chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Hidradenitis, Injection site rash, Pain in extremity
Clinical narrative: Hidradenitis suppurativa; COVID-19; Tiredness; Pain in arm; Rash at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), PAIN IN EXTREMITY (Pain in arm), INJECTION SITE RASH (Rash at site of injection), HIDRADENITIS (Hidradenitis suppurativa) and COVID-19 (COVID-19) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In February 2021, the patient experienced COVID-19 (COVID-19). In 2021, the patient experienced FATIGUE (Tiredness), PAIN IN EXTREMITY (Pain in arm) and INJECTION SITE RASH (Rash at site of injection). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). At the time of the report, FATIGUE (Tiredness), PAIN IN EXTREMITY (Pain in arm), INJECTION SITE RASH (Rash at site of injection) and HIDRADENITIS (Hidradenitis suppurativa) outcome was unknown and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs not reported. No medical history reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the events of Side effects was tired, Sore arm, Rash at the injection site and Hidradenitis Suppurativa was not provided and the reporter causality for the event of COVID-19 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. Treatment drugs not reported.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye disorder
Clinical narrative: EYES FLARED UP; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (EYES FLARED UP) and CHILLS (CHILLS) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In June 2021, the patient experienced EYE DISORDER (EYES FLARED UP). On an unknown date, the patient experienced CHILLS (CHILLS). In October 2021, EYE DISORDER (EYES FLARED UP) had resolved. At the time of the report, CHILLS (CHILLS) had resolved.            No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   The reporter's causality for the event(s) of eyes flared up was not provided. The reporter's causality for the event(s) of chills 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.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Product administration interrupted, Swelling
Clinical narrative: feeling super sick; like couldn't breathe; Arm swelling in shoulder down the back; Did not complete the vaccination series; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling super sick), DYSPNOEA (like couldn't breathe), SWELLING (Arm swelling in shoulder down the back) and PRODUCT ADMINISTRATION INTERRUPTED (Did not complete the vaccination series) in a 20-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling super sick), DYSPNOEA (like couldn't breathe), SWELLING (Arm swelling in shoulder down the back) and PRODUCT ADMINISTRATION INTERRUPTED (Did not complete the vaccination series). At the time of the report, MALAISE (feeling super sick), DYSPNOEA (like couldn't breathe), SWELLING (Arm swelling in shoulder down the back) and PRODUCT ADMINISTRATION INTERRUPTED (Did not complete the vaccination series) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Head injury, Headache, Nausea
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VISUAL IMPAIRMENT (kaleidoscope vision), FALL (Patient fell), HEAD INJURY (Struck head), DIZZINESS (Dizziness) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. No Medical History information was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In February 2021, the patient experienced VISUAL IMPAIRMENT (kaleidoscope vision), FALL (Patient fell), HEAD INJURY (Struck head), DIZZINESS (Dizziness), NAUSEA (nausea) and HEADACHE (Headaches). At the time of the report, VISUAL IMPAIRMENT (kaleidoscope vision), FALL (Patient fell), HEAD INJURY (Struck head), DIZZINESS (Dizziness), NAUSEA (nausea) and HEADACHE (Headaches) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was receiving blood thinners. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. At some point after Moderna vaccine the patient fall, head got struck. MRI was done with no findings. 9d post Pfizer booster dizziness was returned when upright. This was a return of symptoms after 8 weeks of normalcy. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. It was unknown, since the vaccination, has the patient been tested for COVID-19. 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
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VISUAL IMPAIRMENT (kaleidoscope vision), FALL (Patient fell), HEAD INJURY (Struck head), DIZZINESS (Dizziness) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. No Medical History information was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In February 2021, the patient experienced VISUAL IMPAIRMENT (kaleidoscope vision), FALL (Patient fell), HEAD INJURY (Struck head), DIZZINESS (Dizziness), NAUSEA (nausea) and HEADACHE (Headaches). At the time of the report, VISUAL IMPAIRMENT (kaleidoscope vision), FALL (Patient fell), HEAD INJURY (Struck head), DIZZINESS (Dizziness), NAUSEA (nausea) and HEADACHE (Headaches) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was receiving blood thinners. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. At some point after Moderna vaccine the patient fall, head got struck. MRI was done with no findings. 9d post Pfizer booster dizziness was returned when upright. This was a return of symptoms after 8 weeks of normalcy. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. It was unknown, since the vaccination, has the patient been tested for COVID-19. 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: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Fatigue) in a 77-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.    Concurrent medical conditions included Macular degeneration and Crohn's disease (Moderate to severe).   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, the patient experienced CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) had resolved.            No concomitant medication provided. No treatment information mentioned.  Patient had macular degeneration in right eye. Had both COVID Moderna vaccines and after second dose had chills and fatigue for 3 days.   Reporters causality for 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: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Bronchitis, COVID-19, Decreased appetite, Foot deformity
Clinical narrative: Bronchitis; Osteoarthritis; Foot deformity; Pinched nerve; Pain; Pain in hip; Decreased appetite; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decreased appetite), COVID-19 (COVID-19), BRONCHITIS (Bronchitis), OSTEOARTHRITIS (Osteoarthritis) and FOOT DEFORMITY (Foot deformity) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DECREASED APPETITE (Decreased appetite), BRONCHITIS (Bronchitis), OSTEOARTHRITIS (Osteoarthritis), FOOT DEFORMITY (Foot deformity), NERVE COMPRESSION (Pinched nerve), PAIN (Pain) and ARTHRALGIA (Pain in hip). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, DECREASED APPETITE (Decreased appetite) and ARTHRALGIA (Pain in hip) outcome was unknown, BRONCHITIS (Bronchitis), NERVE COMPRESSION (Pinched nerve) and PAIN (Pain) had resolved, OSTEOARTHRITIS (Osteoarthritis) had not resolved and FOOT DEFORMITY (Foot deformity) 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. No concomitant medication was reported. No treatment medication was reported. In Aug-2021 the patient experienced COVID-19. In 2021 COVID-19 resolved. On unknown date patient experienced COVID-19 and resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Live follow Up information received on 10-Feb-2022. New event was added.
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nerve compression, Osteoarthritis, Pain
Clinical narrative: Bronchitis; Osteoarthritis; Foot deformity; Pinched nerve; Pain; Pain in hip; Decreased appetite; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decreased appetite), COVID-19 (COVID-19), BRONCHITIS (Bronchitis), OSTEOARTHRITIS (Osteoarthritis) and FOOT DEFORMITY (Foot deformity) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DECREASED APPETITE (Decreased appetite), BRONCHITIS (Bronchitis), OSTEOARTHRITIS (Osteoarthritis), FOOT DEFORMITY (Foot deformity), NERVE COMPRESSION (Pinched nerve), PAIN (Pain) and ARTHRALGIA (Pain in hip). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, DECREASED APPETITE (Decreased appetite) and ARTHRALGIA (Pain in hip) outcome was unknown, BRONCHITIS (Bronchitis), NERVE COMPRESSION (Pinched nerve) and PAIN (Pain) had resolved, OSTEOARTHRITIS (Osteoarthritis) had not resolved and FOOT DEFORMITY (Foot deformity) 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. No concomitant medication was reported. No treatment medication was reported. In Aug-2021 the patient experienced COVID-19. In 2021 COVID-19 resolved. On unknown date patient experienced COVID-19 and resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Live follow Up information received on 10-Feb-2022. New event was added.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug specific antibody present, Hidradenitis, Impaired healing
Clinical narrative: Hidradenitis suppurativa flare up; Delay wound healing; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare up) and IMPAIRED HEALING (Delay wound healing) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 041620A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    The patient's past medical history included Non-smoker, Alcohol use (One glass of beer once a month), Itching, Fever, Loss of sensation, Loss of smell, Cough, Fatigue, Loss of taste, COVID-19 from February 2020 to March 2020 and Shortness of breath (Worsened shortness of breath). Concurrent medical conditions included Hidradenitis suppurativa, Asthma and Latex allergy (Latex allergy manifested by itchiness). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma.   In October 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In April 2021, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare up) and IMPAIRED HEALING (Delay wound healing). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare up) was resolving and IMPAIRED HEALING (Delay wound healing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2021, Drug specific antibody present: Body created Humira antibodies..         On an unknown date it was reported that Humira had stopped working. On 23 Jun 2021, the patient experienced Humira antibodies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Humira antibodies, hidradenitis suppurativa flare up and delay wound healing with HUMIRA 40MG/0.8ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Humira stopped working 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: REACTION TO COVID VACCINE/VERY SLEEPY AFTER SECOND COVID VACCINE SLEPT THE WHOLE DAY; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (REACTION TO COVID VACCINE/VERY SLEEPY) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.  No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Mar-2021, the patient experienced SOMNOLENCE (REACTION TO COVID VACCINE/VERY SLEEPY). On 21-Mar-2021, SOMNOLENCE (REACTION TO COVID VACCINE/VERY SLEEPY) 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.  No concomitant medication information was provided.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fatigue
Clinical narrative: Something like arthritis in left shoulder joint; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Something like arthritis in left shoulder joint) and FATIGUE (Fatigue) 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 Rheumatoid arthritis.  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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRITIS (Something like arthritis in left shoulder joint) and FATIGUE (Fatigue). At the time of the report, ARTHRITIS (Something like arthritis in left shoulder joint) outcome was unknown and FATIGUE (Fatigue) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication information was reported. No treatment medication information 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: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Knee pain). At the time of the report, ARTHRALGIA (Knee pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment medication was provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Condition aggravated, Pain in extremity
Clinical narrative: MAJOR FLARE UP; ARM SORENESS; BACK PAIN; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (MAJOR FLARE UP), PAIN IN EXTREMITY (ARM SORENESS) and BACK PAIN (BACK PAIN) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Crohn's disease.    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) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (MAJOR FLARE UP), PAIN IN EXTREMITY (ARM SORENESS) and BACK PAIN (BACK PAIN). At the time of the report, CONDITION AGGRAVATED (MAJOR FLARE UP) and PAIN IN EXTREMITY (ARM SORENESS) had resolved and BACK PAIN (BACK PAIN) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  On unknown dates, the patient experienced major flare up, arm soreness and back pain. On unknown dates, major flare up and arm soreness resolved. Moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On unknown  date, patient received covid-19 vaccine manufactured by moderna.  Causality for humira (adalimumab) The reporter's causality for the event (s) of major flare up and arm soreness with humira (adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of back pain was not provided.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity received in the moderna were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Skin disorder, Vaccination site pain
Clinical narrative: Scalp disorder; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Scalp disorder) and VACCINATION SITE PAIN (Vaccination site pain) 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) injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   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. On an unknown date, the patient experienced SKIN DISORDER (Scalp disorder) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, SKIN DISORDER (Scalp disorder) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        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.   No concomitant medication information was  provided.  It was reported that on an unknown dates, the patient experienced scalp issues and sore arm after COVID -19 vaccine and sore arm after COVID -19 vaccine resolved . The suspect drug humira daily dose was reported as citrate free.   No treatment medication information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site haemorrhage, Vaccination site mass
Clinical narrative: Vaccination site lump; Injection site bruising; Injection site redness; Injection site bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Vaccination site lump), INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE HAEMORRHAGE (Injection site bleeding) 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 Rheumatoid arthritis and Psoriatic arthritis.    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 On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced VACCINATION SITE MASS (Vaccination site lump), INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE HAEMORRHAGE (Injection site bleeding). At the time of the report, VACCINATION SITE MASS (Vaccination site lump) was resolving and INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE HAEMORRHAGE (Injection site bleeding) had not resolved.            Concomitant drugs not reported. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the event of Vaccination site Lump reasonable possibility and the reporter causality for the events of Injection site bruising, Injection site redness and Injection site bleeding 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. Treatment drugs not reported.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Liver function test, Nausea, Osteoarthritis
Clinical narrative: Swelling of legs; Osteoarthritis; Paresthesia lower limb; Pain legs; Headache; Fatigue; Nausea; Vomiting; Urination frequency of; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urination frequency of), PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb) and PAIN IN EXTREMITY (Pain legs) in a 48-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 products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and GABAPENTIN for an unknown indication.    No Medical History information was reported.   On 20-Jul-2021, the patient started GABAPENTIN (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On 20-Jul-2021, the patient experienced POLLAKIURIA (Urination frequency of). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb), PAIN IN EXTREMITY (Pain legs), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, POLLAKIURIA (Urination frequency of), PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb), PAIN IN EXTREMITY (Pain legs), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: abnormal. On an unknown date, Platelet count: Low. On an unknown date, Thyroid function test: High(abnormal). On an unknown date, White blood cell count: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs and treatment medications 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Platelet count, Pollakiuria
Clinical narrative: Swelling of legs; Osteoarthritis; Paresthesia lower limb; Pain legs; Headache; Fatigue; Nausea; Vomiting; Urination frequency of; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urination frequency of), PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb) and PAIN IN EXTREMITY (Pain legs) in a 48-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 products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and GABAPENTIN for an unknown indication.    No Medical History information was reported.   On 20-Jul-2021, the patient started GABAPENTIN (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On 20-Jul-2021, the patient experienced POLLAKIURIA (Urination frequency of). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb), PAIN IN EXTREMITY (Pain legs), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, POLLAKIURIA (Urination frequency of), PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb), PAIN IN EXTREMITY (Pain legs), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: abnormal. On an unknown date, Platelet count: Low. On an unknown date, Thyroid function test: High(abnormal). On an unknown date, White blood cell count: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs and treatment medications 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, Vomiting, White blood cell count
Clinical narrative: Swelling of legs; Osteoarthritis; Paresthesia lower limb; Pain legs; Headache; Fatigue; Nausea; Vomiting; Urination frequency of; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urination frequency of), PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb) and PAIN IN EXTREMITY (Pain legs) in a 48-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 products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and GABAPENTIN for an unknown indication.    No Medical History information was reported.   On 20-Jul-2021, the patient started GABAPENTIN (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On 20-Jul-2021, the patient experienced POLLAKIURIA (Urination frequency of). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb), PAIN IN EXTREMITY (Pain legs), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, POLLAKIURIA (Urination frequency of), PERIPHERAL SWELLING (Swelling of legs), OSTEOARTHRITIS (Osteoarthritis), PARAESTHESIA (Paresthesia lower limb), PAIN IN EXTREMITY (Pain legs), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: abnormal. On an unknown date, Platelet count: Low. On an unknown date, Thyroid function test: High(abnormal). On an unknown date, White blood cell count: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs and treatment medications 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) 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.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  In 2021, the patient experienced arm sore from getting the moderna covid booster. 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 received in the moderna were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pyrexia, Somnolence
Clinical narrative: Sleepy after covid vaccination; Tiredness after covid vaccination; Fever after covid vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy after covid vaccination), FATIGUE (Tiredness after covid vaccination) and PYREXIA (Fever after covid vaccination) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SOMNOLENCE (Sleepy after covid vaccination), FATIGUE (Tiredness after covid vaccination) and PYREXIA (Fever after covid vaccination). At the time of the report, SOMNOLENCE (Sleepy after covid vaccination) and FATIGUE (Tiredness after covid vaccination) was resolving and PYREXIA (Fever after covid vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 event(s) of tiredness after covid vaccination and sleepy after covid vaccination with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of fever after covid vaccination 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: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Discomfort, Dyspnoea, Immunisation reaction
Clinical narrative: chest discomfort / chest pressure; vaccination adverse reaction; chest pain; shortness of breath; discomfort; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest discomfort / chest pressure), IMMUNISATION REACTION (vaccination adverse reaction), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath) and DISCOMFORT (discomfort) in a male 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 COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest discomfort / chest pressure), IMMUNISATION REACTION (vaccination adverse reaction), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath) and DISCOMFORT (discomfort). At the time of the report, CHEST DISCOMFORT (chest discomfort / chest pressure), IMMUNISATION REACTION (vaccination adverse reaction), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath) and DISCOMFORT (discomfort) outcome was unknown. No concomitant and 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Flu; General body pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 68-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 METHOTREXATE and HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN) for Rheumatoid arthritis.   In August 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), INFLUENZA (Flu) and PAIN (General body pain). On 11-Mar-2021, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), INFLUENZA (Flu) and PAIN (General body pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information mentioned.  Patient took the first dose of vaccine on 10MAR2021. Experienced flu, rheumatoid arthritis flare up and general body pain. Recovered on 11MAR2021.  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 68 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), on the same day of receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also had influenza and pain. The event resolved. No information on detailed clinical course, relevant investigations  and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-623561 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), on the same day of receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also had influenza and pain. The event resolved. No information on detailed clinical course, relevant investigations  and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthropod sting, Feeling hot, Pruritus, Swelling, Vaccination site pruritus
Clinical narrative: hot; Itchy; Bee sting; Insect Stings; Swelling; Moderna site itchiness; Moderna site rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot), PRURITUS (Itchy), ARTHROPOD STING (Bee sting), ARTHROPOD STING (Insect Stings) and SWELLING (Swelling) 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 Rheumatoid arthritis.    It was unknown if the patient was enrolled in clinical trials.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot), PRURITUS (Itchy), ARTHROPOD STING (Bee sting), ARTHROPOD STING (Insect Stings), SWELLING (Swelling), VACCINATION SITE PRURITUS (Moderna site itchiness) and VACCINATION SITE RASH (Moderna site rash). At the time of the report, FEELING HOT (hot), PRURITUS (Itchy) and VACCINATION SITE PRURITUS (Moderna site itchiness) outcome was unknown and ARTHROPOD STING (Bee sting), ARTHROPOD STING (Insect Stings), SWELLING (Swelling) and VACCINATION SITE RASH (Moderna site rash) had resolved.        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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site rash
Clinical narrative: hot; Itchy; Bee sting; Insect Stings; Swelling; Moderna site itchiness; Moderna site rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot), PRURITUS (Itchy), ARTHROPOD STING (Bee sting), ARTHROPOD STING (Insect Stings) and SWELLING (Swelling) 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 Rheumatoid arthritis.    It was unknown if the patient was enrolled in clinical trials.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot), PRURITUS (Itchy), ARTHROPOD STING (Bee sting), ARTHROPOD STING (Insect Stings), SWELLING (Swelling), VACCINATION SITE PRURITUS (Moderna site itchiness) and VACCINATION SITE RASH (Moderna site rash). At the time of the report, FEELING HOT (hot), PRURITUS (Itchy) and VACCINATION SITE PRURITUS (Moderna site itchiness) outcome was unknown and ARTHROPOD STING (Bee sting), ARTHROPOD STING (Insect Stings), SWELLING (Swelling) and VACCINATION SITE RASH (Moderna site rash) had resolved.        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.