chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Asthma, Drug hypersensitivity, Intervertebral disc degeneration, Intervertebral disc protrusion
Clinical narrative: Spinal stenosis; Degenerative disc disease; BULGING DISC; TROUBLE SPOTS ON ELBOWS AND KNEES; Psoriasis flare-up; ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES; ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL STENOSIS (Spinal stenosis), INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease), INTERVERTEBRAL DISC PROTRUSION (BULGING DISC), ARTHROPATHY (TROUBLE SPOTS ON ELBOWS AND KNEES) and PSORIASIS (Psoriasis flare-up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SPINAL STENOSIS (Spinal stenosis), INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease), INTERVERTEBRAL DISC PROTRUSION (BULGING DISC), ARTHROPATHY (TROUBLE SPOTS ON ELBOWS AND KNEES), PSORIASIS (Psoriasis flare-up), ASTHMA (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES) and DRUG HYPERSENSITIVITY (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES). At the time of the report, SPINAL STENOSIS (Spinal stenosis), INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease) and INTERVERTEBRAL DISC PROTRUSION (BULGING DISC) had not resolved, ARTHROPATHY (TROUBLE SPOTS ON ELBOWS AND KNEES) outcome was unknown, PSORIASIS (Psoriasis flare-up) was resolving and ASTHMA (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES) and DRUG HYPERSENSITIVITY (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No known allergies. Concomitant Drugs Not Reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Psorasis flare ups when it get close to the next dosage. Respiratory disorder (BREATHING ISSUES ) was the reported symptom of the event Asthma. No treatment information 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: Psoriasis, Spinal stenosis
Clinical narrative: Spinal stenosis; Degenerative disc disease; BULGING DISC; TROUBLE SPOTS ON ELBOWS AND KNEES; Psoriasis flare-up; ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES; ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL STENOSIS (Spinal stenosis), INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease), INTERVERTEBRAL DISC PROTRUSION (BULGING DISC), ARTHROPATHY (TROUBLE SPOTS ON ELBOWS AND KNEES) and PSORIASIS (Psoriasis flare-up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SPINAL STENOSIS (Spinal stenosis), INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease), INTERVERTEBRAL DISC PROTRUSION (BULGING DISC), ARTHROPATHY (TROUBLE SPOTS ON ELBOWS AND KNEES), PSORIASIS (Psoriasis flare-up), ASTHMA (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES) and DRUG HYPERSENSITIVITY (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES). At the time of the report, SPINAL STENOSIS (Spinal stenosis), INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease) and INTERVERTEBRAL DISC PROTRUSION (BULGING DISC) had not resolved, ARTHROPATHY (TROUBLE SPOTS ON ELBOWS AND KNEES) outcome was unknown, PSORIASIS (Psoriasis flare-up) was resolving and ASTHMA (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES) and DRUG HYPERSENSITIVITY (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No known allergies. Concomitant Drugs Not Reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Psorasis flare ups when it get close to the next dosage. Respiratory disorder (BREATHING ISSUES ) was the reported symptom of the event Asthma. No treatment information 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Mental fatigue, Vaccination site hypersensitivity
Clinical narrative: Mental fatigue; Sensitive on arm due to covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL FATIGUE (Mental fatigue) and VACCINATION SITE HYPERSENSITIVITY (Sensitive on arm due to covid vaccine) in a 58-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) solution for injection for Plaque psoriasis.    No Medical History information was reported.   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. On an unknown date, the patient experienced MENTAL FATIGUE (Mental fatigue) and VACCINATION SITE HYPERSENSITIVITY (Sensitive on arm due to covid vaccine). At the time of the report, MENTAL FATIGUE (Mental fatigue) had not resolved and VACCINATION SITE HYPERSENSITIVITY (Sensitive on arm due to covid vaccine) had resolved.            No Concomitant medications were reported. 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.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Malaise
Clinical narrative: Inappropriate schedule of vaccine administered; Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 55-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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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) Solution for injection in pre-filled pen. In April 2021, the patient experienced MALAISE (Feeling unwell). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, MALAISE (Feeling unwell) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication information was provided. In April 2021, the patient experienced felt under the weather after the second covid vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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: Arthralgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Received knee brace to help with knee pain) and PAIN IN EXTREMITY (Pain in right leg) in an adult 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. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-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) UNK, Citrate Free. On an unknown date, the patient experienced ARTHRALGIA (Received knee brace to help with knee pain) and PAIN IN EXTREMITY (Pain in right leg). At the time of the report, ARTHRALGIA (Received knee brace to help with knee pain) was resolving and PAIN IN EXTREMITY (Pain in right leg) 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 was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. No treatment medication was reported. The reporter's causality for the event received knee brace to help with knee pain was not provided. The reporter's causality for the event of pain in right leg with Humira was no reasonable possibility. Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Live follow up information was added. Event information was updated, narrative was updated.
Sex: F
Vaccine: COVID19
Symptoms: Colitis microscopic, Diarrhoea
Clinical narrative: micro colitis; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS MICROSCOPIC (micro colitis) 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.     No Medical History information was reported.    In April 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 COLITIS MICROSCOPIC (micro colitis) (seriousness criterion medically significant) and DIARRHOEA (Diarrhea). At the time of the report, COLITIS MICROSCOPIC (micro colitis) and DIARRHOEA (Diarrhea) had not resolved.            Concomitant Drugs Not Reported. 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.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Colitis microscopic, which occurred after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Colitis microscopic, which occurred after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pyrexia, Stenosis, Vomiting
Clinical narrative: Had a stricture; 1st dose received on 03-Mar-2021, 2nd dose received on 21-Mar-2021; Tiredness; throwing up; High fever; This spontaneous case was reported by a consumer and describes the occurrence of STENOSIS (Had a stricture), FATIGUE (Tiredness), VOMITING (throwing up), PYREXIA (High fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 03-Mar-2021, 2nd dose received on 21-Mar-2021) in a 20-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 14-Apr-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced FATIGUE (Tiredness), VOMITING (throwing up) and PYREXIA (High fever). On 21-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 03-Mar-2021, 2nd dose received on 21-Mar-2021). On an unknown date, the patient experienced STENOSIS (Had a stricture). At the time of the report, STENOSIS (Had a stricture), FATIGUE (Tiredness), VOMITING (throwing up) and PYREXIA (High fever) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 03-Mar-2021, 2nd dose received on 21-Mar-2021) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of TIREDNESS/THROWING UP onset in March 2021, TIREDNESS/THROWING UP onset in March 2021 and HIGH FEVER was not provided. The reporter's causality for the event(s) of HAD A STRICTURE with HUMIRA(ADALIMUMAB) was no reasonable possibility. 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, UNK
Symptoms: Osteoporosis
Clinical narrative: Osteoporosis; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOPOROSIS (Osteoporosis) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced OSTEOPOROSIS (Osteoporosis). The patient was treated with DENOSUMAB (PROLIA) at an unspecified dose and frequency. At the time of the report, OSTEOPOROSIS (Osteoporosis) had not resolved.            No concomitant medication information was provided. 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: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: first dose was the Moderna Covid-19 /inadvertently received the Pfizer Covid 19 Vaccine; first dose was the Moderna Covid-19 /inadvertently received the Pfizer Covid 19 Vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dose was the Moderna Covid-19 /inadvertently received the Pfizer Covid 19 Vaccine), COVID-19 IMMUNISATION (first dose was the Moderna Covid-19 /inadvertently received the Pfizer Covid 19 Vaccine) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and TOZINAMERAN (COMIRNATY) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose was the Moderna Covid-19 /inadvertently received the Pfizer Covid 19 Vaccine), COVID-19 IMMUNISATION (first dose was the Moderna Covid-19 /inadvertently received the Pfizer Covid 19 Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (first dose was the Moderna Covid-19 /inadvertently received the Pfizer Covid 19 Vaccine), COVID-19 IMMUNISATION (first dose was the Moderna Covid-19 /inadvertently received the Pfizer Covid 19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (first dose was the Moderna Covid-19 /inadvertently received the Pfizer Covid 19 Vaccine) and COVID-19 IMMUNISATION (first dose was the Moderna Covid-19 /inadvertently received the Pfizer Covid 19 Vaccine).    No concomitant medication was reported. No treatment medication was reported.  Given that the Moderna product was not reported as a co-suspect product and there is no other attribution to the Moderna product in this report from the other manufacturer, the Moderna product is not considered to be a suspect product in this report  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: Death
Clinical narrative: Doctor dies; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Doctor dies) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported. 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.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, 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 'Doctor dies' after getting Moderna and Pfizer Covid vaccines. 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.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, 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 'Doctor dies' after getting Moderna and Pfizer Covid vaccines. 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: Doctor dies
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: had side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (had side effects) in a 23-year-old male patient 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 (had side effects). At the time of the report, IMMUNISATION REACTION (had side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. 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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Live Follow-Up appended
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, COVID-19
Clinical narrative: COVID-19; Broken ankle; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (Broken ankle) and COVID-19 (COVID-19) in a 57-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.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced ANKLE FRACTURE (Broken ankle). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, ANKLE FRACTURE (Broken ankle) and COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: This is a spontaneous case concerning a 57-year-old female patient with Rheumatoid arthritis, who experienced the non-serious unexpected event of COVID-19 (AESI), on an unknown date  after receiving an unspecified dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided. Ankle fracture was also reported as an event. Adalimumab was reported as a co-suspect product.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  No concomitant product was reported. The patient missed two to three doses of Humira because she had COVID-19 virus. On 27-Sep-2021, she had ankle surgery as she broke it. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events with Humira was reported as reasonable possibility. 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.; Sender's Comments: Company comment: This is a spontaneous case concerning a 57-year-old female patient with Rheumatoid arthritis, who experienced the non-serious unexpected event of COVID-19 (AESI), on an unknown date  after receiving an unspecified dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided. Ankle fracture was also reported as an event. Adalimumab was reported as a co-suspect product.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation reaction, Somnolence
Clinical narrative: had a side effect; just slept for a whole day, he just slept; got a headache with both; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (had a side effect), SOMNOLENCE (just slept for a whole day, he just slept) and HEADACHE (got a headache with both) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Overweight.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (had a side effect), SOMNOLENCE (just slept for a whole day, he just slept) and HEADACHE (got a headache with both). In 2021, SOMNOLENCE (just slept for a whole day, he just slept) and HEADACHE (got a headache with both) had resolved. At the time of the report, IMMUNISATION REACTION (had a side effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not recall what dates the patient had the vaccine, it was a week or 2 after her son so sometime in May-2021 and the 2nd she thought the end of May-2021. The patient got the vaccine at 4 in the afternoon and was just feeling off and then got a headache and then fell asleep at 6pm and woke up the next day at 6am. Reporter would like to say it was totally gone and felt fine the next day. He got the Modena vaccine and had the best sleep he had ever had, he slept 12 hours with both and loved it, he said he would take it again so he could sleep. He was taking medications and had a couple that blood pressure medication and some for his stomach and something else. They were monitoring his heart and he was overweight.  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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Live significant FU appended( events added) On 05-Aug-2021: Non-significant FU appended On 16-Sep-2021: Live significant FU appended(patient race, events added)
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Headache
Clinical narrative: Back pain; Knee pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), ARTHRALGIA (Knee pain) and HEADACHE (Headache) in an adult 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.   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain), ARTHRALGIA (Knee pain) and HEADACHE (Headache). At the time of the report, BACK PAIN (Back pain), ARTHRALGIA (Knee pain) and HEADACHE (Headache) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Reporters causality of events with Humira was no reasonable possibility.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) in a 67-year-old female 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.    Concomitant products included METHOTREXATE for an unknown indication.   In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 1 dosage form. In August 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. In 2021, the patient experienced PAIN (Achy). In 2021, PAIN (Achy) had resolved.            The patient got her covid booster vaccine in Aug 2021 and was feeling a bit achy afterwards. She did had to stop the Rinvoq and Methotrexate for a week after the booster and she started feeling a bit achy from that as well. But it was better.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PSORIASIS FLARE UP ON LEGS; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS FLARE UP ON LEGS) in an adult 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 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (PSORIASIS FLARE UP ON LEGS). At the time of the report, PSORIASIS (PSORIASIS FLARE UP ON LEGS) outcome was unknown.            Concomitant medication was not reported.  Patient skin was almost completely clear. Patient took the Moderna vaccine and had a flare up on legs. Patient believed it was a direct cause of the vaccine. Treatment details were not 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Seasonal allergy; Sinus congestion; Nausea; Headache; Chills; Fatigue; Vaccination site pain; Ache; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Seasonal allergy), SINUS CONGESTION (Sinus congestion), PAIN (Ache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Vaccination site pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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) CF, Solution for injection in pre-filled pen. In 2021, the patient experienced PAIN (Ache), VACCINATION SITE PAIN (Vaccination site pain), CHILLS (Chills) and FATIGUE (Fatigue). On 16-Sep-2021, the patient experienced SEASONAL ALLERGY (Seasonal allergy), SINUS CONGESTION (Sinus congestion), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, SEASONAL ALLERGY (Seasonal allergy), SINUS CONGESTION (Sinus congestion), PAIN (Ache), NAUSEA (Nausea), VACCINATION SITE PAIN (Vaccination site pain), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            In 2021, the patient experienced arm pain after covid vaccine, achiness, chills and fatigue. On 16 Sep 2021, the patient experienced nausea, congestion and headache and seasonal allergies.   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: F
Vaccine: COVID19
Symptoms: Seasonal allergy, Sinus congestion, Vaccination site pain
Clinical narrative: Seasonal allergy; Sinus congestion; Nausea; Headache; Chills; Fatigue; Vaccination site pain; Ache; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Seasonal allergy), SINUS CONGESTION (Sinus congestion), PAIN (Ache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Vaccination site pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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) CF, Solution for injection in pre-filled pen. In 2021, the patient experienced PAIN (Ache), VACCINATION SITE PAIN (Vaccination site pain), CHILLS (Chills) and FATIGUE (Fatigue). On 16-Sep-2021, the patient experienced SEASONAL ALLERGY (Seasonal allergy), SINUS CONGESTION (Sinus congestion), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, SEASONAL ALLERGY (Seasonal allergy), SINUS CONGESTION (Sinus congestion), PAIN (Ache), NAUSEA (Nausea), VACCINATION SITE PAIN (Vaccination site pain), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            In 2021, the patient experienced arm pain after covid vaccine, achiness, chills and fatigue. On 16 Sep 2021, the patient experienced nausea, congestion and headache and seasonal allergies.   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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Intervertebral disc disorder, Lumbar spinal stenosis, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain; Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain; welts on left arm; Urinary tract infection; soreness on left arm; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), LUMBAR SPINAL STENOSIS (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), INTERVERTEBRAL DISC DISORDER (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), URTICARIA (welts on left arm) and URINARY TRACT INFECTION (Urinary tract infection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included SULFASALAZINE, FISH OIL, LACOSAMIDE (VIMPAT), FOLIC ACID, METHOTREXATE, VITAMIN D NOS, OMEPRAZOLE, PRAVASTATIN SODIUM, FUROSEMIDE, OXYBUTYNIN, CHLORIDE, OXYCODONE HCL, PHENAZOPYRIDINE HCL, CIPROFLOXACIN HCL, IBUPROFEN, METHYLPREDNISOLONE and LISINOPRIL for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 19-Dec-2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced LUMBAR SPINAL STENOSIS (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), INTERVERTEBRAL DISC DISORDER (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), URTICARIA (welts on left arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY (soreness on left arm). On 30-Dec-2020, COVID-19 (COVID-19) had resolved. At the time of the report, LUMBAR SPINAL STENOSIS (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain) and INTERVERTEBRAL DISC DISORDER (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain) had not resolved, URTICARIA (welts on left arm) and PAIN IN EXTREMITY (soreness on left arm) was resolving and URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Urticaria
Clinical narrative: Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain; Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain; welts on left arm; Urinary tract infection; soreness on left arm; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), LUMBAR SPINAL STENOSIS (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), INTERVERTEBRAL DISC DISORDER (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), URTICARIA (welts on left arm) and URINARY TRACT INFECTION (Urinary tract infection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included SULFASALAZINE, FISH OIL, LACOSAMIDE (VIMPAT), FOLIC ACID, METHOTREXATE, VITAMIN D NOS, OMEPRAZOLE, PRAVASTATIN SODIUM, FUROSEMIDE, OXYBUTYNIN, CHLORIDE, OXYCODONE HCL, PHENAZOPYRIDINE HCL, CIPROFLOXACIN HCL, IBUPROFEN, METHYLPREDNISOLONE and LISINOPRIL for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 19-Dec-2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced LUMBAR SPINAL STENOSIS (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), INTERVERTEBRAL DISC DISORDER (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain), URTICARIA (welts on left arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY (soreness on left arm). On 30-Dec-2020, COVID-19 (COVID-19) had resolved. At the time of the report, LUMBAR SPINAL STENOSIS (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain) and INTERVERTEBRAL DISC DISORDER (Spinal stenosis/l5 was pushing on vertebrae/whenever do housework in lot of pain) had not resolved, URTICARIA (welts on left arm) and PAIN IN EXTREMITY (soreness on left arm) was resolving and URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Neurological symptom, Off label use
Clinical narrative: Neurological and digestive problems; Neurological and digestive problems; off label use in unapproved age group; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (Neurological and digestive problems) and DYSPEPSIA (Neurological and digestive problems) in a 12-year-old female 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.    In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced NEUROLOGICAL SYMPTOM (Neurological and digestive problems) (seriousness criterion hospitalization) and DYSPEPSIA (Neurological and digestive problems) (seriousness criterion hospitalization). On an unknown date, the patient experienced OFF LABEL USE (off label use in unapproved age group). At the time of the report, NEUROLOGICAL SYMPTOM (Neurological and digestive problems) and DYSPEPSIA (Neurological and digestive problems) had not resolved and OFF LABEL USE (off label use in unapproved age group) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient participated in an experiment in Pfizer or Moderna mRNA technology.  patient experienced events 12 hours after second dose.  She has been hospitalized several times and her condition to this day continues to be difficult.  No concomitant medications were reported. 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 concerns a 12-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization) events of neurological symptoms and dyspepsia starting 12 hours after the second dose of mRNA-1273. The report stated that it is unclear whether the patient received the "Pfizer or Moderna mRNA" vaccine. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 12-year-old female patient with no medical history reported, who experienced the unexpected, serious (hospitalization) events of neurological symptoms and dyspepsia starting 12 hours after the second dose of mRNA-1273. The report stated that it is unclear whether the patient received the "Pfizer or Moderna mRNA" vaccine. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Nausea, Peripheral swelling
Clinical narrative: Red swollen arm; Localised erythema; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Red swollen arm), ERYTHEMA (Localised erythema), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in an elderly 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Red swollen arm), ERYTHEMA (Localised erythema), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, PERIPHERAL SWELLING (Red swollen arm), ERYTHEMA (Localised erythema), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) was resolving.        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 treatment medication was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthma, Lethargy, Respiratory disorder
Clinical narrative: Breathing issues; Asthma; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), RESPIRATORY DISORDER (Breathing issues) and ASTHMA (Asthma) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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) 1 dosage form. In 2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced RESPIRATORY DISORDER (Breathing issues) and ASTHMA (Asthma). At the time of the report, LETHARGY (Lethargic), RESPIRATORY DISORDER (Breathing issues) and ASTHMA (Asthma) outcome was unknown.            No concomitant medication information was reported.   No treatment medication was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna.