chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Nausea
Clinical narrative: Fever; Headache; Joint pain; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Waldenstrom's macroglobulinaemia.    No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, MIRTAZAPINE (MIRTAZEPINE TEVA), ONDANSETRON (ZOFRAN [ONDANSETRON]), TRAMADOL, CALCIUM, TESTOSTERONE, ROSUVASTATIN CALCIUM (CRESTOR) and TERIPARATIDE (FORTEO) for an unknown indication.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. 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. On 19-Nov-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, Body temperature: 99.9 99.9 F.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of FEVER 99.9 F, HEADACHE, JOINT PAIN, NAUSEA and FATIGUE with IMBRUVICA(IBRUTINIB) was no reasonable possibility.   No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: Fever; Headache; Joint pain; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Waldenstrom's macroglobulinaemia.    No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, MIRTAZAPINE (MIRTAZEPINE TEVA), ONDANSETRON (ZOFRAN [ONDANSETRON]), TRAMADOL, CALCIUM, TESTOSTERONE, ROSUVASTATIN CALCIUM (CRESTOR) and TERIPARATIDE (FORTEO) for an unknown indication.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. 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. On 19-Nov-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, Body temperature: 99.9 99.9 F.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of FEVER 99.9 F, HEADACHE, JOINT PAIN, NAUSEA and FATIGUE with IMBRUVICA(IBRUTINIB) was no reasonable possibility.   No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hangover, Inappropriate schedule of product administration
Clinical narrative: Moderna Dose-1 on 02-AUG-2021 and Dose-2 on 24-AUG-2021; FELT VERY HUNG OVER DAY AFTER COVID VACCINATION; This spontaneous case was reported by a consumer and describes the occurrence of HANGOVER (FELT VERY HUNG OVER DAY AFTER COVID VACCINATION) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose-1 on 02-AUG-2021 and Dose-2 on 24-AUG-2021) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-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 HANGOVER (FELT VERY HUNG OVER DAY AFTER COVID VACCINATION). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose-1 on 02-AUG-2021 and Dose-2 on 24-AUG-2021). At the time of the report, HANGOVER (FELT VERY HUNG OVER DAY AFTER COVID VACCINATION) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose-1 on 02-AUG-2021 and Dose-2 on 24-AUG-2021) outcome was unknown.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with HUMIRA for the event of FELT VERY HUNG OVER DAY AFTER COVID VACCINATION was not provided. No treatment medication was reported.This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: got hives; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (got hives) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced URTICARIA (got hives). At the time of the report, URTICARIA (got hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was given dose 1 of Moderna vaccine in March, got hives, so they HCP) didn't recommend continuing with Moderna. No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nephrolithiasis
Clinical narrative: Kidney stones; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stones) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stones) (seriousness criterion medically significant). In 2021, NEPHROLITHIASIS (Kidney stones) had resolved.            The patient had seven kidney stones in right kidney. She had first surgery in Sep-2021 and second surgery in Oct-2021 and had not seen physician since to speak about findings.  No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns a 62  year  old female patient, with no relevant medical history, who received two doses of mRNA  1273 vaccine, and experienced the serious medically significant unexpected event of nephrolithiasis. Onset date of the event was not provided; hence latency and temporal association cannot be properly assessed. The report mentioned the patient had seven kidney stones in her right kidney. Approximately 5 months after the second dose of mRNA  1273 she had a first surgery, and 6 months since vaccination a second surgery. The event was recovered. No further clinical information was available for medical reviewing. Co-suspect product included Adalimumab. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62  year  old female patient, with no relevant medical history, who received two doses of mRNA  1273 vaccine, and experienced the serious medically significant unexpected event of nephrolithiasis. Onset date of the event was not provided; hence latency and temporal association cannot be properly assessed. The report mentioned the patient had seven kidney stones in her right kidney. Approximately 5 months after the second dose of mRNA  1273 she had a first surgery, and 6 months since vaccination a second surgery. The event was recovered. No further clinical information was available for medical reviewing. Co-suspect product included Adalimumab. The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure measurement, Chills, Cough
Clinical narrative: Sugar blood level increased; Blood pressure high; Chills; Cough; Breathing difficult; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Sugar blood level increased), COUGH (Cough), DYSPNOEA (Breathing difficult), HYPERTENSION (Blood pressure high) and CHILLS (Chills) in a 69-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 Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On 12-Sep-2021, 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) 1 dosage form. In September 2021, the patient experienced COUGH (Cough), DYSPNOEA (Breathing difficult) and CHILLS (Chills). On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Sugar blood level increased) and HYPERTENSION (Blood pressure high). In 2021, COUGH (Cough), DYSPNOEA (Breathing difficult) and CHILLS (Chills) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (Sugar blood level increased) and HYPERTENSION (Blood pressure high) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: High. On an unknown date, Blood pressure measurement: High.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of CHILLS, ELEVATED SUGAR LEVELS, COUGH, TROUBLE BREATHING and HIGH BLOOD PRESSURE 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  No treatment medication information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertension
Clinical narrative: Sugar blood level increased; Blood pressure high; Chills; Cough; Breathing difficult; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Sugar blood level increased), COUGH (Cough), DYSPNOEA (Breathing difficult), HYPERTENSION (Blood pressure high) and CHILLS (Chills) in a 69-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 Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On 12-Sep-2021, 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) 1 dosage form. In September 2021, the patient experienced COUGH (Cough), DYSPNOEA (Breathing difficult) and CHILLS (Chills). On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Sugar blood level increased) and HYPERTENSION (Blood pressure high). In 2021, COUGH (Cough), DYSPNOEA (Breathing difficult) and CHILLS (Chills) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (Sugar blood level increased) and HYPERTENSION (Blood pressure high) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: High. On an unknown date, Blood pressure measurement: High.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of CHILLS, ELEVATED SUGAR LEVELS, COUGH, TROUBLE BREATHING and HIGH BLOOD PRESSURE 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  No treatment medication information was provided.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Pain
Clinical narrative: Achiness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness) and CHILLS (Chills) 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) solution for injection for Panuveitis.    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. On an unknown date, the patient experienced PAIN (Achiness) and CHILLS (Chills). At the time of the report, PAIN (Achiness) and CHILLS (Chills) had resolved.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain
Clinical narrative: Soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and FATIGUE (Tiredness) 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) UNK citrate free. On an unknown date, the patient experienced PAIN (Soreness) and FATIGUE (Tiredness). At the time of the report, PAIN (Soreness) and FATIGUE (Tiredness) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (ARM SORENESS) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (ARM SORENESS). At the time of the report, PAIN IN EXTREMITY (ARM SORENESS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   The patient had some congestion and allergies. She was placed on a steroid and antibiotic. She had received  allergy injections. She did not take injection on the same day as Skyrizi. She had hearing loss and also had  aids. She had arm soreness with first Covid-19 vaccine injection.  The reporter's causality for the events of hearing loss, allergies, arm soreness, congestion was not provided.  Opinion is that the events of hearing loss, allergies and congestion are not assessable. Opinion is that there is no reasonable possibility that the events of arm soreness are related to Skyrizi (risankizumab).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Laboratory test
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in an 83-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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Nothing wrong.         No relevant concomitant medications were reported.   The reporter's causality for the event of shortness of breath with humira was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Significant follow up received included therapy dates added, event date added, narrative updated.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: Sore thro; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Fatigue) had resolved.            The patient had fatigue but had come out of his a little bit quicker than she did. He had a sore throat for a couple of days then it went away. He felt better one day and when he got up to do something he would feel worse and have to sit back down. He was better.  No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reacted to second dose felt like was coming down /felt down for a few; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reacted to second dose felt like was coming down /felt down for a few) in a 75-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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Apr-2021, the patient experienced VACCINATION COMPLICATION (Reacted to second dose felt like was coming down /felt down for a few). At the time of the report, VACCINATION COMPLICATION (Reacted to second dose felt like was coming down /felt down for a few) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling
Clinical narrative: Painless bump inside upper lip/ formed lumps/ uneven swelling/ uneven hardness; Pain/ soreness; Swelling to both lips; Soreness to both the lips; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (Swelling to both lips), LIP PAIN (Soreness to both the lips), LIP SWELLING (Painless bump inside upper lip/ formed lumps/ uneven swelling/ uneven hardness) and LIP PAIN (Pain/ soreness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products HYALURONIC ACID (RESTYLANE) injection for an unknown indication and HYALURONIC ACID (JUVEDERM) injection for an unknown indication.    The patient's past medical history included Mitral valve repair and Dental implantation in 2020. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), MINOXIDIL, DULOXETINE HYDROCHLORIDE (CYMBALTA), ESTRADIOL (YUVAFEM), IPRATROPIUM, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 FATTY ACID), VITAMIN D3, IRON, COLLAGEN and AREDS 2 PLUS MULTI VITAMIN for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient started HYALURONIC ACID (RESTYLANE) (unknown route) at an unspecified dose and HYALURONIC ACID (JUVEDERM) (unknown route) at an unspecified dose. On 14-May-2021, the patient experienced LIP SWELLING (Swelling to both lips) and LIP PAIN (Soreness to both the lips). In September 2021, the patient experienced LIP SWELLING (Painless bump inside upper lip/ formed lumps/ uneven swelling/ uneven hardness) and LIP PAIN (Pain/ soreness). The patient was treated with PREDNISONE on 20-Sep-2021 at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling to both lips) and LIP PAIN (Soreness to both the lips) had resolved and LIP SWELLING (Painless bump inside upper lip/ formed lumps/ uneven swelling/ uneven hardness) and LIP PAIN (Pain/ soreness) had not resolved.     HCP attempted to inject reversal agent but patient found procedure very painful and could not tolerate injection of reversal agent. Patient did not have any fillers or toxins in the past except for the Juvaderm. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; she was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain; she was a little sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for an unknown indication.    No Medical History information was reported.   On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (unknown route) 150 mg/mL (first dose). On 08-Nov-2021, the patient experienced VACCINATION SITE PAIN (injection site pain; she was a little sore). On 09-Nov-2021, VACCINATION SITE PAIN (injection site pain; she was a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   It was not reported if the patient received a corrective treatment for the event (injection site pain; she was a little sore).  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: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Dizziness, Epistaxis, Heart rate, Hypertension
Clinical narrative: Nasal bleeding; Sinus disorder; Laceration of hand; Blood pressure high; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nasal bleeding), SINUS DISORDER (Sinus disorder), SKIN LACERATION (Laceration of hand), HYPERTENSION (Blood pressure high) and DIZZINESS (Dizziness) in a 57-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 Plaque psoriasis.    No Medical History information was reported.   On 26-Aug-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. On an unknown date, the patient experienced EPISTAXIS (Nasal bleeding), SINUS DISORDER (Sinus disorder), SKIN LACERATION (Laceration of hand), HYPERTENSION (Blood pressure high) and DIZZINESS (Dizziness). At the time of the report, EPISTAXIS (Nasal bleeding), SINUS DISORDER (Sinus disorder), SKIN LACERATION (Laceration of hand), HYPERTENSION (Blood pressure high) and DIZZINESS (Dizziness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Blood pressure 165 out of 110 and Blood pressure 170 out of 100. On an unknown date, Heart rate: Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown date, the patient experienced sinus issues with dizziness and spotting of blood from nose, worsening of cuts on hands, increased heart rate and high blood pressure. 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: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Sinus disorder, Skin laceration
Clinical narrative: Nasal bleeding; Sinus disorder; Laceration of hand; Blood pressure high; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nasal bleeding), SINUS DISORDER (Sinus disorder), SKIN LACERATION (Laceration of hand), HYPERTENSION (Blood pressure high) and DIZZINESS (Dizziness) in a 57-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 Plaque psoriasis.    No Medical History information was reported.   On 26-Aug-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. On an unknown date, the patient experienced EPISTAXIS (Nasal bleeding), SINUS DISORDER (Sinus disorder), SKIN LACERATION (Laceration of hand), HYPERTENSION (Blood pressure high) and DIZZINESS (Dizziness). At the time of the report, EPISTAXIS (Nasal bleeding), SINUS DISORDER (Sinus disorder), SKIN LACERATION (Laceration of hand), HYPERTENSION (Blood pressure high) and DIZZINESS (Dizziness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Blood pressure 165 out of 110 and Blood pressure 170 out of 100. On an unknown date, Heart rate: Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown date, the patient experienced sinus issues with dizziness and spotting of blood from nose, worsening of cuts on hands, increased heart rate and high blood pressure. 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: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Headache, Spinal stenosis
Clinical narrative: Lightheaded; Headache; Spinal stenosis; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL STENOSIS (Spinal stenosis), DIZZINESS (Lightheaded) and HEADACHE (Headache) 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) solution for injection 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, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced SPINAL STENOSIS (Spinal stenosis). On an unknown date, the patient experienced DIZZINESS (Lightheaded) and HEADACHE (Headache). At the time of the report, SPINAL STENOSIS (Spinal stenosis) outcome was unknown and DIZZINESS (Lightheaded) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624685.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing) in an 83-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 Psoriatic arthritis and Plaque psoriasis.    No Medical History information was reported.   On 04-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 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced DYSPNOEA (Trouble breathing). In 2021, DYSPNOEA (Trouble breathing) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  In 2021, the patient experienced trouble breathing. In 2021, the trouble  breathing resolved. 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Pain in extremity
Clinical narrative: Memory loss; ACHE ON ARM; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss) and PAIN IN EXTREMITY (ACHE ON ARM) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced AMNESIA (Memory loss) and PAIN IN EXTREMITY (ACHE ON ARM). In 2021, AMNESIA (Memory loss) had resolved. At the time of the report, PAIN IN EXTREMITY (ACHE ON ARM) outcome was unknown.            NO KNOWN ALLERGIES. No relevant medical history. In 2021, the patient experienced MEMORY LOSS and ACHE ON ARM. In 2021, the MEMORY LOSS resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of MEMORY LOSS and ACHE ON ARM 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Thinking abnormal
Clinical narrative: Could not think straight; COVID-19; 1st dose on 11-Apr-2021 and 2nd dose on 18-May-2021; This spontaneous case was reported by a patient and describes the occurrence of THINKING ABNORMAL (Could not think straight), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-Apr-2021 and 2nd dose on 18-May-2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 18-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-Apr-2021 and 2nd dose on 18-May-2021). On an unknown date, the patient experienced THINKING ABNORMAL (Could not think straight) and COVID-19 (COVID-19). At the time of the report, THINKING ABNORMAL (Could not think straight) had not resolved and COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 11-Apr-2021 and 2nd dose on 18-May-2021) outcome was unknown.            No concomitant product was reported. It was reported that the patient could not think straight. She was in a fog and was coughing, had COVID. No treatment 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.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Atrophy, Magnetic resonance imaging abnormal, Muscular weakness, Neuralgic amyotrophy, Oedema
Clinical narrative: Parsonage Turner syndrome in left shoulder as confirmed by MRI and clinical exam.   Significant pain for approx 1 week followed by severe weakness in suprasponatus and infrasponatus muscles.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Parsonage Turner syndrome in left shoulder as confirmed by MRI and clinical exam.   Significant pain for approx 1 week followed by severe weakness in suprasponatus and infrasponatus muscles.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysmenorrhoea
Clinical narrative: Severe period cramps. I have PCOS so I know what bad cramps feel like, but these are on another level.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Electrocardiogram, Full blood count, Painful respiration
Clinical narrative: pain in chest area left side above the heart area; mostly hurts when inhale and exhale; Stress; pain in back around kidney area; Stress; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (pain in chest area left side above the heart area), PAINFUL RESPIRATION (mostly hurts when inhale and exhale), the first episode of STRESS (Stress), BACK PAIN (pain in back around kidney area) and the second episode of STRESS (Stress) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Rheumatoid arthritis.    The patient's past medical history included Allergic rash. Previously administered products included for Drug use for unknown indication: VICODIN and MORPHINE. Past adverse reactions to the above products included Allergic rash with MORPHINE; and Drug allergy with VICODIN. Concurrent medical conditions included Penicillin allergy (penicillin allergy manifested by rash), Drug allergy (morphine allergy manifested by rash) and Drug allergy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-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) Citrate free. On an unknown date, the patient experienced CHEST PAIN (pain in chest area left side above the heart area), PAINFUL RESPIRATION (mostly hurts when inhale and exhale), the first episode of STRESS (Stress), BACK PAIN (pain in back around kidney area) and the second episode of STRESS (Stress). At the time of the report, CHEST PAIN (pain in chest area left side above the heart area) had not resolved, PAINFUL RESPIRATION (mostly hurts when inhale and exhale) outcome was unknown, BACK PAIN (pain in back around kidney area) was resolving and last episode of STRESS (Stress) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: Normal. On an unknown date, Full blood count: Normal. On an unknown date, Red blood cell sedimentation rate: Normal.         Concomitant medication was not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Medical history and past drug were added. Laboratory data were added. Outcome updated for Chest pain.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Stress
Clinical narrative: pain in chest area left side above the heart area; mostly hurts when inhale and exhale; Stress; pain in back around kidney area; Stress; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (pain in chest area left side above the heart area), PAINFUL RESPIRATION (mostly hurts when inhale and exhale), the first episode of STRESS (Stress), BACK PAIN (pain in back around kidney area) and the second episode of STRESS (Stress) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Rheumatoid arthritis.    The patient's past medical history included Allergic rash. Previously administered products included for Drug use for unknown indication: VICODIN and MORPHINE. Past adverse reactions to the above products included Allergic rash with MORPHINE; and Drug allergy with VICODIN. Concurrent medical conditions included Penicillin allergy (penicillin allergy manifested by rash), Drug allergy (morphine allergy manifested by rash) and Drug allergy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-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) Citrate free. On an unknown date, the patient experienced CHEST PAIN (pain in chest area left side above the heart area), PAINFUL RESPIRATION (mostly hurts when inhale and exhale), the first episode of STRESS (Stress), BACK PAIN (pain in back around kidney area) and the second episode of STRESS (Stress). At the time of the report, CHEST PAIN (pain in chest area left side above the heart area) had not resolved, PAINFUL RESPIRATION (mostly hurts when inhale and exhale) outcome was unknown, BACK PAIN (pain in back around kidney area) was resolving and last episode of STRESS (Stress) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: Normal. On an unknown date, Full blood count: Normal. On an unknown date, Red blood cell sedimentation rate: Normal.         Concomitant medication was not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Medical history and past drug were added. Laboratory data were added. Outcome updated for Chest pain.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: ACHED ARM SWELL UP; ACHED ARM SWELL UP; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (ACHED ARM SWELL UP), PAIN IN EXTREMITY (ACHED ARM SWELL UP), FATIGUE (Fatigue) and NAUSEA (Nausea) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Shoulder replacement (LEFT SIDE REVERSE TOTAL SHOULDER REPLACMENT SURGERY). Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   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. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PERIPHERAL SWELLING (ACHED ARM SWELL UP), PAIN IN EXTREMITY (ACHED ARM SWELL UP), FATIGUE (Fatigue) and NAUSEA (Nausea). In 2021, PERIPHERAL SWELLING (ACHED ARM SWELL UP), PAIN IN EXTREMITY (ACHED ARM SWELL UP), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  It was reported that in 2021, patient took third COVID full dose of Moderna COVID-19 Vaccine.  It was reported that the reporter's causality for the events of LEFT SIDE REVERSE TOTAL SHOULDER REPLACMENT SURGERY with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporter's causality for the events of ACHED ARM SWELL UP unknown onset, ACHED ARM SWELL UP unknown onset, FATIGUE and NAUSEA was not provided.AbbVie's opinion is that there is no reasonable possibility that the events of LEFT SIDE REVERSE TOTAL SHOULDER REPLACMENT SURGERY, ACHED ARM SWELL UP unknown onset, ACHED ARM SWELL UP unknown onset, FATIGUE and NAUSEA are related to RINVOQ(UPADACITINIB).  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.