chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin abrasion
Clinical narrative: Osteoarthritis aggravated; Nodule on extremity; Tiredness; Low grade fever; Headache; Fall; Leg injury; Bruising; Knee injury; Skin abrasion; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), OSTEOARTHRITIS (Osteoarthritis aggravated), LIMB INJURY (Leg injury) and CONTUSION (Bruising) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), LIMB INJURY (Leg injury), CONTUSION (Bruising) and FALL (Fall). In September 2021, the patient experienced FATIGUE (Tiredness), PYREXIA (Low grade fever) and HEADACHE (Headache). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis aggravated) and NODULE (Nodule on extremity). At the time of the report, JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), OSTEOARTHRITIS (Osteoarthritis aggravated), LIMB INJURY (Leg injury), CONTUSION (Bruising), NODULE (Nodule on extremity), FALL (Fall), FATIGUE (Tiredness), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: low grade fever.         On unknown dates, the patient experienced osteoarthritis worsened and knots in hands. In 2021, the patient experienced felt down/hurt both legs and knees/ended up getting bruising and hands scrapped. In September 2021, the patient experienced tired, low grade fever and headache. Case level outcome was reported as worsened. 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, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; The third dose was the Pfizer covid vaccine but the patient's two previous covid vaccines were Moderna; The third dose was the Pfizer covid vaccine but the patient's two previous covid vaccines were Moderna; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (The third dose was the Pfizer covid vaccine but the patient's two previous covid vaccines were Moderna), INTERCHANGE OF VACCINE PRODUCTS (The third dose was the Pfizer covid vaccine but the patient's two previous covid vaccines were Moderna) 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 product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Immunocompromised.   On 20-Sep-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) .3 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced COVID-19 IMMUNISATION (The third dose was the Pfizer covid vaccine but the patient's two previous covid vaccines were Moderna) and INTERCHANGE OF VACCINE PRODUCTS (The third dose was the Pfizer covid vaccine but the patient's two previous covid vaccines were Moderna). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (The third dose was the Pfizer covid vaccine but the patient's two previous covid vaccines were Moderna), INTERCHANGE OF VACCINE PRODUCTS (The third dose was the Pfizer covid vaccine but the patient's two previous covid vaccines were Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was reported that the third dose was the Pfizer COVID vaccine but the patient's two previous COVID vaccines were Moderna.The patient was on daily medication and was on a lot of medicines, not provided the names.  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: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 48-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.    Concurrent medical conditions included Gout.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) 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.   This case was linked to MOD-2021-623510 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Product administration interrupted
Clinical narrative: my sisterinlaw got the moderna. she cannot get her 2nd dose because her arm swelled so bad.; my sisterinlaw got the moderna...she cannot get her 2nd dose because her arm swelled so bad.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my sisterinlaw got the moderna. she cannot get her 2nd dose because her arm swelled so bad.) and PRODUCT ADMINISTRATION INTERRUPTED (my sisterinlaw got the moderna...she cannot get her 2nd dose because her arm swelled so bad. ) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (my sisterinlaw got the moderna. she cannot get her 2nd dose because her arm swelled so bad.) and PRODUCT ADMINISTRATION INTERRUPTED (my sisterinlaw got the moderna...she cannot get her 2nd dose because her arm swelled so bad. ). At the time of the report, PERIPHERAL SWELLING (my sisterinlaw got the moderna. she cannot get her 2nd dose because her arm swelled so bad.) and PRODUCT ADMINISTRATION INTERRUPTED (my sisterinlaw got the moderna..she cannot get her 2nd dose because her arm swelled so bad. ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported. Patients symptoms of COVID lasted for 11 days.  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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-624414:Sister in law's case
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Lip swelling, Urticaria
Clinical narrative: delayed reaction; experiencing lip swelling; hives from head to toe; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (delayed reaction), LIP SWELLING (experiencing lip swelling) and URTICARIA (hives from head to toe) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (delayed reaction), LIP SWELLING (experiencing lip swelling) and URTICARIA (hives from head to toe). In June 2021, LIP SWELLING (experiencing lip swelling) had resolved. At the time of the report, IMMUNISATION REACTION (delayed reaction) and URTICARIA (hives from head to toe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The patient was experiencing lip swelling then a few days later started getting hives. Her allergist didn't think it was possible that this was a reaction to the vaccine but then she reported getting hives from head to toe and lip swelling after her second dose that lasted until Jun-2021. She had not had any symptoms since Jun-2021. 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus
Clinical narrative: getting real bad headaches; She could not sleep last night since she was itching real bad, all over hair and body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She could not sleep last night since she was itching real bad, all over hair and body) and HEADACHE (getting real bad headaches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 933901) for COVID-19 prophylaxis.     The patient's past medical history included Leg pain.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced PRURITUS (She could not sleep last night since she was itching real bad, all over hair and body). On 03-Sep-2021, the patient experienced HEADACHE (getting real bad headaches). At the time of the report, PRURITUS (She could not sleep last night since she was itching real bad, all over hair and body) and HEADACHE (getting real bad headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. 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
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Psoriasis, Pyrexia
Clinical narrative: Plaque psoriasis flare up; Swelling in lymph nodes; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis flare up), LYMPHADENOPATHY (Swelling in lymph nodes), CHILLS (Chills) 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) injection for Rheumatoid arthritis.    Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis flare up), LYMPHADENOPATHY (Swelling in lymph nodes), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PSORIASIS (Plaque psoriasis flare up) outcome was unknown and LYMPHADENOPATHY (Swelling in lymph nodes), CHILLS (Chills) and PYREXIA (Fever) was resolving.            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. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Humira daily dose was citrate free.   This case was linked to MOD-2021-623542 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Psoriasis
Clinical narrative: Psoriasis flare-up; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and FATIGUE (Fatigue) in an elderly 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up) and FATIGUE (Fatigue). At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown and FATIGUE (Fatigue) 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 had non-serious fatigue and psoriasis flare up with SKYRIZI (RISANKIZUMAB).  The patient had psoriasis flare up once a year. He took covid vaccine and was fatigued for about one week. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of fatigue and psoriasis flare up with SKYRIZI (RISANKIZUMAB) was no reasonable possibility. No treatment medications information were 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion
Clinical narrative: Cardiac pacemaker insertion; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) in a 77-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 Ankylosing spondylitis.    No Medical History information was reported.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) (seriousness criterion medically significant). At the time of the report, CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) had not resolved.            No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 77  year  old, female patient, with current condition of ankylosing spondylitis in treatment with Adalimumab, who experienced the serious (medically significant) unexpected event of cardiac pacemaker insertion, one day after the second dose of mRNA  1273 vaccine. No further clinical information was available for medical reviewing. Co  suspect product Adalimumab and patient´s mentioned medical history remains as confounder since ankylosing spondylitis increases the risk of heart disease, which could lead to a cardiac pacemaker insertion. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77  year  old, female patient, with current condition of ankylosing spondylitis in treatment with Adalimumab, who experienced the serious (medically significant) unexpected event of cardiac pacemaker insertion, one day after the second dose of mRNA  1273 vaccine. No further clinical information was available for medical reviewing. Co  suspect product Adalimumab and patient´s mentioned medical history remains as confounder since ankylosing spondylitis increases the risk of heart disease, which could lead to a cardiac pacemaker insertion. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Immunisation reaction
Clinical narrative: She had a bad reaction after her first Moderna Covid-19 vaccine; Mostly bed bound; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She had a bad reaction after her first Moderna Covid-19 vaccine) and BEDRIDDEN (Mostly bed bound) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Myalgic encephalomyelitis (chronic disease) and Multi-organ disorder (create problem with energy delivery to cells).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She had a bad reaction after her first Moderna Covid-19 vaccine) and BEDRIDDEN (Mostly bed bound). At the time of the report, IMMUNISATION REACTION (She had a bad reaction after her first Moderna Covid-19 vaccine) and BEDRIDDEN (Mostly bed bound) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Swelling, Vaccination site pain
Clinical narrative: Pain; Swelling; Fatigue; Vaccination site pain/Tender arm and pain/sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/Tender arm and pain/sore) 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) injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain), SWELLING (Swelling), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/Tender arm and pain/sore). At the time of the report, PAIN (Pain), SWELLING (Swelling), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain/Tender arm and pain/sore) 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 was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysgeusia, Influenza like illness, Malaise, Pyrexia
Clinical narrative: flu-like symptoms; Feeling sick; Has got a 99.5 temperature, has got fever; There's weird taste in mouth like I don't want to say iron but it's sort of like that Taste in my throat every time I cough, this nastiness but nothing is coming up but it doesn't tastes good; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), MALAISE (Feeling sick), PYREXIA (Has got a 99.5 temperature, has got fever) and DYSGEUSIA (There's weird taste in mouth like I don't want to say iron but it's sort of like that Taste in my throat every time I cough, this nastiness but nothing is coming up but it doesn't tastes good) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 034C21A and 047821A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes (Taking Metformin for treatment.). Concomitant products included METFORMIN for Diabetes.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MALAISE (Feeling sick), PYREXIA (Has got a 99.5 temperature, has got fever) and DYSGEUSIA (There's weird taste in mouth like I don't want to say iron but it's sort of like that Taste in my throat every time I cough, this nastiness but nothing is coming up but it doesn't tastes good). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), MALAISE (Feeling sick), PYREXIA (Has got a 99.5 temperature, has got fever) and DYSGEUSIA (There's weird taste in mouth like I don't want to say iron but it's sort of like that Taste in my throat every time I cough, this nastiness but nothing is coming up but it doesn't tastes good) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5.         It was reported that patient have flu like symptoms. On unspecified dates for there was weird taste in patient mouth like iron and taste in patient throat every time patient cough, nastiness but nothing was coming up and it doesn't tastes good. Patient was feeling sick. On unspecified dates patient got a 99.5 temperature and has got fever. Patient ethnicity reported as Caucasian and height over 6 feet 1.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in No treatment medicine was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: she has received the Moderna vaccine and she has experienced side effects that have lasted longer than two months; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (she has received the Moderna vaccine and she has experienced side effects that have lasted longer than two months) 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 IMMUNISATION REACTION (she has received the Moderna vaccine and she has experienced side effects that have lasted longer than two months). At the time of the report, IMMUNISATION REACTION (she has received the Moderna vaccine and she has experienced side effects that have lasted longer than two months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.
Sex: M
Vaccine: COVID19
Symptoms: Dust allergy, Seasonal allergy
Clinical narrative: Dust allergy; Grass allergy; This spontaneous case was reported by a consumer and describes the occurrence of DUST ALLERGY (Dust allergy) and SEASONAL ALLERGY (Grass allergy) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received first 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 DUST ALLERGY (Dust allergy) and SEASONAL ALLERGY (Grass allergy). At the time of the report, DUST ALLERGY (Dust allergy) and SEASONAL ALLERGY (Grass allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: On 14-May-2021, received 1st dose by Moderna. On 19-Jun-2021, received 2nd dose by Moderna.; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), VACCINATION SITE PAIN (Vaccination site pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 14-May-2021, received 1st dose by Moderna. On 19-Jun-2021, received 2nd dose by Moderna.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 14-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In May 2021, the patient experienced FATIGUE (Tiredness). On 19-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 14-May-2021, received 1st dose by Moderna. On 19-Jun-2021, received 2nd dose by Moderna.). At the time of the report, FATIGUE (Tiredness), VACCINATION SITE PAIN (Vaccination site pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 14-May-2021, received 1st dose by Moderna. On 19-Jun-2021, received 2nd dose by Moderna.) outcome was unknown.            No concomitant medications were reported.   In May 2021, the patient experienced first vaccinations had sore arm and felt tired. On 14-May-2021, the patient experienced first vaccinations had sore arm and felt tired. On 16-Nov-2021, the patient experienced felt like did not get full dosage of humira injection. Moderna 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 where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: PAIN IN HANDS; INJECTION SITE PAIN WITH COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (PAIN IN HANDS) and VACCINATION SITE PAIN (INJECTION SITE PAIN WITH COVID VACCINE) 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.   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. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (PAIN IN HANDS) and VACCINATION SITE PAIN (INJECTION SITE PAIN WITH COVID VACCINE). At the time of the report, PAIN IN EXTREMITY (PAIN IN HANDS) had not resolved and VACCINATION SITE PAIN (INJECTION SITE PAIN WITH COVID VACCINE) had resolved.            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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis
Clinical narrative: Hip pain; Knee pain/Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Hip pain) and ARTHRALGIA (Knee pain/Joint pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Wheelchair user, Broken leg (Recovered) in 2010 and Shingles (Recovered) in 2010. Concurrent medical conditions included Rheumatoid arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 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) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Hip pain) and ARTHRALGIA (Knee pain/Joint pain). At the time of the report, ARTHRITIS (Hip pain) outcome was unknown and ARTHRALGIA (Knee pain/Joint pain) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of LEG BROKE was not provided. The reporter's causality for the event(s) of KNEE AND HIP PAIN and SHINGLES with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Significant live follow up. Medical history and Moderna vaccine dosage information were updated. Hip pain was added as an event. Knee pain outcome updated. Reporter causality was updated.
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Hearing loss; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEAFNESS (Hearing loss) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Hearing loss) outcome was unknown.            No concomitant medications were reported. It was reported that patient had got second dose of moderna vaccine and lost hearing a couple of days after that in his left ear. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a patient friend, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Deafness, which occurred a couple of days after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Patient lost hearing in his left ear. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a Spontaneous case reported by a patient friend, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Deafness, which occurred a couple of days after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Patient lost hearing in his left ear. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bronchitis, Malaise
Clinical narrative: Bronchitis; Ill feeling; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Ill feeling) and BRONCHITIS (Bronchitis) in a 79-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.    Concurrent medical conditions included Panuveitis.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, CF. In 2021, the patient experienced MALAISE (Ill feeling). In August 2021, the patient experienced BRONCHITIS (Bronchitis). In 2021, MALAISE (Ill feeling) and BRONCHITIS (Bronchitis) had resolved.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of Ill feeling and Bronchitis was reported as no reasonable possibility for Humira.  No treatment medication were 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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain assessment, Pustule, Skin plaque
Clinical narrative: plaques changed to pustules; plaques changed to pustules; Pain worse; pain in medial area of both knees; This spontaneous case was reported by a consumer and describes the occurrence of PUSTULE (plaques changed to pustules), SKIN PLAQUE (plaques changed to pustules), PAIN (Pain worse) and ARTHRALGIA (pain in medial area of both knees) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Rheumatoid arthritis.    Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and FOLIC ACID for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced PUSTULE (plaques changed to pustules), SKIN PLAQUE (plaques changed to pustules), PAIN (Pain worse) and ARTHRALGIA (pain in medial area of both knees). At the time of the report, PUSTULE (plaques changed to pustules), SKIN PLAQUE (plaques changed to pustules), PAIN (Pain worse) and ARTHRALGIA (pain in medial area of both knees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 6.         No relevant medical history was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was a little sore whwn she left her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little sore whwn she left her arm) 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 VACCINATION SITE PAIN (Arm was a little sore whwn she left her arm). At the time of the report, VACCINATION SITE PAIN (Arm was a little sore whwn she left her arm) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Reporter stated that now her arm hurts but its not where she cant do anything. Its annoying and its little painful when she lifts her arm up and that also happened with second time. Caller also makes statement that her heart starts racing just thinking about what happened to her daughter with the covid 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.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: She had a cousin who was 40something die a month after him and received Moderna; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (She had a cousin who was 40something die a month after him and received Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication information was provided.  The reporter had several family members who died of the COVID-19 vaccines. Her cousin (who was 40something) received Moderna vaccine and died a month after the reporter's uncle died.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  No treatment medication was provided.  Company Comment: This spontaneous case concerns an adult patient (in the 40s), of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient died after receiving the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult patient (in the 40s), of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient died after receiving the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: She had a cousin who was 40something die a month after him and received Moderna
Sex: F
Vaccine: COVID19
Symptoms: Hidradenitis, Influenza like illness
Clinical narrative: Hidradenitis suppurativa; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa) and INFLUENZA LIKE ILLNESS (Flu like symptoms) 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 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 HIDRADENITIS (Hidradenitis suppurativa) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Patient reported non-serious events hidradenitis suppurativa flare up and covid vaccine reaction/had flu Like symptoms with HUMIRA (ADALIMUMAB).   On unknown dates, the patient experienced hidradenitis suppurativa flare up and covid vaccine reaction/had flu like symptoms. On an unknown date, covid vaccine reaction/had flu like symptoms resolved.   Covid-19 vaccine MODERNA (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ear pain, SARS-CoV-2 test, Sinus disorder
Clinical narrative: Sinus disorder; Ear ache; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus disorder), COVID-19 (COVID-19) and EAR PAIN (Ear ache) in a 60-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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 14-Sep-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced SINUS DISORDER (Sinus disorder) and EAR PAIN (Ear ache). At the time of the report, SINUS DISORDER (Sinus disorder) and EAR PAIN (Ear ache) outcome was unknown and COVID-19 (COVID-19) was resolving.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, SARS-CoV-2 test: (Positive) Positive.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.