chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a 13-year-old female patient. The patient did not have any concurrent conditions or medical history. The patient's concomitant therapies were not reported. On 08-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # N020352, expiration date: 10-APR-2020, intramuscularly (dose was not reported) as human papilloma virus (HPV) vaccine. On the same day, the patient was also vaccinated with influenza virus vaccine (unspecified) (dose, route of administration, lot# and expiration date were not reported). On 11-NOV-2017, the patient visited an emergency room and was diagnosed with right shoulder spasms and tics (tic disorder) and subsequently was hospitalized. On 13-NOV-2017, the patient returned to the physician's office and was referred to a neurologist. On 04-DEC-2017, the patient visited the neurologist, where she was diagnosed with auto-immune reaction to GARDASIL 9 vaccine. No lab diagnostics or studies were performed. The outcome of the events was reported as not recovered. The causality betweentic disorder and GARDASIL 9 was not provided. The autoimmune reaction was considered to be related to GARDASIL 9. The events of tic disorder and autoimmune reaction were determined to be medically significant by the reporter.
Had quite a reaction to that dose; Felt rotten for a week; A big, round, bad place on her injection arm that was red and sore; Had a temperature; A big, round, bad place on her injection arm that was red & sore; Possibly received the 3rd dose despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had quite a reaction to that dose), FEELING ABNORMAL (Felt rotten for a week), VACCINATION SITE ERYTHEMA (A big, round, bad place on her injection arm that was red and sore), PYREXIA (Had a temperature) and VACCINATION SITE PAIN (A big, round, bad place on her injection arm that was red & sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 004M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Possibly received the 3rd dose despite not being immunocompromised). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had quite a reaction to that dose), FEELING ABNORMAL (Felt rotten for a week), VACCINATION SITE ERYTHEMA (A big, round, bad place on her injection arm that was red and sore), PYREXIA (Had a temperature) and VACCINATION SITE PAIN (A big, round, bad place on her injection arm that was red & sore). On 21-Aug-2021, OFF LABEL USE (Possibly received the 3rd dose despite not being immunocompromised) had resolved. At the time of the report, VACCINATION COMPLICATION (Had quite a reaction to that dose), FEELING ABNORMAL (Felt rotten for a week), VACCINATION SITE ERYTHEMA (A big, round, bad place on her injection arm that was red and sore), PYREXIA (Had a temperature) and VACCINATION SITE PAIN (A big, round, bad place on her injection arm that was red & sore) outcome was unknown.     No concomitant medication was provided. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow-up received on 17-Nov-2021 and contain no new information.
4 month male infant at clinic for 2 month old immunizations. Anaphylaxis hives without resp. involvement within approximately 5 minutes of multiple immunizations. Raised, red rash on face, scalp, chest, abdomen, back, arms, and legs.  RR=44, HR=144, color pink.  Benedryl 0.2cc IM, HR=148 and RR=52 without rash improvement.  Transported by EMS to hospital ER
Pain during injection site, edema, and macular rash to anterior left upper extremity Today is day 3 of administration of vaccination and patient seen no changes in pain/edema/redness Treated today with prednisone, famotidine, and loratadine scheduled to return to clinic in 2 days
Sore arm at the injection area.  Sore throat.  Stiff and sore knees and ankles/heals. Constipation
Arm started to hurt right away. Pain went down to hands and wrist. The burning pain went away a couple of weeks later but I still have pain and soreness in my arm and shoulder 6 months after the shot. I had nothing wrong before the shot.
tested positive for coronavirus; lack of drug effect; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for coronavirus) and DRUG INEFFECTIVE (lack of drug effect) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A-B, 013A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2022, the patient experienced COVID-19 (tested positive for coronavirus) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, COVID-19 (tested positive for coronavirus) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  It was reported that patient received two doses and one booster dose from Moderna. pharmacist asked when she can receive her 2nd booster dose of the Moderna COVID-19 vaccine if she has coronavirus.  No treatment information were provided.  Comp[any comment: This spontaneous case concerns 71 years old female, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occurred approximately 7 months after receiving third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive On 05-Jun-2022. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 71 years old female, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occurred approximately 7 months after receiving third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive On 05-Jun-2022. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Dizziness, whooshing in head, slight nausea and diarrhea, aching in entire body, and shooting pains in feet and hands, soreness in left arm and left side, weakness. Stayed in bed most of day.  Slept all night and felt 80% well.  Whooshing in head - milder.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 19-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 72 and 40. The lowest recorded temperature was 28. The highest recorded temperature was 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient stated she started feeling periodically lightheaded, warm, and nauseated shortly after leaving the center. Patient now has redness around the site, slightly hardened, and warm to touch. Temperature elevated at 99.8 F.
Patient claims that she has not been able to move her arm above parallel and has been in a lot of pain since the day after her vaccine. She waited until today to obtain treatment (12/26/22) Patient doesn't have a primary doctor.   She saw the urgent care doctor because she doesn't have full use of her arm without pain and does not have full movement. She claims no redness at the injection site, however her arm is a little swollen. Doctor at the urgent care told patient that there is not sign of cellulitis but his thought is that a nerve was hit when she received the injection. Will follow up with the patient to see if improves with steroids.
This case was reported by a consumer and described the occurrence of pain in joint involving shoulder region in a female patient who received BEXSERO for prophylaxis. In August 2018, the patient received the 2nd dose of BEXSERO. In August 2018, 7 days after receiving BEXSERO, the patient experienced pain in joint involving shoulder region. On an unknown date, the outcome of the pain in joint involving shoulder region was not recovered/not resolved. It was unknown if the reporter considered the pain in joint involving shoulder region to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter's daughter (patient) received 2nd injection of the menengitis vaccine a week before the date of reporting and was having severe joint pain in her shoulder at the time of reporting. The reporter said it was getting worse. The reporter was enquiring about how long did the joint pain last and what should be done about it, whether this would be a permanent problem or require extensive measures such as physical therapy.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old patient who experienced an expired ACTHIB vaccine to a 6 month old child and child is on a delayed immunization schedule, while he/she received vaccines DAPTACEL and ACT-HIB. 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 DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI804AAA via unknown route, Expiry date- 22-Sep-2018 in the right thigh. It was a case of actual medication error due to expired vaccine used and Inappropriate schedule of vaccine administered. The patient outcome is reported as Not Applicable for an expired ACTHIB vaccine to a 6 month old child and as Not Applicable for child is on a delayed immunization schedule. 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 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 days after my injection I had extreme shoulder, arm, back, neck and head pain. It lasted until the morning of 1/27. On the 1/31 my arm that was injected swelled up, turned red and itched, with minor pain. I called my doctor after a couple days of feeling bad and she advised me to take acetaminophen 2 tabs every 6 hours. It barely lessoned the pain. I went to the doctor this morning because my employer recommended that I did and she said that my arm looked like I had cellulitis.
The vaccine was administered on 5/11/2021 but was expired per the 30 day rule. Vaccine was received on 4/6/2021.
Mother noticed scabbed lesions on the evening of 2/26/15. Denies fever. Presented to clinic with scabbed lesions on abdomen, leg, buttocks, and chest. Time of office visit 10:20 on 3-2-15.
7/22/05, noted L arm twice the size of right arm and was warm to touch and red in color. These symptoms were present from L upper arm to wrist. Saw MD and was dx'd with cellulitis. Placed on Cephalexin BID for 7 days.
joint pain in her hands and knees; increased hair loss; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced increased hair loss and joint pain in her hands and knees (Arthralgia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included Alopecia and Arthritis.  The patient's Concomitant medication was not reported.   On 04-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route.  On an unknown date, the patient developed a non-serious joint pain in her hands and knees (arthralgia) and increased hair loss (alopecia), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab data was reported.  Final diagnosis was increased hair loss and joint pain in her hands and knees.  No corrective treatment was received by patient   The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for joint pain in her hands and increased hair loss.  Information on batch number is requested.
Vaccine error- vaccine was administered past its beyond use date. The vaccine had been stored in the refrigerator beyond the time frame recommended by the manufacture
Hives; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 15:00 (Lot number: FE3594) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: None, notes: Known allergies: None, Other medical history: None. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: EW0172, Prev dose lot unknown: False, Prev dose administration date: 29Apr2021 , Prev dose number: 2, Prev dose vaccine location: Right arm), administration date: 29Apr2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: EW0158, Prev dose lot unknown: False, Prev dose administration date: 08Apr2021 , Prev dose number: 1 , Prev dose vaccine location: Right arm), administration date: 08Apr2021, when the patient was 58 years old, for Covid-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 15:00, outcome "unknown", described as "booster"; URTICARIA (non-serious) with onset 20Dec2021, outcome "recovered" (2021), described as "Hives". Therapeutic measures were taken as a result of immunisation, urticaria.  Additional information:  The patient did not receive any other vaccines within 4 weeks. Treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-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 (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitants were reported.  No treatment was reported. Reporter stated that Patient should receive the second dose on 08apr2021 and had a scheduled back surgery in 12apr2021.
Pt had been seen 12/18/13 at doctor with 48 hours of fever and croup like sx. Later that evening/early the next am, he developed acute submandibular lymphadenopathy that prompted his parents to take him to the ER.  He tested positive for Influenza A at that time.  The lab typed it as H1N1.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No concomitant medication as provided.
Developed Bell's Palsy on morning of 4/29, with left side of face paralyzed.  Was examined by emergency room physicians for stroke and blood clot, cleared and given prescription for Valacyclovir 1GM (3x day 7days) and Prednisone 50mg (1x day 5 days).   As of 5/5 condition has improved significantly, though paralysis around mouth and neck areas persists.
This patient received his first dose of Moderna on 7/1/21. He presented to the clinic for the second dose and received 0.3mL given in the Left deltoid by medication error from RN on 7/29/21. Patient was notified after error was recognized.
Headache, Fever, chills and body aches (worse than the 1st dose)
Pt's PCP, reports ADR to PREVNAR 13 on 07/13/2015. Reaction was mild localized edema per PCP. Rash.
Injection site reaction including pain, redness, swelling, and pruritus; headache; fatigue
Got a 2-3 inch red raised rash at injection site; Hot to the touch; It's been over two weeks & it's still red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 16:00 (Batch/Lot number: unknown) at the age of 51 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: VACCINATION SITE RASH (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Got a 2-3 inch red raised rash at injection site"; VACCINATION SITE WARMTH (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Hot to the touch"; VACCINATION SITE ERYTHEMA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "It's been over two weeks & it's still red". The events "got a 2-3 inch red raised rash at injection site", "hot to the touch" and "it's been over two weeks & it's still red" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site rash, vaccination site warmth, vaccination site erythema. Additional information: Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The wife called  and said about 2 days after the vaccine, he experienced swelling about 2-3 inches below the injection site.  It was red and warm and about 3-4 inches in diameter.  At the site of injection there was a quarter size red spot.  No other symptoms were experienced.  They iced the swelling and it went away in 4 days.
Pt developed  new hyperglycemia requiring metformin after she received her 2nd Moderna covid vaccine on 4/15/21. Pts hemoglobin A1c was 7.2 on 6/21/21 and she was started on the drug. She did well on this drug alone without issue until she received her booster 3rd Moderna covid vaccine on 11/26/2021 and a few weeks later began to have poor appetite, dry mouth, frequent urination. She thought she was just sick and waited it through. By January 2022 she began to complain of sinus congestion, headaches and poor appetite which continued to persist. she called on 3/17/22 and had a visit where she described her complaints over the last few months and was diagnosed with acid reflux and placed on omeprazole. She returned in May 2022 for a physical and it was discovered she had unintentionally lost over 25 lbs and was experiencing thrush, severe dry mouth, poor appetite and frequent urination. Blood sugar and hemoglobin aic check revealed random blood sugar of 650 and a hemoglobin A1C of >14. She wished to avoid insulin if possible and so her metformin was increased and glipizide was added. At her next visit in June 2022 her blood sugars remain >250 so the glipizide was discontinued and ozempic was added. GAD, insulin and islet cell antibodies are pending. She has never had covid 19 infection. Her antibodies to Sars are positive >2500 for spike protein and negative for nucleocapsid. Her BMI is around 20. She does not smoke and follows an active and healthy lifestyle.  She had not been treated for any blood sugar problems prior to 6/21/21. Her prior random blood glucose checks/non fasting prior to vaccination with her blood work were always in the normal range.