chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient lost her baby when she was pregnant; flu; ill; patient received the flu shot when she was three month-pregnant; Initial information received on 09-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non health care professional via social media.  This case involves a female patient of an unknown demographic who was vaccinated with INFLUENZA VACCINE when she was three months-pregnant (exposure during pregnancy) and lost her baby and was ill with the flu (abortion spontaneous), (malaise) and (influenza).  Data regarding this pregnancy was received retrospectively, i.e. after pregnancy outcome was known as patient lost her baby when she was three month-pregnant.  The gestation period was reported as three months of pregnancy.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's vaccination included Influenza Vaccine for prophylactic vaccination and patient came down with flu (influenza).  The patient's medical history, medical treatments and family history were not provided.   On an unknown date, the patient received a second dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had lost her baby (abortion spontaneous) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient was ill with the flu (influenza), (malaise) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was a case of vaccine exposure during pregnancy.   Relevant prenatal testing and corrective treatment were not reported.  At the time of reporting, outcome of influenza and malaise was unknown.   Information on the batch number was requested.; Sender's Comments: This case involves an adult female patient who had spontaneous abortion, malaise and influenza following vaccination with INFLUENZA VACCINE. The time to onset was not known. Further information regarding personal and family history, subject's obstetric history, condition at the time of vaccination, tolerance, laboratory investigations excluding alternative étiologies is needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Inappropriate schedule of vaccine/ never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose about 2 to 3 years ago over the age of 50).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/ never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Jun-2023 The pharmacist had limited details. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-DEC-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # L021214, expiry date 10-JUN-2017 (strength, dose, route of administration and anatomical location were not reported). No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same source. Additional information has been requested.
17-year-old male who presents with 8 days of headache.  He received his first dose of the Pfizer vaccine on 4/21.  He felt like he had the flu after getting the vaccine and developed right-sided neck pain and a temperature to 100.  The patient did endorse being elbowed in the neck playing basketball during this time as well, as he played in a basketball tournament in right after this.  He got his Covid vaccine in his right deltoid.  He saw his pediatrician on 4/26 and a CT scan of his neck with IV contrast was done and this showed significant diffuse right-sided deep spatial neck edema and right-sided adenopathy.  The pediatrician discussed the findings with ENT who recommended augmentin and a medrol dosepak.  The patient developed a headache several days after this and went to urgent care for evaluation.  There was concern that the augmentin and steroids had caused the headache, so the steroids were stopped and he was switched to keflex on 4/30.  He was given phenergan and toradol at Urgent Care and discharged home.  His mom notes that several days ago he had fevers of 101-104.  He has not had a fever for several days now.  His headache continued and he felt unwell at basketball practice so he returned to urgent care on 5/4.  A CT scan of his head was done which showed right sigmoid and transverse sinus thrombosis as well as thrombophlebitis of the right IJ. He was sent to ED for further management at that time.  In the ED, the patient was hemodynamically stable and well-appearing.  The CTs were overread by our radiologists here.  The patient had some labs done at the outside urgent care but PT/PTT/INR and a CRP were drawn here, which were unremarkable.  A Covid PCR is negative.  Neurosurgery, neurology, and hematology were consulted.  Neurology recommended heparin and a hypercoagulable workup and hematology agreed with this plan.  The patient was admitted to the ICU for neuro checks and monitoring during initiation of heparin.
sick; vomiting; diarrhea; couldn't eat; dizzy; slept most of the time; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea), DECREASED APPETITE (couldn't eat) and DIZZINESS (dizzy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure and COPD.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea), DECREASED APPETITE (couldn't eat), DIZZINESS (dizzy) and HYPERSOMNIA (slept most of the time). On 10-Feb-2021, ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea), DECREASED APPETITE (couldn't eat), DIZZINESS (dizzy) and HYPERSOMNIA (slept most of the time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Medications for congestive heart failure, Medications for COPD. No treatment information was provided.
uncomfortable at injection site; half of my arm is red and spread out; sluggish; hot at injection site; swollen on injection site; felt sore on the injection site,; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (uncomfortable at injection site), ERYTHEMA (half of my arm is red and spread out), SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (hot at injection site) and VACCINATION SITE SWELLING (swollen on injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE DISCOMFORT (uncomfortable at injection site), ERYTHEMA (half of my arm is red and spread out), SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE SWELLING (swollen on injection site), VACCINATION SITE PAIN (felt sore on the injection site,) and FATIGUE (tired). At the time of the report, VACCINATION SITE DISCOMFORT (uncomfortable at injection site), ERYTHEMA (half of my arm is red and spread out), SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE SWELLING (swollen on injection site), VACCINATION SITE PAIN (felt sore on the injection site,) and FATIGUE (tired) 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.   Concomitants included Thyroid medication.  No treatment information was provided.   Reporter did not allow further contact
administered 1 doses of the Pfizer-BioNTech COVID-19 Vaccine beyond the BUD; Received vaccine past beyond use date was refrigerated at recommended temperature 16 days; Anatomical site of injection, Left thigh; Allergic rhinitis; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 7-year-old patient received BNT162b2 (BNT162B2), on 11Apr2022 at 10:34 as dose 1, single (Lot number: FL8094) intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINITIS ALLERGIC (non-serious) with onset 11Apr2022, outcome "unknown", described as "Allergic rhinitis"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 11Apr2022 at 10:34, outcome "unknown", described as "Anatomical site of injection, Left thigh"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 11Apr2022 at 10:34, outcome "recovered", described as "Received vaccine past beyond use date was refrigerated at recommended temperature 16 days"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 11Apr2022 at 10:34, outcome "recovered", described as "administered 1 doses of the Pfizer-BioNTech COVID-19 Vaccine beyond the BUD". Therapeutic measures were not taken as a result of poor quality product administered, product temperature excursion issue, product administered at inappropriate site. Therapeutic measures were taken as a result of rhinitis allergic.  Additional information: The caller reported a patient was administered the Pfizer Pediatric Covid Vaccine after the 10 week expiration date. Caller had questions regarding the safety of patient receiving the Pfizer Pediatric Covid Vaccine after the 10 week expiration date. The caller confirmed that the vaccine was administered to patient, Vaccination Facility Type was doctor's Office/Urgent care. Patient received treatment drug was Loratadine orally 10mg for event Allergic rhinitis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200572850 same reporter/drug/AE, different patient
Red and swelling at injection site (5" diameter). Severe Flu like symptoms: headache, aches, chills, fever, weakness, sweating. Tylenol helps after first night. First time was 2 days, booster did the same thing but still feeling bad on day 3.  He feels it's starting to get better today.
Patient was age 12 at the time of his initial COVID vaccine. The patient received the Pfizer 5-11 dose vaccine instead of the Pfizer 12+ covid vaccine dose.  Patient experienced no ill effects following the vaccine administration.
103 degree Fahrenheit fever; chills; nausea; fatigue; headache; This is a spontaneous report from a contactable nurse (patient). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 08:15 at single dose at left arm for COVID-19 immunization. The patient's medical history included hypertension. No known allergies. The patient's concomitant medications included ergocalciferol (VIT D), ascorbic acid (VIT C) and Beta blocker. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient received second dose on 07Jan2021 19:45 at left arm for COVID-19 immunization. The patient experienced 103 degree Fahrenheit fever, chills, nausea, fatigue, headache for 48 hours on 07Jan2021 19:30. No treatment received. Outcome of the events was recovered.  Information about Lot/Batch has been requested.
Left arm pain: rash at arm and trunk with increased pain x 3 days./ 20 Ster Cx: Acyclovir 400 mg GID x Tylenol with codeine q6 prn 5-7 days.
Within 3 minutes after vaccine administration at 11:00am, person had two seizures within 5 minutes of each other.  Decreased pulse, blood pressure and oxygen saturation.  Loss of consciousness for several minutes each time.   Emergency measures initiated, including IV and oxygen.  Transported by EMS to Emergency Department at 11:25am.
Injection site reaction - redness & swelling and c/o "throat feeling tight" - reaction delayed (occurred the next day).
This spontaneous report was received from a medical assistant, concerning a 12 years old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On an unspecified date, the patient was inadvertently vaccinated with an adult formulation dose of VAQTA with lot # M039055 and expiration date on 22-JUL-2018 (strength, dose, frequency and anatomical location were not provided), administered intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
Redness and swelling, size of egg to injection site, in addition itchiness at injection site.Overall had feelings of being achy, tired and sore.
Given client expired Rotavirus, had client to wait 15 min after meds given; no problem noted. Inform Dr. & supervisor. Will call or send letter to revaccinate.
Pfizer-BioNTech COVID-19 Vaccine EUA  Woke up with pounding heart rate, short of breath, cold forehead. Stood up and walked to next room, pulse continued to rise, ultimately plateauing around 160bpm. Called family doctor, was advised to apply pressure to one side of neck and monitor for the next half hour. Followed advice, sat down with knees bent, and did slow breathing. Pulse slowly decreased and returned to normal rate around half an hour later.
This spontaneous report as received from a physician refers to a 56 year old female patient. The patient's medical history included "mild case of shingles 4 to 6 weeks prior to received ZOSTAVAX. No drug reactions or allergies were reported. On 06-FEB-2014, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous for "shingles prevention". Approximately on 08-FEB-2014 (also reported as "48 hours later after receiving vaccination), the patient had vesicular rash reaction and discoloration of the skin at the injection site area that was 6x3 inches sizes after receiving ZOSTAVAX. The reporter stated that the patient's vesicular rash reaction resolved without treatment, but discoloration around the injection site still present and not resolved. No treatment was given for the adverse event. No lab diagnostics studies were performed. On an unspecified date, the patient sought medical attention, contacted the primary physician. Additional information has been requested.
Red; Soreness; A spontaneous report was received from a HCP concerning a 71 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain and vaccination site erythema.  The patient's medical history was not provided.  Relevant concomitant medication was provided as Irbesartan, Pantoprazole, Tamsulosin and Doxycycline.  On 04-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the Anatomical location which is unknown for prophylaxis of COVID-19 infection.  On 04-FEB-2021, The patient experienced the events vaccination site pain and vaccination site erythema. No Lab details provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   Recovering, ongoing, not resolved or unknown outcomes: At the time of this report, the outcome of the event(s) (vaccination site pain and vaccination site erythema.) was recovering.  The reporter assessed the event(s), [vaccination site pain and vaccination site erythema], as related to study drug.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011917:Reporter case
Kinzie appears to have Chicken Pox. She is not running a fever or anything like that, just the sores on her arms, legs and torso. Not sure if she should go to the doctor or not, have called the advice nurse. Expect that calomine lotion and TLC will do best. Absence of fever indicates this is not too severe.
Complained of itching on neck and bilateral underarms and arms after receiving vaccine 3 hours prior.
This spontaneous report was received from nurse via field representative, refers to an anonymous twin 15 months old boys. Medical history, concurrent conditions and concomitant medications were unspecified. On 15-FEB-2015, the twin boys were vaccinated with M-M-R II, 0.5 ml, single injection, subcutaneously. On 24-FEB-2015, one of the twin boys was seen by the infectious disease pediatrician, for an unspecified reason. The pediatrician diagnosed the child with measles. No treatment was given for the adverse event. The outcome of the event was unknown. Causality assessment was not provided. Therapy with M-M-R II was not reintroduced. No product quality complaint (PQC) was involved. No further information provided regarding the adverse effect. Additional information has been requested.
I received the shot at approximately 11:15am then waited for 15 minutes in an observation area. I was feeling fine and was allowed to leave. I began driving to pick up my husband from work and approximately 5 minutes later, I began to feel woozy and unwell. I wanted to pull the car over, but I was stuck at a red light. The next thing I remember is two men opening the doors to my car and telling me  I had had a seizure. While I was unconscious the car had driven into a fire hydrant and water was shooting over the car and street. The men helped me from the car and I laid on the sidewalk until the ambulance arrived. I was transported to the hospital.
Soreness, shivering, headache, feeling extremely cold. Have been treating with cold medication and ibuprofen. Symptoms lighter but still ongoing
Peripheral neuropathy and/or paresthesia in hands, feet and (occasionally) face.
Patient, reported to physician on 12/5/2016 that since her vaccination she has had decreased motion of her right arm and pain.  This started the next day after her vaccination and she continued to have difficulty at the time of report.
Patient was given 2nd Gardasil vaccine 9:00am on 2/14. Patient was fine until after dinner when she fainted.  She came to my clinic on 2/20 and no signs of any additional problems.
Administrated JJ covid shot about 145pm. while having patient wait for 15 minutes, the patient started to feel faint &dizzy.  His blood pressure was taken, the meter produced error. upon re trying blood pressure was measured at 70/60mmhg. The patient never lost conscious or passed out. Had patient remained sitting while continuing to monitor.  I suggested that the patient allow us to call EMS, The patient declined. Chose to leave store against my medical advice. I suggested the patient follow up with emergency medicine or urgent care for assessment.
This initial spontaneous case, received on 27-Oct-2017 was reported by other health professional and concerns a 33-year-old, adult, female patient. The patient's concomitant medications included: Vitamins (as reported) and potassium for an unknown indication. On 02-Oct-2017, the patient was administered with FLUCELVAX QIV (batch number: 195128, dose: less than a full dose (as reported), route of administration, anatomical location, expiry date: not reported). On the same day, while pulling the needle out, vaccine sprayed on the patient's face, hitting her glasses. It was reported that, while removing vial from carton, the vial or carton didn't appear to be wet. There was no product residue and no discoloration. It was reported that, leakage was between stopper and metal crimp and from needle insertion site at the stopper, no leaking was noted upon removing, the flip cap and metal crimp was appeared properly. Reporter stated that, there were no evidences of cracks or breakage on the vial. It was reported that, vaccine was drawn when the vial was noted to be leaked and the vaccine came out forcefully, hitting face and glasses as well. It was reported that, 25-gauge needle and 3 ml needle was used for vaccination. Reporter stated that, 3 or 4 times the vial had been pierced before leakage. No air was injected into the vial. It was reported that, while withdrawing doses, there was no overage drawn into syringe for aspiration. It was reported that, full dose was administered to the patient and there was no evidence of damage. This case was associated with PTC number (1025609). Based on the investigation performed, it was concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. The reporter assessed this case as non-serious. Non-significant follow-up received 15-Nov-2017: PTC number (1025609) was updated. Amended narrative accordingly. Follow-up received on 12-Dec-2017: PTC report was received. The narrative was amended accordingly.
presents to the ED for evaluation of cough. The patient states she has been tested positive for the COVID-19 on November 2nd. The patient admits having a severe cough that has worsened today prior to coming to ED. She states that she so not uses an oxygen. She admits having a chest tightness as well as runny nose, nausea and vomiting.
Low back Pain, osteophytosis, L5-S1 disc bulge, joint pain, diabetes, high blood pressure, right and left foot spur, right shoulder pain and depressive disorder, memory lost. Medical records for DOS 1/24/04-1/24/06 Yellow fever vaccine administered in 01/25/1995. Diagnoses: diabetes mellitus. low back pain due to L5-S1 disc bulge and osteophytosis. Right heel pain. Right shoulder pain. Axis I depressive disorder not otherwise specified as manifested by difficulty falling asleep and middle of the night awakenings, irritability, feeling tense and keyed up, easily drawn to angry outbursts and low dysphoric mood. Precipitating stressors: chronic pain and loss of previous level of functioning. Predisposition: non known. impairment for further military duty. Axis II; Deferred. Axis III: Hypertension. Non-insulin dependent diabetes mellitus. Lumbar disc disease. Recommendation: service member fails to meet retention standards.
I have an autoimmune disease. Mid to late September, 2022, I started to notice some nerve pain going down my leg. In November, 2022, my doctor ran some tests and my blood shows Rheumatoid Arthritis. I did three weeks of physical therapy and received a steroid injection in my hip area and I changed my diet to an inflammation diet. I also got a prescription for meloxicam.