chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 40-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 Ankylosing spondylitis.    The patient's past medical history included Seizures (The morning after surgery she had seizure.) in 2020, Ureteral disorder, Weight gain, Postoperative complication, Migraine, Tingling, Ureteric rupture (The patient experienced collapsed ureter tube/artery laying across kidney/caused from  gainig weight/morning after surgery had seizures.) in 2020, Head pain (She had searing pain down left side of head), Numbness, Pain (She had overexertion which caused pain) and Surgery (Patient experienced kidney surgery due to collapsed ureter tube, artery laying across it which was due to gaining weight.) in 2020.   On 02-Jun-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) Citrate free. In June 2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  After receiving first dose of Moderna Covid vaccine patient's arm was sore. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event pain in extremity was not provided with HUMIRA(ADALIMUMAB).  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.   This case was linked to MOD-2021-624027 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills from COVID-19 Moderna vaccinations; Fatigue from COVID-19 Moderna vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills from COVID-19 Moderna vaccinations) and FATIGUE (Fatigue from COVID-19 Moderna vaccinations) 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) solution for injection for Crohn's disease.    No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-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, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced CHILLS (Chills from COVID-19 Moderna vaccinations) and FATIGUE (Fatigue from COVID-19 Moderna vaccinations). At the time of the report, CHILLS (Chills from COVID-19 Moderna vaccinations) and FATIGUE (Fatigue from COVID-19 Moderna vaccinations) had resolved.            No concomitant medication was reported.  The co-suspect Humira formulation was reported as solution for injection in pre-filled pen. After second dose, patient had reaction of chills and fatigue for three days. No treatment information was reported.  The reporter causality for events chills from COVID-19 Moderna vaccinations and fatigue from COVID-19 Moderna vaccinations with co-suspect 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.   This case was linked to MOD-2021-623188 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Platelet count, White blood cell count
Clinical narrative: Covid vaccine related issues; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Covid vaccine related issues) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Knee replacement (Left knee). Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 21-Oct-2021, the patient experienced IMMUNISATION REACTION (Covid vaccine related issues). At the time of the report, IMMUNISATION REACTION (Covid vaccine related issues) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, Platelet count: Low. On 21-Nov-2021, White blood cell count: Low.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of low white count and low platelet count with Moderna was provided as probable. The reporter's causality for the event(s) of right knee was bone on bone, fatigue, low white count, right knee pain, covid vaccine related issues and low platelet count with RINVOQ 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.   This case was linked to MOD-2021-626133 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Nausea, Pain
Clinical narrative: Sweating increased; nausea; tired; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HYPERHIDROSIS (Sweating increased), NAUSEA (nausea) and FATIGUE (tired) in an adult 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.    Concurrent medical conditions included Plaque psoriasis.   In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced PAIN (body aches), NAUSEA (nausea) and FATIGUE (tired). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating increased). In September 2021, PAIN (body aches), NAUSEA (nausea) and FATIGUE (tired) had resolved. At the time of the report, HYPERHIDROSIS (Sweating increased) had not resolved.            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 information was provided.   This case was linked to MOD-2021-622199 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE SORENESS AFTER SECOND COVID SHOT; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (INJECTION SITE SORENESS AFTER SECOND COVID SHOT) 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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   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 and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown. On an unknown date, the patient experienced INJECTION SITE PAIN (INJECTION SITE SORENESS AFTER SECOND COVID SHOT). At the time of the report, INJECTION SITE PAIN (INJECTION SITE SORENESS AFTER SECOND COVID SHOT) had resolved.            It was reported that, there was no known allergies.  No concomitant medications were reported.  On an unknown date, laboratory test of biopsy and colonoscopy was reported as unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event injection site pain was not provided with HUMIRA(ADALIMUMAB).  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.   This case was linked to MOD-2021-642637 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Influenza like illness, Intervertebral disc disorder, Neck pain
Clinical narrative: Lower back hurt giving a concern 4th and 5th vertebrae; Neck hurts; Right knee hurting; Lower back hurting; Flu like; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC DISORDER (Lower back hurt giving a concern 4th and 5th vertebrae), VACCINATION SITE PAIN (Arm sore), NECK PAIN (Neck hurts), ARTHRALGIA (Right knee hurting) and INFLUENZA LIKE ILLNESS (Flu like) in a 65-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.   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. 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) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Arm sore) and INFLUENZA LIKE ILLNESS (Flu like). On an unknown date, the patient experienced INTERVERTEBRAL DISC DISORDER (Lower back hurt giving a concern 4th and 5th vertebrae), NECK PAIN (Neck hurts), ARTHRALGIA (Right knee hurting) and BACK PAIN (Lower back hurting). The patient was treated with MENTHOL (FLEXALL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INTERVERTEBRAL DISC DISORDER (Lower back hurt giving a concern 4th and 5th vertebrae), VACCINATION SITE PAIN (Arm sore), NECK PAIN (Neck hurts), ARTHRALGIA (Right knee hurting), INFLUENZA LIKE ILLNESS (Flu like) and BACK PAIN (Lower back hurting) had not resolved.            No concomitant medication provided.  On an unknown date patient experienced lower back hurting, with concerns to 4th and 5th vertebrae. Neck and right knee hurt as well. In 2021, patient experienced arm sore, felt congestion and flu like symptoms after the booster shot.  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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Lower back hurt giving a concern 4th and 5th vertebrae; Neck hurts; Right knee hurting; Lower back hurting; Flu like; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC DISORDER (Lower back hurt giving a concern 4th and 5th vertebrae), VACCINATION SITE PAIN (Arm sore), NECK PAIN (Neck hurts), ARTHRALGIA (Right knee hurting) and INFLUENZA LIKE ILLNESS (Flu like) in a 65-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.   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. 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) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Arm sore) and INFLUENZA LIKE ILLNESS (Flu like). On an unknown date, the patient experienced INTERVERTEBRAL DISC DISORDER (Lower back hurt giving a concern 4th and 5th vertebrae), NECK PAIN (Neck hurts), ARTHRALGIA (Right knee hurting) and BACK PAIN (Lower back hurting). The patient was treated with MENTHOL (FLEXALL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INTERVERTEBRAL DISC DISORDER (Lower back hurt giving a concern 4th and 5th vertebrae), VACCINATION SITE PAIN (Arm sore), NECK PAIN (Neck hurts), ARTHRALGIA (Right knee hurting), INFLUENZA LIKE ILLNESS (Flu like) and BACK PAIN (Lower back hurting) had not resolved.            No concomitant medication provided.  On an unknown date patient experienced lower back hurting, with concerns to 4th and 5th vertebrae. Neck and right knee hurt as well. In 2021, patient experienced arm sore, felt congestion and flu like symptoms after the booster shot.  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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN RIGHT ARM; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORENESS IN RIGHT ARM) in a 59-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.    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. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In April 2021, the patient experienced PAIN IN EXTREMITY (SORENESS IN RIGHT ARM). In 2021, PAIN IN EXTREMITY (SORENESS IN RIGHT ARM) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient reported in Apr 2021, she had first covid vaccine and her right arm was really sore for about 12 days. But it was okay as of 18 Nov 2021.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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.   This case was linked to MOD-2021-642680.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 59-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.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. In 2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: about 100, which lasted for about the hours.   No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for RINVOQ(UPADACITINIB) was not provided 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.   This case was linked to MOD-2021-642636 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: NAUSEA AFTER THIRD DOSE OF COVID VACCINE; SICK FROM COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICK FROM COVID VACCINE) and NAUSEA (NAUSEA AFTER THIRD DOSE OF COVID VACCINE) in a 27-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 Crohn's disease.    Previously administered products included for Drug use for unknown indication: STELARA. Past adverse reactions to the above products included No adverse event with STELARA. Concurrent medical conditions included Crohn's disease and Obsessive-compulsive disorder. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Obsessive-compulsive disorder.   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 20-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced NAUSEA (NAUSEA AFTER THIRD DOSE OF COVID VACCINE). In November 2021, the patient experienced ILLNESS (SICK FROM COVID VACCINE). On 14-Nov-2021, NAUSEA (NAUSEA AFTER THIRD DOSE OF COVID VACCINE) had resolved. In November 2021, ILLNESS (SICK FROM COVID VACCINE) had resolved.            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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medications were not reported.  The reporter's causality for the event(s) of sick from covid vaccine and nausea after third dose of covid vaccine with Humira 40mg/0.4ml(adalimumab) was no reasonable possibility.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Eye inflammation, Feeling hot, Fungal skin infection, Nasal ulcer
Clinical narrative: Bronchitis; Nasal ulcer/Sores inside nose; Itching at injection site; Injection site allergic reaction; Eye inflammation/Inflammation of eye; Fungal skin infection; Feeling hot/Feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), FUNGAL SKIN INFECTION (Fungal skin infection), EYE INFLAMMATION (Eye inflammation/Inflammation of eye), FEELING HOT (Feeling hot/Feeling feverish) and NASAL ULCER (Nasal ulcer/Sores inside nose) in a 49-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) injection for Crohn's disease.    No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In August 2021, the patient experienced FEELING HOT (Feeling hot/Feeling feverish). In October 2021, the patient experienced FUNGAL SKIN INFECTION (Fungal skin infection). In November 2021, the patient experienced EYE INFLAMMATION (Eye inflammation/Inflammation of eye). On an unknown date, the patient experienced BRONCHITIS (Bronchitis), NASAL ULCER (Nasal ulcer/Sores inside nose), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE HYPERSENSITIVITY (Injection site allergic reaction). In December 2021, FUNGAL SKIN INFECTION (Fungal skin infection) had resolved. At the time of the report, BRONCHITIS (Bronchitis), EYE INFLAMMATION (Eye inflammation/Inflammation of eye), FEELING HOT (Feeling hot/Feeling feverish), NASAL ULCER (Nasal ulcer/Sores inside nose) and VACCINATION SITE HYPERSENSITIVITY (Injection site allergic reaction) outcome was unknown and VACCINATION SITE PRURITUS (Itching at injection site) had not resolved.            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.   This case was linked to MOD-2022-624170 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hypersensitivity, Vaccination site pruritus
Clinical narrative: Bronchitis; Nasal ulcer/Sores inside nose; Itching at injection site; Injection site allergic reaction; Eye inflammation/Inflammation of eye; Fungal skin infection; Feeling hot/Feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), FUNGAL SKIN INFECTION (Fungal skin infection), EYE INFLAMMATION (Eye inflammation/Inflammation of eye), FEELING HOT (Feeling hot/Feeling feverish) and NASAL ULCER (Nasal ulcer/Sores inside nose) in a 49-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) injection for Crohn's disease.    No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In August 2021, the patient experienced FEELING HOT (Feeling hot/Feeling feverish). In October 2021, the patient experienced FUNGAL SKIN INFECTION (Fungal skin infection). In November 2021, the patient experienced EYE INFLAMMATION (Eye inflammation/Inflammation of eye). On an unknown date, the patient experienced BRONCHITIS (Bronchitis), NASAL ULCER (Nasal ulcer/Sores inside nose), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE HYPERSENSITIVITY (Injection site allergic reaction). In December 2021, FUNGAL SKIN INFECTION (Fungal skin infection) had resolved. At the time of the report, BRONCHITIS (Bronchitis), EYE INFLAMMATION (Eye inflammation/Inflammation of eye), FEELING HOT (Feeling hot/Feeling feverish), NASAL ULCER (Nasal ulcer/Sores inside nose) and VACCINATION SITE HYPERSENSITIVITY (Injection site allergic reaction) outcome was unknown and VACCINATION SITE PRURITUS (Itching at injection site) had not resolved.            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.   This case was linked to MOD-2022-624170 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Seasonal allergy, Visual impairment
Clinical narrative: Ear pain; Seasonal allergy; Visual issues; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain), SEASONAL ALLERGY (Seasonal allergy) and VISUAL IMPAIRMENT (Visual issues) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 08-Apr-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced EAR PAIN (Ear pain), SEASONAL ALLERGY (Seasonal allergy) and VISUAL IMPAIRMENT (Visual issues). At the time of the report, EAR PAIN (Ear pain), SEASONAL ALLERGY (Seasonal allergy) and VISUAL IMPAIRMENT (Visual issues) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial . Concomitant medications were not reported.  No treatment information was provided by the 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: F
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: back surgery for internal infusion; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (back surgery for internal infusion) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BACK DISORDER (back surgery for internal infusion) (seriousness criterion medically significant). At the time of the report, BACK DISORDER (back surgery for internal infusion) outcome was unknown.            No concomitant medications were reported. Patient was having back surgery for internal infusion. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of internal infusion was Not reported for cosuspect rinvoq. 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 adult female patient of unspecified age with concurrent medical condition of HIDRADENITIS that was treated with UPADACITINIB (RINVOQ), who experienced the unexpected, serious (medically significant) of Back disorder (back surgery for internal infusion) that occurred on an unknown date in context to a dose of mRNA-1273 vaccine. The clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Hidradenitis treated with UPADACITINIB (RINVOQ) co-suspect remains a risk factor for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns adult female patient of unspecified age with concurrent medical condition of HIDRADENITIS that was treated with UPADACITINIB (RINVOQ), who experienced the unexpected, serious (medically significant) of Back disorder (back surgery for internal infusion) that occurred on an unknown date in context to a dose of mRNA-1273 vaccine. The clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The medical history of Hidradenitis treated with UPADACITINIB (RINVOQ) co-suspect remains a risk factor for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye inflammation
Clinical narrative: Eye inflammation getting worse; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFLAMMATION (Eye inflammation getting worse) 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) solution for injection for Panuveitis and Ulcerative colitis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE INFLAMMATION (Eye inflammation getting worse). At the time of the report, EYE INFLAMMATION (Eye inflammation getting worse) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial . Concomitant medications were not reported.  No treatment information was provided by the 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well due to receiving COVID-19 vaccine shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well due to receiving COVID-19 vaccine shot) 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 UPADACITINIB (RINVOQ) for Plaque psoriasis and Rheumatoid arthritis.    No Medical History information was reported.   On 25-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 25-Apr-2022, the patient experienced MALAISE (Not feeling well due to receiving COVID-19 vaccine shot). At the time of the report, MALAISE (Not feeling well due to receiving COVID-19 vaccine shot) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial . Concomitant medications were not reported.  No treatment information was provided by the 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: F
Vaccine: COVID19, COVID19
Symptoms: Immunosuppression
Clinical narrative: Immunosupressant problem; This spontaneous case was reported by a patient and describes the occurrence of IMMUNOSUPPRESSION (Immunosupressant problem) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 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 On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNOSUPPRESSION (Immunosupressant problem) (seriousness criterion medically significant). At the time of the report, IMMUNOSUPPRESSION (Immunosupressant problem) outcome was unknown.            Concomitant medications details were not reported.  Patient received all 3 doses which were of Moderna vaccine. Treatment details were not 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 female patient of an unknown age, who experienced the unexpected, serious  (medically significant) event of Immunosuppression (Immunosupressant problem) on an unknown date in the context of receiving mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and onset of event were not provided. Three doses of mRNA-1273 vaccine were received on unknown dates and intervals. There is very limited information for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, who experienced the unexpected, serious  (medically significant) event of Immunosuppression (Immunosupressant problem) on an unknown date in the context of receiving mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and onset of event were not provided. Three doses of mRNA-1273 vaccine were received on unknown dates and intervals. There is very limited information for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive) in a 54-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 22-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 25-Jan-2022, 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 19-Mar-2022, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue ulceration
Clinical narrative: Tongue ulceration; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ULCERATION (Tongue ulceration) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia.    No Medical History information was reported.   In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 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 IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient experienced TONGUE ULCERATION (Tongue ulceration). At the time of the report, TONGUE ULCERATION (Tongue ulceration) had not resolved.            No concomitant medications was reported. No treatment medications was 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance
Clinical narrative: Difficult to walk; Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficult to walk) and ARTHRITIS (Arthritis) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced GAIT DISTURBANCE (Difficult to walk) and ARTHRITIS (Arthritis). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (Difficult to walk) and ARTHRITIS (Arthritis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Illness, Pain
Clinical narrative: Pain; Localised erythema, arm was red; Fatigue; Sickness; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sickness), PAIN (Pain), ERYTHEMA (Localised erythema, arm was red) and FATIGUE (Fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2022, 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) (unknown route) Citrate free. In April 2022, the patient experienced ILLNESS (Sickness). On an unknown date, the patient experienced PAIN (Pain), ERYTHEMA (Localised erythema, arm was red) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Sickness), PAIN (Pain) and FATIGUE (Fatigue) had not resolved and ERYTHEMA (Localised erythema, arm was red) had resolved.            No concomitant medications were reported. 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: U
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Injection site rash, Pain
Clinical narrative: Patient took 2nd dose on 3 may and 3rd dose on 16 may 2021; Body pain after covid vaccine; Tiredness after covid vaccine; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 3 may and 3rd dose on 16 may 2021), PAIN (Body pain after covid vaccine), FATIGUE (Tiredness after covid vaccine) and INJECTION SITE RASH (Rash at injection site) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 3 may and 3rd dose on 16 may 2021), PAIN (Body pain after covid vaccine), FATIGUE (Tiredness after covid vaccine) and INJECTION SITE RASH (Rash at injection site). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose on 3 may and 3rd dose on 16 may 2021), PAIN (Body pain after covid vaccine), FATIGUE (Tiredness after covid vaccine) and INJECTION SITE RASH (Rash at injection site) had resolved.            The reporter's causality for the event(s) of Rash at injection site with HUMIRA(ADALIMUMAB) was a reasonable possibility.  Concomitant product use was not provided by the reporter. 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.   This case was linked to MOD-2022-624664 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; vaccination failure; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (vaccination failure) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A, 029L20A and 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (vaccination failure). At the time of the report, COVID-19 (COVID-19) had resolved and VACCINATION FAILURE (vaccination failure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (COVID-19) to be related. No further causality assessment was provided for VACCINATION FAILURE (vaccination failure).    Race of the patient was reported.  Patient's age was reported as approximately 59 or 61.  Concomitant medications details were not reported.  The reporter was nurse who was reporting for herself. It was reported that the patient had non the damage of symptoms (further clarification unknown) but said was grateful that patient does not had any lung or cardiac involvement, so patient just said annoying cough occasionally, loss of appetite and said that was out of work for 2 weeks. She had COVID in mid of October 2021. Patient was fine at the time of reporting.   No treatment information 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: F
Vaccine: COVID19
Symptoms: Back pain, Chills
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and CHILLS (Chills) in an elderly female patient who received mRNA-1273 ( for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273  (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273(Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain) and CHILLS (Chills). At the time of the report, BACK PAIN (Back pain) had not resolved and CHILLS (Chills) had resolved.     No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Vaccination site pain
Clinical narrative: FELT THE STOMACH PAIN AGAIN; VACCINE CAUSED PAIN IN ARM; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (FELT THE STOMACH PAIN AGAIN) and VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN ARM) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (FELT THE STOMACH PAIN AGAIN) and VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN ARM). At the time of the report, ABDOMINAL PAIN UPPER (FELT THE STOMACH PAIN AGAIN) was resolving and VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN ARM) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  The reporter's causality for the event of FELT THE STOMACH PAIN AGAIN was a reasonable possibility and for the event of VACCINE CAUSED PAIN IN ARM was no reasonable possibility with HUMIRA(ADALIMUMAB).   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.