chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Pruritus, Swelling
Clinical narrative: ITCHINESS WHEN DUE FOR NEXT SKYRIZI INJECTION with SKYRIZI (RISANKIZUMAB); UNSPECIFIED SWELLING; SICK; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (ITCHINESS WHEN DUE FOR NEXT SKYRIZI INJECTION with SKYRIZI (RISANKIZUMAB)), SWELLING (UNSPECIFIED SWELLING) and ILLNESS (SICK) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PRURITUS (ITCHINESS WHEN DUE FOR NEXT SKYRIZI INJECTION with SKYRIZI (RISANKIZUMAB)), SWELLING (UNSPECIFIED SWELLING) and ILLNESS (SICK). At the time of the report, PRURITUS (ITCHINESS WHEN DUE FOR NEXT SKYRIZI INJECTION with SKYRIZI (RISANKIZUMAB)), SWELLING (UNSPECIFIED SWELLING) and ILLNESS (SICK) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient was doing well on Skyrizi, but had itchiness when was due for next Skyrizi injection. The patient also had unspecified swelling and was sick for one week following injection.  The reporter's causality for the events of UNSPECIFIED SWELLING and SICK with SKYRIZI(RISANKIZUMAB) was not related and for evet of ITCHINESS WHEN DUE FOR NEXT SKYRIZI INJECTION with SKYRIZI(RISANKIZUMAB) was a related  No treatment drug details was reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dry skin, Fungal infection, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Dry skin; Itchy skin; Injection site warmth; Yeast infection; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry skin), PRURITUS (Itchy skin), INJECTION SITE WARMTH (Injection site warmth), FUNGAL INFECTION (Yeast infection) and INJECTION SITE ERYTHEMA (Injection site redness) 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 Psoriatic arthritis and Rheumatoid arthritis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced DRY SKIN (Dry skin), PRURITUS (Itchy skin), INJECTION SITE WARMTH (Injection site warmth), FUNGAL INFECTION (Yeast infection) and INJECTION SITE ERYTHEMA (Injection site redness). At the time of the report, DRY SKIN (Dry skin) and PRURITUS (Itchy skin) was resolving and INJECTION SITE WARMTH (Injection site warmth), FUNGAL INFECTION (Yeast infection) and INJECTION SITE ERYTHEMA (Injection site redness) outcome was unknown.            Patient received moderna as a booster dose.  Reporter's causality for the events of dry skin, Itchy skin, Yeast infection, Injection site warmth and injection site redness for humira drug were not reported.  No treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Age: 40.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Influenza like illness, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Flu like symptoms; Injection site itching; Injection site pain; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 40-year-old 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 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. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness). In 2022, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE ERYTHEMA (Injection site redness) had not resolved.            No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of pain, red, itching at injection site for booster dose had worst reaction with Humira ( Adalinumab) was a reasonable possibility. The reporter's causality for the event of FLU LIKE SYMPTOMS was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Joint swelling, Pain
Clinical narrative: Felt Pain; SWOLLEN JOINTS; Pain abdominal; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt Pain), JOINT SWELLING (SWOLLEN JOINTS) and ABDOMINAL PAIN (Pain abdominal) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Feb-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) at an unspecified dose. In February 2021, the patient experienced PAIN (Felt Pain). In 2021, the patient experienced JOINT SWELLING (SWOLLEN JOINTS) and ABDOMINAL PAIN (Pain abdominal). At the time of the report, PAIN (Felt Pain), JOINT SWELLING (SWOLLEN JOINTS) and ABDOMINAL PAIN (Pain abdominal) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.   The reporter did not provide causality for events swollen joints, pain and abdominal pain with Humira.  The reporter assessed event as pain possibly related to Moderna COVID-19 vaccine and did not provide causality for event swollen joints and pain abdominal.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment details were reported.   This case was linked to MOD-2022-627625 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Minimal side effects, one day; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Minimal side effects, one day) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 023M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included RITUXIMAB (RITUXAN) for Rheumatoid arthritis.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Minimal side effects, one day). In 2021, IMMUNISATION REACTION (Minimal side effects, one day) had resolved.            No treatment details were provided   This case was linked to MOD-2022-627444, MOD-2022-611803 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I was sick) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 028L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included RITUXIMAB (RITUXAN) for Rheumatoid arthritis.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was sick). At the time of the report, ILLNESS (I was sick) outcome was unknown.            Patient reported was sick for nearly week after the injection.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-627434, MOD-2022-611803 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Pain
Clinical narrative: HEALTH DECLINING/STRUGGLING WITH HEALTH; ACHES/PAIN; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (HEALTH DECLINING/STRUGGLING WITH HEALTH) and PAIN (ACHES/PAIN) in a 60-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 Ankylosing spondylitis and Rheumatoid arthritis.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth 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 2022, the patient experienced PAIN (ACHES/PAIN). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (HEALTH DECLINING/STRUGGLING WITH HEALTH). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (HEALTH DECLINING/STRUGGLING WITH HEALTH) and PAIN (ACHES/PAIN) outcome was unknown.            No concomitant medications were reported. Physician advertently wrote prescription for every two weeks but requiring Humira once weekly/provided incorrect directions, might be from electronic Submission. No treatment medications were reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fibromyalgia
Clinical narrative: Fibromyalgia; Pain in joint involving shoulder region; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia) and ARTHRALGIA (Pain in joint involving shoulder region) 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 Psoriatic 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) Citrate Free. On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia) and ARTHRALGIA (Pain in joint involving shoulder region). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Migraine, at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (Fibromyalgia) outcome was unknown and ARTHRALGIA (Pain in joint involving shoulder region) had not resolved.            Concomitant medications details were not reported by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient was treated with EXCEDRIN for Migraine. Formulation for HUMIRA was reported as Solution for injection in pre-filled pen.  Company Comment: This is a spontaneous case concerning an adult female patient with intake of the co-suspect, non-company product Adalimumab (Humira) as treatment for Psoriatic Arthritis, who experienced the unexpected, non-serious, adverse event of special interest, Fibromyalgia and the, expected, non-serious event of Arthralgia. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and the co-suspect Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event Arthralgia has not resolved while Fibromyalgia was unknown. The medical condition of Psoriatic Arthritis that is being treated with Adalimumab remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient with intake of the co-suspect, non-company product Adalimumab (Humira) as treatment for Psoriatic Arthritis, who experienced the unexpected, non-serious, adverse event of special interest, Fibromyalgia and the, expected, non-serious event of Arthralgia. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and the co-suspect Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event Arthralgia has not resolved while Fibromyalgia was unknown. The medical condition of Psoriatic Arthritis that is being treated with Adalimumab remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Joint lock, Pain in extremity
Clinical narrative: Joints fingers middle finger locks; Right hand aches; Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), JOINT LOCK (Joints fingers middle finger locks) and PAIN IN EXTREMITY (Right hand aches) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    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, pre-filled pen. On an unknown date, the patient experienced ILLNESS (Sick), JOINT LOCK (Joints fingers middle finger locks) and PAIN IN EXTREMITY (Right hand aches). At the time of the report, ILLNESS (Sick) had resolved and JOINT LOCK (Joints fingers middle finger locks) and PAIN IN EXTREMITY (Right hand aches) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications information was reported. The information was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Vaccination site pain
Clinical narrative: Increased osteoarthritis pain; Vaccination site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Increased osteoarthritis pain) and VACCINATION SITE PAIN (Vaccination site tenderness) 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 Crohn's disease.    No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-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) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (Increased osteoarthritis pain) and VACCINATION SITE PAIN (Vaccination site tenderness). At the time of the report, PAIN (Increased osteoarthritis pain) and VACCINATION SITE PAIN (Vaccination site tenderness) outcome was unknown.            No concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality for Humira was given as the reporter's causality for the events of vaccination site tenderness and increased osteoarthritis pain were not provided. No Treatment information was not provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Flu like symptoms; PAIN IN HANDS HERE AND THERE; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (PAIN IN HANDS HERE AND THERE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) for COVID-19 vaccination.   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 INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (PAIN IN HANDS HERE AND THERE). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved and PAIN IN EXTREMITY (PAIN IN HANDS HERE AND THERE) had not resolved.            No treatment medications were reported.  The reporter's causality for the events of pain in hand and flu like symptoms was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 2nd dose administered on 11-MAR-2021 and Dose 3 administered on 24-JUN-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 11-MAR-2021 and Dose 3 administered on 24-JUN-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis). Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis, APREMILAST (OTEZLA) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 11-MAR-2021 and Dose 3 administered on 24-JUN-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 11-MAR-2021 and Dose 3 administered on 24-JUN-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was reported.   This case was linked to MOD-2022-623920 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Arthropathy
Clinical narrative: Knee problems; PAIN IN RIGHT KNEE; This spontaneous case was reported by a patient and describes the occurrence of ARTHROPATHY (Knee problems) and ARTHRALGIA (PAIN IN RIGHT KNEE) in an 83-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.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free,Solution for injection in. On 01-Mar-2022, the patient experienced ARTHRALGIA (PAIN IN RIGHT KNEE). On an unknown date, the patient experienced ARTHROPATHY (Knee problems). The patient was treated with CELECOXIB (CELEBREX) at a dose of Unknown. At the time of the report, ARTHROPATHY (Knee problems) and ARTHRALGIA (PAIN IN RIGHT KNEE) was resolving.            NO KNOWN ALLERGIES Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of Pain in right knee with humira was not provided.  The reporter's causality for the event of Knee problems with humira was no reasonable possibility   Reporter did not allow further contact
Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Hidradenitis, Pain, Pyrexia
Clinical narrative: ACHE.; HIDRADENITIS SUPPURATIVA FLARE; HIDRADENITIS SUPPURATIVA FLARE; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ACHE.), HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE), CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE) and PYREXIA (FEVER) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 05-Apr-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 05-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) Solution for injection in pre-filled pen, CF. On an unknown date, the patient experienced PAIN (ACHE.), HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE), CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE) and PYREXIA (FEVER). At the time of the report, PAIN (ACHE.) and PYREXIA (FEVER) outcome was unknown and HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE) and CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE) was resolving. Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for the event of hidradenitis suppurativa flare, fever and ache with co suspect Humira was not reported.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Gait disturbance, Urinary tract infection
Clinical narrative: Patient could hardly walk; Urinary tract infection; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Patient could hardly walk), URINARY TRACT INFECTION (Urinary tract infection) and COVID-19 (COVID-19) in a 68-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced GAIT DISTURBANCE (Patient could hardly walk) and URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, GAIT DISTURBANCE (Patient could hardly walk) had resolved, URINARY TRACT INFECTION (Urinary tract infection) had not resolved and COVID-19 (COVID-19) outcome was unknown.            No concomitant medications were reported.  It was reported that on unknown date patient took Moderna Booster dose through intramuscular route.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The reporters causality for HUMIRA(ADALIMUMAB) for the events were not provided.   No treatment medications were reported.  Company comment: This spontaneous case concerns 68 years old female patient, with no medical history, who experienced the unexpected non serious AESI event of Covid-19, which occurred unspecified days after second dose of mRNA-1273 vaccine. At the time of report event outcome is unknown. Current ongoing pandemia remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected.; Sender's Comments: This spontaneous case concerns 68 years old female patient, with no medical history, who experienced the unexpected non serious AESI event of Covid-19, which occurred unspecified days after second dose of mRNA-1273 vaccine. At the time of report event outcome is unknown. Current ongoing pandemia remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Sick/looked like dead; Injection site itching/Red mark and Itching; Injection site pain; Injection site redness/Red mark and Itching; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick/looked like dead), INJECTION SITE PRURITUS (Injection site itching/Red mark and Itching), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE ERYTHEMA (Injection site redness/Red mark and Itching) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient experienced ILLNESS (Sick/looked like dead), INJECTION SITE PRURITUS (Injection site itching/Red mark and Itching), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE ERYTHEMA (Injection site redness/Red mark and Itching). At the time of the report, ILLNESS (Sick/looked like dead), INJECTION SITE PRURITUS (Injection site itching/Red mark and Itching), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE ERYTHEMA (Injection site redness/Red mark and Itching) outcome was unknown.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.  The reporter causality for the events of sick/looked like dead, injection site pain, red mark and itching with Humira was not reported.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Hidradenitis, Pain in extremity
Clinical narrative: hidradenitis suppurativa flare up under left arm and right leg; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (hidradenitis suppurativa flare up under left arm and right leg), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No medical history was reported.  Concomitant products included DOXYCYCLINE for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HIDRADENITIS (hidradenitis suppurativa flare up under left arm and right leg), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). At the time of the report, HIDRADENITIS (hidradenitis suppurativa flare up under left arm and right leg) had not resolved and FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. The patient received co-suspect Humira in formulation of solution for injection in pre-filled pen (batch no.: 1160294). The patient received Doxycycline at a dose of 100 mg and frequency of once in 2 days. The reporter's causality for the event of hidradenitis suppurativa flare up under left arm and right leg was reported as probable with the co-suspect product Humira. The reporter's causality for the events of sore arm and fatigue was reported as not related with the co-suspect product Humira.  No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Allergy to vaccine
Clinical narrative: Allergic reaction to first dose of COVID vaccine; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction to first dose of COVID vaccine) in a 64-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 Ankylosing spondylitis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In February 2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction to first dose of COVID vaccine). At the time of the report, ALLERGY TO VACCINE (Allergic reaction to first dose of COVID vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details was not reported.  The patient received co-suspect Humira at a dose of 40 mg/0.4 ml (40 milligram solution for injection in pre-filled pen) with the citrate free formulation (40 mg, frequency :once in 2 weeks).  It was unknown if the patient was enrolled in a COVID-19 vaccine trial or not.  The reporter's causality for the event of allergic reaction to first dose of COVID vaccine was not provided with the co-suspect product Humira.  No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) 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 Crohn's disease.    No Medical History information was reported.   On 12-Jul-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 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) Citrate Free. In July 2022, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) was resolving. Patient received moderna third dose as a booster dose. No concomitant medications were reported.  The reporter's causality for the event of felt tired with HUMIRA(ADALIMUMAB) was reported as no reasonable possibility.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Illness, Musculoskeletal discomfort
Clinical narrative: PROBLEMS WITH HIP AREA; GOT SICK WITH COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (PROBLEMS WITH HIP AREA) and ILLNESS (GOT SICK WITH COVID VACCINE) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (PROBLEMS WITH HIP AREA) and ILLNESS (GOT SICK WITH COVID VACCINE). At the time of the report, MUSCULOSKELETAL DISCOMFORT (PROBLEMS WITH HIP AREA) had not resolved and ILLNESS (GOT SICK WITH COVID VACCINE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103, Concomitant medications details were not reported. The reporter causality for the events was not provided with respect to HUMIRA (ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: Occasional sorness in hands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Occasional sorness in hands) 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.    The patient's past medical history included Pain in hip (Hurt in joints in hips.). Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis.).   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. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced PAIN IN EXTREMITY (Occasional sorness in hands). At the time of the report, PAIN IN EXTREMITY (Occasional sorness in hands) had resolved.            No concomitant medications were reported.  The dose patient received on 15-Dec-2021 was third/Booster dose.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality of Humira was reported as reasonable possibility/probable for the event Occasional sorness in hands.  No treatment medications were reported.
Age: 2.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; A child received the 1st dose of Moderna Covid-19 on 15-Jul-2022 and received the 2nd dose of Pfizer Covid-19 vaccine on 10-Aug-2022; A child received the 1st dose of Moderna Covid-19 on 15-Jul-2022 and received the 2nd dose of Pfizer Covid-19 vaccine on 10-Aug-2022; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (A child received the 1st dose of Moderna Covid-19 on 15-Jul-2022 and received the 2nd dose of Pfizer Covid-19 vaccine on 10-Aug-2022), COVID-19 IMMUNISATION (A child received the 1st dose of Moderna Covid-19 on 15-Jul-2022 and received the 2nd dose of Pfizer Covid-19 vaccine on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) 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 15-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2022, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 10-Aug-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (A child received the 1st dose of Moderna Covid-19 on 15-Jul-2022 and received the 2nd dose of Pfizer Covid-19 vaccine on 10-Aug-2022) and COVID-19 IMMUNISATION (A child received the 1st dose of Moderna Covid-19 on 15-Jul-2022 and received the 2nd dose of Pfizer Covid-19 vaccine on 10-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (A child received the 1st dose of Moderna Covid-19 on 15-Jul-2022 and received the 2nd dose of Pfizer Covid-19 vaccine on 10-Aug-2022), COVID-19 IMMUNISATION (A child received the 1st dose of Moderna Covid-19 on 15-Jul-2022 and received the 2nd dose of Pfizer Covid-19 vaccine on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (A child received the 1st dose of Moderna Covid-19 on 15-Jul-2022 and received the 2nd dose of Pfizer Covid-19 vaccine on 10-Aug-2022) and COVID-19 IMMUNISATION (A child received the 1st dose of Moderna Covid-19 on 15-Jul-2022 and received the 2nd dose of Pfizer Covid-19 vaccine on 10-Aug-2022).    No concomitant medications was reported. Patient administered 2nd dose of Pfizer with lot number FT9142 on 10-Aug-2022. No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse reaction) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose administered after 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine administered on 08-Aug-2022). No concomitant medication information was provided. The reporter reported that they administered 1 dose of the Moderna COVID-19 Vaccine from 1 vial to a patient within 6 to 11 years of age after 30 day use by date. It was unknown if this was the first dose for the patient or not. The date when the vial was initially stored in the refrigerator was 08-Jul-2022. It was unknown if the patient experienced any symptoms after getting the vaccine or not. The vial did not undergo any temperature excursions. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (two doses of the Moderna covid vaccine and it was the 2nd dose she got sick) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The patient's past medical history included Bladder infection (bladder infection at that time and ended up in the hospital for vomiting and she couldn't stop vomiting.) and Foot surgery (right foot was 6 weeks ago). Previously administered products included for Prophylaxis: Shingrix (Several years ago had some other shingles vaccine right arm); for Arthritis: Meloxicam. Past adverse reactions to the above products included No adverse event with Meloxicam ; and Shingles with Shingrix. Concurrent medical conditions included Arthritis (Takes Meloxicam for arthritis.). On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (two doses of the Moderna covid vaccine and it was the 2nd dose she got sick). At the time of the report, ILLNESS (two doses of the Moderna covid vaccine and it was the 2nd dose she got sick) outcome was unknown. Patient ethnicity was reported. No concomitant medications was provided by the reporter. Patient had two doses of the Moderna covid vaccine and it was the 2nd dose patient got sick on and does not know the dates, lots, expiry dates or NDC numbers to provide. Patient remembers they stuck her in the arm and it was very different because it is a different kind of medical care going through a drive through. Patient received Prevnar 20 vaccine on 14Jul2022 08:30am 1st dose administered to left arm and experienced some events such as soreness, feel nauseous, chills, vomiting. Patient had shingles with the 2nd covid vaccine but it was never clear if it was because of the vaccine or there was something else as patient had a bladder infection at that time. No treatment medications was provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Arthralgia, Joint swelling
Clinical narrative: Swollen joints; Pain abdominal; Generalised joint pain/AFTER SECOND COVID-19 VACCINATION PAIN EVERYWHERE IN JOINTS; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen joints), ABDOMINAL PAIN (Pain abdominal) and ARTHRALGIA (Generalized joint pain/AFTER SECOND COVID-19 VACCINATION PAIN EVERYWHERE IN JOINTS) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced JOINT SWELLING (Swollen joints), ABDOMINAL PAIN (Pain abdominal) and ARTHRALGIA (Generalized joint pain/AFTER SECOND COVID-19 VACCINATION PAIN EVERYWHERE IN JOINTS). At the time of the report, JOINT SWELLING (Swollen joints), ABDOMINAL PAIN (Pain abdominal) and ARTHRALGIA (Generalized joint pain/AFTER SECOND COVID-19 VACCINATION PAIN EVERYWHERE IN JOINTS) had not resolved.    No concomitant medication was reported. It was reported that patient felt pain after the first COVID-19 vaccination, Humira not working/ not effective and pain did not go away. No treatment medication was reported. This case was linked to MOD-2022-627432 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (around the injection site, a certain spot in the left arm begin aching, sporadic pain) and PAIN IN EXTREMITY (soreness in left arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 031L20A and 013L20A) for COVID-19 vaccination. The patient had never tested positive for COVID test. Concurrent medical conditions included Lactose intolerance, Sulfonamide allergy (sulfa drug) and Seasonal allergy. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In May 2022, the patient experienced VACCINATION SITE PAIN (around the injection site, a certain spot in the left arm begin aching, sporadic pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in left arm). At the time of the report, VACCINATION SITE PAIN (around the injection site, a certain spot in the left arm begin aching, sporadic pain) had not resolved and PAIN IN EXTREMITY (soreness in left arm) had resolved. No concomitant medications were provided by the reporter. It was reported that the patient completed her vaccine series and only had soreness in left arm which lasted 3 days and did not had any severe problems. However, in the month of May 2022, around the injection site, she begin experiencing a certain spot in the left arm which began aching, sporadic pain, occurring 2 to 3 times per day, lasting less than a minute, but in the past week it had been a daily occurrence. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The adverse event did not cause the patient to seek medical care. It was unknown if the patient experienced a similar event in the past. No treatment medications were provided by the reporter.