chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood clot on the left side of neck; This is a spontaneous report from a contactable HCP (patient). The patient was a Respiratory Therapist. A 60-year-old male patient received his secondo dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration on 03Apr2021 (at the age of 60-years-old) as single dose for COVID-19 immunisation.  The patient took the first dose of BNT162b2 (lot number EN6199) on an unspecified date for COVID-19 immunisation. Medical history included high cholesterol and hypertension from an unknown date and unknown if ongoing. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for hypertension, start and stop date were not reported; rosuvastatin taken for blood cholesterol increased, start and stop date were not reported.  The patient experienced blood clot on the left side of on an unspecified date in Apr2021. The event was treated with blood thinner. Patient thought it was called Xarelto because they called him on 07Apr2021. He was not sure how to spell that. Treatment was started on 07Apr2021. Consumer stated he first started having symptoms on the night of the injection. On an unspecified date in Apr2021 the patient did the ultrasound and that's when they found blood clot and he just got the results back. Recently, may be 2 weeks before reporting, patient had routine blood work and It was normal. It was nothing abnormal. The outcome of event was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Clot blood cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Pt's father reported that within 24 hours of first dose on 6/6/22 pt had small hive-like rashes on body, mostly between fold of arm at elbow. Pt's father stated that hydrocortisone cream was applied and claritin given. Pt recovered without any complications. Pt and pt's father denied any respiratory involvement, difficulty breathing, or rash on neck, chest, or face. Pt's father stated that hive-like rash reappeared several times throughout the last several weeks when showering and when at the lake but resolved on it's own. Unsure if related to vaccination.
The employee reported itching and soreness at the injection site but was not at the location at the time it was reported. She states it may be from the injection and it may be from the bandaid used to cover the site because this has happened with other kinds of vaccines because of the bandaid. She was instructed over the phone to apply and ice pack and take benadryl as needed for the itching. She was also instructed to seek outside medical care or call EMS if symptoms persisted or got worse.
Fever, Chills, vomiting, headache, swollen arm, lethargic.
Hives all over body; started at lower end and moved up towards face; mostly on back, genital area and legs.  Still has loss of appetitie, very tired and clingy.
Pt vaccinated with MMR on 16JUL90.  Subsequently experienced malaise, headache and myalgia and was hospitalized on 5AUG90 for fever and hepattis. Additional details being requested.
I tuck two shots and then shingles/suspected vaccination failure; Bad case of Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK receipt date: 05-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took two shots and then had a bad case of shingles. The patient so stated that he/she thought their shots were worthless. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
cold-like symptoms; arm hurt for a day (specially close to injection site); This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Mar2021 (Lot number: EN6208) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "arm hurt for a day (specially close to injection site)"; NASOPHARYNGITIS (non-serious) with onset 15Mar2021, outcome "unknown", described as "cold-like symptoms".  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a other health professional refers to unspecified patients of unknown age. In 2017 the patients were vaccinated with VARIVAX lot # M024678 for prophylaxis.    Concomitant therapies included sterile diluent (STERILE DILUENT). In 2017 the patients experienced incorrect product storage. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to VARIVAX; Sender's Comments:  US-009507513-1709USA010135:
slight headache; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced slight headache. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  Information about lot/batch number has been requested.
"a single carcinoid tumor that only needs surgery which doesn't require immunosuppression"; This spontaneous case was reported by a physician and describes the occurrence of CARCINOID TUMOUR ("a single carcinoid tumor that only needs surgery which doesn't require immunosuppression") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007m20a and 012l20a) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included FISH OIL and TIMOLOL for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARCINOID TUMOUR ("a single carcinoid tumor that only needs surgery which doesn't require immunosuppression") (seriousness criterion medically significant). At the time of the report, CARCINOID TUMOUR ("a single carcinoid tumor that only needs surgery which doesn't require immunosuppression") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication use information was not provided by reporter. Concomitant medication use information was  provided by reporter that includes supplements. Patient wants to get 3rd dose of Moderna vaccine . Patient were to have to mayor lung surgery on Aug the 19th.  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. Sender'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.
I went to go get my flu vaccine and was accidentally  administered a Pfizer COVID vaccine. I already received my first two doses of Pfizer 02/12/2021 and 03/12/2021. Although I do not expect to have any major issues. This was an error.
Patient began feeling unwell (experiencing loss of appetite, nausea, and weakness) around lunchtime after receiving FLUZONE HD in the morning on 9/29/2016. He experienced diarrhea throughout the evening and one bout in the morning on 9/30/2016. Patient felt alternately hot and cold as if he had a fever but did not have one on checking with a thermometer (98.6F). Patient was counseled to treat his symptoms as needed (with rest, fluids, ibuprofen or acetaminophen) and seek medical attention if symptoms persisted or worsened. Negative for shortness of breath, rash, or hives. Patient began to feel "almost back to normal 100%" by the afternoon on 9/30/2016.
heart rate variability below my personal range; elevated troponin; Tachycardia; Breathing rate above my personal range; Heart Palpitations while sitting at my desk in a video meeting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY RATE INCREASED (Breathing rate above my personal range), PALPITATIONS (Heart Palpitations while sitting at my desk in a video meeting), TACHYCARDIA (Tachycardia), HEART RATE VARIABILITY DECREASED (heart rate variability below my personal range) and TROPONIN INCREASED (elevated troponin) 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 at 7:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced RESPIRATORY RATE INCREASED (Breathing rate above my personal range) (seriousness criterion hospitalization) and HEART RATE VARIABILITY DECREASED (heart rate variability below my personal range) (seriousness criterion hospitalization). On 29-Apr-2021, the patient experienced PALPITATIONS (Heart Palpitations while sitting at my desk in a video meeting) (seriousness criterion hospitalization), TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization) and TROPONIN INCREASED (elevated troponin) (seriousness criterion hospitalization). The patient was hospitalized from 29-Apr-2021 to 30-Apr-2021 due to PALPITATIONS, RESPIRATORY RATE INCREASED, TACHYCARDIA and TROPONIN INCREASED. At the time of the report, RESPIRATORY RATE INCREASED (Breathing rate above my personal range), PALPITATIONS (Heart Palpitations while sitting at my desk in a video meeting), TACHYCARDIA (Tachycardia), HEART RATE VARIABILITY DECREASED (heart rate variability below my personal range) and TROPONIN INCREASED (elevated troponin) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Heart rate: 202 (Inconclusive) 202 beats per minute. On 29-Apr-2021, Troponin: increased (High) Elevated Troponin. On 30-Apr-2021, Echocardiogram: normal (normal) Negative for Heart Attack.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       I got an allergy shot in both my left and right arms on 26 Apr 2021 at 4:00 PM. On 20 Apr 2021  I went to the ER at 2:00 PM , elevated Troponin was detected and I was admitted at 4:00 PM for an evaluation for a heart attack.  On 4/30/21,  I was discharged from the hospital because the Echocardiogram and Stress test were negative for a heart attack.  No concomitant medications or treatment information were provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Over the first eight hours muscle and bone aching occurring, caused inability to lift arm. Swelling developed from distal axilla to mid forearm. Aching 5 days. Redness developed after 36 hrs and persisted for 6 days.
pt states after she got the second dose her middle knuckle became red and purple, like a bruise but no pain associated with it.  She had redness and itching on both cheeks.  She had body aches and chills with no fever but she felt very hot.  Pt took 2 extra strength Tylenol.  the next day the next day all symptoms were gone.
On 4/18/2019 patient called to report an injection site reaction to a SHINGRIX vaccination administered on 4/16/2019. Patient reported experiencing swelling, redness and pain/soreness at the injection site (an area of approximately 3 inches) that started after injection but symptoms were improving. Patient reported no difficulty breathing or symptoms. On the follow up call on 4/19/2019 patient reports there is still some pain but that the reaction was continuing to improve.
patient developed a swelling under her lip; t felt like a wad of cotton between her lip and gum; This is a spontaneous report received. A contactable consumer (patient) reported a non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unknown route of administration on 09Mar2021 (batch/lot number: not reported) as 1st dose, single dose for COVID-19 immunisation. Patient's medical history included myocardial bridging (myocardial bridge). Concomitant medications included ranolazine (RANEXA), meloxicam, diltiazem hydrochloride (CARTIA), metoprolol and sertraline for unspecified indications. It was reported that the patient had an allergy to ACE inhibitors. Approximately 3 hours after administration of BNT162B2, the patient developed a swelling under her lip. The patient stated that it felt like a wad of cotton between her lip and gum. She wasn't sure if it was related but she felt it should be reported as it was very strange. The patient visited the physician's office for consultation regarding her condition. She was treated with steroid and diphenhydramine (BENADRYL) shots. The patient was able to recover from the reported event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable pharmacist via a sales representative, who reported similar events for four patients. This is the first of four reports. An adult patient of an unspecified gender, who was over 60 years, received a single dose of PREVNAR 13, in Dec2016 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced localized allergic reactions in Dec2016 with outcome of unknown. Patient was taken to Urgent care center and it was unknown if was hospitalized or received treatments. Sender's Comments: Linked Report(s): US-PFIZER INC-2016595828 same reporter/drug/event, different patient.
Information has been received from a other health professional referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-JAN-2016 the patients were vaccinated with improperly stored doses of VAQTA (lot # was reported as "L034381" with expiration date 21-DEC-2016, dose and route were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt came in on 12/8/16 saying that he had a redness at the injection site at 8 cm in diameter. RPH on duty recommended BENADRYL. RPH called MD. No response from MD. Called pt to check on him, and he was fine.
Fussy, irritable, screaming, no appetite started soon after receiving vaccines at HD today. Signs and symptoms lasted > 2 hours.
This child had urticaria on the back and upper extremities. The resolved after Epi.
The patient was vaccinated on 5/26/21 for dose one and 6/16/21 for dose two with Pfizer COVID-19 vaccine. Patient passed away the day following her second dose on 6/17/21.
Day 1-1-1/2  Slight soreness at vaccine site; Days 2-3  Soreness throughout chest (as with the flu); Days 4-5  Soreness in left side of chest; Day 6 - present  Soreness concentrated in one area of left chest/side; more intense and "takes my breath away," at times, with certain movement and total inflation or deflation of lungs.
ON 1/21/21 DEVELOPED NAUSEA, BODY ACHES AND WEAKNESS. SHE CALLED HER DOCTOR, WHO TOLD HER TO WAIT OUT THE SYMPTOMS OR GO TO THE ER IF THEY GOT WORSE. SHE DID NOT GO TO THE ER.
a week after vaccination an  inch below vaccination site red blotchy (mosquito bite/hives) looking
VACCINE GIVEN WITH IMPROPER STORAGE CONDITION; OUT OF SPECIFICATIONS PRODUCT USE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine given with improper storage condition, and out of specifications product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given with improper storage condition and out of specifications product use was not reported. This report was non-serious.
Within one day of administration, developed significant fatigue, myalgias, and joint pain, particularly about the hands and feet. The fatigue and myalgias largely resolved a few weeks after administration, but the joint pain has persisted since that time and is debilitating.  Any sort of physical exertion causes a drastic increase in symptom severity.   Treatment to date includes NSAIDs, Turmeric, Vitamin C, Vitamin D+K, Gammadyn Cu Au Ag, HepaCaps, wrist braces, online PT. Considering trial of low dose Naltrexone for vaccine injury. Sertraline was suspended Jan. 2022-current in an effort to determine if joint pain might be a side effect issue; it has been six months and the joint pain still persists.
This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included wasp sting, and non-smoker, and other pre-existing medical conditions included unknown. The patient was previously treated with varicella zoster vaccine rge (cho) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) .5 ml, administered on AUG-2020 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2020, Laboratory data included: Antibody test (NR: not provided) antibodies present. On AUG-2020, the subject experienced flu. On AUG-2020, the subject experienced shivers. On AUG-2020, the subject experienced rib cage ache. On AUG-2020, the subject experienced felt lousy. On AUG-2020, the subject experienced muscle aches. On AUG-2020, the subject experienced stung at arm. On AUG-2020, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu, shivers, rib cage ache, felt lousy, muscle aches, and stung at arm on AUG-2020, and had not recovered from fatigue. Product Quality Complaint number:90000173522 This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria)- , this report does not contain any indication of a pqc but only mentions pure ae's which are outside of the scope of quality investigation. Based on the PQC evaluation/investigation performed.
expired dose of Havrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAV (Havrix 1440) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2022, the patient received the 1st dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 15th June 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The clinic Supervisor stated that an expired dose of Havrix was administered to a patient. The reporter consented to follow up. Additional Supportive Information: The patient received expired Havrix which led to expired vaccine used.
day 2 redness and sore arm day  4  symptoms resolved day 7 symptoms reappear and are more pronounced such as itching redness and soreness at day 8 feeling better
Information has been received from a physician concerning a 47 year old female patient with gastrooesophageal reflux disease and depression who on unknown dates was vaccinated with two complete series of RECOMBIVAX HB, 10 microgram per milliliter (route and lot # were not reported). The physician reported that the patient continued to have low hepatitis B antibody titers. Laboratory diagnostics studies included "hepatitis B titers". The patient was seen by the physician. At the time of reporting the patient had not recovered. Additional information has been requested.
Tinnitus -had it after 1st shot, but was not sure of cause- definitely stronger soon after 2nd vaccine; extreme chills for hours so hard to sleep, because whole body shaking; arm sore to raise and lower, all joints ache, especially knees and neck; fatigue and little energy; runny nose.  Feeling better next day, but tinnitus noise still strong, left arm and joints hurt, and low energy.
3 days p/vax pt exp diarrhea; event subsided p/1 day;
Redness, swelling at vaccination site to more than 5 by 5 cm.  Area warm.  Pt seen at our clinic 1/12 and family reassured.  Then went to ED the next day due to concern for increased size of area.  Antibiotics were prescribed (cephalexin.)