chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Joint effusion, Pyrexia
Clinical narrative: Knee effusion; Hoarse voice; Feeling hot; Anxiety; Bronchitis; Chest pain; Breathing difficult; Weakness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of JOINT EFFUSION (Knee effusion), DYSPHONIA (Hoarse voice), FEELING HOT (Feeling hot), ANXIETY (Anxiety) and BRONCHITIS (Bronchitis) in a 48-year-old 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.    It was unknown if the patient was enrolled in an clinical trials.  Concurrent medical conditions included Rheumatoid arthritis.   In August 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced JOINT EFFUSION (Knee effusion), DYSPHONIA (Hoarse voice), FEELING HOT (Feeling hot), ANXIETY (Anxiety), BRONCHITIS (Bronchitis), CHEST PAIN (Chest pain), DYSPNOEA (Breathing difficult), ASTHENIA (Weakness) and PYREXIA (Fever). The patient was treated with ALPRAZOLAM (XANAX) at a dose of 1 dosage form. At the time of the report, JOINT EFFUSION (Knee effusion) had not resolved and DYSPHONIA (Hoarse voice), FEELING HOT (Feeling hot), ANXIETY (Anxiety), BRONCHITIS (Bronchitis), CHEST PAIN (Chest pain), DYSPNOEA (Breathing difficult), ASTHENIA (Weakness) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The causality for the events Knee effusion with respect to Humira was reported as reasonable possibility. The causality for the events Weakness,Feeling hot, Fever, Chest pain,Breathing difficult with respect to Humira was reported as No reasonable possibility.  The causality for the events Anxiety, Bronchitis with respect to Humira was reported as not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination site pain
Clinical narrative: Terrible pain in side after taking flu vaccine; Sick after taking COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after taking COVID vaccine) and VACCINATION SITE PAIN (Terrible pain in side after taking flu vaccine) in a 66-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   In February 2021, 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. In February 2021, the patient experienced ILLNESS (Sick after taking COVID vaccine). In September 2021, the patient experienced VACCINATION SITE PAIN (Terrible pain in side after taking flu vaccine). In 2021, ILLNESS (Sick after taking COVID vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (Terrible pain in side after taking flu vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient was administered with FLU Vaccine VII (influenza vaccine) and was unknown if patient was enrolled in a COVID-19 vaccine trial. The event of vaccination site pain resolved on 2021.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone, Blood testosterone decreased, COVID-19, Dermatitis contact, Exposure to toxic agent
Clinical narrative: Osteopenia; Osteoporosis; UNDERSIZED PITUITARY GLAND; LESS TESTOSTERONE; COVID-19; Vaccination failure; ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY; ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY; FUNGAL RASH FROM GENITALS TO UPPER BACK; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK), EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), OSTEOPENIA (Osteopenia) and OSTEOPOROSIS (Osteoporosis) in a 48-year-old 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 Ankylosing spondylitis and Ulcerative colitis.    Concurrent medical conditions included Allergy to plants (Poison ivy).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-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 FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK). In August 2021, the patient experienced EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY) and DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY). On 24-Aug-2021, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure). On an unknown date, the patient experienced OSTEOPENIA (Osteopenia), OSTEOPOROSIS (Osteoporosis), HYPOPITUITARISM (UNDERSIZED PITUITARY GLAND) and BLOOD TESTOSTERONE DECREASED (LESS TESTOSTERONE). In 2021, FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK) had resolved. At the time of the report, EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), OSTEOPENIA (Osteopenia), OSTEOPOROSIS (Osteoporosis), HYPOPITUITARISM (UNDERSIZED PITUITARY GLAND) and BLOOD TESTOSTERONE DECREASED (LESS TESTOSTERONE) had not resolved, COVID-19 (COVID-19) had resolved and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Blood testosterone: less testosterone. On 24-Aug-2021, SARS-CoV-2 test: (Positive) Positive.         It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  COVID-19 was resolved in 2021.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fungal skin infection, Hypopituitarism, Osteopenia, Osteoporosis, SARS-CoV-2 test
Clinical narrative: Osteopenia; Osteoporosis; UNDERSIZED PITUITARY GLAND; LESS TESTOSTERONE; COVID-19; Vaccination failure; ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY; ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY; FUNGAL RASH FROM GENITALS TO UPPER BACK; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK), EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), OSTEOPENIA (Osteopenia) and OSTEOPOROSIS (Osteoporosis) in a 48-year-old 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 Ankylosing spondylitis and Ulcerative colitis.    Concurrent medical conditions included Allergy to plants (Poison ivy).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-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 FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK). In August 2021, the patient experienced EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY) and DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY). On 24-Aug-2021, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure). On an unknown date, the patient experienced OSTEOPENIA (Osteopenia), OSTEOPOROSIS (Osteoporosis), HYPOPITUITARISM (UNDERSIZED PITUITARY GLAND) and BLOOD TESTOSTERONE DECREASED (LESS TESTOSTERONE). In 2021, FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK) had resolved. At the time of the report, EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), OSTEOPENIA (Osteopenia), OSTEOPOROSIS (Osteoporosis), HYPOPITUITARISM (UNDERSIZED PITUITARY GLAND) and BLOOD TESTOSTERONE DECREASED (LESS TESTOSTERONE) had not resolved, COVID-19 (COVID-19) had resolved and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Blood testosterone: less testosterone. On 24-Aug-2021, SARS-CoV-2 test: (Positive) Positive.         It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  COVID-19 was resolved in 2021.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Osteopenia; Osteoporosis; UNDERSIZED PITUITARY GLAND; LESS TESTOSTERONE; COVID-19; Vaccination failure; ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY; ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY; FUNGAL RASH FROM GENITALS TO UPPER BACK; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK), EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), OSTEOPENIA (Osteopenia) and OSTEOPOROSIS (Osteoporosis) in a 48-year-old 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 Ankylosing spondylitis and Ulcerative colitis.    Concurrent medical conditions included Allergy to plants (Poison ivy).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-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 FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK). In August 2021, the patient experienced EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY) and DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY). On 24-Aug-2021, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure). On an unknown date, the patient experienced OSTEOPENIA (Osteopenia), OSTEOPOROSIS (Osteoporosis), HYPOPITUITARISM (UNDERSIZED PITUITARY GLAND) and BLOOD TESTOSTERONE DECREASED (LESS TESTOSTERONE). In 2021, FUNGAL SKIN INFECTION (FUNGAL RASH FROM GENITALS TO UPPER BACK) had resolved. At the time of the report, EXPOSURE TO TOXIC AGENT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), DERMATITIS CONTACT (ALLERGIC TO POISON IVY AND BROKE OUT IN POISON IVY), OSTEOPENIA (Osteopenia), OSTEOPOROSIS (Osteoporosis), HYPOPITUITARISM (UNDERSIZED PITUITARY GLAND) and BLOOD TESTOSTERONE DECREASED (LESS TESTOSTERONE) had not resolved, COVID-19 (COVID-19) had resolved and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Blood testosterone: less testosterone. On 24-Aug-2021, SARS-CoV-2 test: (Positive) Positive.         It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  COVID-19 was resolved in 2021.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal hernia, Blood testosterone, Chills, Pain, Thyroid disorder
Clinical narrative: THYROID OVER 150; HERNIA ABOVE NAVEL TO RIB CAGE; BODY ACHES; Chills; This spontaneous case was reported by a consumer and describes the occurrence of THYROID DISORDER (THYROID OVER 150), ABDOMINAL HERNIA (HERNIA ABOVE NAVEL TO RIB CAGE), PAIN (BODY ACHES) and CHILLS (Chills) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    It was unknown if the patient was enrolled in any clinical trials.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced THYROID DISORDER (THYROID OVER 150), ABDOMINAL HERNIA (HERNIA ABOVE NAVEL TO RIB CAGE), PAIN (BODY ACHES) and CHILLS (Chills). At the time of the report, THYROID DISORDER (THYROID OVER 150) and ABDOMINAL HERNIA (HERNIA ABOVE NAVEL TO RIB CAGE) had not resolved and PAIN (BODY ACHES) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood testosterone: Testosterone zero. On an unknown date, Thyroid function test: Thyroid over 150. Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The reporter causality for the events with respect to Rinviq was reported as not reported.  The treatment medication was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Thyroid function test
Clinical narrative: THYROID OVER 150; HERNIA ABOVE NAVEL TO RIB CAGE; BODY ACHES; Chills; This spontaneous case was reported by a consumer and describes the occurrence of THYROID DISORDER (THYROID OVER 150), ABDOMINAL HERNIA (HERNIA ABOVE NAVEL TO RIB CAGE), PAIN (BODY ACHES) and CHILLS (Chills) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    It was unknown if the patient was enrolled in any clinical trials.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced THYROID DISORDER (THYROID OVER 150), ABDOMINAL HERNIA (HERNIA ABOVE NAVEL TO RIB CAGE), PAIN (BODY ACHES) and CHILLS (Chills). At the time of the report, THYROID DISORDER (THYROID OVER 150) and ABDOMINAL HERNIA (HERNIA ABOVE NAVEL TO RIB CAGE) had not resolved and PAIN (BODY ACHES) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood testosterone: Testosterone zero. On an unknown date, Thyroid function test: Thyroid over 150. Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The reporter causality for the events with respect to Rinviq was reported as not reported.  The treatment medication was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: COVID-19; Vaccination site erythema/Arm got really red after the covid shot; Vaccination site swelling/Arm got really swollen after the covid shot; Vaccination site pain/Arm got really painful; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), VACCINATION SITE ERYTHEMA (Vaccination site erythema/Arm got really red after the covid shot), VACCINATION SITE SWELLING (Vaccination site swelling/Arm got really swollen after the covid shot) and VACCINATION SITE PAIN (Vaccination site pain/Arm got really painful) in a 52-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 Hidradenitis suppurativa.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2021, the patient experienced COVID-19 (COVID-19). In 2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema/Arm got really red after the covid shot), VACCINATION SITE SWELLING (Vaccination site swelling/Arm got really swollen after the covid shot) and VACCINATION SITE PAIN (Vaccination site pain/Arm got really painful). In 2021, COVID-19 (COVID-19), VACCINATION SITE ERYTHEMA (Vaccination site erythema/Arm got really red after the covid shot), VACCINATION SITE SWELLING (Vaccination site swelling/Arm got really swollen after the covid shot) and VACCINATION SITE PAIN (Vaccination site pain/Arm got really painful) had resolved. Not provided          This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Humrira daily dose was reported as Citrate free. It was reported that the Humira therapy stop date of APR-2021 and again patient started therapy with Humira on an unknown date of 2021 and stop date was MAY-2021. The reporter's causality of Humira for the events of arm got really red after the covid shot, arm got really swollen , after the covid shot, arm got really painful after the covid shot and COVID-19 was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Maternal exposure during pregnancy, No adverse event
Clinical narrative: Maternal exposure during pregnancy; Maternal exposure during breast feeding; No Adverse event; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No Adverse event) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No Adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications was not reported. Patient had a 3 year old and a 2 month old child.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This Spontaneous case describes the occurrence of maternal exposure during breastfeeding and maternal exposure during pregnancy in a female patient of unknown age, with no medical history reported, who experienced no adverse event. The exposure occurred after vaccination with an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: No New information received.; Sender's Comments: This Spontaneous case describes the occurrence of maternal exposure during breastfeeding and maternal exposure during pregnancy in a female patient of unknown age, with no medical history reported, who experienced no adverse event. The exposure occurred after vaccination with an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus, Skin exfoliation
Clinical narrative: SWELLING OF LEGS, LEGS HAD DOUBLED IN SIZE, SWELLING IN THE CALVES; CALVES AND FEET FELT LIKE THEY WERE ON FIRE; SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY; SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY; SKIN ITCHED REAL BAD; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (SWELLING OF LEGS, LEGS HAD DOUBLED IN SIZE, SWELLING IN THE CALVES), BURNING SENSATION (CALVES AND FEET FELT LIKE THEY WERE ON FIRE), ERYTHEMA (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY), SKIN EXFOLIATION (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY) and PRURITUS (SKIN ITCHED REAL BAD) in a 62-year-old male 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 26-Oct-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (SWELLING OF LEGS, LEGS HAD DOUBLED IN SIZE, SWELLING IN THE CALVES), BURNING SENSATION (CALVES AND FEET FELT LIKE THEY WERE ON FIRE), ERYTHEMA (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY), SKIN EXFOLIATION (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY) and PRURITUS (SKIN ITCHED REAL BAD). At the time of the report, PERIPHERAL SWELLING (SWELLING OF LEGS, LEGS HAD DOUBLED IN SIZE, SWELLING IN THE CALVES), BURNING SENSATION (CALVES AND FEET FELT LIKE THEY WERE ON FIRE), ERYTHEMA (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY), SKIN EXFOLIATION (SKIN WAS REDDENED WITH SCALY PATCHES ALL OVER THE BODY) and PRURITUS (SKIN ITCHED REAL BAD) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: Fatigue; Felt crummy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and MALAISE (Felt crummy) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-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 September 2021, the patient experienced MALAISE (Felt crummy). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) and MALAISE (Felt crummy) had resolved.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Product administered to patient of inappropriate age
Clinical narrative: A 13 year old boy who died after receiving Moderna; Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (A 13 year old boy who died after receiving Moderna) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (A 13 year old boy who died after receiving Moderna) (seriousness criteria death and medically significant) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown. No concomitant medication information was provided. No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case of product administered to patient of inappropriate age for this 13-year-old, male patient with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient died after receiving the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Non-significant FU appended On 27-Sep-2021: Non-significant FU appended; Sender's Comments: This is a spontaneous case of product administered to patient of inappropriate age for this 13-year-old, male patient with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient died after receiving the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Death.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of vaccine administered; No Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007821A and 003A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy, Pilonidal cyst, Non-tobacco user and Ex-alcohol user. Concomitant products included ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No treatment medications were reported It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623819.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 68-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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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) at an unspecified dose. In 2021, the patient experienced CHILLS (Chills). In 2021, CHILLS (Chills) had resolved.            No relevant concomitant medications were reported. On an unknown date patient was on a CPAP machine (Positive airway pressure therapy). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of on a CPAP machine and chills with Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No Adverse Event; 1st Dose was taken as Pfizer and 2nd Dose was taken as Moderna; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st Dose was taken as Pfizer and 2nd Dose was taken as Moderna), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (First dose of Pfizer) on 26-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st Dose was taken as Pfizer and 2nd Dose was taken as Moderna) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st Dose was taken as Pfizer and 2nd Dose was taken as Moderna), COVID-19 IMMUNISATION (Revaccination with different COVID-19 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 assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (1st Dose was taken as Pfizer and 2nd Dose was taken as Moderna) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine).    No concomitant medications were reported.   Caller reports one of their nurses gave incorrect second dose of Moderna covid vaccine to a patient which should have been Pfizer covid vaccine. Patient was accidentally said yes to getting Moderna vaccine but marked Pfizer vaccine on questionnaire.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Spinal stenosis, Vaccination site pain
Clinical narrative: JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT; JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT; SPINAL STENOSIS; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT), VACCINATION SITE PAIN (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT) and SPINAL STENOSIS (SPINAL STENOSIS) 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 Rheumatoid arthritis.  No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received 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. In 2021, the patient experienced SPINAL STENOSIS (SPINAL STENOSIS). On an unknown date, the patient experienced ARTHRALGIA (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT) and VACCINATION SITE PAIN (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT). At the time of the report, ARTHRALGIA (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT) and VACCINATION SITE PAIN (JOINT PAIN and SORENESS OF ARM AROUND THE INJECTION OF COVID-19 SECOND SHOT) had resolved and SPINAL STENOSIS (SPINAL STENOSIS) outcome was unknown.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.   This case was linked to MOD-2021-620470 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arms hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arms hurt) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arms hurt). At the time of the report, VACCINATION SITE PAIN (Arms hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. Her husband had zero side effects and patient were on Moderna. Patient's kids got Pfizer and arms hurt. Patients first shot and her arm hurt for three days and then a week later and she looked and had a covid arm. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 50-year-old male 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-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 HEADACHE (Headache). In 2021, HEADACHE (Headache) had resolved.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the event(s) of SECOND COVID VACCINE RESULTED IN A HEADACHE was not provided. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects). At the time of the report, IMMUNISATION REACTION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. Patient got moderna and had side effects and stated that most Pfizer people he knew had a less. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: LITTLE REACTION; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (LITTLE REACTION) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 15-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. In 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, Solution for injection in pre-filled pen. On an unknown date, the patient experienced IMMUNISATION REACTION (LITTLE REACTION). At the time of the report, IMMUNISATION REACTION (LITTLE REACTION) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporter's causality for the event of LITTLE REACTION WITH THE BOOSTER OF COVID VACCINE was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Skin plaque
Clinical narrative: Fatigue; Headache; Skin plaque; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Skin plaque), FATIGUE (Fatigue) and HEADACHE (Headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Concurrent medical conditions included Psoriasis.   On 19-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received first 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. In 2021, the patient experienced SKIN PLAQUE (Skin plaque). On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). In 2021, SKIN PLAQUE (Skin plaque) had resolved. At the time of the report, FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of Fatigue, Headache was reported as no reasonable possibility and for Skin plaque was reported as reasonable possibility for Humira.  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Trouble sleeping; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Trouble sleeping) and PAIN IN EXTREMITY (Sore arm) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Trouble sleeping) and PAIN IN EXTREMITY (Sore arm). At the time of the report, INSOMNIA (Trouble sleeping) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Patient experienced trouble sleeping for first night and sore arm post moderna shot. Event took place after use of product.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Attention deficit hyperactivity disorder, Fatigue, Malaise
Clinical narrative: Attention deficit hyperactivity disorder; Feeling sick; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), MALAISE (Feeling sick) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and ATOMOXETINE HYDROCHLORIDE (STRATTERA) for an unknown indication.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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) citrate free and ATOMOXETINE HYDROCHLORIDE (STRATTERA) (unknown route) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder) and MALAISE (Feeling sick). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) at an unspecified dose and frequency. In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder) outcome was unknown and MALAISE (Feeling sick) was resolving.            No concomitant medications were reported.   On unknown dates, the patient experienced strattera made sick and attention deficit hyperactivity disorder. In 2021, the patient experienced second covid-19 vaccine injection had only fatigue.  In 2021, the second covid-19 vaccine injection had only fatigue resolved. Moderna vaccine and Strattera (atomoxetine hydrochloride) were also considered suspect.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.