chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Emergency hip replacement operation to correct an infection that was in the hip; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRITIS INFECTIVE (Emergency hip replacement operation to correct an infection that was in the hip) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS INFECTIVE (Emergency hip replacement operation to correct an infection that was in the hip) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Emergency hip replacement operation) for Arthritis infective. At the time of the report, ARTHRITIS INFECTIVE (Emergency hip replacement operation to correct an infection that was in the hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Patient received the vaccine by a pharmacist on 10/10/18. Patient was then seen at Clinic by her primary care provider on 10/12/18,  complaining of itchiness, warmth, and redness at the vaccine site. The physician determined that the vaccine was given in the biceps instead of the deltoid, and diagnosed the patient with cellulitis due to vaccine administration. The patient was given a 7 day course of cephalexin 500 mg, 1 capsule three times daily, and symptoms have resolved.
1) Itching and stinging sensation - began 2/20/21 morning - ongoing but diminishing in frequency and discomfort. 2) Fever - 101.8 began about 2 pm 2/20/21 and continued until about 10 pm.   For item 20 below: Fever - yes Itching/stinging - no
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
Rash started about 8 days after injection ? located on both arms, chest and neck.   I inquired with my pharmacist about whether it could be a reaction to medicine I was taking. He didn?t think it was since I?ve taking that since December 2020.  He mentioned I might want to report it.
Three episodes of vomiting every 3 to 4 hours, accompanied by diarrhea, chills, and extreme fatigue.  Dizziness and inability to stand, unaided.
bleeding under the skin; reported bruising at the injection site; administration may have been too high in the deltoid, closer to the joint/temperature excursion at 76 F to 78 fahrenheit as left out of refrigerator for 12 hours; Initial information received on 21-Jan-2022 regarding an unsolicited valid non-serious case received from healthcare professional.  This case involves a 24 years old female patient who had bleeding under the skin, reported bruising at the injection site and administration may have been too high in the deltoid, closer to the joint while receiving diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-May-2022, the patient received a dose 0.5 ml total once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Strength: standard form: injection lot C5923AA, expiry date: 14-Oct-2022 via intramuscular route in the right deltoid but might have been a little high for Immunisation.  On 13-May-2022 (Latency: same day) the patient developed a non-serious bleeding under the skin (skin haemorrhage), bruising at the injection site (vaccination site bruising) and administration may have been too high in the deltoid, closer to the joint and temperature excursion at 76 F to 78 Fahrenheit as left out of refrigerator for 12 hours (product administration error).   The caller stated that the administration may have been too high in the deltoid, closer to the joint. The caller noted that there may be bleeding under the skin. The patient was worried that it wasn't administered properly since it was little high and caused bruising. The patient denies any pain, redness, swelling, or drainage.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (bleeding under the skin, reported bruising at the injection site).  At time of reporting, the outcome was Unknown for all the events (bleeding under the skin, was Unknown for the event reported bruising at the injection site and was Unknown for the event administration may have been too high in the deltoid, closer to the joint.)    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 guidelines. 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.   Additional information was received on 16-May-2022: case was updated from non-case to valid case. Patient details, Therapy details, event details and medically confirmed was updated.
Loss of consciousness; ankle fracture; Fall; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 54-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.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ) from 11-Feb-2021 to an unknown date for Rheumatoid arthritis.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 15-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), ANKLE FRACTURE (ankle fracture) and FALL (Fall). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), ANKLE FRACTURE (ankle fracture) and FALL (Fall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   RINVOQ(UPADACITINIB) is the only concomitant drug reported by the reporter which indicated for sever to moderate rheumatoid arthritis. No tobacco or alcohol use reported. The reporter's causality for the loss of consciousness with the RINVOQ (UPADACITINIB) was no reasonable possibility.The causality of the other reported events was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 79-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Sweated through my clothes at almost 12 hours to the exact time of dose, nausea to the point of trying not to vomit, diarrhea, shivers, very sore arm (difficult to lift). Lasted approximately 4 hours.  Drank water, took 1 Advil. Waited it out until symptoms reduced. Did not sleep most of the night.
joint pains, chills, lightheadedness, nausea & emesis x 1; t101.2; advil w/some relief;
Any sudden movement give me pain(7 in the pain scale); The inner part and top part where the injection went in is swollen; Pain transferred to the right arm,Pain goes down to the arm; Hardly can lift the arm; Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts; Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Any sudden movement give me pain(7 in the pain scale)), LIMB DISCOMFORT (Hardly can lift the arm), PAIN IN EXTREMITY (Pain transferred to the right arm,Pain goes down to the arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) and MYALGIA (Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Fibromyalgia, Arthritis, Hyperlipidemia, Chronic obstructive pulmonary disease and Bipolar disorder.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (Hardly can lift the arm) and MYALGIA (Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts). On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Pain transferred to the right arm,Pain goes down to the arm). On an unknown date, the patient experienced PAIN (Any sudden movement give me pain(7 in the pain scale)) and VACCINATION SITE SWELLING (The inner part and top part where the injection went in is swollen). On 24-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved. At the time of the report, PAIN (Any sudden movement give me pain(7 in the pain scale)), LIMB DISCOMFORT (Hardly can lift the arm), PAIN IN EXTREMITY (Pain transferred to the right arm,Pain goes down to the arm), MYALGIA (Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts) and VACCINATION SITE SWELLING (The inner part and top part where the injection went in is swollen) outcome was unknown.            Patient's inner part and top part where the injection went became swollen.  Doctor suggested the patient for Physical Therapy but the patient not joined.  Treatment includes Doctor prescribed medication for muscle pain.  Concomitant product information includes 3 pills for bipolar.  Action taken with mRNA-1273 in response to the events is not applicable.
Spontaneous nosebleed, did not subside with pressure; treatment at ER from 4:20 pm, discharged at 8:33 pm. Two separate episodes of cauterization done.  Random light, stoppable bleeding for next several days.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a health care professional. This case involves an 18-months-old male patient who moved away while vaccination and received less than the full dose of 0.5 ml of PENTACEL (lot UJ104AA, expiry date 31-Oct-2020) via unknown route in the right leg on 09-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received Hepatitis A vaccine concomitantly. It was a case of actual medication error due to vaccine under dose. The patient did not experience any adverse event at the time of report (reported as none symptoms). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Wrist drop syndrome radial nerve palsy on side of injection. Not able to work as she is a waitress.
Mom states she noticed a red lump on childs Rt thigh the size of a baseball on the morning of 9/21/18. Leg sore, child limping. Child recovered without incidence.
Woke with large swelling and pain to left arm, unable to move arm well due to pain, redness to site.
pt recvd vax & w/in 24 hrs devel inj site rxn (erythema & induration approx 2cm in diameter); tx'd w/APAP/warm compresses; As of this report, rxn unchanged; seen by RN; no new tx iniitated; last tetanus was approx 7 yrs ago
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of PROQUAD (dosage, frequency and route of administration were not reported), lot#: N013295 (expiration date: 28-APR-2019), lot#: N012489 (expiration date: 17-OCT-2018) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. Lot number N013295 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of four reports received from the same source. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008839: US-009507513-1802USA008840: US-009507513-1802USA008841: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and later from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months in approximately 2018. The patient was 1 year old female. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1808USA010810: US-009507513-1809USA004055: US-009507513-1809USA004056: US-009507513-1809USA004057: US-009507513-1809USA004061: US-009507513-1809USA004059: US-009507513-1809USA004060.
Pain in right knee, swelling of the right knee, fluid pocket in the right knee. It's been a month and it's still bad. My Dr ordered an xray and it says I now have ostheoarthritis and osteophytes in my right knee.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case included information of patient 07 th patient out of 190 reported patients. Concomitant product use was not provided by the reporter. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 190 patients received a vaccine past the beyond use date from 9 different lot number vials.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
Pulmonary fibrosis; Dizzy spells; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4190337-00.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY FIBROSIS (medically significant), outcome "unknown", described as "Pulmonary fibrosis"; DIZZINESS (non-serious), outcome "recovered" (2021), described as "Dizzy spells". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of pulmonary fibrosis with Ofev 150 milligrams.It was unknown if she was enrolled in a COVID-19 vaccine trial. The reporter considered "dizzy spells" not associated to bnt162b2. The reporter's assessment of the causal relationship of the event Pulmonary fibrosis with the suspect product was not provided at the time of this report.The reporter's causality for the event(s) of pulmonary fibrosis and dizzy spells with HUMIRA(ADALIMUMAB) was no reasonable possibility. Manufacturer opinion is that the event of pulmonary fibrosis is not assessable. Manufacturer opinion is that there is no reasonable possibility that the event of dizzy spells is related to HUMIRA(ADALIMUMAB).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Pulmonary fibrosis, Dizziness  and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt experienced all of the expected symptoms for 36 hrs after injection including fatigue, low grade fever and arm soreness. No redness at injection site. 5/31/18 PM area around injection site was red, hot and swollen. Rx'd with Clindamycin 300mg TID x 7d.