chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse via a company representative refers to a female patient of unknown age without pertinent medical history. Concurrent conditions and allergies were not reported. On 19-FEB-2015, the patient was vaccinated with the first dose of GARDASIL, dose and frequency reported as "per the prescribing information", intramuscularly, (strength and anatomical location were not reported) (reported as "as indicated"). On 21-APR-2015, the patient was vaccinated with the second dose of GARDASIL, dose and frequency reported as "per the prescribing information" intramuscularly, (strength and anatomical location were not reported), (lot # K005083, expiration date: 04-NOV-2016) (reported as "as indicated"). Other suspect and concomitant therapies were not reported. On 21-APR-2015, the patient experienced injection site pain, flushing of the skin and headache. The patient sought medical attention the same day while in the office and was given chewable ibuprofen for the headache. None lab diagnostics studies were performed. Additionally was reported that the patient's mother called the following day and reported that the patient still had not recovered. The outcome of flushing of the skin, headache and injection site pain was reported as not recovered/not resolved. The relatedness between flushing of the skin, headache and injection site pain and therapy with GARDASIL was not reported. Additional information has been requested.
Patient was accidentally administered 2 doses of COVID vaccine for a booster dose. One dose was supposed to be flu.
Pain in right upper chest and ribs, unavailable to move or breath normally for 3 days, a month after getting the shot. It?s been 2 weeks with the same problem and nothing seems to improve.
Chills, fever, aching muscles and joints, followed by rash on 10/20, 10/21 & 10/22.
Rec'd pneumococcal vacc Mon. 8/19/02. HA; fever, chills, malaise-on eve. of 8/20 and local site tenderness; redness. Also rec'd Polio vac.
Extreme migraine, ibuprofen. Temperature fluctuate between 104-96. Body aches. Joint pain. Extreme injection site pain. Dizziness. Incontinence, diarrhea, jaw pain, ear pain, inability to urinate.
Husband called for wife DOB 8/30/1985. She received first Pfizer vaccine last Wednesday. Next day she had headache, was tired, and had swollen lymph nodes behind ears, and they have resolved for the most part,except for headache. He stated today has a headache and that she was having SOB a few times lasting only a few seconds. RN directed him to call provider and or go to Urgent care now as SOB needs to be evaluated.
Patient c/o tired, fever, chills, bone pain, nausea, vomiting, x 4 1/2 days.
Brain fog, confusion, dizziness, headaches, and loss of short-term memory, mental confusion, extreme fatigue, muscle pain, Joint pain continuing 5 weeks after vaccination.
This spontaneous report as received from a consumer via Clinic refers to a currently 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB 1 dose unit (lot # M025193, Expiry date: 21-MAR-2019) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Arm pain and red coloring of the arm around where the shot was administered. Very sore and tender which has moved to the top inside of the arm. And down the backside of the arm. Sometimes it is itchy very sensitive to touch.
Developed erythema, tenderness, swelling and warmth at injection site. Seen in urgent care and given Keflex, symptoms improved.
Day 1 (02/05/22): no issue besides sore arm.  Day 2 (02/06/22): arm pain increased.  Day 3 (02/07/22, approx 4pm-5pm): Swelling of right side of face, rash on cheeks with burning sensation, rash on sides and at injection site, sweating/chills, diarrhea, loss of appetite/thirst, severe panic (was considering seeking medical care).  Pt denies difficulty breathing at any point.
administered expired Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th March 2022, unknown after receiving Twinrix and Twinrix 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 details were provided as follows: The health care professional reported that the patient was administered an expired dose of Twinrix, which led to expired vaccine used. No reactions were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up via email.
Sore arm beginning in the evening which got progressively worse for a couple of days then subsided completely.  Some heart fluttering and some slight shortness of breath beginning a couple of days after.  More a nuisance.  No other symptoms I'm aware of although every little thing I feel now I think may or may not be a symptom like slight head throb but not consistent pain.  Not sure because of vaccine.
Swollen, red, warm 3" area at site of injection - about 2 wks after immunization.
Two and half month I ended up with COVID-19 after receiving the Pfizer. I was sick with fever 4 or 5 days. I had affect 10 day after and till this day I have on and off symptoms. Extreme fatigue and shortness of breath. I have been dragging around.
Initial report received from a consumer on 08 September 2008.  A 52-year-old male patient with medical history of seizure disorder, atrial fibrillation, bipolar disorder and "reaction to Tylenol and codeine", had received an intramuscular left deltoid injection of ADACEL (lot number not reported) on 02 September 2008 and two days later, he experienced a general feeling of illness.  Three days after the vaccination, the patient developed symptoms of headache, sharp stabbing pain in the head, dizziness, profuse sweating, shortness of breath, fatigue, muscle weakness, tingling in hands and feet, weakness, tiredness and lightheadedness.  The patient spoke with his physician who advised the patient to go to the emergency room if symptoms persisted.  At the time of the report, the patient had not visited the doctor's office or emergency room.  Patient outcome was reported as 'not recovered'.
Vaccine administered 10/25/01. Mother reports child fussy on Thursday. Had slight fever on Friday. On Saturday child's face pale and non-responsive. Unable to arouse. Mother felt child was not breathing-began CPR. Child came to but eyes would roll back in head and then would come to again. Took to ER at Redwood Falls Hospital. By that time child aroused and crying
Numb sensation and  urinary incontinence, tingling in feet and heightened sensitivity in body
stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications were not reported. Treatment information was not provided
I had the vaccine on 01/28/21 and one week later on 02/04/2021 my upper left arm where vaccinated began to itch with hives showing which lasted several minutes.  My upper arm then began to get hot, red, and swollen to just beneath the elbow with the itching continuing.  This lasted for the remainder of the evening with symtoms no longer spiking and gradually fading. By noon the next morning all symtoms had faded away.
Red, itchy, raised rash near injection site (in the same area as the pain post injection, just under the needle scar). The rash is so far about the size of my hand spread out.
The vaccine given had expired past the 30-day recommendation. At this time there have been no s/s of an adverse event
Fevers 103-104 with Tylenol and ibuprofen 3 days later respiratory distress which lead to respiratory failure to awaiting lung transplant.
2 months shots 06/14/2005 high pitched cry for 3-4 hours nonstop, continuous. 4Month shots 08/17/2005 brief less then 5 mins urticaria bilateral knees only and low grade fever 101.6, malaise.
palpitation; lightheadedness; Nausea; HERO-TOGETHER: A POST-EMERGENCY USE AUTHORIZATION OBSERVATIONAL COHORT STUDY TO EVALUATE THE SAFETY OF THE PFIZER-BIONTECH COVID-19 VACCINE IN US HEALTHCARE WORKERS  This is a report from a non-interventional study source and post authorization safety study for Protocol C4591008. This is a Non-Interventional Study report with non-serious event only. A 49-year-old female subject participated in above mentioned study. The subject received first dose of BNT162B2 (reported as Pfizer COVID-19 vaccine, lot/batch number has been requested) on 17Dec2020 via an unspecified route of administration as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The subject experienced adverse vaccine reaction on 17Dec2020 and reported as non-serious event. On 17Dec2020, the subject presented to emergency department with concern of palpitations and lightheadedness after receiving the COVID vaccine. Denied chest pain. She received the COVID vaccine and then a short while later began to have some palpitations and lightheadedness with some nausea. This was coming and going and currently denied symptoms while in emergency department. She had no other complaints. Vital signs at 12:42: pulse 95, respiratory rate 15, blood pressure 139/97. Vital signs at 13:49: pulse 62, respiratory rate 14, blood pressure 123/82.  The subject was brought to exam room, interviewed and examined. An IV was established and labs obtained. EKG was sinus rhythm, rate 88, nonspecific ST-T wave changes without signs of acute ischemia. She was treated with normal saline bolus as well as ondansetron (ZOFRAN) and diphenhydramine hydrochloride (BENADRYL). complete blood count (CBC) and chemistries were stable. She was feeling better on recheck and would be discharged home to follow-up with primary physician to recheck symptoms and return for worsening. Discharge code: T50.Z95A Adverse effect of other vaccines and biological substances, initial encounter. The subject received unknown manufacturer COVID-19 vaccine as second dose on 18Mar2021. The action taken in response to the event for BNT162B2 was not applicable.  The outcome of the event was recovered on 17Dec2020.  The reporter considered the event was related to COVID-19 vaccine.; Sender's Comments: ALL events Palpitations, lightheadedness and Nausea are reported to occur after administration of bnt162B2 (reported as Pfizer COVID-19 vaccine). Due to strong temporal relationship between the events and administration of vaccine., all the events are considered as related to the vaccine.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Patient reports having experienced issues with talking, concentrating, swallowing, severe headaches, fever, sensitivity to light and loud noises,and states that he passed out in chair sitting up.  Patient shared that he believes the symptoms are related to aluminum in the vaccine, and that he is currently completing detox process for aluminum poisoning.
I am breastfeeding and the day after receiving the Pfizer-BioNTech COVID19 vaccine and breastfeeding that day, my one month old had diarrhea for approximately 36 hours.  There were no other changes to diet.  Approximately 14 hours prior to the diarrhea I had one dose of tylenol to help with the aches from the vaccine reaction.
Tinnitus in left ear beginning at 1 PM on 11/10/21, very strong ringing sound for first 10 hours (until sleep), dissipated but present the next morning and day. Noise sensitivity in both ears beginning at 1 PM on 11/10/21, strong for first 10 hours (until sleep), dissipated but present the next morning and day. Dizziness approximately 20 hours after tinnitus (9 AM on 11/11/21), had to sit down multiple times because I felt like I would have fallen over. Faint ringing sound in both ears as of 6:30 PM on 11/11/21.
Patient's left thigh was swollen, red and hot to the touch. Warm/cold compresses, massages as needed.
I developed pericardial effusion and Graves disease,  after taking the 2nd Covid 19 vaccine.  Long months with chest pain,  palpitations,  high blood pressure,  high heart rate.  CT scan done on November 2022, pericardial effusion 10mm.  Resolved after an electrocardiogram done on January 2022, showing 0mm. Blood tests on April 2022, TSH<0.01mcIU/ml (February 2021 1.21mcIU//ml).  T4 1.1 ng/dL, TPO AB 10.2IU/ml, T3 121ng/ dL, Thyroid Stimulating Immunoglobulins, QL 252%. No prior history of thyroid disease,  no covid 19 disease,  no family history of thyroid disorder.
Chest tightness  Shortness of breath (intermittent) Tachycardia  Dizziness  Didn?t receive any treatment.
pain and swelling at the injection site for a week and a half. Tiredness, headache, muscle pain, chills, joint pain, nausea, vomiting, dizzy, and fever of 104.00
Higher than authorized dose of the correct formulation administered.  Pfizer vaccine mixed with too little diluent.
Squamous Cell Skin Carcinoma (Keratoacanthoma); white scab; Initial information regarding an unsolicited non-valid non-serious case was received on 02-Jul-2021 from a Consumer via Medical Information (Reference number- 00667476) and transmitted to Sanofi on 02-Jul-2021.  This case involves a 60-year-old female patient who experienced white scab (scab) and diagnosed with non-serious squamous cell skin carcinoma (keratoacanthoma) (keratoacanthoma) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for prophylactic vaccination.  On 20-Sep-2020, the patient received 0.7 ml dose (total) (once) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ484AA via and expiry date 30-Jun-2021] via intramuscular route in the right arm for prophylactic vaccination.  On 20-Sep-2020 the patient developed non-serious white scab (scab) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 11-Mar-2021 the patient diagnosed with non-serious squamous cell skin carcinoma (keratoacanthoma) 5 months 22 days following the following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that, "Caller from Pharmacy Claims Services reports that a patient received a Fluzone Quadrivalent High Dose vaccine on 20Sep2020 and then developed a white scab. On 21Feb2021, the patient went to the Dermatologist and was tested and returned on 11Mar2021 and was diagnosed with Squamous Cell Skin Carcinoma (Keratoacanthoma). The patient believes that it is due to the Fluzone Quadrivalent High Dose vaccine potentially leaking down her arm and causing the skin cancer. The skin cancer and the vaccine anre in the same location. This was treated by excising and removing the lesion. There is no further information regarding this. Product used: Used. Still using product: No. Was Device Used: Yes".  It was unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  The patient was treated by excising and removing the lesion.  At the time of report, the outcome of events was unknown.
Sore throat X 1 day. Red pustules X many over upper torso and scalp. Ulcerated pustules X 3 on back.
acute ischemic stroke; thoracic aortic aneurysm without rupture; bilateral blurry vision; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 19-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a sudden onset of blurry vision and chronic numbness and tingling in his legs. The patient was diagnosed with an acute ischemic stroke, thoracic aortic aneurysm without rupture and bilateral blurry vision. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered acute ischemic stroke, thoracic aortic aneurysm without rupture and bilateral blurry vision to be disability.   Upon internal review, acute ischemic stroke was determined to be medically significant.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 18th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown. The reporter considered the injection site erythema to be related to SHINGRIX. Additional information was received as follows: The patient was administered the vaccine subcutaneously on the back of her left arm, which led to the redness around the injection site and intramuscular formulation administered by other route.
Pt vaccinated w/DTP/OPV developed T 104, shrill high pitched scream never heard before by either parent.
The vaccination site became black and blue; Pain under my armpit; headaches; Bled alot (almost squirting out blood from arm); Vaccinator put the bandage on first then injected patient with the needle (over the bandage); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bled alot (almost squirting out blood from arm)), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccinator put the bandage on first then injected patient with the needle (over the bandage)), VACCINATION SITE DISCOLOURATION (The vaccination site became black and blue), AXILLARY PAIN (Pain under my armpit) and HEADACHE (headaches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease and Hashimoto's thyroiditis in 2014. Concurrent medical conditions included Grass allergy, Allergy to molds and Allergy to antibiotic. Concomitant products included CANNABIDIOL (CBD OIL) for Joint pain, MAGNESIUM, CALCIUM, ZINC and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bled alot (almost squirting out blood from arm)) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccinator put the bandage on first then injected patient with the needle (over the bandage)). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (The vaccination site became black and blue), AXILLARY PAIN (Pain under my armpit) and HEADACHE (headaches). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bled alot (almost squirting out blood from arm)), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccinator put the bandage on first then injected patient with the needle (over the bandage)), VACCINATION SITE DISCOLOURATION (The vaccination site became black and blue), AXILLARY PAIN (Pain under my armpit) and HEADACHE (headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided   This case was linked to US-MODERNATX, INC.-MOD-2021-077210 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07-May 2021: New events, medical history, concomitant medication were added and vaccine information (anatomical location) was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077210:
Two days after the first dose of the Pfizer vaccine I had a migraine, and I took Tylenol. The next day I had another bad migraine. I have not had a migraine in a while and now it?s leading me to believe that these two migraines were caused by the vaccine.