chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection, lot #L034372, expiration date 08-SEP-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 17 degrees Fahrenheit for 52 minutes and 30 seconds. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. It was also reported that the vaccines ZOSTAVAX, PROQUAD (Merck) and M-M-R II were also improperly stored, however, those vaccines were not administered to patients. This is one of two reports received from the same reporter. Additional information has been requested.
clover shaped red area w/white circle on rt thigh;no raised area or hardness, no fever, guarding or pain;referred to physician; size of silver dollar
developing vaginal clots/has not stopped bleeding; Body Ache; shortness of breath and breathing; developed TPI in left arm; rash on my toe; blood underneath my nail beds; chest pain; severe headache; Construction in my left arm and bleeding underneath the skin of my left arm/bleeding in my left arm; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 50 years) via an unspecified route of administration, administered in Arm Right on 09Sep2021 (Batch/Lot Number: FC3184) as dose 1, single for covid-19 immunisation. Medical history included thyroid cancer, pituitary microadenoma and anxiety. Concomitant medications included levothyroxine sodium (SYNTHROID) and clonazepam taken for anxiety. The patient got the Pfizer COVID vaccine on 09Sep2021. The day after she got her shot (10Sep2021), she had severe headache and body ache; she end up with chest pain, "shortness of breath and breathing", she developed "TPI" in her left arm, bleeding in her left arm, had rash on her toes, and blood underneath nail beds. Four days after the vaccine (13Sep2021), she started developing vaginal clots that required her to go the gynecologist because that has not stopped bleeding. She had her lab work done when she went to see her doctor because of the side effects. She went in on 13Sep2021 and listed as CBP, CMP. The result was stable that is all she knows. She has had more lab work yesterday (Sep2021) because she was continually having vaginal clots, she does not know those results yet. On 10Sep2021, she started with a headache and body ache, chest pain shortness of breath, and "construction in my left arm and bleeding underneath the skin of my left arm". As of right now, she was witnessing back to her gynecologist; she had an ultrasound done yesterday (Sep2021) and was waiting for the final result so they know what they have to do. The patient mentioned that the bleeding is persisting. The second dose was scheduled on 30Sep2021, but her doctor has told not to take second dose. The outcome of the events "construction in my left arm and bleeding underneath the skin of my left arm/bleeding in my left arm", and "developing vaginal clots/has not stopped bleeding" was not recovered while the other events were unknown.  Follow-up attempts are completed. No further information is expected.
Pt. felt like tongue was swelling and throat was closing. Was taken to ER via EMS. ER Dr notes patient airway with no distress with no swelling. Pt. administered 60mg Prednisone PO and 25mg BENADRYL PO then prescribed 40mg Prednisone dly x 4 days and 25mg BENADRYL x 3 days every 8 hours. Total episode lasted 4-5 hours.
Excessive night sweats, night terrors, and insomnia for 6 days following the second vaccine (given intradermal route). No side effects other than a nodule and pain at the injection site for my first vaccine given via subcutaneous route.
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant). This case involves a 61 years old male patient received vaccine FLUZONE HIGH DOSE. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 07-Nov-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ047AA, expiry date 28-May-2019 via unknown route in the left deltoid. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that MA gave FLUZONE HD to a male 61-year-old, thinking that he was 65 years of age. The patient did not experience any adverse reaction after the injection. 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.
pt passed away at home; from most recent clinic visit on 08/27/2021; pt presented with cellulitis; HPI: tenderness of bilateral lower extremities with redness, edema and discharge. Pt reported drainage as light yellowish with scant bloody discharge. Hx of HIV, arthritis, hypertension, obesity, anxiety, obstructive sleep apnea, anemia
~4 weeks after administration of 2nd dose of Pfizer in left arm patient developed left shoulder and arm pain. He felt a lump around injection site. US showed "Impression: SMALL ROUGHLY 4.8 MM IN GREATEST DIMENSION DEEP SUBCUTANEOUS TISSUE HYPERECHOIC AREA IN THE AREA OF CONCERN MOST COMPATIBLE WITH FAT NECROSIS/IN AN IMMUNE RELATED ADVERSE EVENT."  He presented to care again in July with persistent pain and MRI showed likely brachial neuritis. He was referred to PT but was lost of follow-up. He presented to care again in October/November with weakness and atrophy which was of the bilat. UE, L>R. He has seen Neurosurgery who does not feel symptoms are consistent with cervical stenosis or C5 radiculopathy but rather concern for myelitis secondary to vaccine. He has pending eval. with Neurology.
nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine or Pfizer-Biontech Covid-19 Vaccine; lot number: EL0140; expiration date: Mar2021), via an unspecified route of administration on 29Dec2020 08:15 at single dose for Covid-19 vaccination. The patient has no medical history. Concomitant medication includes unspecified birth control pills. The patient reported that she got the vaccine this morning and about maybe 30-45 min after getting the vaccine, she started being nauseous and vomiting. She doesn't have a prescribing doctor. She vomited 15 minutes ago. She has vomited 2-3 times in the last hour. She is trying to drink sprite and crackers to settle her stomach, but it is still there. She is not taking any other medication. She does take birth control but doesn't think it is pertinent. She is calling to see what she should do for symptom management and how long these side effects will last for. She mentioned that vomiting started after nausea. The patient reported that her employer does not believe she is having side effects. The outcome of the events was not recovered.
I experienced hives, with itching and burning sensations on my face arms and legs after the vaccine. I have chronic idiopathic urticaria which the vaccine doses have caused massive flare ups, it had been under control until I began my COVID-19 vaccine series. This lasted for 7 days. I have been receiving Xolair injections bi-weekly due to my reactions to the COVID-19 vaccines.
Swelling of face Bad shin hive-like rash on my face that has not gone away
never went for my second moderne dose. My first dose was March; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never went for my second moderne dose. My first dose was March) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never went for my second moderne dose. My first dose was March). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never went for my second moderne dose. My first dose was March) had resolved.            No concomitant product information was provided.  Treatment information was not provided.
Vaccine was administered at 10:45 a.m.; patient began experiencing blotchy rash, itching and swelling to face/hands at approximately 11:45 a.m. Evaluated and treated in Emergency Department from approximately 12:38 p.m. until 15:02. Received IV fluids, 125mg solumedrol IV, pepcid 20mg IV, 25mg vistaril IM, prednisone 50mg p.o. and benadryl 50 mg. p.o.
varicella cellulitis of inj site of lt arm given 29DEC97 by nurse; allergy sulfa;
I have had 9 consecutive days of profound night sweats starting the night of vaccination; completely wet around 3-4 in the morning having to change multiple times per night. I also keep getting 1-2 chills in the early evenings; I am a physician
Several hours later developed diffuse joint pain, severe fatigue and nausea.  Slept for 16 hours.  Nausea and joint pain continued for 2 days, then resolved.
The evening of the shot, I felt a wave of chills through my body. I felt a sore throat begin. I felt light headed and nausea. By the time I went to bed,  my body was extremely sensitive. Entering my bed was painful due to the cold sheets, the cold was contrasted by the occasional heat flash. The night was full of body aches, hot and cold flashes, and loads of sweating. I woke up with a headache and body soreness. That was the worst of it. Spent the remainder of the day resting in bed.  Notes: I rarely get sick, maybe like this once every few years. I probably could have drank more water to flush out my system following the shot.
Patient reports lethargy and pain for 3 days, starting the night of the vaccination date. "Everything ached" and patient was freezing the next morning. Arm was painful and red, and needed help getting out of bed.
Headache, lightheadedness, disoriented, sore at injection site, achy
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203), on 15Mar2021 as dose 2, single (Lot number: EN6208) and on 22Nov2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZITHROMAX. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jul2023 at 19:00, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Human papilloma virus test: (29Sep2021) Positive, notes: Her HPV APTIMA positive test; Weight: (unspecified date) 121 lbs, notes: was 121 pounds before this started a week ago. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265894 same reporter/patient/product, different AE/dose;
This case was reported by a sales representative and described the occurrence of hives in a 78-year-old female subject who was vaccinated with seasonal trivalent influenza vaccine Dresden (manufacturer unspecified).  A physician or other health care professional has not verified this report.  On 30 December 2009 the subject received 1st dose of influenza HA vaccine (unknown).  On 3 January 2010, 4 days after vaccination with influenza HA vaccine, the subject experienced hives, neck swelling, swelling of face and hand swelling.  The subject was treated with cortisone and antihistamine.  At the time of reporting the outcome of the events was unspecified.
Extreme body aches muscles and joints; Extreme body aches muscles and joints; Headache; extreme swollen lymph nodes in axil area traveling to Brest and back; Nausea; vomiting; Dizziness; lethargy; Unable to move arm with injection site huge lump; Unable to move arm with injection site huge lump; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 14:15 (at the age of 43-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. Patient medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took ace inhibitors and experienced drug hypersensitivity. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and not tested for covid post vaccination. On 05Mar2021, the patient experienced extreme body aches muscles and joints, headache, extreme swollen lymph nodes in axil area traveling to breast and back, nausea, vomiting, dizziness, lethargy, unable to move arm with injection site huge lump. It was reported that, on 05Mar2021 at 04:00 PM the patient had extreme body aches muscles and joints. Headache extreme swollen lymph nodes in axil area traveling to breast and back. Nausea and vomiting. Dizziness and lethargy. Unable to move arm with injection site huge lump. No treatment was received for the events. Outcome of the events were recovered with sequelae in 2021(Recovered with lasting effects).  No follow-up attempts are possible; information about lot/batch number cannot been obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021168274 same patient, different shot/event
Development of a rash on and around genitals; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient 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 17Jun2021 at 10:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medial history and concomitant medications were not reported. 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. It was unknown if the patient had allergies to medications, food, or other products. On 18Jun2021 at 01:00, the patient had development of a rash on and around genitals. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event development of a rash on and around genitals was not recovered at the time of this report.
tingling, numbness radiating down left arm-goes into fingers at times,  comes and goes over last 2 weeks-
Vaccine received at approximately 1000 hrs on 09/22/2009.  Arm ached initially (muscle type ache)with slight redness at injection site.  On 09/23/2009 at approximately 0945 hrs, severe sensation of total body ice cold, antecubital and behind neck felt extremely hot, moderate nausea.  At 1145 shaking with mild diaphoresis but temperature not taken - still nauseated.  Two Ibuprophen taken.  Headache began.  Rested until 1400 hrs.  Shaking stopped, headache persisted. Fever approximately 99.4F at 1500 hrs.  Gradually, symptoms subsided with all but a mild headache by 0900 hrs. on 09/24/2009.  No urticaria, itching or neurological signs i.e. numbness or loss of function.  Did not seek medical care.
Lethargic,  hot, red, at injection site,  labored breathing. I went to urgent care Feb 8th 2021 they screened me for covid 19, said it was a normal reaction to the vaccine and diagnosed me with afib.  Called Dr office again two days later at  first was told to come in the next day, then rec'd a call back from a physician ( not my usual Dr ) who advised me to go to the ER due to the symptoms ( left arm swelling ).  Went to ER diagnosed with pulmonary emboli, DVT, and afib.  Placed on a blood thinner IV, and numerous tests/xrays done.  I was admitted on Feb 10th.  Continued IV of blood thinners, told I had too many emboli to count, DVT left arm, and afib.
This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unknown age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX vial, subcutaneous (lot number, expiration date and dosages were not reported) which was improperly exposed to defrost cycling up to 7F for <1 hour per cycle for 1 cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No know adverse effects were reported.   Follow up information has been received from a pharmacist refers to a 71 years old patient of unknown gender. On 25-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, in the left arm (circle one). This is one of several reports received from the same reporter. Additional information has been requested.
Severe, teeth chattering chills and incapacitating muscle aches   Never experienced before with a flu shot
Headache, Myalgia, Fever,  CHILLS, FEVER, SORE ARM, HEADACHE Narrative: LOW GRADE TERM, CHILLS, SORE ARM, HEADACHE.
May not give you the flu but it can certainly make you feel like you have the flu or worse; Was sick the entire winter; Initial information was received on 11-Nov-2020 and a live follow up was received on 08-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.   This case involves a patient (unknown demographics) who felt like having the flu or worse (influenza like illness) and was sick the entire winter (sickness), after the patient received vaccine INFLUENZA VACCINE (flu shot).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency), the patient was sick the entire winter (sickness) and was at the doctor weekly after getting INFLUENZA VACCINE (flu shot). The patient reported that the vaccine might not give the flu, but it could certainly make one feel like having the flu or worse (influenza like illness).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
his arm was sore/ her husband's arm ached; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 59 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Apr2021, outcome "recovered" (Apr2021), described as "his arm was sore/ her husband's arm ached".  Additional Information: It was reported that the patients arm ached after the injection and it went away after a day or two. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. List all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as no. The AE(s) did not require a visit to Emergency Room/Physician Office.  No follow-up attempts are possible. No further information is expected.
Feeling hot, weak, dizzy, pale color, fast heart beat and hoarseness. Near syncope. Total time about 20 minutes. 911 was called. Feeling better during ride to hospital.
Patient developed a 3 inch welt with a 2 inch reddened area that was warm and hard to touch within 24 hours of the vaccine. He complained of itching at the site. I applied ice and aloe for relief which did help. The welt was gone on day 4 after the vaccine but still had a 1 inch reddened area that was slightly warm and somewhat firm.
Itchy red spots on back, legs. About a dozen. About a week but not developed blisters.
stomach upset; Joint ache; Body aches; headache; weakness; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration, in left arm on 16Mar2021 at 12:30 (at the age of 72-years-old), as single dose for COVID-19 immunisation. Medical history included asthma and type 2 diabetes. The patient had allergic history to penicillin and also some adverse stomach reaction to antibiotics. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 23Feb2021. Concomitant medications included ADVAIR, metformin (MANUFACTURER UNKNOWN), CRESTOR, diltiazem (MANUFACTURER UNKNOWN), EFFEXOR, all for unknown indication from an unknown date. The patient had received other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient had experienced body aches, headache, weakness and dizziness. On 18Mar2021, the patient had experienced joint aches and stomach upset. No therapeutic measures were taken for the events reported. The clinical outcome of the events body aches, headache, weakness, dizziness, joint aches and stomach upset were recovering at the time of reporting.   Information about lot number cannot be obtained. No further information is expected.