chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The new shingles vaccine, my first dosage, had the commonly reported reddness at site of injection, pain in arm radiating down to my hand causing numbness, nausea and mild headache for about 3 days.    My concern is a blood panel taken by my endocrinologist on July 10th, revealing an abnormal  liver ensyme, ALT (SGPT) of 55 IU/L.  I would have not thought anything about the shingles vaccine if I had not had a blood panel done on June 25, 2018 at my annual physical with primary care doctor, showing the same liver ensyme at 25.  My doctor regulary does liver panels due to the statin drugs I take.  I can't help but think the shingles vaccine on top of my regular medications sent this ensyme above normal range.  Hopefully it will go back within normal range given time.  I will not be taking the second dose of this vaccine.
A non-serious spontaneous report of '2 children each received a dose of expired H1N1 LAIV' was received from a pharmacist concerning a eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-jan-2010. On 26-Feb-2010, the patient received expired H1N1, intranasal for an unknown indication. There was no adverse event associated with this medication error therefore treatment and reporter causality assessments are not applicable, and the event was considered resolved.
No additional adverse events reported; PROQUAD that was administered after improperly stored; This spontaneous report was received from a certified medical assistant (CMA) and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 05-OCT-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot # U002534, expiration date 24-JUL-2022 (dose number, route of administration and vaccination site were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 8.5 degrees Fahrenheit for 18 minutes and 11.9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. No additional adverse events were reported.
SHORTNESS OF BREATH; CHEST TIGHTNESS; DIFFICULTY TO TALK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy, athletic and anti-vaxxer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ceftazidime for drug used for unknown indication.  On SEP-2021, the patient experienced shortness of breath. On SEP-2021, the patient experienced chest tightness. On SEP-2021, the patient experienced difficulty to talk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, chest tightness, and difficulty to talk. This report was non-serious.
pt recv vax 1JUL98 & devel macular papular, sl erythematous rash  noted on lower extremities 16JUL98;states rash began 14JUL98 similar rash also present on trunk but was resolved;also c/o joint soreness, aching in hands;
After 1st dose child had sore throat and flu like symptoms didn't think anything of it. The 2nd dose is when her life changed, she face planted from standing position on to a cement floor having what was observed as a seizure, came to was confused and very tired. She had several episodes following that one which several of those times resulted in her busting up her face and hitting head, being treated for seizures, depression, gastro issues, fainting issues. Stretch marks all over her body which become inflamed and irritated... The list goes on....
fatigue; Eyesight; Dizzy; bell's palsy; This is a spontaneous report from a contactable consumer (patient's son). A 97-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6207) intramuscularly in the right arm on 11Mar2021 at 14:00 as a single dose for COVID-19 immunization. Patient's medical history included glaucoma for more than 25 years - 'implants caser' (as reported), thyroid disorder for more than 25 years, eye disorder, and gastrointestinal disorder. The patient had no other prior vaccinations to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6201) intramuscularly in the right arm on 18Feb2021 at 15:00 as a single dose for COVID-19 immunization and experienced cannot focus with her eyes and full body aches and pains. Ongoing concomitant medications included timolol ("Timnol") drops for the eyes since more than 5 years, levothyroxine sodium (LEVOTHYROXIN) pill for thyroid since more than 20 years, and omeprazaole pill for stomach for 5 years. One week after the second injection (Mar2021), the patient experienced Bell's Palsy at 20:30, reported as serious for important medical event. On 12Mar2021 at 22:00, patient was dizzy and 'eyesight', both events reported as non-serious. It was further described as, "She saw patient over everything so she slept. Day after 2nd she had to had most of day as too Dizzy/fatigued to be mobile. Dangling/twisting side of face last 7 days ongoing." The patient did not receive treatment for Bell's palsy, dizzy or eyesight. The clinical outcome of Bell's palsy was not recovered, of dizzy was recovering, of eyesight was recovered on unspecified date, of fatigued was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185916 Same patient, reporter, event, different vaccine dosing
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: Localized redness at injection site. warm to the touch with mild swelling. Soreness after 2 hours.
S:  Patient began to develop petechiae within about 10 minutes of her vaccination today.  She felt well, without respiratory distress or urticaria. Later on, she developed some tingling in the right palm and part of her forearm.  Her vaccination was on the left side.  There were no visible changes associated with these symptoms.   O: I personally witnessed the spontaneous appearance of small petechiae on patient's forearm.  She had about 10 of them on either forearm and a couple on her shoulders.   No erythema, rash, wheals.   BP128/66 P 70 sPO2 100% RR 12     A:  I was unsure regarding the importance of this finding, so I called emergency department and conferred with one of the MDs there.  We felt that, since the patient was in no distress, and this condition was not getting worse, we would allow her to head home.   After a total of an hour of monitoring, no signs or symptoms consistent with anaphylaxis or respiratory distress of any sort had emerged.
Redness and swelling at injection site for 3 days. Fever, chills, muscle aches.
tested positive for COVID-19 infection/ she received the Pfizer COVID-19 vaccine and still got infected with COVID; tested positive for COVID-19 infection/ she received the Pfizer COVID-19 vaccine and still got infected with COVID; sicker and sicker; 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 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2022, outcome "unknown" and all described as "tested positive for COVID-19 infection/ she received the Pfizer COVID-19 vaccine and still got infected with COVID"; ILLNESS (non-serious) with onset Jan2022, outcome "unknown", described as "sicker and sicker". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) negative; (27Jan2022) positive, notes: the test turned out positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, illness.   Clinical course: Caller stated that she had received most of her vaccines confirmed that she received the Pfizer COVID-19 vaccine and still got infected with COVID. She mentioned that she tested negative Tuesday on 25Jan2022 but she was getting sicker and sicker and got tested again today on 27Jan2022 and the test turned out positive. Patient stated that she has been prescribed Paxlovid because she tested positive for COVID-19 infection today on 27Jan2022. She took her last dose of Augmentin this morning and the patient was wanting to know if there was an interaction between Augmentin and Paxlovid.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Extreme arm soreness; Pregnancy; Extreme muscle soreness; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Extreme arm soreness), EXPOSURE DURING PREGNANCY (Pregnancy) and MYALGIA (Extreme muscle soreness) in a 36-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20-2A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (occasional use). Concurrent medical conditions included Allergy to antibiotic (Allergic to amoxicillin) and Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-May-2020 to an unknown date for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Extreme arm soreness), EXPOSURE DURING PREGNANCY (Pregnancy) and MYALGIA (Extreme muscle soreness). The delivery occurred  on 29-Jan-2021, which was reported as Full-term. For neonate 1, the birth weight was 3231 grams (7lbs 2oz). The outcome was reported as Term Birth w/o Complications. Born at 37 weeks and 5 days not pre-term. On 13-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 15-Jan-2021, PAIN IN EXTREMITY (Extreme arm soreness) and MYALGIA (Extreme muscle soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Pregnancy test: positive (Positive) positive.         Patient had ultrasound and Glucose Tolerance Test on unknown date and reported no findings.    No treatment details was provided.   This case was linked to MOD-2021-162876 (Parent-Child Link).   See case MOD-2021-162876 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: This follow-up was received on 19-MAY-2021 which updated re-challenge date and events.
Mother of pt. phoned clinic 9/29/10 approx. 12:30pm and stated her child had immunizations here 9/28/10. She reports pt. woke up this am with red itchy bumps all over her body, without fever. Mom wanted to know was it from immun. Mom was told unsure and advised to take child to her pediatrician. Clinic supervisor informed of above.
Headache, bodyache, chills lasted two days. Sore arm at shot, swollen lymph nodes under arm still there.
Five days following vaccine administration patient developed severe muscles aches in her lower extremities bilaterally, right greater than left. She also noted the development of a rash consistent of two small raised erythematous and pruritic lesions located over her right inner thigh, followed by the development of two similar lesions over her  right gluteal region and then one underneath her right breast. She was seen by her primary care physician at which time labs were performed results of which revealed CPK in the 6000s. She was directed to Hospital ER at which time repeat labs showed a CPK of 6271. Mild ALT elevation was also noted. Patient was admitted and initiated on IVFs with rapid decline in CPK and resolution of muscle aches. Rash however persisted and work-up remains ongoing.  Patient is currently scheduled to follow-up with Dermatology on 11/5/21 for further evaluation and potential skin biopsy.
Case number PHEH2012US015771 is an initial spontaneous report received from a physician on 06 Aug 2012. This case refers to a patient of unspecified age and gender. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on an unspecified date. On an unknown date after vaccination the patient developed rashes. The outcome, causality and seriousness of the event was not reported. No other information was available at the time of this report.
Developed extreme SOB, difficulty breathing. Dx'd with pneumonia about 12 hours after administration of vaccine. Afebrile, productive cough.
After receiving vaccine pt became pale and sweaty. Nurse took vitals 100% on RA. Most likely vagal response.
Day of injection, got a headache and have had headache ever since. Did not sleep AT ALL Saturday nite (day of injection). Sunday felt nauseous and felt like I was going to have diarrhea, but never had either. Still have these symptoms on day 5. I've been dizzy and light-headed since Sunday. Extreme brain-fog. Blurry vision. Aches and pains, especially where I've had surgeries/injuries (back/breasts/foot). I wake up feeling WORSE every day. Extremely lethargic (this gets worse every day). EXTREME cotton-mouth since Sunday. I have NEVER felt so bad in my entire life, even after surgeries
Exaggerated local reaction (L arm) (rash, numbness, erythema, swelling).
flare up of arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (flare up of arthritis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included CELECOXIB (CELEBREX) for Arthritis.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ARTHRITIS (flare up of arthritis). At the time of the report, ARTHRITIS (flare up of arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Shortly after receiving the vaccine, the patient fainted onto the ground.  She was throwing up and very pale, but conscious and sitting on a chair.  Emergency services responded and paramedics checked in on her - her vital signs were normal.  She opted to return home with her father and not go to the hospital.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 1:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 1:31 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.66 years for dose administered on 02-Mar-2021 and 68.74 for dose administered on 30-Mar-2021.  No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 to 36 degrees Fahrenheit from 09:00 AM to 03:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
After routine 2m shots child had a 3d of 101 fever then macular rash.  Differential for rash is  ROSEOLLA (at 2 m!), MILEA RUBRA (not so papular), Immunization rxn or TYLENOL allergy.  Looks like viral exam thum * sometimes seen with ROTAVIRUS
FEVER CHILLS BODY ACHE JOINT PAIN MUSCLE PAIN DIZZYNESS
reconstituted with the incorrect diluent of sterile water instead of the supplied 0.6 mL Sodium Chloride, with no reported adverse event; Initial information received on 22-Mar-2023 regarding an unsolicited valid non-serious case received from Non-Healthcare Professional.  This case involves two patients (demographics unknown) for whom YELLOW FEVER VACCINE [YF-VAX], reconstituted with the incorrect diluent of sterile water instead of the supplied 0.6 ml sodium chloride, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE Solution for injection (strength, route: unknown) (lot number: UJ782AA, expiry date: 17-Feb-2024) (Sodium chloride Diluent lot: U7056AA Expiry date: Oct-2024) in unknown administration site for Immunization and it was reconstituted with the incorrect diluent of sterile water instead of the supplied 0.6 ml sodium chloride, with no reported adverse event (product preparation error) (unknown latency).  It was reported, caller is wanting to know next steps to take. Caller does not have patient's information at time of call. This situation is reported as a medication error due to two patients being administered YF-VAX that was reconstituted with sterile water instead of the supplied diluent.  Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Two hours after my first shot I noticed a zinc taste in my mouth and moderately bothersome tinnitus. Both lasted the rest of the day, about 12 hours, and gone the next day. About five days after my second shot the tinnitus returned.  Now, around 10 days later, the tinnitus has progressed to the point where it is bothering me all day and interfering with already difficult sleep.
Hives, Eye Swelling, tingling, Benadryl, prednisone, hydroxyzine, cetirizine. Hives and swelling are gone.
Facial numbness and swelling entire right side of face and ear began at 11:50 after leaving the clinic. Symptoms not noted until in car.  No difficulty breathing noted.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "mild high blood pressure" (unspecified if ongoing), notes: other medical history: mild high blood pressure; "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs. Concomitant medication(s) included: PROGESTERONE. Past drug history included: Iodine, reaction(s): "Allergy: iodine", notes: known allergies: iodine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced redness, swelling, heat around injection site and large area on back of arm and broke out in a rash all over. Patient claims MD confirmed it was shingles. Method of confirmation unknown.
Patient reported about 10 days after receiving her flu shot that she was beginning to have complications in the shoulder in which she had received her vaccination in. She had stated that she was going to be following up with her doctor to help determine what may be the cause of the shoulder complications and that she would get back to us.
Immediately p/receiving vax started trembling 940AM became pale & clammy; Head lowered, cool towel applied to face; BP 90/50 P78; 958AM BP 92/52 P72; Left under own power;
Fever, redness and swelling at injection sites, fussy, irritable, fear of falling, zoning out, decreased eating (although still takes bottles) but have to go back to tube feeds for enough calories through her g-tube and to prevent dehydration.
The vial was punctured at 1551 on 2/8/21. The patient did not receive the vaccine within the 6-hour time frame. She received her dose at 2240 the same day.  The patient has not had a reaction since receiving the vaccine.