chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Felt achy; High temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy) and PYREXIA (High temperature) 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 Ulcerative colitis.    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) Solution for injection in pre-filled pen, Citrate free. On an unknown date, the patient experienced PAIN (Felt achy) and PYREXIA (High temperature). At the time of the report, PAIN (Felt achy) and PYREXIA (High temperature) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High.         The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dyspepsia, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose), POLLAKIURIA (frequent urination), DYSPEPSIA (Indigestion), ABDOMINAL PAIN UPPER (extreme stomach pain) and DIARRHOEA (Diarrhea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced NASAL CONGESTION (stuffy nose). On an unknown date, the patient experienced POLLAKIURIA (frequent urination), DYSPEPSIA (Indigestion), ABDOMINAL PAIN UPPER (extreme stomach pain), DIARRHOEA (Diarrhea), HEADACHE (Headaches), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, NASAL CONGESTION (stuffy nose), POLLAKIURIA (frequent urination), DYSPEPSIA (Indigestion), ABDOMINAL PAIN UPPER (extreme stomach pain), DIARRHOEA (Diarrhea), HEADACHE (Headaches), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) had not resolved. 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Nausea, Pollakiuria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose), POLLAKIURIA (frequent urination), DYSPEPSIA (Indigestion), ABDOMINAL PAIN UPPER (extreme stomach pain) and DIARRHOEA (Diarrhea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced NASAL CONGESTION (stuffy nose). On an unknown date, the patient experienced POLLAKIURIA (frequent urination), DYSPEPSIA (Indigestion), ABDOMINAL PAIN UPPER (extreme stomach pain), DIARRHOEA (Diarrhea), HEADACHE (Headaches), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, NASAL CONGESTION (stuffy nose), POLLAKIURIA (frequent urination), DYSPEPSIA (Indigestion), ABDOMINAL PAIN UPPER (extreme stomach pain), DIARRHOEA (Diarrhea), HEADACHE (Headaches), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) had not resolved. 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.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: the symptoms are only obvious i think first 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (the symptoms are only obvious i think first 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Cholesterol and Hypertension.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (the symptoms are only obvious i think first 24 hours). At the time of the report, IMMUNISATION REACTION (the symptoms are only obvious i think first 24 hours) outcome was unknown.            Grandma also got the Moderna.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dyspnoea, Inappropriate schedule of product administration, Lung disorder
Clinical narrative: Memory loss; On 01 Apr 2021, she received first dose and On 01 Jun 2021, she received second dose; Lung disorder; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (Lung disorder), AMNESIA (Memory loss), DYSPNOEA (Shortness of breath) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 01 Apr 2021, she received first dose and On 01 Jun 2021, she received second dose) in an 81-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 Psoriatic arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-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) 40 milligram every two weeks. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 01 Apr 2021, she received first dose and On 01 Jun 2021, she received second dose). In June 2021, the patient experienced LUNG DISORDER (Lung disorder) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced AMNESIA (Memory loss). At the time of the report, LUNG DISORDER (Lung disorder) had not resolved, AMNESIA (Memory loss) was resolving and DYSPNOEA (Shortness of breath) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 01 Apr 2021, she received first dose and On 01 Jun 2021, she received second dose) outcome was unknown.            Concomitant medications and treatment medications were not reported.  On an unknown date, the patient experienced Covid vaccine caused memory loss. In June 2021, the patient experienced lung issues and shortness of breath.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporters causality for the events of lung issues, covid vaccine caused memory loss and shortness of breath 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: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Asthma
Clinical narrative: Asthma-like condition; Arthralgia aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma-like condition) and ARTHRALGIA (Arthralgia aggravated) in a 52-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 and Ulcerative colitis.    The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Rheumatoid arthritis and Ulcerative colitis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced ASTHMA (Asthma-like condition) and ARTHRALGIA (Arthralgia aggravated). At the time of the report, ASTHMA (Asthma-like condition) outcome was unknown and ARTHRALGIA (Arthralgia aggravated) had not resolved.            No concomitant medication were reported. On unknown dates patient experienced more joint pain three to four days before injection was due and had asthma like issues.  No treatment medication were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Nasal congestion
Clinical narrative: Stuffiness might be due to getting moderna booster; Headache almost daily might be due to getting moderna booster; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffiness might be due to getting moderna booster), HEADACHE (Headache almost daily might be due to getting moderna booster) and INJECTION SITE ERYTHEMA (Redness at injection site) 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 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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASAL CONGESTION (Stuffiness might be due to getting moderna booster), HEADACHE (Headache almost daily might be due to getting moderna booster) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, NASAL CONGESTION (Stuffiness might be due to getting moderna booster) and HEADACHE (Headache almost daily might be due to getting moderna booster) had not resolved and INJECTION SITE ERYTHEMA (Redness at injection site) was resolving.            The concomitant medication was not reported by reporter. On unknown dates, the patient experienced stuffiness and headache almost daily might be due to patient received moderna booster and redness at injection site. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Endoscopy small intestine, Injection site pain, Vaccination site erythema
Clinical narrative: Injection site redness; RIGHT ARM SORENESS DUE TO COVID-19 SHOT/INJECTION SITE SORENESS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PAIN (RIGHT ARM SORENESS DUE TO COVID-19 SHOT/INJECTION SITE SORENESS) in a 76-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.    The patient's past medical history included Intestinal resection in 2016. Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF,Solution for injection in pre-filled pen. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PAIN (RIGHT ARM SORENESS DUE TO COVID-19 SHOT/INJECTION SITE SORENESS). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown and INJECTION SITE PAIN (RIGHT ARM SORENESS DUE TO COVID-19 SHOT/INJECTION SITE SORENESS) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2016, Endoscopy small intestine: The patient had a surgery for take out section of intestines.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown dates, the patient experienced right arm soreness due to COVID-19 shot, Injection site redness and Injection site soreness. In 2016, The patient had a surgery for take out section of intestines.  The reporter's causality for the events of TAKE OUT SECTION OF INTESTINES, RIGHT ARM SORENESS DUE TO COVID-19 SHOT and INJECTION SITE REDNESS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of INJECTION SITE SORENESS was not provided. RA's opinion is that there is no reasonable possibility that the events of TAKE OUT SECTION OF INTESTINES and RIGHT ARM SORENESS DUE TO COVID-19 SHOT are related to HUMIRA(ADALIMUMAB). RA's opinion is that there is a reasonable possibility that the events of INJECTION SITE REDNESS and INJECTION SITE SORENESS are related to HUMIRA(ADALIMUMAB).  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Liver transplant, SARS-CoV-2 antibody test
Clinical narrative: Liver Transplant; This spontaneous case was reported by a consumer and describes the occurrence of LIVER TRANSPLANT (Liver Transplant) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic (I'm diabetic).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER TRANSPLANT (Liver Transplant) (seriousness criterion medically significant). At the time of the report, LIVER TRANSPLANT (Liver Transplant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: had a low response.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient want to get a booster shot for the Covid vaccine.  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 received in the Moderna were missed to be booked-in. Company comment-This spontaneous case concerns a patient of unspecified age and gender with no relevant medical history reported, who experienced the unexpected serious (medically significant) of Liver transplant that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. Patient had a quantitative antibody test which showed a low response on an unknown date.  No further information on detailed clinical course, investigations, procedure details was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender with no relevant medical history reported, who experienced the unexpected serious (medically significant) of Liver transplant that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. Patient had a quantitative antibody test which showed a low response on an unknown date.  No further information on detailed clinical course, investigations, procedure details was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (HAD 2 SPOTS THAT WOULD NOT GO AWAY/WERE SORE IF RUBBED UP) and VACCINATION SITE PAIN (ARM WAS SORE FROM THE COVID VACCINE AT INJECITON SITE) 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 Hidradenitis suppurativa. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (HAD 2 SPOTS THAT WOULD NOT GO AWAY/WERE SORE IF RUBBED UP) and VACCINATION SITE PAIN (ARM WAS SORE FROM THE COVID VACCINE AT INJECITON SITE). At the time of the report, PAIN (HAD 2 SPOTS THAT WOULD NOT GO AWAY/WERE SORE IF RUBBED UP) and VACCINATION SITE PAIN (ARM WAS SORE FROM THE COVID VACCINE AT INJECITON SITE) 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 events of ARM WAS SORE FROM THE COVID VACCINE AT INJECITON SITE was not provided. The reporter's causality for the event(s) of HAD 2 SPOTS THAT WOULD NOT GO AWAY/WERE SORE IF RUBBED UP with HUMIRA(ADALIMUMAB) was no reasonable possibility. 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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Hiccups, Positron emission tomogram
Clinical narrative: Out of it; hiccups for 8 hours; This spontaneous case was reported by a patient and describes the occurrence of DISORIENTATION (Out of it) and HICCUPS (hiccups for 8 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product AXITINIB (INLYTA) for Renal carcinoma.    The patient's past medical history included Disorientation, Dehydration, Fatigue, Diarrhea, Decreased appetite, Foggy feeling in head, Pain, Stomach cramps, Kidney transplant (Done 9 years ago), Nephrectomy (3 years ago), Surgery and Surgery. Previously administered products included for Cancer: cabozantinib and Cabometyx. Past adverse reactions to the above products included Pancreatitis with Cabometyx and cabozantinib. Concurrent medical conditions included Kidney carcinoma and DVT. Concomitant products included EVEROLIMUS for Immunosuppression, PREDNISONE, TORSEMIDE, APIXABAN (ELIQUIS), VITAMIN D [VITAMIN D NOS], LOSARTAN, CARVEDILOL and EZETIMIBE for an unknown indication.   In January 2020, the patient started AXITINIB (INLYTA) (unknown route) 5 milligram twice a day. In January 2020, AXITINIB (INLYTA) (unknown route) dosage was changed to 2 milligram twice a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISORIENTATION (Out of it) and HICCUPS (hiccups for 8 hours). At the time of the report, DISORIENTATION (Out of it) and HICCUPS (hiccups for 8 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Positron emission tomogram: Second PET scan showed slight decreased in cancer and Third PET scan showed cancer remained same.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The patient took Inlyta and symptoms got worsened and then took a break from medication and symptoms improved. Patient was not on Inlyta during the first PET scan on JAN 2021,which showed cancer metastasized  The concomitant medication was reported as Cabametics.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity
Clinical narrative: Pain in hand; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PAIN IN EXTREMITY (Pain in hand) in a 55-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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jul-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 24-Jul-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in hand). At the time of the report, COVID-19 (COVID-19) was resolving and PAIN IN EXTREMITY (Pain in hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported. It was unknown if the 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster, Neuropathy peripheral
Clinical narrative: NEUROPATHY LEGS; MORE JOINT PAIN WHEN CLOSE TO INJECTION TIME; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (NEUROPATHY LEGS) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis and Rheumatoid arthritis.    Concurrent medical conditions included Panuveitis and Rheumatoid arthritis.   On 19-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) UNK, cf. On 21-Aug-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (NEUROPATHY LEGS) (seriousness criterion medically significant) and ARTHRALGIA (MORE JOINT PAIN WHEN CLOSE TO INJECTION TIME). At the time of the report, NEUROPATHY PERIPHERAL (NEUROPATHY LEGS), HERPES ZOSTER (Shingles) and ARTHRALGIA (MORE JOINT PAIN WHEN CLOSE TO INJECTION TIME) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication were not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 47-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Neuropathy peripheral together with non-serious event of Herpes zoster. The event occurred on unknown date after receiving the first dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Herpes zoster occurrence 2 days after receiving the first dose of mRNA-1273 could be contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 47-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Neuropathy peripheral together with non-serious event of Herpes zoster. The event occurred on unknown date after receiving the first dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Herpes zoster occurrence 2 days after receiving the first dose of mRNA-1273 could be contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event(s) of fever, nausea and headache with Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fall, Limb discomfort, Pruritus, Rib fracture, Skin fissures
Clinical narrative: Fractured ribs; break out on heel mostly on right foot/cracking bleeding; Arm discomfort; itchiness on palms; Fall; Skin fissure; This spontaneous case was reported by a consumer and describes the occurrence of RIB FRACTURE (Fractured ribs), SKIN HAEMORRHAGE (break out on heel mostly on right foot/cracking bleeding), LIMB DISCOMFORT (Arm discomfort), PRURITUS (itchiness on palms) and FALL (Fall) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RIB FRACTURE (Fractured ribs), SKIN HAEMORRHAGE (break out on heel mostly on right foot/cracking bleeding), LIMB DISCOMFORT (Arm discomfort), PRURITUS (itchiness on palms), FALL (Fall) and SKIN FISSURES (Skin fissure). At the time of the report, RIB FRACTURE (Fractured ribs) was resolving and SKIN HAEMORRHAGE (break out on heel mostly on right foot/cracking bleeding), LIMB DISCOMFORT (Arm discomfort), PRURITUS (itchiness on palms), FALL (Fall) and SKIN FISSURES (Skin fissure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  She had fractured rib due to fall in shower. She was wrapped with bandage at doctor's office. 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Skin haemorrhage
Clinical narrative: Fractured ribs; break out on heel mostly on right foot/cracking bleeding; Arm discomfort; itchiness on palms; Fall; Skin fissure; This spontaneous case was reported by a consumer and describes the occurrence of RIB FRACTURE (Fractured ribs), SKIN HAEMORRHAGE (break out on heel mostly on right foot/cracking bleeding), LIMB DISCOMFORT (Arm discomfort), PRURITUS (itchiness on palms) and FALL (Fall) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RIB FRACTURE (Fractured ribs), SKIN HAEMORRHAGE (break out on heel mostly on right foot/cracking bleeding), LIMB DISCOMFORT (Arm discomfort), PRURITUS (itchiness on palms), FALL (Fall) and SKIN FISSURES (Skin fissure). At the time of the report, RIB FRACTURE (Fractured ribs) was resolving and SKIN HAEMORRHAGE (break out on heel mostly on right foot/cracking bleeding), LIMB DISCOMFORT (Arm discomfort), PRURITUS (itchiness on palms), FALL (Fall) and SKIN FISSURES (Skin fissure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  She had fractured rib due to fall in shower. She was wrapped with bandage at doctor's office. 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.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feverish; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feverish) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 22-Dec-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) Solution for injection in pre-filled pen. On 23-Dec-2021, the patient experienced PYREXIA (Feverish). At the time of the report, PYREXIA (Feverish) outcome was unknown. Not Provided          No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Had more joint discomfort; pain on my hands; Pain on my hands and kness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Had more joint discomfort), PAIN IN EXTREMITY (pain on my hands) and ARTHRALGIA (Pain on my hands and kness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Had more joint discomfort), PAIN IN EXTREMITY (pain on my hands) and ARTHRALGIA (Pain on my hands and kness). The patient was treated with TOFACITINIB CITRATE (XELJANZ) at a dose of 5 milligram. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Had more joint discomfort), PAIN IN EXTREMITY (pain on my hands) and ARTHRALGIA (Pain on my hands and kness) 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.   Concomitant medications were not reported.  The patient had took the COVID vaccine the Moderna and it seemed like since she had taken the vaccine she had more joint discomfort and pain on her hands.and knees.  Patient was prescribed Xeljanz 5 mg tablets.  The date the event description reported was 09-Jul-2021.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: developed bursitis; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (developed bursitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURSITIS (developed bursitis). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) for Bursitis, at an unspecified dose and frequency and LIDOCAINE for Bursitis, at an unspecified dose and frequency. At the time of the report, BURSITIS (developed bursitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. It was reported that patient got the Covid 19 shot and in sometime patient developed bursitis. Patient went to orthopedic surgeon; they gave patient Depo Medrol steroid shot in shoulder area and mixed it with lidocaine for numbing agent. Before they injected patient noticed that the liquid in the syringe was cloudy. 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Headache, Pain in extremity
Clinical narrative: Condition aggravated; Dizziness; Headache; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (Dizziness), HEADACHE (Headache) and PAIN IN EXTREMITY (Pain in arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Plaque psoriasis.    No Medical History information was reported.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (Dizziness), HEADACHE (Headache) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, CONDITION AGGRAVATED (Condition aggravated) was resolving and DIZZINESS (Dizziness), HEADACHE (Headache) and PAIN IN EXTREMITY (Pain in arm) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant medications and treatment medications were not reported.   Causality for HUMIRA(ADALIMUMAB)  The reporter's causality for the events of dizziness, flare ups, headache and sore arm 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Live significant FU (Event added)
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The reporter stated that her daughter took modern booster shot. And developed some of the same symptoms as reporter  The treatment medication was not provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: Very sick; temperature of 100 degrees; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick) and PYREXIA (temperature of 100 degrees) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PREGABALIN (LYRICA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and PREGABALIN (LYRICA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Very sick) and PYREXIA (temperature of 100 degrees). At the time of the report, ILLNESS (Very sick) and PYREXIA (temperature of 100 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degree.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.   Patient was never been that sick with a vaccinations. It took her five days to get over this and ran a temperature of 100 degrees.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Illness, Joint stiffness, Nasopharyngitis, Psoriasis
Clinical narrative: Sickness; Ear discomfort; Psoriasis flare-up; Joint tightness; Cold; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), JOINT STIFFNESS (Joint tightness), PSORIASIS (Psoriasis flare-up), EAR DISCOMFORT (Ear discomfort) and NASOPHARYNGITIS (Cold) in a 41-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 Rheumatoid arthritis.    No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. In September 2020, the patient experienced NASOPHARYNGITIS (Cold). In 2021, the patient experienced JOINT STIFFNESS (Joint tightness). In August 2021, the patient experienced PSORIASIS (Psoriasis flare-up). In September 2021, the patient experienced EAR DISCOMFORT (Ear discomfort). On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness), JOINT STIFFNESS (Joint tightness), PSORIASIS (Psoriasis flare-up), EAR DISCOMFORT (Ear discomfort) and NASOPHARYNGITIS (Cold) outcome was unknown.            Concomitant medications and treatment medications were not provided.  On an unknown date, the patient experienced sick. In September 2020, the patient experienced lingering cold. In 2021, the patient experienced joint tightness after Covid vaccine. In August 2021, the patient experienced flare/ couple small psoriasis spots on skin. In September 2021, the patient experienced stopped up ears.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event of sick and stopped up ears was not provided. The reporter's causality for the events of joint tightness after covid vaccine, flare/ couple small psoriasis spots on skin and lingering cold with HUMIRA(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Gastroenteritis viral, SARS-CoV-2 test, Vaccination site mass, Vaccination site swelling
Clinical narrative: Stomach virus; COVID-19; Hot; Lump on arm after Covid-19 vaccination; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), VACCINATION SITE WARMTH (Hot), GASTROENTERITIS VIRAL (Stomach virus), VACCINATION SITE MASS (Lump on arm after Covid-19 vaccination) and VACCINATION SITE SWELLING (Swelling) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In January 2021, the patient experienced COVID-19 (COVID-19). In May 2021, the patient experienced GASTROENTERITIS VIRAL (Stomach virus). In 2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE MASS (Lump on arm after Covid-19 vaccination) and VACCINATION SITE SWELLING (Swelling). In 2021, VACCINATION SITE WARMTH (Hot), GASTROENTERITIS VIRAL (Stomach virus), VACCINATION SITE MASS (Lump on arm after Covid-19 vaccination) and VACCINATION SITE SWELLING (Swelling) had resolved. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the events with Humira and for the event of stomach virus with Moderna vaccine.  The reporter assessed the events of Covid-19, vaccination site warmth, vaccination site swelling and vaccination site mass to be possibly related to Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Stomach virus; COVID-19; Hot; Lump on arm after Covid-19 vaccination; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), VACCINATION SITE WARMTH (Hot), GASTROENTERITIS VIRAL (Stomach virus), VACCINATION SITE MASS (Lump on arm after Covid-19 vaccination) and VACCINATION SITE SWELLING (Swelling) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In January 2021, the patient experienced COVID-19 (COVID-19). In May 2021, the patient experienced GASTROENTERITIS VIRAL (Stomach virus). In 2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE MASS (Lump on arm after Covid-19 vaccination) and VACCINATION SITE SWELLING (Swelling). In 2021, VACCINATION SITE WARMTH (Hot), GASTROENTERITIS VIRAL (Stomach virus), VACCINATION SITE MASS (Lump on arm after Covid-19 vaccination) and VACCINATION SITE SWELLING (Swelling) had resolved. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the events with Humira and for the event of stomach virus with Moderna vaccine.  The reporter assessed the events of Covid-19, vaccination site warmth, vaccination site swelling and vaccination site mass to be possibly related to Moderna vaccine.  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.