chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via field employee refers to a multiple unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored MMR II lot # L020188 (expiry date: 03-JUN-2017), L012481 (expiry date: 10-APR-2017) and K018990 (expiry date: 15-OCT-2016) (dosage not reported). No adverse effects reported. The vaccine was stored at temperature 57.4F, time frame was 7.25 hours and no previous temperature excursion was reported. No further information was provided. Additional information has been requested.
Dizzy, pale, diaphoretic, and syncopal event. Patient was caught by staff and  parent, did not fall. Blood pressure taken, placed in a chair and then on a cot, cold compress, monitored for 20 minutes. Educated parent to have child in supine position during 2nd dose.
This is in follow-up to report (s) previously submitted on 12/23/2008. Information has been received from a physician concerning an approximately 70 year old patient who on an unspecified date was vaccinated with a dose of ZOSTER vaccine (lot # 659759/1873U). The physician reported that after vaccination the patient had shingles at the injection site and then had a "dermatomal outbreak". The patient sought unspecific medical attention. At the time of the report the patient was recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/merck vaccine VZV strain. Follow-up information has been received from a physician concerning a 70 year old female with pencicillin and hydrochlorothiazide/triamterene allergy and a history of chickenpox in childhood who on 07-FEB-2008 was vaccinated in her left arm (deltoid area) with a 0.65ml dose of ZOSTAVAX (Oka/Merck) (lot # 659759/1873U). Concomitant therapy included aspirin, calcium (unspecified ) (+) vitamin D and PROTONIX. On 09-FEB-2008, the patient developed small local cluster followed by more complete left arm dermatome about 5 days later. There were multiple vesicles on the left dermatomo, right across the injection site. She has no recent exposure to chicken pox or shingles. No specimen was obtained because the patient presented after scabs nearly resolved. The rash was also described as an initial cluster of blisters at injection site by 2 days after injection, then full left arm dermatoma with multiple lesions fully crusted and near resolution by 21-FEB-2008. The patient recovered. A direct flourescent antibody was not performed. A photo was not taken. No further information is available.
Fever up to 101 for 4 days followed by episodes of sweats for days, headache, extreme pain from low back to tips of toes, painful itch in vaginal area and anal area, hemorrhoids, constipation for inflamed left eye, red, scaly patch on left eyebrow, red scaly patch on outer left ear canal, raw feeling on tip of tongue and inner area of lips. Tiredness.
Information has been received on 16-JAN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 17-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-APR-2015, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed gabapentin for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19: Pfizer vaccine. Concurrent medical conditions included Tardive dyskinesia.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste). At the time of the report, DYSGEUSIA (Metallic taste) outcome was unknown. Not Provided          Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
pt recv vax on 5/26/99 & was dx w/viral meningitis 5/27/99;
She was diagnosed with the POPS syndrome, Postal tachycardia syndrome.; This is a spontaneous report from a contactable consumer (patient's husband). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172) via an unspecified route of administration, administered in Arm Left on 29Apr2021 at age of 27-year-old at single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) taken for contraception. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: "EW0158.") on 08Apr2021 at age of 27-year-old at left arm for COVID-19 Immunisation. The reporter reported the adverse effect from the Pfizer vaccine do to with the patient so, she was usually vaccinated. She had a first dose on 08Apr2021 and second on 29Apr2021 so, after her second dose between 29 within 1-2 minutes of getting the vaccine on 29Apr2021, she lost her vision, had severe headache, dizziness and that subsided and about 30 minutes after that, it came back and didn't go away. Quite a few day they had to go to emergency room, she was admitted by the night. Some of them were shorten since then, she had been in emergency room four times, undergoing medical treatments with medical doctors, cardiologists, neurologist and medical doctors, then they saw to specialist and she diagnosed with POPS syndrome by the result of the Pfizer vaccine. The reporter stated the doctor believed for the vaccine so just wanted to report that. When probed treatment for adverse events: Reporter stated, nitially, When taken her in emergency room and admitted, she was given migraine cocktail through IV, she had severe migraine since she got her vaccine, that was cleared about 50%, then she was diagnosed with the POPS syndrome, postal tachycardia syndrome (as reported), that was medical person, diagnosed with professional at doctor office which result from the Pfizer vaccine, since then she was diagnosed with undergone treatments to health people, Involves. She was having IV therapy. She was taking puncture black supplement (not further clarify) magnesium Albertine, she was having soft pills for blood pressure which was very very low. She took some pain killer for headache, that has not gone away since that day. She took NAD, injections. She also a therapist to her Cardiovascular health and exercise. Reporter stated, "Well help her some medical dose." Lab test information included she had full blood worked on, She was actually like tested everything(not further clarified). The outcome of the event(s) was recovering.  Follow-up (30Aug2021): Follow-up attempts are completed. No further information is expected.
pt recv vax 27AUG96 & PM on 28AUG96 pt was adm to hosp d/t tachycardia of 140, high pitched crying, vomiting, fever of 103.5;@ completion of form;pt remained in hosp w/improvement noted;
breathing issue, difficulty breathing; headache; tender & soreness in the arm of her injection; trouble sleeping; This is a spontaneous report received from a contactable consumer (reporting on herself).   A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration in Arm Left on Apr2021, as 2nd dose, single for COVID-19 immunization. The patient medical history and Concomitant medication(s) included acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. Patient received her first Pfizer Covid 19 Vaccine on 06May2021. A few hours later she felt a slight headache, tender and soreness in the arm of her injection. The following day she felt short winded and experienced trouble sleeping. She did call EMS out for the breathing issue but was treated at home. She had been working around in the yard. That night she took one Tylenol for her pain. Patient read in the Fact sheet about problems breathing may be related to a serious reaction. Patient asking if she will be okay to take the vaccine since she experienced the breathing issue the following day. While glancing at the fact sheet, she noticed that blood thinners are not allowed after the first dose. She was prescribed a blood thinner after her first dose. She called in to know if it was safe for her to take the second dose while on blood thinners or does she need to stop taking it until her second dose. Clarified and she said that she took the blood thinner after her first dose. She also experienced difficulty breathing the next day and called paramedics to check on her. She wants to know if it will happen again on her second dose. She has been prescribed aspirin 81 mg. She is scheduled to have her second dose on 27May2021. Patinet will receive her second Pfizer Covid 19 Vaccine on 27May2021. Asking if she safe to take the second vaccine. She mentioned that she experienced a headache and minor reactions that went away quickly after the first dose. At night, she had trouble sleeping. She also experienced difficulty breathing the next day and called paramedics to check on her. She wants to know if it will happen again on her second dose. She is scheduled to have her second dose on 27May2021. The outcome of the tender & soreness in the arm of her injection, trouble sleeping, breathing issue and difficulty breathing was unknown and  for event headache was recovered on an unspecified.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
MISS TO TAKE SECOND DOSE IN 6 WEEKS; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (MISS TO TAKE SECOND DOSE IN 6 WEEKS) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (MISS TO TAKE SECOND DOSE IN 6 WEEKS). At the time of the report, PRODUCT DOSE OMISSION ISSUE (MISS TO TAKE SECOND DOSE IN 6 WEEKS) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Began feeling weak, fatigued within 3 hours of injection.  At 5 hours began running a fever of 105 degrees F; full body chills, severe muscle, joint and bone pain.  Fever would not respond to OTC medications until about 24 hours post injection.  Still feverish (but does respond to OTC) at nearly 48 hours post injection.  Could not get out of bed the first 24 hours; unable to work or perform self care activities.   Injection site very swollen, hot to the touch.  Numerous lymph nodes adjacent to the injection site are swollen and painful.
Itchy; blotchy red hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 as dose 4 (booster), single (Lot number: GJ7696) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Chronic inflammatory demyelinating polyneuropathy" (ongoing), notes: a neurological genetic disorder; diagnosed: around 7 years ago; "autoimmune deficiency" (ongoing), notes: Diagnosed: 6 or 7 years ago. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EW0162, anatomical location: Right arm), administration date: 15Apr2021, when the patient was 46-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Lot: EW0164, anatomical location: Right arm thinks), administration date: 06May2021, when the patient was 46-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3 (booster), single, Lot: FD0809, anatomical location: Left arm), administration date: 04Dec2021, when the patient was 46-year-old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 13May2023, outcome "not recovered", described as "Itchy"; URTICARIA (non-serious) with onset May2023, outcome "not recovered", described as "blotchy red hives". Therapeutic measures were not taken as a result of urticaria, pruritus.  Additional information: called about the Pfizer COVID vaccine, went in last week and got the booster, clarified got the Pfizer COVID bivalent vaccine booster, since last week has had blotchy red hives, itchy, nonstop itching. Talked to location where caller got the vaccine and was told to call Pfizer to report this information. Blotchy red hives: Start date of adverse event: Got the shot on 11May2023 in the morning between 9AM and 10AM, Thinks right arm, thinks on 13May2023 the itching started and then noticed the hives around the same time, later that night noticed was a little more red than normal, next day noticed hives on whole body, so hives started either 13May2023 or 14May2023. Not as bright, but still red and itchy. Goes up and down, two days ago stopped itching then came back, had one free day then itching came back. Clarified and confirmed this was patient's 4th dose, 3 prior doses were all the Pfizer COVID vaccine. Going to start traveling more via airlines and has autoimmune deficiency so wanted to make sure caller was covered. Concomitant products: No, nothing out of the ordinary that caller would not normally take. No additional information provided. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No test performed for Thromboembolic Events with Thrombocytopenia Include specific relevant test above. No visit and no investigation performed. The event does not require the initiation of new medication/other treatment/procedure (No not as of yet).
Menstrual cycle has stopped for 2 cycles now after the booster. The 2 prior vaccine doses with Pfizer menstrual cycle missed once each time, but returned by the second month each time. This time it hasn't returned.
Total extremity (R arm) swelling, onset a few hrs after injection with tense edema, erythema.  No fever.  Treated with ice packs and analgesic/anti-inflammatories, improved slowly without further intervention.  Imm given 5/3/08.  Seen in clinic for arm swelling 5/5, 5/6, and 5/8.
Information has been received from a Registered Nurse concerning a 11 year old female with seasonal allergy who on 08-JUN-2009 was vaccinated with a first dose of GARDASIL (lot # 659054/0315Y) 0.5ml, intramuscularly in left upper arm. On 10-AUG-2009 she received second dose of GARDASIL (lot # 662404/0312Y) 0.5ml, intramuscularly in her right upper arm. Concomitant therapy included Tdap and MENACTRA administered on 08-JUN-2009, CLARITIN and FLONASE. A couple days after receiving first and second dose of GARDASIL the patient developed a rash on both arms from shoulders down to her elbows. The  patient sought unspecified medical attention. At the time of the report on 29-OCT-2009 the patient was recovered. No further information is available.
Unable to make out the Lot number due to illegible.  The pain in my right arm and around the back of my head and neck increased all day on Saturday, latter that night the pain woke me out of my sleep, and as I attempted to go to the restroom, I passed out.  I woke up on the floor where I had passed out face down, with a busted bloody lip and bruises and broken skin on both knees.  Very frightening, Thank God that I woke up because I live alone.   Thank you.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 23-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL (lot # K006960 exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/15/2021 MELENA
No additional adverse event; Inadvertently administered a dose of VAQTA that was expired; This spontaneous report was received from a nurse referring to a 12 month old male patient. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 22-JUL-2020, the patient was inadvertently vaccinated with an expired dose hepatitis a vaccine, inactivated (VAQTA) (lot # S005725, expiration date: 10-JUL-2020) for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported). No additional adverse event was reported.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S005725; expirationdate: 10-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Had not had a menstrual cycle in 9 months. On July 7th my menstrual cycle started and last for 10 days. It was extremely heavy and clotted. My doctor it me on loloestrin BCP on August 1. On august 12 my cycle has started again. Heavy so far.
Information has been received from a pharmacist concerning an "adult" female patient with no known drug allergies who about 10 years ago in approximately 1999 and on 16-OCT-2009 was vaccinated IM with a first and second (lot# 663889/0632Y) 0.5ml doses of PNEUMOVAX 23. On 16-OCT-2009 "within 12 hours of vaccination" the patient experienced pain, swelling, heat, redness and possible bruising at the injection site. The patient did not have fever. The patient was instructed to take BENADRYL and ibuprofen. At the time of the report, the patient was recovering. The patient came to the pharmacy to seek medical attention. No lab diagnostic study was performed. Follow up information has been received from a pharmacist concerning a 60 year old female pharmacy technician with no pertinent medical history and no illness at the time of vaccination who on 27-OCT-2009 (previously reported at 16-OCT-2009), at 11:00 AM was vaccinated IM into her arm with a first (previously reported as second) dose of PNEMOVAX 23 (lot# 665401/1320Y, previously reported as 663889/0632Y). On 27-OCT-2009 the patient's arm was swollen, hot and painful. The patient also had itching (slight). At the time of the report, the patient recovered. This is one of several reports received from the same source. Additional information is not available.
trouble sleeping x2no, red marks on arms taken to MD;rx DPH-arm @ inj hot, swollen, hard;stomach cramp;
gotten a little sick from a flu shot; Initial information received on 26-Nov-2020 regarding an unsolicited valid non-serious case from a patient.   This case involves a patient of unknown age who gotten a little sick from a flu shot (illness), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylaxis vaccination.   On an unknown date, (latency unknown) after the administration of suspect vaccine therapy, the patient gotten a little sick from a flu shot (illness).   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.     There will be no information available on the batch number for this case.
Exactly four hours after the second vaccination for covid, I felt very tired and dizzy.  I felt severely disoriented and had to go to bed.  One day later I had a terrible headache (April 7)  Over the next six weeks I had forgetfulness and trouble concentrating while driving.  I felt like the vaccine altered my brain.   On May 19, I had the extreme foggy brain feeling again similar to the feeling on April 6.  I had a dementia type instance for the first time and went to the wrong wall to turn on a light switch in the home that we built and I know exactly where everything is because I decided where everything was installed.  On June 2 I had a moment driving where I didn't know how to turn a u-turn in an intersection that I use all the time.  Ever since my second covid shot I feel as if my brain was altered.
I had chest pains that started the night before that progressively got worse. The next morning, I went to the emergency room, where they started running and EKG to rule out a heart attack. They also ran a dimer test looking for blood clots. From this test they determined they needed to do a CT with contrast. They found a blood clot in my lung, gave me blood thinners kept me overnight to monitor me. I left with the diagnosis, of pulmonary embolism and am currently working with my primary care physician.
2 days after - sore arm 1 week later - bumpy/lump formed - redness (spreading) - itchy
Erythema at the site, local swelling to the site, pain that started approx 4 hours after vaccine was given. Patient treated herself with NSAIDs and warm compresses with little relief.
Per patient, she was vaccinated at an outside facility on 3/6/2021 and 4/3/2021 both with Moderna COVID-19 vaccines. Patient recently returned from another locale visiting her daughter who was COVID positive. Patient did home COVID tests twice on 8/12/21 and were both positive. Patient presented to hospital on 8/16/2021 where another COVID test was performed on 8/16/2021 and was also positive.
Patient stated that her arm is swollen up like a baseball bat with several knots.  It is so painful she cannot lay on it and it is throbbing.
This patients wife told me today that about 5 hours after the shot her husband had fevers chills and the rigors and they did not call the pharmacy or doctor. It last about 18 hours. They were not sure if it was from the shot or an allergy to something else.