chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Decreased appetite, Injection site reaction, Psoriasis
Clinical narrative: PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND; Appetite suppression; Weakness; HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PSORIASIS (PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND), DECREASED APPETITE (Appetite suppression), ASTHENIA (Weakness) and INJECTION SITE REACTION (HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PSORIASIS (PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND), DECREASED APPETITE (Appetite suppression), ASTHENIA (Weakness) and INJECTION SITE REACTION (HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS). At the time of the report, COVID-19 (COVID-19) and INJECTION SITE REACTION (HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS) had resolved, PSORIASIS (PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND) was resolving, DECREASED APPETITE (Appetite suppression) had not resolved and ASTHENIA (Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Weight: lost 5 pound.     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 and treatment information was provided.  The reporter's causality with humira (adalimumab) for the events of appetite suppression and half-dollar-sized local reaction was a reasonable possibility, not provided for event weakness and was no reasonable possibility for events psoriasis flares/psoriasis outbreaks on the right palm of the hand and covid.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up information included patient age, moderna covid-19 vaccine dosage regimen updated, event outcome updated and reporter causality updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND; Appetite suppression; Weakness; HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PSORIASIS (PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND), DECREASED APPETITE (Appetite suppression), ASTHENIA (Weakness) and INJECTION SITE REACTION (HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PSORIASIS (PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND), DECREASED APPETITE (Appetite suppression), ASTHENIA (Weakness) and INJECTION SITE REACTION (HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS). At the time of the report, COVID-19 (COVID-19) and INJECTION SITE REACTION (HALF-DOLLAR-SIZED LOCAL REACTION WITH HUMIRA INJECTIONS) had resolved, PSORIASIS (PSORIASIS FLARES/PSORIASIS OUTBREAKS ON THE RIGHT PALM OF THE HAND) was resolving, DECREASED APPETITE (Appetite suppression) had not resolved and ASTHENIA (Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Weight: lost 5 pound.     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 and treatment information was provided.  The reporter's causality with humira (adalimumab) for the events of appetite suppression and half-dollar-sized local reaction was a reasonable possibility, not provided for event weakness and was no reasonable possibility for events psoriasis flares/psoriasis outbreaks on the right palm of the hand and covid.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up information included patient age, moderna covid-19 vaccine dosage regimen updated, event outcome updated and reporter causality updated.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itch the day before his dose is due since starting Dupixent /starts to itch the day before his dose is due since starting dupixent; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch the day before his dose is due since starting Dupixent /starts to itch the day before his dose is due since starting dupixent) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.  No Medical History information was reported.   On 10-Jul-2021, the patient DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram once a day. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a day. On an unknown date, the patient experienced PRURITUS (Itch the day before his dose is due since starting Dupixent /starts to itch the day before his dose is due since starting dupixent). At the time of the report, PRURITUS (Itch the day before his dose is due since starting Dupixent /starts to itch the day before his dose is due since starting dupixent) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.  On an unknown date the patient developed a start to itch the day before his dose was due since starting dupixent following the first dose intake of DUPILUMAB and COVID-19 VACCINE MRNA (MRNA 1273). It was notices that he starts to itch the day before his dose was due since starting Dupixent. No treatment reported for the itching and after the dose was given it goes away but starts to itch again the day before dose was due. It was also reported that consumer took Moderna vaccine last Tuesday and started to itch on areas that are healing and not scarred yet. The nurse received the information from consumer's wife. At the time of the report, the Dupixent was continued.  No concomitant medication information was provided.  No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles after receiving the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (developed shingles after receiving the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Cancer (resolved until recently) in 2011, Epstein-Barr virus infection (resolved until recently) in 2011 and Shingles (resolved until recently) in 2016.    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 HERPES ZOSTER (developed shingles after receiving the Moderna vaccine). At the time of the report, HERPES ZOSTER (developed shingles after receiving the Moderna vaccine) outcome was unknown. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported. 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.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: chest discomfort; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST DISCOMFORT (chest discomfort) 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 06-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest discomfort). At the time of the report, CHEST DISCOMFORT (chest discomfort) outcome 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.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: My sister is permanently damaged from Mdrna shots; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (My sister is permanently damaged from Mdrna shots) 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, received 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 (My sister is permanently damaged from Mdrna shots). At the time of the report, IMMUNISATION REACTION (My sister is permanently damaged from Mdrna shots) outcome was unknown.            Relevant concomitant medications were not reported.  It was reported that patient got permanently damaged from Moderna shots.  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: Synovial cyst
Clinical narrative: Ganglion cyst; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (Ganglion cyst) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNOVIAL CYST (Ganglion cyst). At the time of the report, SYNOVIAL CYST (Ganglion cyst) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  Treatment Drugs Not Reported.  The reporter's causality for the event(s) of GANGLION CYST with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Booster shot of Moderna COVID-19 vaccine caused some fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Booster shot of Moderna COVID-19 vaccine caused some fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's other relevant history was not reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Daily Dose: CF, Solution for injection in prefilled pen. On an unknown date, the patient experienced FATIGUE (Booster shot of Moderna COVID-19 vaccine caused some fatigue). At the time of the report, FATIGUE (Booster shot of Moderna COVID-19 vaccine caused some fatigue) outcome was unknown.            Concomitant Drugs were not reported.  The patient had received booster dose of COVID-19 vaccine manufactured by Moderna and experienced some fatigue.  The reporter's causality for the event Booster shot of Moderna COVID-19 vaccine caused some fatigue with HUMIRA(Adalimumab) drug was no reasonable possibility.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash
Clinical narrative: Had sore arm; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had sore arm) and VACCINATION SITE RASH (Rash at injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Had sore arm) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, PAIN IN EXTREMITY (Had sore arm) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.   It was reported that post first shot had sore arm and week later rash at injection site.  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.   This case was linked to MOD-2021-624806 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Congestion; Felt Terrible/the caller states she kind of lost the days; COVID/She definetly had a postive COVID-19 test; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (Congestion), FEELING ABNORMAL (Felt Terrible/the caller states she kind of lost the days) and COVID-19 (COVID/She definetly had a postive COVID-19 test) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PREGABALIN (LYRICA) capsule for Fibromyalgia.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and PREGABALIN (LYRICA) (Oral) 150 milligram twice a day. On an unknown date, the patient experienced NASAL CONGESTION (Congestion), FEELING ABNORMAL (Felt Terrible/the caller states she kind of lost the days) and COVID-19 (COVID/She definetly had a postive COVID-19 test). At the time of the report, NASAL CONGESTION (Congestion) and FEELING ABNORMAL (Felt Terrible/the caller states she kind of lost the days) had not resolved and COVID-19 (COVID/She definetly had a postive COVID-19 test) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Had positive COVID test which was about two weeks ago..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient weight was reported as 68.04 kgs.  Patient states she is 10x better but didn't start getting better till today. symptoms had lasted for four days. She is a lot better now.  Patient stated that she had not had any problems with the medication Lyrica. she did not noticed anything but felt terrible.  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: Migraine, Vaccination site movement impairment
Clinical narrative: Couldn't move arm post 2; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move arm post 2) and MIGRAINE (Migraine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move arm post 2) and MIGRAINE (Migraine). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move arm post 2) and MIGRAINE (Migraine) outcome was unknown.            No concomitant products were reported.  It was reported that, post first shot had sore arm and week later rash at injection site. Post second shot, couldn't move arm post 2 hours, migraine that night.   No treatment information was reported 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.   This case was linked to MOD-2021-624798.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Rash, Swelling face
Clinical narrative: Strong reaction; Face became swollen; Skin rash became much worse; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Strong reaction), SWELLING FACE (Face became swollen) and RASH (Skin rash became much worse) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   In April 2021, the patient started DUPILUMAB (DUPIXENT) (unknown route) 300 milligram. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Strong reaction), SWELLING FACE (Face became swollen) and RASH (Skin rash became much worse). In 2021, IMMUNISATION REACTION (Strong reaction), SWELLING FACE (Face became swollen) and RASH (Skin rash became much worse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed all the events as related to Moderna vaccine and not related to Dupixent.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Colitis.   On 25-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 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In August 2021, the patient experienced CHILLS (Chills). On 17-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and CHILLS (Chills) had not resolved.            No concomitant medication was reported. In August 2021, the patient experienced CHILLS. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of CHILLS 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Liver disorder, Nausea, Vomiting
Clinical narrative: ANXIETY; nausea; vomiting; STAGE 4 LIVER DISEASE; This spontaneous case was reported by a consumer and describes the occurrence of LIVER DISORDER (STAGE 4 LIVER DISEASE), ANXIETY (ANXIETY), NAUSEA (nausea) and VOMITING (vomiting) in a 59-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 Plaque psoriasis.   On an unknown date, the patient received second 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced LIVER DISORDER (STAGE 4 LIVER DISEASE). On an unknown date, the patient experienced ANXIETY (ANXIETY), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with DULOXETINE for Anxiety, at a dose of 30 milligram twice a day. At the time of the report, LIVER DISORDER (STAGE 4 LIVER DISEASE) and ANXIETY (ANXIETY) outcome was unknown and NAUSEA (nausea) and VOMITING (vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: Possible stage 4 liver disease.         The patient had a possible stage 4 liver disease as revealed in a recent blood work. He had sore arm after first covid-19 vaccine and for the second had nausea and vomiting, then it went away like four hours.   The reporter's causality for the events of stage 4 liver disease, nausea after covid-19 vaccine and vomiting after covid-19 vaccine was not provided. The reporter's causality for the event of anxiety with skyrizi(risankizumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Moderna.  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-2021-623082 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Significant follow-up received included narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included DUPILUMAB (DUPIXENT) for an unknown indication.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid infection). At the time of the report, COVID-19 (Covid infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. It was reported that patient got covid infection during Dupixent therapy. 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.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as event onset date was not provided. Clinical course, laboratory, and treatment details were not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as event onset date was not provided. Clinical course, laboratory, and treatment details were not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Therapeutic response shortened
Clinical narrative: Pain; Fatigue; Headache; Wearing off effect; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), FATIGUE (Fatigue), HEADACHE (Headache) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Diabetes, Chronic kidney disease stage 3 and Rheumatoid arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to citrate free (1 in 1 wk). In 2021, the patient experienced PAIN (Pain), FATIGUE (Fatigue), HEADACHE (Headache) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, PAIN (Pain), FATIGUE (Fatigue), HEADACHE (Headache) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown.            Formulation of Humira was reported as Solution for injection in pre-filled pen.   No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns a female patient aged 63 years with relevant medical history of Rheumatoid Arthritis on Humira  reported, who experienced the non-serious unexpected event Therapeutic response shortened that occurred on an unknown date in the context of mRNA-1273 vaccination. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 63 years with relevant medical history of Rheumatoid Arthritis on Humira  reported, who experienced the non-serious unexpected event Therapeutic response shortened that occurred on an unknown date in the context of mRNA-1273 vaccination. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She got sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She got sick) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She got sick). At the time of the report, ILLNESS (She got sick) outcome was unknown.            The concomitant medication was not reported by reporter. Patient stated that someone she knew got the Pfizer and she herself had the Moderna and she got sick after the second dose, and she could not find the number for Moderna. The treatment medication was not reported by reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: after receiving the first dose of the Moderna Covid-19 her arm was sore; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (after receiving the first dose of the Moderna Covid-19 her arm was sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (after receiving the first dose of the Moderna Covid-19 her arm was sore). In 2021, VACCINATION SITE PAIN (after receiving the first dose of the Moderna Covid-19 her arm was sore) had resolved. Not provided.     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.   Race of the patient was reported. Concomitant medications details were not reported.  The patient does not take any medicine. The patient was a Retired Registered Nurse who thought to received first dose of the vaccine was in the last week of Jan 2021 and had the sore arm lasted about 4 to 5 days.  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.   This case was linked to MOD-2021-624848 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant Live Follow Up received on 27-Jul-21, included patient Demographics, Vaccination Start Date added and narrative updated.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: arm was sore; Fever; had body aches; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (arm was sore), PYREXIA (Fever) and MYALGIA (had body aches) in an 81-year-old female patient 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.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (arm was sore), PYREXIA (Fever) and MYALGIA (had body aches). In February 2021, VACCINATION SITE PAIN (arm was sore), PYREXIA (Fever) and MYALGIA (had body aches) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Race of the patient was reported. Concomitant medications details were not reported.  The patient had not taken any medicine.  The patient was Retired Registered Nurse who got the second dose of moderna COVID-19 around 24 Feb 2021 or 25 Feb 2021. Patient reported arm was sore for a week maybe, that was very painful.  Patient reported the symptoms were not serious; said if they had gone on any longer patient would said they were serious.  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.   This case was linked to MOD-2021-624847 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant Live Follow Up received on 27-Jul-22, included patient demographics and vaccination Start Date added and narrative updated.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No Adverse Event; Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna; Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna), COVID-19 IMMUNISATION (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was 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 COVID-19 prophylaxis.    No Medical History information was reported.   On 19-Sep-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna) and COVID-19 IMMUNISATION (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna), COVID-19 IMMUNISATION (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna) 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 received in the Moderna were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up received: updated reporter information.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: other people who received the Moderna Covid-19 vaccine and got sick; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (other people who received the Moderna Covid-19 vaccine and got sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (other people who received the Moderna Covid-19 vaccine and got sick). At the time of the report, IMMUNISATION REACTION (other people who received the Moderna Covid-19 vaccine and got sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported.  The reporter was Retired Registered Nurse who mentioned that other people had gotten Moderna and gotten sick, no identifying information provided.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-624848 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non Significant Follow Up Appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-624848:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Friend got the Moderna vaccine and he got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Friend got the Moderna vaccine and he got sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Friend got the Moderna vaccine and he got sick). At the time of the report, ILLNESS (Friend got the Moderna vaccine and he got sick) 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: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19 Virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19 Virus) 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 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 COVID-19 (Positive for COVID-19 Virus). At the time of the report, COVID-19 (Positive for COVID-19 Virus) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Relevant concomitant medications were not reported.  Patient had both doses of Moderna COVID-19 Vaccine and tested positive for COVID-19 Virus. She only felt bad for a day or two. She also stated that the vaccine worked because she avoided the hospital.  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 spontaneous case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date after receiving the second dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and onset date of event were not provided. SARS-CoV-2 test was positive on an unknown date. Outcome of the event was resolving at the time of the report. Patient previously received a dose of mRNA-1273 vaccine on unknown date, and at unknown interval. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow-up received and contains patient information, suspect details and event details.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date after receiving the second dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and onset date of event were not provided. SARS-CoV-2 test was positive on an unknown date. Outcome of the event was resolving at the time of the report. Patient previously received a dose of mRNA-1273 vaccine on unknown date, and at unknown interval. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHE; EXTREMELY TIRED; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (BODY ACHE) and FATIGUE (EXTREMELY TIRED) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received 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 PANCREATIN (CREON) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (BODY ACHE) and FATIGUE (EXTREMELY TIRED). At the time of the report, PAIN (BODY ACHE) outcome was unknown and FATIGUE (EXTREMELY TIRED) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624592 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Felt sick with second covid vaccine; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High Fever) and MALAISE (Felt sick with second covid vaccine) in a 55-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 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (High Fever). In August 2021, the patient experienced MALAISE (Felt sick with second covid vaccine). At the time of the report, PYREXIA (High Fever) was resolving and MALAISE (Felt sick with second covid vaccine) outcome was unknown.            Concomitant medications were not reported.  Patient reported non-serious events had both covid vaccines and did had high fever and felt sick with second covid vaccine with HUMIRA (ADALIMUMAB).  In 2021, the patient experienced had both covid vaccines and did had high fever.  MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of had both covid vaccines and did had high fever with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of felt sick with second covid vaccine was not provided.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624937 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: it made her sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (it made her sick) 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 ILLNESS (it made her sick). At the time of the report, ILLNESS (it made her sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  It was reported that patient got the Moderna COVID-19 Vaccine and it made her sick.  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.