chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an adult female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date after receiving the mRNA-1273 vaccine. Onset latency could not be determined as event onset date was not provided. Clinical course, laboratory, and treatment details were not reported. The outcome of event was reported as resolving. Patient received 1st and 2nd doses of mRNA-1273 vaccine 28 days apart. On unknown date, patient received co-suspect Adalimumab for rheumatoid arthritis which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date after receiving the mRNA-1273 vaccine. Onset latency could not be determined as event onset date was not provided. Clinical course, laboratory, and treatment details were not reported. The outcome of event was reported as resolving. Patient received 1st and 2nd doses of mRNA-1273 vaccine 28 days apart. On unknown date, patient received co-suspect Adalimumab for rheumatoid arthritis which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: 1x Moderna, Booster was hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (1x Moderna, Booster was hard) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Biontech (Dose 2) and Biontech (Dose 1). Past adverse reactions to the above products included No adverse event with Biontech and Biontech.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (1x Moderna, Booster was hard). At the time of the report, VACCINATION COMPLICATION (1x Moderna, Booster was hard) 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.  No concomitant product use was reported.   No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: Occasional allergies; Left middle finger swelled and painful; Left middle finger swelled and painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Occasional allergies), PAIN IN EXTREMITY (Left middle finger swelled and painful) and PERIPHERAL SWELLING (Left middle finger swelled and painful) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced HYPERSENSITIVITY (Occasional allergies), PAIN IN EXTREMITY (Left middle finger swelled and painful) and PERIPHERAL SWELLING (Left middle finger swelled and painful). At the time of the report, HYPERSENSITIVITY (Occasional allergies), PAIN IN EXTREMITY (Left middle finger swelled and painful) and PERIPHERAL SWELLING (Left middle finger swelled and painful) had not resolved.            No concomitant medication provided. No treatment information mentioned.  The patients left middle finger swelled and was painful after second dose of Moderna vaccine. She had occasional allergies.  Reporters causality of events with Rinvoq was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Fatigue; Burning with last injection; Sore arm; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), INJECTION SITE PAIN (Burning with last injection), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), INJECTION SITE PAIN (Burning with last injection), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever). At the time of the report, FATIGUE (Fatigue), INJECTION SITE PAIN (Burning with last injection), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever) had resolved.            No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of fatigue, sore arm and low-grade fever was not provided. The reporter's causality for the event of burning with last injection 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal disorder
Clinical narrative: Neck problems; Feeling more ache in joints; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISORDER (Neck problems) and ARTHRALGIA (Feeling more ache in joints) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. 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 dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient experienced MUSCULOSKELETAL DISORDER (Neck problems) and ARTHRALGIA (Feeling more ache in joints). At the time of the report, MUSCULOSKELETAL DISORDER (Neck problems) and ARTHRALGIA (Feeling more ache in joints) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Malaise, SARS-CoV-2 test
Clinical narrative: COVID-19; They are sick and not doing well; They are sick and not doing well; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), ILLNESS (They are sick and not doing well) and MALAISE (They are sick and not doing well) 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. 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 COVID-19 (COVID-19), ILLNESS (They are sick and not doing well) and MALAISE (They are sick and not doing well). At the time of the report, COVID-19 (COVID-19), ILLNESS (They are sick and not doing well) and MALAISE (They are sick and not doing well) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient received booster dose of Moderna. 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 US-MODERNATX, INC.-MOD-2022-623837 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-623837:mother case.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Fatigue, Pain
Clinical narrative: Pain; Discomfort; Dizziness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DISCOMFORT (Discomfort), DIZZINESS (Dizziness) and FATIGUE (Tiredness) in a 68-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain), DISCOMFORT (Discomfort), DIZZINESS (Dizziness) and FATIGUE (Tiredness). At the time of the report, PAIN (Pain), DISCOMFORT (Discomfort), DIZZINESS (Dizziness) and FATIGUE (Tiredness) had resolved.            Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the event(s) of PAIN, DIZZINESS, DISCOMFORT and TIREDNESS was not provided.  Treatment Drugs 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: Blood cholesterol, Blood cholesterol increased, Blood pressure measurement, Herpes zoster, Hypertension
Clinical narrative: Shingles; High cholesterol; Blood pressure high; Lymphadenopathy axillary; Inappropriate route of vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), BLOOD CHOLESTEROL INCREASED (High cholesterol), HYPERTENSION (Blood pressure high), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccine administration) and LYMPHADENOPATHY (Lymphadenopathy axillary) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-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 started (HUMIRA) (Subcutaneous) . In June 2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccine administration). On an unknown date, the patient experienced HERPES ZOSTER (Shingles), BLOOD CHOLESTEROL INCREASED (High cholesterol), HYPERTENSION (Blood pressure high) and LYMPHADENOPATHY (Lymphadenopathy axillary). At the time of the report, HERPES ZOSTER (Shingles), BLOOD CHOLESTEROL INCREASED (High cholesterol) and HYPERTENSION (Blood pressure high) was resolving, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccine administration) outcome was unknown and LYMPHADENOPATHY (Lymphadenopathy axillary) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: High. On an unknown date, Blood pressure measurement: High.         Concomitant Drugs Not Reported  The reporter's causality for the event(s) of shingles, high cholesterol, high blood pressure and swollen lymph node under left arm pit with Humirawas no reasonable possibility.  Treatment Drugs 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: Incorrect route of product administration, Lymphadenopathy
Clinical narrative: Shingles; High cholesterol; Blood pressure high; Lymphadenopathy axillary; Inappropriate route of vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), BLOOD CHOLESTEROL INCREASED (High cholesterol), HYPERTENSION (Blood pressure high), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccine administration) and LYMPHADENOPATHY (Lymphadenopathy axillary) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-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 started (HUMIRA) (Subcutaneous) . In June 2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccine administration). On an unknown date, the patient experienced HERPES ZOSTER (Shingles), BLOOD CHOLESTEROL INCREASED (High cholesterol), HYPERTENSION (Blood pressure high) and LYMPHADENOPATHY (Lymphadenopathy axillary). At the time of the report, HERPES ZOSTER (Shingles), BLOOD CHOLESTEROL INCREASED (High cholesterol) and HYPERTENSION (Blood pressure high) was resolving, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccine administration) outcome was unknown and LYMPHADENOPATHY (Lymphadenopathy axillary) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: High. On an unknown date, Blood pressure measurement: High.         Concomitant Drugs Not Reported  The reporter's causality for the event(s) of shingles, high cholesterol, high blood pressure and swollen lymph node under left arm pit with Humirawas no reasonable possibility.  Treatment Drugs 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 49-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 Crohn's disease.    No Medical History information was reported.   On 09-Mar-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, Citrate free pen. In March 2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        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-2022-618958 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Scratch, Skin haemorrhage, Skin lesion, Vaccination site pain
Clinical narrative: Skin bleeding/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED; Skin lesion/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS; Scratch/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED; Fever; Vaccination site pain/ AFTER SECOND AND BOOSTER COVID SHOT FELT ACHY AND SORE INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (Skin bleeding/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED), SKIN LESION (Skin lesion/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS ), SCRATCH (Scratch/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED), PYREXIA (Fever) and VACCINATION SITE PAIN (Vaccination site pain/ AFTER SECOND AND BOOSTER COVID SHOT FELT ACHY AND SORE 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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SKIN HAEMORRHAGE (Skin bleeding/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED), SKIN LESION (Skin lesion/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS ), SCRATCH (Scratch/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED), PYREXIA (Fever) and VACCINATION SITE PAIN (Vaccination site pain/ AFTER SECOND AND BOOSTER COVID SHOT FELT ACHY AND SORE INJECTION SITE). At the time of the report, SKIN HAEMORRHAGE (Skin bleeding/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED), SKIN LESION (Skin lesion/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS ), SCRATCH (Scratch/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED) and VACCINATION SITE PAIN (Vaccination site pain/ AFTER SECOND AND BOOSTER COVID SHOT FELT ACHY AND SORE INJECTION SITE) had not resolved and PYREXIA (Fever) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medication was not provided.  No information regarding treatment medication was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: BODY CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (BODY CHILLS) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for 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. In 2021, the patient experienced CHILLS (BODY CHILLS). At the time of the report, CHILLS (BODY CHILLS) had resolved.            Concomitant product use was not provided by the reporter.  The patient's second vaccine caused body chills. The patient's body created too many antibodies against Humira. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624375, MOD-2022-624376 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Live follow up: Received updates to event information, reporter opinion of causality and narrative description.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) 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 COVID-19 (covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Patient received Moderna COVID-19 Vaccine and she had COVID. On an unknown date, patient started Paxlovid and at the time of report it was day 2 or 3 of the 5 days. She confirmed that patient started with diarrhea and stomach cramping after taking Paxlovid.  She was taking the Paxlovid at the time of report because she had COVID.  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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst
Clinical narrative: Breast cyst; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CYST (Breast cyst) in an 85-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.    The patient's past medical history included Breast cancer in 2012 and Mastectomy bilateral (She had both breast removed.) in 2012.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In March 2022, the patient experienced BREAST CYST (Breast cyst). At the time of the report, BREAST CYST (Breast cyst) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623371 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: On the left one there was a burning feeling; Both calfs hurt; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (On the left one there was a burning feeling) and PAIN IN EXTREMITY (Both calfs hurt) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (On the left one there was a burning feeling) and PAIN IN EXTREMITY (Both calfs hurt). At the time of the report, BURNING SENSATION (On the left one there was a burning feeling) and PAIN IN EXTREMITY (Both calfs hurt) outcome was unknown.            Relevant concomitant medications were not reported.  Patient received second dose of Moderna COVID-19 vaccine and both calf felt hurt and on the left one there was a burning feeling.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624237 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Breakthrough pain, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Breakthrough pain; Anemic; Patient received first dose of Moderna on 08-Mar-2021, second dose on 05-Apr-2021 and third booster dose on 30-Aug-2021; Low grade fever; Headache; Fatigue; Welts; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH PAIN (Breakthrough pain), ANAEMIA (Anemic), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 50-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 HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started  (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced PYREXIA (Low grade fever), (Headache), (Fatigue) and URTICARIA (Welts). On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna on 08-Mar-2021, second dose on 05-Apr-2021 and third booster dose on 30-Aug-2021). On an unknown date, the patient experienced (Breakthrough pain) and(Anemic). At the time of the report,Breakthrough pain) and ANAEMIA (Anemic) had not resolved, PYREXIA (Low grade fever),  (Headache), FATIGUE (Fatigue) and URTICARIA (Welts) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna on 08-Mar-2021, second dose on 05-Apr-2021 and third booster dose on 30-Aug-2021) outcome was unknown.            Concomitant product use was not provided by the reporter.   The reporter's causality with Humira for the events of breakthrough pain, fatigue, low grade fever, headache and large welt like fluid gathering under skin at injection site/ down to arm to elbow was a reasonable possibility and for the event of anemic was not provided.  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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Breakthrough pain; Anemic; Patient received first dose of Moderna on 08-Mar-2021, second dose on 05-Apr-2021 and third booster dose on 30-Aug-2021; Low grade fever; Headache; Fatigue; Welts; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH PAIN (Breakthrough pain), ANAEMIA (Anemic), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 50-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 HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started  (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced PYREXIA (Low grade fever), (Headache), (Fatigue) and URTICARIA (Welts). On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna on 08-Mar-2021, second dose on 05-Apr-2021 and third booster dose on 30-Aug-2021). On an unknown date, the patient experienced (Breakthrough pain) and(Anemic). At the time of the report,Breakthrough pain) and ANAEMIA (Anemic) had not resolved, PYREXIA (Low grade fever),  (Headache), FATIGUE (Fatigue) and URTICARIA (Welts) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna on 08-Mar-2021, second dose on 05-Apr-2021 and third booster dose on 30-Aug-2021) outcome was unknown.            Concomitant product use was not provided by the reporter.   The reporter's causality with Humira for the events of breakthrough pain, fatigue, low grade fever, headache and large welt like fluid gathering under skin at injection site/ down to arm to elbow was a reasonable possibility and for the event of anemic was not provided.  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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Generalized aching/body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching/body aches) and CHILLS (Chills) in a 53-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 Hidradenitis suppurativa.    The patient's past medical history included COVID-19 in 2020, Foggy feeling in head (COVID brain fog) in 2020, Coughing blood in 2020 and COVID-19 pneumonia in 2020. Concurrent medical conditions included Hidradenitis suppurativa.   On 20-Jan-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, Citrate free pen. On an unknown date, the patient experienced PAIN (Generalized aching/body aches) and CHILLS (Chills). At the time of the report, PAIN (Generalized aching/body aches) and CHILLS (Chills) 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-2022-623988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Non Significant follow-up(NNI)
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint swelling, Myalgia, Pain
Clinical narrative: Joint swelling/ swelling in joints; Generalized aching/ Body aches; Fatigue; Joint pain; Pain in arm/ Arm was hurting; Fever; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Joint swelling/ swelling in joints), PAIN (Generalized aching/ Body aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Pain in arm/ Arm was hurting) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2022, 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) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Joint swelling/ swelling in joints), PAIN (Generalized aching/ Body aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (Pain in arm/ Arm was hurting), PYREXIA (Fever) and MYALGIA (Muscle ache). At the time of the report, JOINT SWELLING (Joint swelling/ swelling in joints), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Pain in arm/ Arm was hurting) had resolved and PAIN (Generalized aching/ Body aches), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Muscle ache) outcome 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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Joint swelling/ swelling in joints; Generalized aching/ Body aches; Fatigue; Joint pain; Pain in arm/ Arm was hurting; Fever; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Joint swelling/ swelling in joints), PAIN (Generalized aching/ Body aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Pain in arm/ Arm was hurting) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2022, 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) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Joint swelling/ swelling in joints), PAIN (Generalized aching/ Body aches), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (Pain in arm/ Arm was hurting), PYREXIA (Fever) and MYALGIA (Muscle ache). At the time of the report, JOINT SWELLING (Joint swelling/ swelling in joints), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Pain in arm/ Arm was hurting) had resolved and PAIN (Generalized aching/ Body aches), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Muscle ache) outcome 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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Headache, Insomnia, Liver function test
Clinical narrative: Insomnia; Weight gain; Blood sugar increased/ ELEVATED BLOOD SUGAR; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia), WEIGHT INCREASED (Weight gain), BLOOD GLUCOSE INCREASED (Blood sugar increased/ ELEVATED BLOOD SUGAR) and HEADACHE (Headache) 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.    Concurrent medical conditions included Crohn's disease.   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) Citrate Free. In March 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced INSOMNIA (Insomnia), WEIGHT INCREASED (Weight gain) and BLOOD GLUCOSE INCREASED (Blood sugar increased/ ELEVATED BLOOD SUGAR). At the time of the report, INSOMNIA (Insomnia), WEIGHT INCREASED (Weight gain), BLOOD GLUCOSE INCREASED (Blood sugar increased/ ELEVATED BLOOD SUGAR) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Weight: 25 Pounds increased. On an unknown date, Blood glucose: ELEVATED BLOOD SUGAR (25 Pounds). On an unknown date, Liver function test: Elevated.         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.  Concomitant medication was not provided.  No information regarding treatment medication was provided.   This case was linked to MOD-2022-624417 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: Insomnia; Weight gain; Blood sugar increased/ ELEVATED BLOOD SUGAR; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia), WEIGHT INCREASED (Weight gain), BLOOD GLUCOSE INCREASED (Blood sugar increased/ ELEVATED BLOOD SUGAR) and HEADACHE (Headache) 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.    Concurrent medical conditions included Crohn's disease.   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) Citrate Free. In March 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced INSOMNIA (Insomnia), WEIGHT INCREASED (Weight gain) and BLOOD GLUCOSE INCREASED (Blood sugar increased/ ELEVATED BLOOD SUGAR). At the time of the report, INSOMNIA (Insomnia), WEIGHT INCREASED (Weight gain), BLOOD GLUCOSE INCREASED (Blood sugar increased/ ELEVATED BLOOD SUGAR) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Weight: 25 Pounds increased. On an unknown date, Blood glucose: ELEVATED BLOOD SUGAR (25 Pounds). On an unknown date, Liver function test: Elevated.         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.  Concomitant medication was not provided.  No information regarding treatment medication was provided.   This case was linked to MOD-2022-624417 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test abnormal, Thyroid hormones test
Clinical narrative: Elevated thyroid levels; This spontaneous case was reported by a consumer and describes the occurrence of THYROID FUNCTION TEST ABNORMAL (Elevated thyroid levels) in an adult female patient who received mRNA-1273 (Spikevax) 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 an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced THYROID FUNCTION TEST ABNORMAL (Elevated thyroid levels). At the time of the report, THYROID FUNCTION TEST ABNORMAL (Elevated thyroid levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid hormones test: Elevated.     mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported.  The co-suspect Humira formulation was reported as solution for injection in pre-filled pen. It was unknown if patient was enrolled in COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for event Elevated thyroid levels with co-suspect 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
Symptoms: Illness, Migraine, Vomiting
Clinical narrative: Migraine; Unspecified sickness; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), ILLNESS (Unspecified sickness) and VOMITING (Vomiting) 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 Hidradenitis suppurativa.    No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-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 MIGRAINE (Migraine), ILLNESS (Unspecified sickness) and VOMITING (Vomiting). At the time of the report, MIGRAINE (Migraine), ILLNESS (Unspecified sickness) and VOMITING (Vomiting) outcome was unknown.            No concomitant medication was reported.  It was unknown if patient was enrolled in COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for events migraine, unspecified sickness and vomiting with co-suspect 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
Symptoms: Condition aggravated
Clinical narrative: Disorder aggravation; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Disorder aggravation) 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 Hidradenitis suppurativa and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (Disorder aggravation). At the time of the report, CONDITION AGGRAVATED (Disorder aggravation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: With the second dose of the Moderna covid vaccine the caller had flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (With the second dose of the Moderna covid vaccine the caller had flu like symptoms) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (With the second dose of the Moderna covid vaccine the caller had flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (With the second dose of the Moderna covid vaccine the caller had flu like symptoms) outcome was unknown.            No concomitant medications were reported.  The caller was calling about the booster shot and he developed a lump under his armpit (From 31-Jan-2022 To Ongoing). The lump had neem there for about a week already and had not gone away. The caller confirmed that he was calling about the third dose of the Pfizer covid vaccine. Saturday the caller took the shot and the lump started on Monday morning. The caller thought the lump was getting a little bit bigger. The caller got the third dose on 29-Jan-2022. The caller received the vaccine in his right arm which was the same arm that he had the lump in his armpit. The caller had the Moderna covid vaccines for his first and second dose. Batch number of Pfizer vaccine was FL3209.  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.