chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Paraesthesia oral
Clinical narrative: tingly lips/ tip of tongue felt tingly; sore left arm; tingly face on the left side; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA ORAL (tingly lips/ tip of tongue felt tingly), PARAESTHESIA (tingly face on the left side) and PAIN IN EXTREMITY (sore left arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (1st primary series dose,Lot number: EN6208,  Intramuscular) on 22-Mar-2021, Pfizer (2nd primary series dose and Lot number: EW0153) on 12-Apr-2021; for Product used for unknown indication: Flu vaccine in October 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine, Pfizer and Pfizer. Concurrent medical conditions included Allergy, Overweight, Allergic reaction to antibiotics (Terramycin,) and Drug allergy (Codeine).   On 05-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 23-Jun-2021, the patient experienced PARAESTHESIA (tingly face on the left side). On 23-Jun-2022, the patient experienced PARAESTHESIA ORAL (tingly lips/ tip of tongue felt tingly) and PAIN IN EXTREMITY (sore left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 23-Jun-2022 at a dose of 25 milligram, Dry free liquid gel. On 23-Jun-2022, PARAESTHESIA ORAL (tingly lips/ tip of tongue felt tingly) and PARAESTHESIA (tingly face on the left side) had resolved. At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.            Concomitant medications were not reported.  The batch number for 2nd booster was reported as 056M21 (last letter cut off on vaccination card).  It was unknown whether the patient  had been diagnosed with/ tested positive for COVID 19.   The patient reported 20 minutes after administration of the injection, patient experienced a tingly face on the left side, tingly lips and tip of tongue felt tingly. Patient reported  it was just like that patient experienced after the first Moderna dose. The patient reported had no trouble breathing and no rash had a sore left arm. The patient took 25 mg,Benadryl (dye free liquid gel) and reported the events resolved 45 minutes later. The Benadryl patient took as treatment was expired in November 2018.   This case was linked to MOD-2022-594691 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inflammation
Clinical narrative: Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    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 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced INFLAMMATION (Inflammation). At the time of the report, INFLAMMATION (Inflammation) outcome was unknown.   No concomitant medications were reported No treatment medications were reported  It was unknown if patient was enrolled in a COVID-19 Vaccine trial. ADALIMUMAB  The reporter's causality for the event of Inflammation with Humira(Adalimumab) was no reasonable possibility.
Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Panic attack, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: COVID-19; Respiratory Problems; Panic attacks; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), RESPIRATORY DISORDER (Respiratory Problems) and PANIC ATTACK (Panic attacks) in a 67-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.  Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.  No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2022, the patient experienced COVID-19 (COVID-19), RESPIRATORY DISORDER (Respiratory Problems) and PANIC ATTACK (Panic attacks). At the time of the report, COVID-19 (COVID-19), RESPIRATORY DISORDER (Respiratory Problems) and PANIC ATTACK (Panic attacks) was resolving. Not provided.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: positive (Positive) Patient had COVID.  The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  No concomitant medication was reported. Patient was on an inhaler, and it helped him a lot and it came from the effects of the COVID. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. The reporter's causality for the event of COVID with SKYRIZI (RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event of respiratory problems and panic attacks with SKYRIZI (RISANKIZUMAB) was not provided.  Company comment: This is a spontaneous case concerning a 67-year-old, male patient with no relevant medical history, who experienced the unexpected non serious of COVID-19 and other non serious events such as respiratory disorder and panic attack. Patient test positive for SARS-CoV-2. It is unknow timeframe between the event and the administration of a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 67-year-old, male patient with no relevant medical history, who experienced the unexpected non serious of COVID-19 and other non serious events such as respiratory disorder and panic attack. Patient test positive for SARS-CoV-2. It is unknow timeframe between the event and the administration of a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022; Dose administered after 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial did not undergo any temperature excursions.  The reporter believed that lot numbers for previous doses of the patient was Moderna, but was unsure.  No treatment information was provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12(US)hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12hours post puncture) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022 at 10:07 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022 at 10:07 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12(US)hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12(US)hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient received drug from the vials which were drew from more than 12 hours. There were 2 Booster doses. Vial was initially stored in the refrigerator on 15-Jun-2022. The vial was first punctured on 24-Jun-2022 10:10 AM. The vial was stored in the Fridge post punctured. The vial did not undergo any temperature excursions.Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F for More than 24 hours. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-595070 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-595070:Patient-2
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022 at 10:07 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   On 15 Jun 2022, the vial was initially stored in the refrigerator. On 23 Jun 2022, at 10:10 A. M. the vial was first punctured. Total amount of time the vial was exposed to room temperature range was (8 degree to 25 degree C-46 degree C to 77 degree F): less than 24 hours.
Sex: F
Vaccine: COVID19, PPV
Symptoms: Immunisation reaction
Clinical narrative: first booster at the end of October last year Caller was due for second booster but ended up getting the pneumonia vaccine and had a pretty bad reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (first booster at the end of October last year Caller was due for second booster but ended up getting the pneumonia vaccine and had a pretty bad reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE for an unknown indication.    No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and dose of PNEUMOCOCCAL VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (first booster at the end of October last year Caller was due for second booster but ended up getting the pneumonia vaccine and had a pretty bad reaction). At the time of the report, IMMUNISATION REACTION (first booster at the end of October last year Caller was due for second booster but ended up getting the pneumonia vaccine and had a pretty bad reaction) outcome was unknown.            No concomitant drug reported. No treatment information was provided by the reporter.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: Pediatric patient received vaccine from a vial that had been first punctured more than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patient received vaccine from a vial that had been first punctured more than 12 hours ago) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient received vaccine from a vial that had been first punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patient received vaccine from a vial that had been first punctured more than 12 hours ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-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.   The age of the patient reported as 2.7 years.  No concomitant medications were reported. It was reported that, the clinic began administering Pediatric doses and accidentally administered left tight  a dose for 6month to 5 year old children more than 12 hours after the vial was first withdrawn. The vial was initially stored in the refrigerator on 21-Jun-2022 The vial was first punctured on 23-Jun-2022 at 2:00PM The date and time of administration of vaccine was 23-Jun-2022 9 patients between 2 PM and 5:30 PM and 24-Jun-2022 at 10:15 AM The vial did not undergo any temperature excursions. No treatment medications were provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: muscle pain; joint pain; Fever; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 031M20A and 025A21A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy (Allergy to Hydrocodone) and Allergy to antibiotic (Allergy to Ciprofloxacin). Concomitant products included ATORVASTATIN, METFORMIN, METOPROLOL, SERTRALINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (Fever). On 26-Nov-2021, MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (Fever) had resolved.            On 19-NOV-2021 the patient received 1st booster dose. After receiving dose, the patient experienced muscle pain, joint pain, and fever. The patients symptoms lasted for a week, after which felt better.  The patient was never tested positive or diagnosed with COVID. The patient not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No treatment drug details was reported.   This case was linked to MOD-2022-595147 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 25-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced COVID-19 (Patient went to country and upon return Contracted COVID). At the time of the report, COVID-19 (Patient went to country and upon return Contracted COVID) was resolving. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication information provided.  No treatment medication information provided. The reporter causality for the event of patient upon return contracted COVID with HUMIRA was no reasonable possibility.  Company comment- This spontaneous case concerns a 71-year-old female patient treated with Adalimumab (reported as co-suspect) for an unknown indication, who experienced the unexpected non-serious AESI COVID-19. A dose of mRNA-1273 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Onset date of the event was not provided; hence, latency cannot be assessed. Details of symptoms, clinical course, investigation reports and treatment were not provided. Patient´s elderly age and treatment with Adalimumab remain as possible risk factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old female patient treated with Adalimumab (reported as co-suspect) for an unknown indication, who experienced the unexpected non-serious AESI COVID-19. A dose of mRNA-1273 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Onset date of the event was not provided; hence, latency cannot be assessed. Details of symptoms, clinical course, investigation reports and treatment were not provided. Patient´s elderly age and treatment with Adalimumab remain as possible risk factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain / Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain / Ache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain / Ache). At the time of the report, PAIN (Pain / Ache) outcome was unknown.            No concomitant medications were reported  It was unknown if the patient was enrolled in a COVID-19 Vaccine trial. Causality for Moderna: Ache (Causality as per reporter (Drug/Vaccine) reported as Possible.  Causality for Humira: The reporters causality for the event of pain before next Humira injection unknown onset, pain before next Humira injection unknown onset and aches after moderna covid vaccine was not provided.  No treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Fluid retention, Sluggishness
Clinical narrative: Sluggishness; Fluid retention around ankles; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness) and FLUID RETENTION (Fluid retention around ankles) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 16-Mar-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) solution for injection in prefilled pen. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggishness) and FLUID RETENTION (Fluid retention around ankles). At the time of the report, SLUGGISHNESS (Sluggishness) outcome was unknown and FLUID RETENTION (Fluid retention around ankles) had not resolved.       No concomitant medication information provided. No treatment information provided.     It was unknown if patient was enrolled in Covid-19 vaccine trial.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Sinusitis
Clinical narrative: Got sick when vaccinated; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Got sick when vaccinated) and SINUSITIS (Sinus infection) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient experienced IMMUNISATION REACTION (Got sick when vaccinated) and SINUSITIS (Sinus infection). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (Got sick when vaccinated) outcome was unknown and SINUSITIS (Sinus infection) was resolving.            Concomitant product use was not provided by the reporter.  The formulation of Humira was solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Having a reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Having a reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Egg allergy.    On 24-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced IMMUNISATION REACTION (Having a reaction). At the time of the report, IMMUNISATION REACTION (Having a reaction) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported. The patient took the Moderna booster dose. It was reported that the patient wants to know if the reaction was produced in an egg base.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 16-May-2022; Administered vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 16-May-2022) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     Patient had no known allergies to medications, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before. Patient did not have any chronic illness or long-standing health conditions. Patient neither diagnosed with COVID-19 nor tested positive. Patient was not taking prescriptions, over the counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event. No other vaccines received within one month prior to any dose of Moderna vaccine.    On 16-May-2022 at 11:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-May-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 16-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Mar-2022 and the dose was administered on 16-May-2022) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Reported that administered vaccine after the Beyond Use by Date (BUD) from  08-Mar-2022 to 01-Jun-2022. The vial was initially stored in refrigerator on 08-Mar-2022. The vial did not undergo the temperature excursion. The patient had not reported symptoms. No additional doses, medications, or treatments had been administered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored more than 30 days in a refrigerator; Vaccine was administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the 30 day BUD) and PRODUCT STORAGE ERROR (Vaccine was stored more than 30 days in a refrigerator) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 33K212A and 027L21A) for COVID-19 prophylaxis.     The patient had no known allergies. It was reported that patient has never been diagnosed or tested positive for COVID-19. It was reported, patient had no acute illness at the time of vaccination and up to one month before.  It was unknown if patient had chronic or long-standing health conditions.    On 22-Apr-2022 at 11:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-May-2022 at 11:00 AM, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored more than 30 days in a refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the 30 day BUD) and PRODUCT STORAGE ERROR (Vaccine was stored more than 30 days in a refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination were reported as unknown.  First dose was stored in refrigerator on 28-Feb-2022 and was administered on 22-Apr-2022 . Second dose was stored in refrigerator on 08-Mar-2022 and was administered on 20-May-2022. The vials did not undergo any temperature excursion. The patients have not reported any symptoms.  No treatment information was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 administered on 8-Mar-2021 and dose 2 administered on 21-Nov-2021 that is after 258 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 8-Mar-2021 and dose 2 administered on 21-Nov-2021 that is after 258 days.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B and 1805031) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 8-Mar-2021 and dose 2 administered on 21-Nov-2021 that is after 258 days.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 8-Mar-2021 and dose 2 administered on 21-Nov-2021 that is after 258 days.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was provided.   This case was linked to MOD-2022-592920 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Third dose administerd of 0.30 ml instead of 0.25 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (Third dose administerd of 0.30 ml instead of 0.25 ml) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FH8020, 006B21A and 023M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .3 milliliter. On 12-Dec-2021, the patient experienced OVERDOSE (Third dose administerd of 0.30 ml instead of 0.25 ml). At the time of the report, OVERDOSE (Third dose administerd of 0.30 ml instead of 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-592899 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Heart rate, Heart rate increased, Myalgia, Peripheral swelling
Clinical narrative: She had arm swelling; rapid heart rate; muscle aches; Headache; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (She had arm swelling), HEART RATE INCREASED (rapid heart rate), MYALGIA (muscle aches) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product OFATUMUMAB (KESIMPTA) for an unknown indication.    No Medical History information was reported.   In June 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started OFATUMUMAB (KESIMPTA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (She had arm swelling), HEART RATE INCREASED (rapid heart rate), MYALGIA (muscle aches) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (She had arm swelling), HEART RATE INCREASED (rapid heart rate), MYALGIA (muscle aches) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: rapid (increased) Rapid (Increased).  Concomitant medications were not provided by the reporter. It was reported that patient had a Moderna COVID booster vaccine 2 weeks ago in preparation for her cruise. Patient experienced headaches and rapid heart rate which may or may not be related to kesimpta and/or the vaccine. Those symptoms have since resolved as well. No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Source document contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Moderna Covid Vaccine - Covid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Moderna Covid Vaccine - Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Moderna Covid Vaccine - Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Moderna Covid Vaccine - Covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Moderna Covid Vaccine - Covid) to be related.    Concomitant medication list was not provided. The patient's doctor prescribed Paxlovid for COVID-19 and it had an alert about milk. Caller was asking if there was a lot of milk in there. The patient saw lactose listed and did not think it would be enough to set caller off. The patient declines to report, just wanted to know if it was ok for the patient to take. The patient stated this had been hell and had 4 shots, had 2 boosters. The patient had the Moderna COVID-19 vaccine for all doses.  Company comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the fourth dose of mRNA-1273. The patient was scheduled to receive paxlovid as treatment. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Product quality number added.; Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the fourth dose of mRNA-1273. The patient was scheduled to receive paxlovid as treatment. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Osteoarthritis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Breast cancer) in a 55-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. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant) and OSTEOARTHRITIS (Osteoarthritis). At the time of the report, BREAST CANCER (Breast cancer) and OSTEOARTHRITIS (Osteoarthritis) had not resolved. Concomitant product use was not provided by the reporter. Dosage text was reported as First Dose (1 in 1 Once) on 04-Mar-2021 and Booster Dose (1 in 1 Once) on 22-Aug-2021 dose. The reporter's causality for the events of Breast cancer and Osteoarthritis with Rinvoq (Upadacitinib) was reported as no reasonable possibility and the opinion was that the event of Breast cancer was not assessable and there was no reasonable possibility for the event Osteoarthritis was related to Rinvoq (Upadacitinib).  It was unknown if the patient was enrolled in a COVID-19 vaccine trial. Treatment information was not provided. Company Comment: This spontaneous case concerns a 55-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Breast cancer and non-serious event of Osteoarthritis unspecified days after a dose (booster) of mRNA-1273 vaccine. No further details on clinical course, other lab test results and treatment received were reported. The outcome of both events was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 55-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Breast cancer and non-serious event of Osteoarthritis unspecified days after a dose (booster) of mRNA-1273 vaccine. No further details on clinical course, other lab test results and treatment received were reported. The outcome of both events was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine had reached working expiration on 6/18/22; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had reached working expiration on 6/18/22) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     Patient had No Known Allergies (NKA).  Concurrent medical conditions included Dementia (Recent changes in condition status: No) since 16-Dec-2020, GERD (Recent changes in condition status: No) since 09-Jan-2019, Hypertension (Recent changes in condition status: No) since 06-Dec-2015, Hyperlipidemia (Recent changes in condition status: No) since 06-Dec-2015 and Chronic kidney disease (Recent changes in condition status: No) since 21-Jun-2022. Concomitant products included MEMANTINE from 16-Dec-2021 to an unknown date for Dementia, OMEPRAZOLE from 16-Dec-2021 to an unknown date for GERD, PRAVASTATIN from 26-Jan-2022 to an unknown date for Hyperlipidemia, FUROSEMIDE from 23-Dec-2021 to an unknown date and HCTZ from 17-Dec-2021 to an unknown date for Hypertension.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022 at 11:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had reached working expiration on 6/18/22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had reached working expiration on 6/18/22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Anatomical location was reported as deltoid for all the three doses of the Moderna vaccine.  It was reported that patient had No adverse reactions.  It was reported that the Booster dose did not undergo any temperature excursions.  No treatment medications reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic lymphocytic leukaemia
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic Lymphoid Leukemia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21A) for COVID-19 prophylaxis. Patient had no known allergies to medications, food, and other products. Concurrent medical conditions included Coronary artery disease since 21-Jan-2020, Atrial fibrillation since 21-Jan-2020, Hyperlipidemia since 21-Jan-2020, Hypertension since 21-Jan-2020 and Depression. Concomitant products included DIGOXIN from 21-Jan-2020 to an unknown date for AFib, ACETYLSALICYLIC ACID (ASPIRIN 81) from 21-Jan-2020 to an unknown date for Coronary artery disease, METOPROLOL TARTRATE from 21-Jan-2020 to an unknown date for Coronary artery disease and AFib, FLUOXETINE from 21-Jan-2020 to an unknown date for Depression, SIMVASTATIN from 21-Jan-2020 to an unknown date for Hyperlipidemia. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Jan-2021, the patient experienced CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic Lymphoid Leukemia) (seriousness criterion medically significant). At the time of the report, CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic Lymphoid Leukemia) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had no acute illnesses at the time of vaccination and up to one month before. Patient stated that he had no adverse events. It was unknown whether the patient had been diagnosed with tested positive for COVID-19. No treatment medications were reported. COMPANY COMMENT: This is an spontaneous case concerning an 76-years-old male patient with no related medical history who experienced the unexpected event of Chronic Lymphocytic Leukaemia 14 days after the 1st. dose of mRNA-1273 vaccine. Furthermore, the patient received a booster dose of Moderna COVID vaccine on 6/21/22 with working expiration on 6/18/22.", then "expired product administered" is also an unexpected event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-593752 (Patient Link). Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 76-years-old male patient with no related medical history who experienced the unexpected event of Chronic Lymphocytic Leukaemia 14 days after the 1st. dose of mRNA-1273 vaccine.  Furthermore, the patient received a booster dose of Moderna COVID vaccine on 6/21/22 with working expiration on 6/18/22.", then "expired product administered" is also an unexpected event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Incorrect route of product administration, Skin warm
Clinical narrative: warm in a different site than the common site of injection, in the back of the arm; redness in a different site than the common site of injection, in the back of the arm; dose possibly administered in the wrong injection site/it might be due to the vaccine was not administered in the deltoid; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN WARM (warm in a different site than the common site of injection, in the back of the arm), ERYTHEMA (redness in a different site than the common site of injection, in the back of the arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose possibly administered in the wrong injection site/it might be due to the vaccine was not administered in the deltoid) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose possibly administered in the wrong injection site/it might be due to the vaccine was not administered in the deltoid). On 25-Jun-2022, the patient experienced SKIN WARM (warm in a different site than the common site of injection, in the back of the arm) and ERYTHEMA (redness in a different site than the common site of injection, in the back of the arm). At the time of the report, SKIN WARM (warm in a different site than the common site of injection, in the back of the arm) and ERYTHEMA (redness in a different site than the common site of injection, in the back of the arm) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose possibly administered in the wrong injection site/it might be due to the vaccine was not administered in the deltoid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  it was reported that it might be due to the vaccine was not administered in the deltoid muscle, but HCP was not sure.  HCP prescribed treatment medication Benadryl or Claritin to the patient, but he was not sure whether patient took the treatment. Patient symptoms still ongoing