chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Allergic cough, Hypersensitivity, Oropharyngeal pain, Seasonal allergy, Vaccination site pain
Clinical narrative: Sore throat; Allergic cough; Seasonal allergy; Allergy; Vaccination site pain / Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Seasonal allergy), HYPERSENSITIVITY (Allergy) and VACCINATION SITE PAIN (Vaccination site pain / Sore arm) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   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) at an unspecified dose. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Seasonal allergy), HYPERSENSITIVITY (Allergy) and VACCINATION SITE PAIN (Vaccination site pain / Sore arm). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Seasonal allergy) and HYPERSENSITIVITY (Allergy) was resolving and VACCINATION SITE PAIN (Vaccination site pain / Sore arm) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had taken Humira drug in the form of Solution for injection in pre filled pen. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PSORIASIS ACCELERATED/ GETTING WORSENED/ STARTED TO COME BACK; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (PSORIASIS ACCELERATED/ GETTING WORSENED/ STARTED TO COME BACK) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriasis.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second 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) 80 milligram. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient experienced PSORIASIS (PSORIASIS ACCELERATED/ GETTING WORSENED/ STARTED TO COME BACK). At the time of the report, PSORIASIS (PSORIASIS ACCELERATED/ GETTING WORSENED/ STARTED TO COME BACK) outcome was unknown.            No concomitant medications were reported. For co-suspect Humira  80mg/0.8ml daily dose was reported as Citrate Free, On day 1 (80 mg) with no causality reported. For co-suspect Humira  40mg/0.4ml daily dose was reported as Citrate Free, Day 8 (40 mg) and Citrate Free (40 mg,1 in 2 week)  with no causality reported. No treatment medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and COVID-19 VACCINE NRVV AD26 for COVID-19 vaccination.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medication information provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient received booster dose of Moderna COVID-19 vaccine.  Action taken was reported as unknown for Humira (Solution for injection in pre-filled pen) (Adalimumab) and action taken was reported as not applicable for COVID-19 VACCINE NRVV AD26.  Reporter causality for Humira (Solution for injection in pre-filled pen) (Adalimumab) was reported as not related and reporter causality for COVID-19 VACCINE NRVV AD26 was reported as Possible.  No treatment medication information provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Skin plaque, Vaccination site pain
Clinical narrative: LARGE PLAQUE KNEE; LOST ALL OF HAIR; BAD ARM PAIN FROM THE COVID BOOSTER SHOT; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (LARGE PLAQUE KNEE), ALOPECIA (LOST ALL OF HAIR) and VACCINATION SITE PAIN (BAD ARM PAIN FROM THE COVID BOOSTER SHOT) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PAIN (BAD ARM PAIN FROM THE COVID BOOSTER SHOT). On an unknown date, the patient experienced SKIN PLAQUE (LARGE PLAQUE KNEE) and ALOPECIA (LOST ALL OF HAIR). At the time of the report, SKIN PLAQUE (LARGE PLAQUE KNEE) was resolving, ALOPECIA (LOST ALL OF HAIR) had not resolved and VACCINATION SITE PAIN (BAD ARM PAIN FROM THE COVID BOOSTER SHOT) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.  The patient had one big plaque on knee, but still so much better everywhere else, now on other parts of body. Scalp used to be horrible. Patient lost all of hair prior and had not really grown back. Per physician, if it grows back it would likely take a year. Patient also had really bad arm pain from the COVID booster shot.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of large plaque knee with Skyrizi (risankizumab) was a reasonable possibility (or probable). The reporter's causality for the event of lost all of hair and bad arm pain from the COVID booster shot was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Asthenia, Immunisation reaction, Joint swelling, Joint warmth
Clinical narrative: Knee swelling; Vaccination related malaise; Weakness; Joint warmth; Visual impairment; Hip arthropathy; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling), IMMUNISATION REACTION (Vaccination related malaise), ASTHENIA (Weakness), JOINT WARMTH (Joint warmth) and VISUAL IMPAIRMENT (Visual impairment) in an adult male 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 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) CF. On an unknown date, the patient experienced JOINT SWELLING (Knee swelling), IMMUNISATION REACTION (Vaccination related malaise), ASTHENIA (Weakness), JOINT WARMTH (Joint warmth), VISUAL IMPAIRMENT (Visual impairment), ARTHROPATHY (Hip arthropathy) and TREMOR (Shaking). At the time of the report, JOINT SWELLING (Knee swelling), IMMUNISATION REACTION (Vaccination related malaise), ASTHENIA (Weakness), JOINT WARMTH (Joint warmth), VISUAL IMPAIRMENT (Visual impairment), ARTHROPATHY (Hip arthropathy) and TREMOR (Shaking) had not resolved.      No Concomitant medication reported. It was reported that, patient's knees get hot and swell up, did not feel well after covid booster, became shaky and weak after switching to weekly dose, eyesight became worse after increasing dose and bad hips with Humira (adalimumab). It was unknown if patient was enrolled in covid-19 vaccine trial. No Treatment medication reported.
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: Knee swelling; Vaccination related malaise; Weakness; Joint warmth; Visual impairment; Hip arthropathy; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling), IMMUNISATION REACTION (Vaccination related malaise), ASTHENIA (Weakness), JOINT WARMTH (Joint warmth) and VISUAL IMPAIRMENT (Visual impairment) in an adult male 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 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) CF. On an unknown date, the patient experienced JOINT SWELLING (Knee swelling), IMMUNISATION REACTION (Vaccination related malaise), ASTHENIA (Weakness), JOINT WARMTH (Joint warmth), VISUAL IMPAIRMENT (Visual impairment), ARTHROPATHY (Hip arthropathy) and TREMOR (Shaking). At the time of the report, JOINT SWELLING (Knee swelling), IMMUNISATION REACTION (Vaccination related malaise), ASTHENIA (Weakness), JOINT WARMTH (Joint warmth), VISUAL IMPAIRMENT (Visual impairment), ARTHROPATHY (Hip arthropathy) and TREMOR (Shaking) had not resolved.      No Concomitant medication reported. It was reported that, patient's knees get hot and swell up, did not feel well after covid booster, became shaky and weak after switching to weekly dose, eyesight became worse after increasing dose and bad hips with Humira (adalimumab). It was unknown if patient was enrolled in covid-19 vaccine trial. No Treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: bad reactions that were extremely unpleasant; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (bad reactions that were extremely unpleasant) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (bad reactions that were extremely unpleasant). At the time of the report, IMMUNISATION REACTION (bad reactions that were extremely unpleasant) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysphagia, Dyspnoea, Gastrointestinal disorder, Headache
Clinical narrative: Hard time breathing ,could not catch her breath; Her mouth was so dry; Could not swallow; Felt some constriction; GI problems; Heart was racing; Rash on her neck; Nausea; A really bad headache; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Hard time breathing ,could not catch her breath), DRY MOUTH (Her mouth was so dry), DYSPHAGIA (Could not swallow), THROAT TIGHTNESS (Felt some constriction) and GASTROINTESTINAL DISORDER (GI problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder NOS (Thyroid issues). Previously administered products included for COVID-19 immunization: Johnson & Johnson (First); for Product used for unknown indication: Miralax (Experienced the same events (Rash on her neck, a hard time breathing, couldn't catch her breath, her mouth was so dry, she couldn't swallow, felt some constriction, had GI problems, nausea and a really bad headache and her heart was racing) with MiraLax on an unspecified date); for Polyethylene glycol allergy: Zyrtec. Past adverse reactions to the above products included Adverse event with Miralax; and No adverse event with Johnson & Johnson and Zyrtec. Concurrent medical conditions included Polyethylene glycol allergy (allergic reaction to polyethylene glycol) and Autoimmune disorder.    On 26-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Hard time breathing ,could not catch her breath), DRY MOUTH (Her mouth was so dry), DYSPHAGIA (Could not swallow), THROAT TIGHTNESS (Felt some constriction), GASTROINTESTINAL DISORDER (GI problems), PALPITATIONS (Heart was racing), RASH (Rash on her neck), NAUSEA (Nausea) and HEADACHE (A really bad headache). At the time of the report, DYSPNOEA (Hard time breathing ,could not catch her breath), DRY MOUTH (Her mouth was so dry), DYSPHAGIA (Could not swallow), THROAT TIGHTNESS (Felt some constriction), GASTROINTESTINAL DISORDER (GI problems), PALPITATIONS (Heart was racing), RASH (Rash on her neck), NAUSEA (Nausea) and HEADACHE (A really bad headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that the patient received a booster of the COVID-19 Vaccine (Moderna) at an unspecified dose and frequency as a COVID-19 precautionary.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Rash, Throat tightness
Clinical narrative: Hard time breathing ,could not catch her breath; Her mouth was so dry; Could not swallow; Felt some constriction; GI problems; Heart was racing; Rash on her neck; Nausea; A really bad headache; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Hard time breathing ,could not catch her breath), DRY MOUTH (Her mouth was so dry), DYSPHAGIA (Could not swallow), THROAT TIGHTNESS (Felt some constriction) and GASTROINTESTINAL DISORDER (GI problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder NOS (Thyroid issues). Previously administered products included for COVID-19 immunization: Johnson & Johnson (First); for Product used for unknown indication: Miralax (Experienced the same events (Rash on her neck, a hard time breathing, couldn't catch her breath, her mouth was so dry, she couldn't swallow, felt some constriction, had GI problems, nausea and a really bad headache and her heart was racing) with MiraLax on an unspecified date); for Polyethylene glycol allergy: Zyrtec. Past adverse reactions to the above products included Adverse event with Miralax; and No adverse event with Johnson & Johnson and Zyrtec. Concurrent medical conditions included Polyethylene glycol allergy (allergic reaction to polyethylene glycol) and Autoimmune disorder.    On 26-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Hard time breathing ,could not catch her breath), DRY MOUTH (Her mouth was so dry), DYSPHAGIA (Could not swallow), THROAT TIGHTNESS (Felt some constriction), GASTROINTESTINAL DISORDER (GI problems), PALPITATIONS (Heart was racing), RASH (Rash on her neck), NAUSEA (Nausea) and HEADACHE (A really bad headache). At the time of the report, DYSPNOEA (Hard time breathing ,could not catch her breath), DRY MOUTH (Her mouth was so dry), DYSPHAGIA (Could not swallow), THROAT TIGHTNESS (Felt some constriction), GASTROINTESTINAL DISORDER (GI problems), PALPITATIONS (Heart was racing), RASH (Rash on her neck), NAUSEA (Nausea) and HEADACHE (A really bad headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that the patient received a booster of the COVID-19 Vaccine (Moderna) at an unspecified dose and frequency as a COVID-19 precautionary.  Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rectal examination, Vaccination site swelling
Clinical narrative: Vaccination site swelling/ARM REALLY BAD/THREE TIMES THE SIZE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling/ARM REALLY BAD/THREE TIMES THE SIZE) in a 43-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 Crohn's disease.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second 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) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling/ARM REALLY BAD/THREE TIMES THE SIZE). In 2021, VACCINATION SITE SWELLING (Vaccination site swelling/ARM REALLY BAD/THREE TIMES THE SIZE) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2022, Rectal examination: healing.         No concomitant drug information was provided.  No treatment drug information was provided.  It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered with expired Moderna vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     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 EXPIRED PRODUCT ADMINISTERED (Administered with expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered with expired Moderna vaccine).    No concomitant medication information was provided.  Number of doses administered was 35 from 4 vials. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines were reported as 1-Apr-2022, 5-Apr-2022, 6-Apr-2022, 8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022.  The date of individual vaccine administration was not reported and it was unknown whether patient took first dose, second dose or first and or second booster doses.  No treatment medication information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired doses administered/ administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered/ administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered/ administered with expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered/ administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired doses administered/ administered with expired vaccine).    No concomitant medications information was reported.  Number of doses/vials- 35 doses, 4 vials Date the vial was initially stored in the refrigerator- 07-Jun-2022 Expiration date: 01-Apr-2022  Date(s) of administration of the vaccine: 01-Apr-2022, 05-Apr-2022, 06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022.  The date of individual vaccine administration was not reported and it was unknown whether patient took first dose, second dose or first and or second booster doses.  The vial did not undergo any temperature excursions.  No treatment medications were provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient).    No concomitant medication information was provided.  The vial was initially stored in refrigerator on 07-Jun-2022.  The vial did not undergo any temperature excursions.  The patient was administered on any one of these dates (vaccine administration dates) of 01-Apr-2022, 05-Apr-2022, 06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022.  No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine).    No concomitant medications were reported.  The vial was initially stored in refrigerator on 07-Jun-2022. The date for the patient vaccine administration was not known, and it was also unknown whether the patient took first, second or first and second booster doses.  It was reported that a total of 35 doses were given from 4 vials for approximately 40 patients. The dates on which vaccinations were given from 01-Apr-22, 05-Apr-22, 08-Apr-22, 06-Apr-22, 11-Apr-22, 12-Apr-22, 13-Apr-22, 14-Apr-22, 22-Apr-22, 09-Jun-22, 10-Jun-22, 13-Jun-22, 18-Jun-22, and 22-Jun-22. The vial had not undergone any temperature excursions.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information was provided. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). No concomitant medication was provided. The vial was initially stored in refrigerator on 07-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 01-Apr-2022, 05-Apr-2022, 06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient).    No concomitant medication information was provided.  The vial was initially stored in refrigerator on 07-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.   The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses.  No treatment medication information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-589423 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-589423:Master case
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administrated with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administrated with expired vaccine) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administrated with expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administrated with expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administrated with expired vaccine).    No concomitant medications were reported.  Number of doses administered was 35 from 4 vials. The vials were initially stored in the refrigerator on 07-Jun-2022, they had not undergone any temperature excursions. It was reported that the dates of vaccine administration were 01-Apr-2022, 05-Apr-2022,06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. The date of the patient vaccine administration was not known, and it was also unknown whether patient took first, second or first and or second booster doses.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine).    No concomitant medication information was provided.  The dates of administration of the vaccines was reported as 1 Apr 2022, 5 Apr 2022, 6 Apr 2022, 8 Apr 2022, 11 Apr 2022, 12 Apr 2022, 13 Apr 2022, 14 Apr 2022, 22 Apr 2022, 9 Jun 2022, 10 Jun 2022, 13 Jun 2022, 18 Jun 2022 and 22 Jun 2022. It was unknown whether patient took first, second or first and or second booster doses.   The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions.  No treatment medication information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered with an expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with an expired moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered with an expired moderna vaccine).    No concomitant medication information was reported.  Number of doses administered was 35 from 4 vials. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines were reported as 1-Apr-2022, 5-Apr-2022, 6-Apr-2022, 8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022.  The date of individual vaccine administration was not reported and it was unknown whether patient took first dose, second dose or first and or second booster doses.  No treatment medication information was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (No adverse event) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, NO ADVERSE EVENT (No adverse event) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information was provided. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.   This case was linked to MOD-2022-589423 (E2B Linked Report).; Sender's Comments:  MOD-2022-589423:Master case
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient).    No concomitant medication information was provided. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). Concomitant product use was not provided by the reporter. The date of vaccine administration and dose number was not reported. The date the vial was initially stored in the refrigerator was 07-Jun-2022. Number of doses/vials were 35 doses and 4 vials. The vial did not undergo any temperature excursions. Date of administration of the vaccines were 1-Apr-2022, 5-Apr-2022, 6-Apr-2022, 8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. The date of vaccine administration was not reported, and it was unknown whether patient took first, second, first booster or second booster doses. Treatment information was not provided. This case was linked to -MODERNATX, INC.-MOD-2022-589423 (E2B Linked Report).; Sender's Comments: -MODERNATX, INC.-MOD-2022-589423:Master case
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient).    No concomitant medication was provided.  The vial was initially stored in refrigerator on 07-Jun-2022.  The vial did not undergo any temperature excursions.  The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022. The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (No adverse event) and EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, NO ADVERSE EVENT (No adverse event) and EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient).    The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses.  No concomitant medications were reported.  The vial was initially stored in refrigerator on 07-Jun-2022.  A total of 35 doses were given from 4 vials. The dates in which vaccination were given from 1-Apr-22, 5-Apr-22, 8-Apr-22, 6-Apr-22, 11-Apr-22,  12-Apr-22, 13-Apr-22, 14-Apr-22, 22-Apr-22, 9-Jun-22, 10-Jun-22, 13-Jun-22, 18-Jun-22 and 22-Jun-22.  The vial did not undergo any temperature excursions.  No treatment medications were reported.