chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm sore after Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore after Moderna booster) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm sore after Moderna booster). At the time of the report, VACCINATION SITE PAIN (Arm sore after Moderna booster) outcome was unknown.            The concomitant medication was not reported by reporter. Patients arm sore after Moderna booster and flu shot.  It was unknown if he 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.   This case was linked to MOD-2021-625103 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered after the expiration time having passed; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the expiration time having passed) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the expiration time having passed) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after the expiration time having passed) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    No Medical History information was reported.   In March 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) CF. On 15-Dec-2021, the patient experienced SINUSITIS (Sinus infection). The patient was treated with PREDNISONE at an unspecified dose and frequency and AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection) was resolving.            No concomitant medications were reported.   Patient took booster dose of unspecified COVID-19 vaccine intramuscularly on 14-Dec-2021.  On 15 Dec 2021, the patient experienced sinus infection. Moderna vaccine were also considered suspect.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear of death, Illness, Immunisation reaction
Clinical narrative: Felt like she was going to die; Had an extremely horrific reaction to moderna; So incredibly sick; This spontaneous case was reported by a consumer and describes the occurrence of FEAR OF DEATH (Felt like she was going to die), IMMUNISATION REACTION (Had an extremely horrific reaction to moderna) and ILLNESS (So incredibly sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEAR OF DEATH (Felt like she was going to die), IMMUNISATION REACTION (Had an extremely horrific reaction to moderna) and ILLNESS (So incredibly sick). At the time of the report, FEAR OF DEATH (Felt like she was going to die), IMMUNISATION REACTION (Had an extremely horrific reaction to moderna) and ILLNESS (So incredibly sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Patient had an extremely horrific reaction to Moderna. She received product, it was great. States she had an adverse event felt like she was going to die. Horrific experience. Had antibodies from Moderna, no T cells.  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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Dec-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 December 2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.            No concomitant medications were reported.  In December 2021, the patient experienced nausea and vomiting. Moderna was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   15-Dec-2021, cardiac test result was unknown.  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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Suspected COVID-19
Clinical narrative: Injection site itching; Suspected COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Suspected COVID-19) and INJECTION SITE PRURITUS (Injection site itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-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) citrate free. In 2021, the patient experienced SUSPECTED COVID-19 (Suspected COVID-19). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Injection site itching). In 2021, SUSPECTED COVID-19 (Suspected COVID-19) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site itching) had resolved.            No concomitant medications were reported.   On an unknown date, the patient experienced itchy at injection site. In 2021,the patient experienced covid-19 symptoms. In 2021, the covid-19 symptoms resolved. On an unknown date, itchy at injection site resolved. 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, C-reactive protein, C-reactive protein increased, Headache, Vaccination site pain
Clinical narrative: C-reactive protein result high/C-REACTIVE PROTEIN WAS HIGH; Vaccination site pain/ ARM PAIN CAUSED BY COVID VACCINES AND BOOSTER; Joint pain; Headache/ HEADACHE CAUSED BY COVID VACCINES AND BOOSTER; This spontaneous case was reported by a consumer and describes the occurrence of C-REACTIVE PROTEIN INCREASED (C-reactive protein result high/C-REACTIVE PROTEIN WAS HIGH), VACCINATION SITE PAIN (Vaccination site pain/ ARM PAIN CAUSED BY COVID VACCINES AND BOOSTER), ARTHRALGIA (Joint pain) and HEADACHE (Headache/ HEADACHE CAUSED BY COVID VACCINES AND BOOSTER) 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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis. Concomitant products included METHOTREXATE and HYDROXYCHLOROQUINE for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced C-REACTIVE PROTEIN INCREASED (C-reactive protein result high/C-REACTIVE PROTEIN WAS HIGH), VACCINATION SITE PAIN (Vaccination site pain/ ARM PAIN CAUSED BY COVID VACCINES AND BOOSTER), ARTHRALGIA (Joint pain) and HEADACHE (Headache/ HEADACHE CAUSED BY COVID VACCINES AND BOOSTER). At the time of the report, C-REACTIVE PROTEIN INCREASED (C-reactive protein result high/C-REACTIVE PROTEIN WAS HIGH) and ARTHRALGIA (Joint pain) had not resolved and VACCINATION SITE PAIN (Vaccination site pain/ ARM PAIN CAUSED BY COVID VACCINES AND BOOSTER) and HEADACHE (Headache/ HEADACHE CAUSED BY COVID VACCINES AND BOOSTER) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: High.         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 information regarding treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Feeling unwell/ NOT FEELING WELL; Runny nose; Cough; Dizzy; Headache; Tiredness/ TIRED; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell/ NOT FEELING WELL), RHINORRHOEA (Runny nose), COUGH (Cough), DIZZINESS (Dizzy) and HEADACHE (Headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 21-Dec-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. 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 MALAISE (Feeling unwell/ NOT FEELING WELL), RHINORRHOEA (Runny nose), COUGH (Cough), DIZZINESS (Dizzy), HEADACHE (Headache), FATIGUE (Tiredness/ TIRED) and NAUSEA (Nausea). At the time of the report, MALAISE (Feeling unwell/ NOT FEELING WELL), RHINORRHOEA (Runny nose), COUGH (Cough), DIZZINESS (Dizzy), HEADACHE (Headache), FATIGUE (Tiredness/ TIRED) and NAUSEA (Nausea) had not 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.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Rhinorrhoea
Clinical narrative: Feeling unwell/ NOT FEELING WELL; Runny nose; Cough; Dizzy; Headache; Tiredness/ TIRED; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell/ NOT FEELING WELL), RHINORRHOEA (Runny nose), COUGH (Cough), DIZZINESS (Dizzy) and HEADACHE (Headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 21-Dec-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. 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 MALAISE (Feeling unwell/ NOT FEELING WELL), RHINORRHOEA (Runny nose), COUGH (Cough), DIZZINESS (Dizzy), HEADACHE (Headache), FATIGUE (Tiredness/ TIRED) and NAUSEA (Nausea). At the time of the report, MALAISE (Feeling unwell/ NOT FEELING WELL), RHINORRHOEA (Runny nose), COUGH (Cough), DIZZINESS (Dizzy), HEADACHE (Headache), FATIGUE (Tiredness/ TIRED) and NAUSEA (Nausea) had not 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: General body pain; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain), FATIGUE (Fatigue) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced PAIN (General body pain), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, PAIN (General body pain) was resolving and FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On unknown dates, the patient experienced fever and fatigue after vaccination and general pain. On an unknown date, fever and fatigue after vaccination resolved. Moderna vaccine was also considered suspect.  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 received in the Moderna were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis aggravated/ PSORIATIC ARTHRITIS FLARE; Generalized aching/ BODY ACHES; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ PSORIATIC ARTHRITIS FLARE) in an adult male 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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   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 PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ PSORIATIC ARTHRITIS FLARE) (seriousness criterion medically significant) and PAIN (Generalized aching/ BODY ACHES). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ PSORIATIC ARTHRITIS FLARE) and PAIN (Generalized aching/ BODY ACHES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not reported. It was reported that Humira did not last the fourteen days. 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 an adult male patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (psoriatic arthritis aggravated), after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of psoriatic arthritis remains a risk 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 an adult male patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (psoriatic arthritis aggravated), after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tiredness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm ) and FATIGUE (tiredness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm ) and FATIGUE (tiredness). At the time of the report, PAIN IN EXTREMITY (sore arm ) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had a sore arm and tiredness after the Moderna COVID vaccine and he was fine.  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: F
Vaccine: COVID19, FLUX
Symptoms: Injection site swelling, Joint swelling, Laboratory test, Nausea, Pain in extremity
Clinical narrative: SWELLING IN LEFT ANKLE/RIGHT WRIST; SORE ARM; SWELLING AT INJECTION SITE; NAUSEA; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (SWELLING IN LEFT ANKLE/RIGHT WRIST), PAIN IN EXTREMITY (SORE ARM), INJECTION SITE SWELLING (SWELLING AT INJECTION SITE) and NAUSEA (NAUSEA) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced JOINT SWELLING (SWELLING IN LEFT ANKLE/RIGHT WRIST), PAIN IN EXTREMITY (SORE ARM), INJECTION SITE SWELLING (SWELLING AT INJECTION SITE) and NAUSEA (NAUSEA). At the time of the report, JOINT SWELLING (SWELLING IN LEFT ANKLE/RIGHT WRIST), PAIN IN EXTREMITY (SORE ARM), INJECTION SITE SWELLING (SWELLING AT INJECTION SITE) and NAUSEA (NAUSEA) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Reduced inflammation.         No relevant concomitant medications were reported.   The reporter's causality for the event(s) of swelling in left ankle/right wrist, sore arm, swelling at injection site and nausea with humira and influenza vaccine 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
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted, Rash
Clinical narrative: Product administration interuppted; She got a skin rash that lasted for 3 months; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (She got a skin rash that lasted for 3 months) and PRODUCT ADMINISTRATION INTERRUPTED (Product administration interuppted) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (She got a skin rash that lasted for 3 months) and PRODUCT ADMINISTRATION INTERRUPTED (Product administration interuppted). At the time of the report, RASH (She got a skin rash that lasted for 3 months) had resolved and PRODUCT ADMINISTRATION INTERRUPTED (Product administration interuppted) 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.   No relevant concomitant medications were reported. No treatment medication reported.   Patient was advised by her doctor to restart the vaccination series using the Pfizer-BioNTech COVID-19 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: 77.0
Sex: F
Vaccine: UNK
Symptoms: Drug interaction
Clinical narrative: Might be humira not working because of the vaccines; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Might be humira not working because of the vaccines) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In November 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) at an unspecified dose. In 2021, the patient experienced DRUG INTERACTION (Might be humira not working because of the vaccines). At the time of the report, DRUG INTERACTION (Might be humira not working because of the vaccines) had not resolved.            No concomitant medication was reported. For patient Humira might not be working because of the vaccines and Pfizer-Biontech covid-19 vaccine injectable was not efficacious.  Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the mailbox were missed to be booked-in.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Inflammatory marker increased, Joint swelling, Pain in extremity, Pyrexia
Clinical narrative: Inflammatory marker increased; Knee swelling; Persistent cough; Leg pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATORY MARKER INCREASED (Inflammatory marker increased), JOINT SWELLING (Knee swelling), COUGH (Persistent cough), PAIN IN EXTREMITY (Leg pain) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-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 PYREXIA (Fever). On an unknown date, the patient experienced INFLAMMATORY MARKER INCREASED (Inflammatory marker increased), JOINT SWELLING (Knee swelling), COUGH (Persistent cough) and PAIN IN EXTREMITY (Leg pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLAMMATORY MARKER INCREASED (Inflammatory marker increased), JOINT SWELLING (Knee swelling), COUGH (Persistent cough) and PAIN IN EXTREMITY (Leg pain) was resolving and PYREXIA (Fever) outcome was unknown.            No concomitant medicine were reported. There was no reported medical history. For HUMIRA, the reporter causality for the events of Inflammation level high, Knee swollen, Lingering cough and Heat makes legs hurt was no reasonable possibility and for the event of Fever was not provided. Lab data included Inflammation levels: High  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Tiredness; Vaccination site pain/left arm soreness from covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain/left arm soreness from covid vaccine) in a 73-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.    There was no reported medical history.    In 2021, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On 30-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In August 2021, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain/left arm soreness from covid vaccine). In 2021, FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain/left arm soreness from covid vaccine) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication details were provided. No treatment medication details were provided.   The reporter's causality for the events of vaccination site pain and fatigue was not provided.  The patient had her Covid booster and was tired for a day or two and her left arm sore from the shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Seasonal allergy, Vision blurred
Clinical narrative: Pollen allergy; Eye lens get foggy towards the evening; Felt slightly sick; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Pollen allergy), VISION BLURRED (Eye lens get foggy towards the evening) and MALAISE (Felt slightly sick) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Bullous pemphigoid. Concomitant products included LEVOTHYROXINE for an unknown indication.  On 27-Sep-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEASONAL ALLERGY (Pollen allergy), VISION BLURRED (Eye lens get foggy towards the evening) and MALAISE (Felt slightly sick). At the time of the report, SEASONAL ALLERGY (Pollen allergy) outcome was unknown, VISION BLURRED (Eye lens get foggy towards the evening) had not resolved and MALAISE (Felt slightly sick) had resolved.     No concomitant medication information was reported. No treatment medication information 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation reaction, Psoriasis
Clinical narrative: OCCASIONALLY LIGHT PSORIASIS FLARES; COVID; COVID-19; AFTER VACCINE SUFFERED SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), IMMUNISATION REACTION (AFTER VACCINE SUFFERED SYMPTOMS), PSORIASIS (OCCASIONALLY LIGHT PSORIASIS FLARES) and COVID-19 (COVID) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In October 2020, the patient experienced COVID-19 (COVID-19) and IMMUNISATION REACTION (AFTER VACCINE SUFFERED SYMPTOMS). In 2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced PSORIASIS (OCCASIONALLY LIGHT PSORIASIS FLARES). At the time of the report, COVID-19 (COVID-19) and COVID-19 (COVID) had resolved, IMMUNISATION REACTION (AFTER VACCINE SUFFERED SYMPTOMS) outcome was unknown and PSORIASIS (OCCASIONALLY LIGHT PSORIASIS FLARES) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was  provided.  It was reported that In October 2020, the patient experienced Covid and after vaccine suffered symptoms. The patient had occasional light psoriasis flare that last only for a day or so. Patient had covid in Oct 2020 and  had these symptoms after each vaccination.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the 2nd shot of Moderna hurts a lot for one night but everything's fine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (the 2nd shot of Moderna hurts a lot for one night but everything's fine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received 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 VACCINATION SITE PAIN (the 2nd shot of Moderna hurts a lot for one night but everything's fine). At the time of the report, VACCINATION SITE PAIN (the 2nd shot of Moderna hurts a lot for one night but everything's fine) had resolved.            No concomitant medication was reported.    Patient stated that she already got 2 shots of Moderna early January where she experienced a bit of headache, a rash mosquito bite but not itchy and her arm was sore. And then she went and got her booster shot from Pfizer a few days ago, and she had a red arm and a bit of a headache, she said that there's no side effects at all compared to Moderna, the second shot of Moderna hurts a lot for one night but everything's fine.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity received in the Moderna  were missed to be booked-in.   This case was linked to MOD-2021-019829 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Gait disturbance, Injection site pain, Psoriasis, Stress
Clinical narrative: Stress; Psoriasis flare-up/Psoriasis flare in the area by injury; Discomfort/Felt discomfort; Difficulty in walking; Injection site pain/Syringe causes pain; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (Stress), PSORIASIS (Psoriasis flare-up/Psoriasis flare in the area by injury), DISCOMFORT (Discomfort/Felt discomfort), GAIT DISTURBANCE (Difficulty in walking) and INJECTION SITE PAIN (Injection site pain/Syringe causes pain) 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) injection for Plaque psoriasis.    No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced STRESS (Stress), PSORIASIS (Psoriasis flare-up/Psoriasis flare in the area by injury), DISCOMFORT (Discomfort/Felt discomfort), GAIT DISTURBANCE (Difficulty in walking) and INJECTION SITE PAIN (Injection site pain/Syringe causes pain). At the time of the report, STRESS (Stress), DISCOMFORT (Discomfort/Felt discomfort), GAIT DISTURBANCE (Difficulty in walking) and INJECTION SITE PAIN (Injection site pain/Syringe causes pain) outcome was unknown and PSORIASIS (Psoriasis flare-up/Psoriasis flare in the area by injury) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: Low.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Stress; Psoriasis flare-up/Psoriasis flare in the area by injury; Discomfort/Felt discomfort; Difficulty in walking; Injection site pain/Syringe causes pain; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (Stress), PSORIASIS (Psoriasis flare-up/Psoriasis flare in the area by injury), DISCOMFORT (Discomfort/Felt discomfort), GAIT DISTURBANCE (Difficulty in walking) and INJECTION SITE PAIN (Injection site pain/Syringe causes pain) 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) injection for Plaque psoriasis.    No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced STRESS (Stress), PSORIASIS (Psoriasis flare-up/Psoriasis flare in the area by injury), DISCOMFORT (Discomfort/Felt discomfort), GAIT DISTURBANCE (Difficulty in walking) and INJECTION SITE PAIN (Injection site pain/Syringe causes pain). At the time of the report, STRESS (Stress), DISCOMFORT (Discomfort/Felt discomfort), GAIT DISTURBANCE (Difficulty in walking) and INJECTION SITE PAIN (Injection site pain/Syringe causes pain) outcome was unknown and PSORIASIS (Psoriasis flare-up/Psoriasis flare in the area by injury) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: Low.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Macular degeneration
Clinical narrative: Macular degeneration; This spontaneous case was reported by a consumer and describes the occurrence of MACULAR DEGENERATION (Macular degeneration) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe) and Macular degeneration (had low vision due to inherited macular degeneration.).   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 MACULAR DEGENERATION (Macular degeneration) (seriousness criterion medically significant). At the time of the report, MACULAR DEGENERATION (Macular degeneration) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  On an unknown date, the patient experienced Inherited macular degeneration. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered as suspect.  The patient had low vision due to inherited macular degeneration. Patient  stated that it had nothing to do with Humira. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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.  Company  Comment: This is a Spontaneous case reported by a consumer, concerning an elderly female patient, with relevant medical condition of inherited macular degeneration, who experienced the unexpected and serious (due to medically significant) event of Macular degeneration, which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an elderly female patient, with relevant medical condition of inherited macular degeneration, who experienced the unexpected and serious (due to medically significant) event of Macular degeneration, which occurred related to an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; Sleep difficult; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), INSOMNIA (Sleep difficult) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and VACCINATION SITE PAIN (Vaccination site pain) had resolved and INSOMNIA (Sleep difficult) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information 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.  Company comment: This spontaneous case concerns an adult female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The event resolved. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The event resolved. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: No adverse event, Product contamination
Clinical narrative: the first 2 vials there is only saline, in the third vial there is Aluminum Carbide Lifeforms; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT CONTAMINATION (the first 2 vials there is only saline, in the third vial there is Aluminum Carbide Lifeforms) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) 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, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT CONTAMINATION (the first 2 vials there is only saline, in the third vial there is Aluminum Carbide Lifeforms) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT CONTAMINATION (the first 2 vials there is only saline, in the third vial there is Aluminum Carbide Lifeforms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2022: Significant Live follow up received included QE number updated.