very sore) and NAUSEA (nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included cold and flu medication.  No relevant concomitant medications reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Site of administration red, swollen, and hot. Pt following up at urgent care. Slightly painful. Swollen arm.
fever; 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 PYREXIA (fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Tingling right arm; red mark appearance; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling right arm) and INJECTION SITE ERYTHEMA (red mark appearance) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (red mark appearance). On 07-Mar-2021, the patient experienced PARAESTHESIA (Tingling right arm). At the time of the report, PARAESTHESIA (Tingling right arm) and INJECTION SITE ERYTHEMA (red mark appearance) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Within the first 10 minutes I was nauseous, developed a headache and started feeling very warm.  They had put me in the 15 minute wait area, and I did not report my symptoms as I didn't immediately think it was cause for concern or necessarily a reaction related to the shot.  After the 15 minute waiting period, I returned to my vehicle and started driving. At this point, I was hot enough that I took off my coat and turned the A/C to 67 degrees even though it was 35 degrees outside.  About 10 minutes later (25 minutes after receiving the shot), my upper lip started tingling, and within another 5 minutes (30 minutes after the shot) I looked in the review mirror and noticed my face and upper lip were swollen.  The vaccinated clinic was 45 minutes from my home and there is not much between the clinic site and my home, therefore, I kept driving.  About 50 minutes after getting the shot, the face and lip swelling started to decrease . I was able to access Benadryl at this point in time by stopping at a pharmacy, which helped my allergic type symptoms from that point onward.  I did continue to have a headache, fatigue, and chills for the remainder of that day.
water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt; scratched it and it hurt; upper arm was very sensitive, like it burn; Shingles; had a very big rash on my back, looked like the halo rash that you get with lyme disease. 6; in the opposite side of the injection site in her arm it was sore; red mark the size of a dime /Red mark increased in size, size of a silver dollar; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (red mark the size of a dime /Red mark increased in size, size of a silver dollar), PRURITUS (water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt), PAIN (scratched it and it hurt), BURNING SENSATION (upper arm was very sensitive, like it burn) and HERPES ZOSTER (Shingles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease (I have had lyme disease). Concomitant products included THYROID, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (red mark the size of a dime /Red mark increased in size, size of a silver dollar). On 08-Mar-2021, the patient experienced PRURITUS (water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt), PAIN (scratched it and it hurt), BURNING SENSATION (upper arm was very sensitive, like it burn), HERPES ZOSTER (Shingles), RASH (had a very big rash on my back, looked like the halo rash that you get with lyme disease. 6) and VACCINATION SITE PAIN (in the opposite side of the injection site in her arm it was sore). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at a dose of 1 gram. At the time of the report, ERYTHEMA (red mark the size of a dime /Red mark increased in size, size of a silver dollar), PRURITUS (water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt), PAIN (scratched it and it hurt), BURNING SENSATION (upper arm was very sensitive, like it burn), HERPES ZOSTER (Shingles), RASH (had a very big rash on my back, looked like the halo rash that you get with lyme disease. 6) and VACCINATION SITE PAIN (in the opposite side of the injection site in her arm it was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
The patient experienced some bleeding with the injection (it stopped quickly with applied pressure), however immediately after the injection the patient developed a fairly large bump that was beginning to turn black and blue. I had the patient wait a little bit after the administration to make sure it did not expand. It did go down slightly before the patient left the store but the bump was still there. I called and followed up with the patient later on in the day and she said it was a little bit sore but not more so than she would expect after a vaccine. She said the bump was still there and it was still black and blue but she thought it would be ok and that it had not worsened since he had been here. I had recommended ice to see if it would help with the swelling but she had not gotten a chance to try that option yet as of when I spoke to her
Baby began to run a fever of 101F. Then baby lost appetite. Then baby developed a 1" diameter welt at location of injection on uppermost LT. Very red and angry looking and very hard. Symptoms continued until 11/25/09 and family came back to get assessment from PH Department. Injection was either the PCV7 or the ACTHIB. Family stated that breathing was not affected. Family stated that baby did develop diarrhea on 11/24/09 and it continued for about 12 hours.
Got my Moderna COVID 19 shot booster (3rd shot) yesterday. Had small headache most of the day then suddenly before bed got dizzy/nauseated and faint feeling. My hands/arms and feet/legs went tingly, numb and weak. My jaw and throat hurt badly and I had a slight shortness of breath.
Client reports receiving "Cansino" COVID-19 vaccine in April 2021.  Client reports that one and a half days later, she experienced diarrhea, chills, felt cold and was fatigued for about 2 hours.  Client reports that symptoms resolved after taking an Acetaminophen-like medication.  Client reports drug allergies to "phedrines" medications.    Elevated to Clinical Supervisor, who received approval from medical provider for  client to receive Janssen COVID-19 vaccine, according to current Interim CDC Guidelines.   Explained risks/benefits/emergency precautions to client who verbalizes understanding and provides this nurse with verbal consent to administer Janssen COVID-19 vaccine (Lot # 1855194).   No adverse side effects noted or reported by client during 15 minute post-observation period. - , RN
Pt was admitted to hospital. We have no information regarding his history/workup/treatment/outcome.
After receiving the second dose, immediately the patient didn't feel right; By the time she got to her car, her upper lip started to go numb; About 20 minutes after vaccine her cheeks were numb; Took about 12 hours before she could feel her lip again; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (After receiving the second dose, immediately the patient didn't feel right), HYPOAESTHESIA (By the time she got to her car, her upper lip started to go numb), HYPOAESTHESIA (About 20 minutes after vaccine her cheeks were numb) and HYPOAESTHESIA ORAL (Took about 12 hours before she could feel her lip again) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL (After receiving the second dose, immediately the patient didn't feel right), HYPOAESTHESIA (By the time she got to her car, her upper lip started to go numb), HYPOAESTHESIA (About 20 minutes after vaccine her cheeks were numb) and HYPOAESTHESIA ORAL (Took about 12 hours before she could feel her lip again). At the time of the report, FEELING ABNORMAL (After receiving the second dose, immediately the patient didn't feel right), HYPOAESTHESIA (By the time she got to her car, her upper lip started to go numb), HYPOAESTHESIA (About 20 minutes after vaccine her cheeks were numb) and HYPOAESTHESIA ORAL (Took about 12 hours before she could feel her lip again) outcome was unknown. Not Provided          No concomitants were reported. No treatment was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.