chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK 5730, expiry date unknown) via unspecified route of administration at left arm on 30Dec2020 08:30 at single dose for Covid-19 immunization in a hospital facility. The patient was not diagnosed with Covid-19 prior vaccination. Medical history was none. Concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 08:45, the patient experienced allergic reaction which resulted to patient visiting doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. The patient received treatment of epinephrine, decadron and Benadryl due to the event. The patient was not Covid tested post vaccination. The outcome of the event allergic reaction was recovering at this time of the report. The reporter considered the event non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.; 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 Allergic reaction cannot be totally 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.
Burning sensation under skin on lower back radiating to bilateral lower extremities after receiving SHINGRIX vaccine in left deltoid on 11/26/2018.
Within 1 minute of administering 3 immunizations listed above, pt began having seizure. o2 was administered and vitals monitored. Seizure was approx. 5-10 secs. She was observed for more than 30 mins until she was able to leave office safely.
Rash went across my chest and up my neck and was burning and itched; Lips puffed up; Sore Arm; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash went across my chest and up my neck and was burning and itched), LIP SWELLING (Lips puffed up), ARTHRALGIA (Sore Arm) and PYREXIA (fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), SALBUTAMOL (ALBUTEROL HFA), EPINEPHRINE (EPIPEN), POTASSIUM CHLORIDE, HYDROCHLOROTHIAZIDE, AMLODIPINE, LOSARTAN, ISOSORBIDE MONONITRATE, ACETYLSALICYLIC ACID (ASPIRIN 81), METOPROLOL SUCCINATE and GABAPENTIN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced RASH (Rash went across my chest and up my neck and was burning and itched), LIP SWELLING (Lips puffed up), ARTHRALGIA (Sore Arm) and PYREXIA (fever). At the time of the report, RASH (Rash went across my chest and up my neck and was burning and itched), LIP SWELLING (Lips puffed up), ARTHRALGIA (Sore Arm) and PYREXIA (fever) outcome was unknown.            Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-063879 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-063879:Second dose vaccination
This case was reported by a pharmacist via patient support programs and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX (batch number 9KT7T, expiry date unknown) for prophylaxis. On 25th November 2018, the patient received SHINGRIX 0.5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was received from the healthcare provider via the vaccine patient assistance program. The patient received vaccine injection in the left arm and was suffering from soreness at injection site for over one month. The event product complaint did not include in the case. No further information was provided at time of reporting. The reporter had agreed to have safety team follow-up with them via postal mail.
Expanding injection-site erythema ~10x10 cm, warmth, tenderness.
This spontaneous report as received from a nurse practitioner refers to an 18 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with GARDASIL. Dose, route, frequency and lot number were not provided. Concomitant therapies included "Birth Control Pills". On an unknown date, "one or two weeks after vaccination" the patient developed pancreatitis and was hospitalized (unknown name and address). She was treated with "IV antibiotics" and was released after treatments. The outcome of pancreatitis was reported as recovered/resolved (date unspecified). No reporter causality was provided. Pancreatitis was determined medically significant upon internal review. Additional information has been requested.
After the shot: next day - area around the eyes swollen, itchy/numb nose; After the shot: next day - area around the eyes swollen, itchy/numb nose; After the shot: next day - area around the eyes swollen, itchy/numb nose; face swelled up; After the shot:12 minutes - minor headache; After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); After the shot: 30 minutes - swollen throat/throat swelled up, shaking legs, pale color, medicine taste in mouth (was administered 2 pills of benadryl); This is a spontaneous report from a contactable consumer. A 43-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: EW0161), via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 08:45 AM as single dose (at the age of 43-year-old) for covid-19 immunisation. The patient's medical history included allergic reaction to the fruit, pears (had a severe allergic reaction after eating a long time ago, 10-15 years ago). Concomitant medications included pre-natal vitamins within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. As per report it was reported that, on 12Apr2021 at 09:00, after the shot, 15 minutes later face swelled up, 12 minutes later patient experienced minor headache. After 30 minutes patient experienced swollen throat/throat swelled up, shaking legs, pale colour, medicine taste in mouth (patient was administered 2 pills of benadryl). Next day on 13Apr2021 area around the eyes was swollen and also itchy/numb nose. Patient was given Benadryl at the clinic (location of the vaccination). Patient took 1 pill of Cetirizine Hydrochloride 10mg. Therapeutic measures were taken as a result of the events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Increased arm pain and then noted bruising and blisters to left arm at site of vaccination.
This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from healthcare professional regarding a 3 yr old male pt who developed autism. At 16 months of age, the pt received the third dose on 17Apr01. The pt also received the fourth dose of Hib titer vaccine (haemophilus b conjugate vaccine (diphtheria crm197 protein conjugate) (injection) on 17Apr01. Pt's medical history reported as negative. Indication for Prevnar was immunization. Product was administered on 17Apr01 Dose regimen was 1 dose (IM). Additional suspect medication included Hib titer vaccine (haemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate) injection), diphtheria/tetanus toxoids/acellular pertussis vaccine (diphtheria/tetanus toxoid/acellular pertussis vaccine) and hep V vaccine. Concomitant medications were not reported. A physician reported that pt was diagnosed with autism at the age of 3.5 years (Jun 03). No additional information was available at the time of this report.
Persistent pain at injection site in right deltoid, began several hours after injection received and has been present since. Has lessened significantly but still present. Treatments include Tylenol (first few days only), warm moist heat to site, rest.
Experienced head about 12 hoursafter shot that lasted 24hour; Currently Left arm is red swollenpainful and itching around the injection; Currently Left arm is red swollenpainful and itching around the injection; Currently Left arm is red swollenpainful and itching around the injection; Currently Left arm is red swollenpainful and itching around the injection; Neck and arm pain on the left side; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 30Apr2021 at 12:00  as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 as a single dose for COVID-19 immunisation. 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 01May2021 at 00:00, the patient experienced currently left arm is red swollen, painful and itching around the injection site nearly 72 hours after the shot, neck and arm pain on the left side experienced head about 12 hours after shot, that lasted 24hours. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events  redness, painful and itching around the injection site, neck , arm pain on the left side and headache were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected
Got my shot and ended up in ICU (intensive care unit) for a week; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hospitalization (Verbatim: Got my shot and ended up in ICU (intensive care unit) for a week) (serious criteria hospitalization).  The outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingles vaccine.     It was unknown if the company considered the hospitalization to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. Follow-up would not possible as no contact details were available.
About 5 hours after receiving 6 vaccinations, patient woke up from his nap with a fever of 101.3. It progressed through the day and eventually got to 104.1 before we took him to Urgent Care at 8:30pm. We alternated between TYLENOL & MOTRIN every 4 hours to make him more comfortable but the fever never broke until the next afternoon.
Typhoid Vi administered on (L) deltoid on 12/13/16. Patient developed (L) axillary lymphadenopathy on 12/19/16. No fever. No (L) deltoid erythema.
pt vaxed 19APR94 & on 23APR94 devel fever 101.8 & had a sz; taken to ER observed 3-4hrs; no further szs; pt also had a red throat; rx'd w/Amoxicillin; sent home fever resolved; MD confirms febrile sz; pt recovered; also had tonsillitis;
flu symptoms; splitting headache; neck pain; back pain; chills; total body myalgia; weakness to the point of barely being able to make it to the bathroom, unable to move; dizziness; nausea; can not eat or drink; sick on stomach; near fainting spells; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 66-year-old female patient (nurse) who could not eat or drink (eating disorder) and experienced near fainting (presyncope), sick on stomach (abdominal discomfort), dizziness, nausea and flu symptoms (influenza) with splitting headache (headache), neck pain, back pain, chills, total body myalgia (myalgia), weakness to the point of barely being able to make it to the bathroom, unable to move (asthenia) , after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination included flu vaccine which she received every year and she never had any symptoms but short of mild myalgia. The patient's past medical treatment(s), family history and concomitant medication were not provided.   On 30-Sep-2020 at 13:00, the patient received a 0.7 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (prefilled syringe, batch number and expiry date not reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 30-Sep-2020 at 19:00, the patient could not eat or drink (eating disorder) and developed near fainting (presyncope), sick on stomach (abdominal discomfort), dizziness, nausea and flu symptoms (influenza) with splitting headache (headache), neck pain, back pain, chills, total body myalgia (myalgia), weakness to the point of barely being able to make it to the bathroom, unable to move (asthenia) , 6 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Patient stated that the symptoms all together hit at once. Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient had not recovered from headache and could not eat or drink and outcome was not reported for other events.   There will be no information available on the batch number for this case.
I had shingles/Now I have shingles; I'm allergic to the vaccine; I feel horrible with the people who have shingles.; All bumpy on my chest; itchy on my chest; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced shingles, allergy to vaccine, feeling bad, papular rash and itchy rash. Shingles vaccine was discontinued. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the allergy to vaccine, feeling bad, papular rash and itchy rash were unknown.   The reporter considered the shingles to be related to Shingles vaccine. It was unknown if the reporter considered the allergy to vaccine, feeling bad, papular rash and itchy rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 31-July-2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient never had shingles in his/her life. As a precautionary measure he/she got the first dose of vaccine because he/she was over 60 years.  The patient thought he or she was allergic to the vaccine. Within 24 hours he/she got shingles. All bumpy and itchy on my chest. The patient stated that the vaccine gave him/her shingles. Not fun. It keeps spreading. The patient stated would not be getting the second dose. Obviously, he/she was allergic to whatever was in that vaccine, but how would he/she know what he/she was allergic to with words he/she could not even pronounce. The patient felt horrible with the people who had shingles. Now the patient had shingles. The patient stated do not get that vaccine unless you do your research. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Patient had the first dose of the Pfizer COVID vaccine (LOT#  EL9264) on 1/29/21 at the vaccination center at Medical Center (set up in Hotel). He had the second dose on 2/19/21 (LOT# EN6201) at 12:30pm, and reported leg pain and difficulty breathing on 2/26/21 as he was going to bed. He presented to the ER at Hospital that day, and was diagnosed with a deep venous thrombosis and pulmonary embolism. He is currently taking Xarelto, and will schedule an appointment with Hematology, as he has no family or personal history of clotting disorder.
Red and sore for 3 days after injection. 03/11/2021 injection site started itching badly. Redness about 2 inches in size around injection site. Hot to the touch and a little swollen.
Patient admitted to Nurse she might be pregnant. Pt had #3 HPV; #2 MCV4 & Flu IM.
This case was reported by a consumer and described the occurrence of vaccination failure in a female subject of unspecified age who was vaccinated with DTPA (with small D + P), manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date in 2008 the subject received unspecified dose of DTPA (with small D + P) (unknown). At an unspecified time after vaccination with DTPA (with small D + P), the subject experienced vaccination failure, pertussis, clear nasal discharge, cough, fatigue and post-tussive vomiting. The subject stated that "there should be some mention of the rare possibility of the vaccine being ineffective. I had my TDAP two years ago. I understand there is another strain of Pertussis that is not affected by the vaccine". The subject's physician originally diagnosed her with bronchitis but the cough continued and worsened after about two weeks. The physician "recognized my symptoms of cough, fatigue, post-tussive vomiting, clear nasal discharge". The subject stated she currently has Pertussis (Paroxysmal stage). This case was assessed as medically serious by GSK. At the time of reporting the pertussis, clear nasal discharge, cough, fatigue and post-tussive vomiting were unresolved.
At the time of vaccination, the nurse mistakenly took the Moderna Booster 0.25ml vaccine. Which was administered in the left arm.
Pt's mother called the next day and stated that the pt needed to take 1/2 NORCO the night of the vaccine and the next morning due to severe pain and swelling. She was unable to lift her arm to get dressed. Pt was advised to go to the Emergency room.
Information has been received from a medical assistant for GARDASIL, a pregnancy registry product; concerning a 24 year old female with no known medical history or drug allergies, who on 09-JAN-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 661046/0546X), intramuscularly. Concomitant therapy included NUVARING. On 12-JAN-2009 the patient discovered that she was pregnant. On 09-JAN-2009 the patient had an RPR, HIV and herpes 1 and 2 tests. The patient performed a home urine pregnancy that was positive, and the office performed another urine pregnancy test on 12-JAN-2009 that was positive. No adverse effects reported. The patient sought medical attention through an office visit. The reporter stated that the patient was planning to terminate the pregnancy (not due to the vaccine). Follow up information received from a home care coordinator indicated that the patient wasn't pregnant during the GARDASIL vaccination series; (the patient finished the GARDASIL series on an unspecified date). Follow up information received from the home care coordinator indicated that the patient had a termination of her pregnancy on 27-MAR-2009. The patient returned to the office for her follow up evaluation and was considered recovered without complications. Additionally she was provided contraceptions. She also mentioned that the patient returned for the second and third GARDASIL doses (dates and lot numbers not provided). Upon internal review termination of her pregnancy was determined to be an other important medical event. No further information is available.
Arm pain at site of injection every so often.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28May2021 17:00 (Lot number: EW0182) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8736, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 07May2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Arm pain at site of injection every so often.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from an administrator refers to a patient of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (lot# 1018503 and expiration date 16-APR-2017)(dosing regimen and frequency unknown). No adverse effect reported. No product quality complaint (PQC) filed. Additional information has been requested.