chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine administered; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.  The patient's past medical history included COVID-19 (resolved on an unknown date.) on 12-Nov-2020.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In March 2021, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided.  No treatment medication was provided.   This case was linked to MOD-2021-621454, MOD-2021-621439 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: CROHN'S DISEASE FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHN'S DISEASE FLARE UP) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (CROHN'S DISEASE FLARE UP) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (CROHN'S DISEASE FLARE UP) was resolving.            Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns an adult male patient with relevant medical history of Crohn's disease on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohn's disease flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as onset date of the event was not provided. Outcome of the event was reported as resolving. Patient received a 2-dose primary series of mRNA-1273 vaccine given 31 days apart which falls within the recommended dosing schedule The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with relevant medical history of Crohn's disease on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohn's disease flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as onset date of the event was not provided. Outcome of the event was reported as resolving. Patient received a 2-dose primary series of mRNA-1273 vaccine given 31 days apart which falls within the recommended dosing schedule The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: BREAK THROUGH PSORIASIS/PSORIASIS VULGARIS FLARE; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (BREAK THROUGH PSORIASIS/PSORIASIS VULGARIS FLARE) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 22-Feb-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PSORIASIS (BREAK THROUGH PSORIASIS/PSORIASIS VULGARIS FLARE). At the time of the report, PSORIASIS (BREAK THROUGH PSORIASIS/PSORIASIS VULGARIS FLARE) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.  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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: Headache; right arm is hurting and puffy/injection arm that is hurting, which is the right arm. It is a little puffy; right arm is hurting and puffy/injection arm that is hurting, which is the right arm. It is a little puffy; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), VACCINATION SITE PAIN (right arm is hurting and puffy/injection arm that is hurting, which is the right arm. It is a little puffy) and VACCINATION SITE SWELLING (right arm is hurting and puffy/injection arm that is hurting, which is the right arm. It is a little puffy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 prophylaxis.     The patient's past medical history included Breast cancer (Left breast).   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (right arm is hurting and puffy/injection arm that is hurting, which is the right arm. It is a little puffy) and VACCINATION SITE SWELLING (right arm is hurting and puffy/injection arm that is hurting, which is the right arm. It is a little puffy). At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (right arm is hurting and puffy/injection arm that is hurting, which is the right arm. It is a little puffy) and VACCINATION SITE SWELLING (right arm is hurting and puffy/injection arm that is hurting, which is the right arm. It is a little puffy) had not resolved.            Ethnicity of the patient reported as Other. No concomitant medication was reported. Patient had lost a lot of weight since having cancer. she reiterated the headache was like a fob. No treatment medication was reported.  Given that the Moderna product was not reported as a co-suspect product and there is no other attribution to the Moderna product in this report from the other manufacturer, the Moderna product is not considered to be a suspect product in this report.  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: Inappropriate schedule of product administration, Skin exfoliation
Clinical narrative: first dose on 23 Feb 2021 and second doce on 17 Mar 2021; FLAKENESS ABOVE EYEBROW; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (FLAKENESS ABOVE EYEBROW) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 23 Feb 2021 and second doce on 17 Mar 2021) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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) at an unspecified dose. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 23 Feb 2021 and second doce on 17 Mar 2021). In 2021, the patient experienced SKIN EXFOLIATION (FLAKENESS ABOVE EYEBROW). At the time of the report, SKIN EXFOLIATION (FLAKENESS ABOVE EYEBROW) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 23 Feb 2021 and second doce on 17 Mar 2021) outcome was unknown.            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.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Skin induration
Clinical narrative: It's hard and it's on her back and butt area; skin allergy; This spontaneous case was reported by a patient and describes the occurrence of SKIN INDURATION (It's hard and it's on her back and butt area) and ALLERGY TO VACCINE (skin allergy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN INDURATION (It's hard and it's on her back and butt area) and ALLERGY TO VACCINE (skin allergy). At the time of the report, SKIN INDURATION (It's hard and it's on her back and butt area) and ALLERGY TO VACCINE (skin allergy) outcome was unknown.            No concomitant medications were reported.   Caller advised she got her 2nd dose in May and has now developed a skin allergy and at night it's hard and it's on her back and butt area. Caller advised her HCP prescribed a medication to her.  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: Influenza like illness, Myalgia, Nausea
Clinical narrative: Experienced occasional nausea from Humira; Got covid vaccine and experienced body pain similar to flu; Got covid vaccine and experienced body pain similar to flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Got covid vaccine and experienced body pain similar to flu), MYALGIA (Got covid vaccine and experienced body pain similar to flu) and NAUSEA (Experienced occasional nausea from Humira) 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.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF Pen. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Got covid vaccine and experienced body pain similar to flu), MYALGIA (Got covid vaccine and experienced body pain similar to flu) and NAUSEA (Experienced occasional nausea from Humira). At the time of the report, INFLUENZA LIKE ILLNESS (Got covid vaccine and experienced body pain similar to flu) and MYALGIA (Got covid vaccine and experienced body pain similar to flu) had resolved and NAUSEA (Experienced occasional nausea from Humira) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of occasional nausea from Humira with Humira(adalimumab) was a reasonable possibility. the reporter's causality for the events of got covid vaccine and experienced body pain similar to flu unknown onset with Humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received, event outcome and narrative description updated.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: yet to experience a herpes cold sore type outbreak/herpes outbreak suppression; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (yet to experience a herpes cold sore type outbreak/herpes outbreak suppression) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Concurrent medical conditions included Oral herpes (Semi-annually for the last 10 years).   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. In January 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (yet to experience a herpes cold sore type outbreak/herpes outbreak suppression). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (yet to experience a herpes cold sore type outbreak/herpes outbreak suppression) outcome was unknown.            No concomitant medications were reported.  It was reported that, since getting COVID-19 and the subsequent 2 doses of the Moderna vaccine (approximately since Jan-2021), the patient yet to experience a herpes cold sore type outbreak.   No treatment details 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: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE).   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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns an adult female patient with use of Adalimumab (Humira) for chronic plaque psoriasis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date after receiving the first dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and date of event onset were not provided. SARS-CoV-2 test was positive on an unknown date. No information on any other doses of COVID-19 vaccination was provided. Adalimumab is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient with use of Adalimumab (Humira) for chronic plaque psoriasis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date after receiving the first dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and date of event onset were not provided. SARS-CoV-2 test was positive on an unknown date. No information on any other doses of COVID-19 vaccination was provided. Adalimumab is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Pain
Clinical narrative: Felt bad; she was sweaty; Arm was sore; Headache; chills; fever; Achy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Achy), FEELING ABNORMAL (Felt bad), HYPERHIDROSIS (she was sweaty), PAIN IN EXTREMITY (Arm was sore) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Aug-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced FEELING ABNORMAL (Felt bad). In August 2021, the patient experienced PAIN (Achy), HYPERHIDROSIS (she was sweaty), PAIN IN EXTREMITY (Arm was sore), HEADACHE (Headache), CHILLS (chills) and PYREXIA (fever). On 12-Aug-2021, PAIN (Achy), FEELING ABNORMAL (Felt bad), HYPERHIDROSIS (she was sweaty), PAIN IN EXTREMITY (Arm was sore), HEADACHE (Headache), CHILLS (chills) and PYREXIA (fever) had resolved.            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
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Felt bad; she was sweaty; Arm was sore; Headache; chills; fever; Achy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Achy), FEELING ABNORMAL (Felt bad), HYPERHIDROSIS (she was sweaty), PAIN IN EXTREMITY (Arm was sore) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Aug-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced FEELING ABNORMAL (Felt bad). In August 2021, the patient experienced PAIN (Achy), HYPERHIDROSIS (she was sweaty), PAIN IN EXTREMITY (Arm was sore), HEADACHE (Headache), CHILLS (chills) and PYREXIA (fever). On 12-Aug-2021, PAIN (Achy), FEELING ABNORMAL (Felt bad), HYPERHIDROSIS (she was sweaty), PAIN IN EXTREMITY (Arm was sore), HEADACHE (Headache), CHILLS (chills) and PYREXIA (fever) had resolved.            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, UNK
Symptoms: Fatigue, Headache, Injection site reaction, Pain, Urticaria
Clinical narrative: General body pain; Injection site reaction; Hives; Headache; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain), INJECTION SITE REACTION (Injection site reaction), URTICARIA (Hives), HEADACHE (Headache) and FATIGUE (Exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No known allergies.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (General body pain), INJECTION SITE REACTION (Injection site reaction), URTICARIA (Hives), HEADACHE (Headache) and FATIGUE (Exhaustion). At the time of the report, PAIN (General body pain) had not resolved and INJECTION SITE REACTION (Injection site reaction), URTICARIA (Hives), HEADACHE (Headache) and FATIGUE (Exhaustion) outcome was unknown.            No relevant medical history. No concomitant medications were reported. No treatment medications were 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.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain
Clinical narrative: 2nd Moderna Shot Kicked my ass with cold chills and soreness all over; 2nd Moderna Shot Kicked my ass with cold chills and soreness all over; 2nd Moderna Shot Kicked my ass with cold chills and soreness all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (2nd Moderna Shot Kicked my ass with cold chills and soreness all over), FEELING COLD (2nd Moderna Shot Kicked my ass with cold chills and soreness all over) and CHILLS (2nd Moderna Shot Kicked my ass with cold chills and soreness all over) 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 PAIN (2nd Moderna Shot Kicked my ass with cold chills and soreness all over), FEELING COLD (2nd Moderna Shot Kicked my ass with cold chills and soreness all over) and CHILLS (2nd Moderna Shot Kicked my ass with cold chills and soreness all over). At the time of the report, PAIN (2nd Moderna Shot Kicked my ass with cold chills and soreness all over), FEELING COLD (2nd Moderna Shot Kicked my ass with cold chills and soreness all over) and CHILLS (2nd Moderna Shot Kicked my ass with cold chills and soreness all over) outcome was unknown.            Only minor tiredness from the Pfizer booster.  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: Impaired driving ability, Nasopharyngitis, Poor quality sleep
Clinical narrative: HAD TROUBLE WITH LONG DRIVES; NOT SLEEPING WELL; FEELING COLD LIKE SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (HAD TROUBLE WITH LONG DRIVES), POOR QUALITY SLEEP (NOT SLEEPING WELL) and NASOPHARYNGITIS (FEELING COLD LIKE SYMPTOMS) 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 ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-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 IMPAIRED DRIVING ABILITY (HAD TROUBLE WITH LONG DRIVES), POOR QUALITY SLEEP (NOT SLEEPING WELL) and NASOPHARYNGITIS (FEELING COLD LIKE SYMPTOMS). The patient was treated with MERCAPTOPURINE at an unspecified dose and frequency. In 2021, POOR QUALITY SLEEP (NOT SLEEPING WELL) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (HAD TROUBLE WITH LONG DRIVES) was resolving and NASOPHARYNGITIS (FEELING COLD LIKE SYMPTOMS) outcome was unknown.            No concomitant medication was reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erectile dysfunction, Malaise
Clinical narrative: Impotence; Over all uneasiness; Severe joint pain; This spontaneous case was reported by a patient and describes the occurrence of ERECTILE DYSFUNCTION (Impotence) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 ERECTILE DYSFUNCTION (Impotence) (seriousness criterion medically significant), MALAISE (Over all uneasiness) and ARTHRALGIA (Severe joint pain). At the time of the report, ERECTILE DYSFUNCTION (Impotence), MALAISE (Over all uneasiness) and ARTHRALGIA (Severe joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Vaccine was administered several months ago and since then patient was experiencing impotence, severe joint pain and over all uneasiness. Otherwise healthy male with a family. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a patient, concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected serious (medically significant) event of Erectile dysfunction, reported as impotence, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. Patient also experienced severe joint pain and over all uneasiness. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected serious (medically significant) event of Erectile dysfunction, reported as impotence, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. Patient also experienced severe joint pain and over all uneasiness. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Influenza like illness, Sleep apnoea syndrome
Clinical narrative: Sleep apnea; Influenza like illness; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP APNOEA SYNDROME (Sleep apnea) and INFLUENZA LIKE ILLNESS (Influenza like illness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Influenza like illness). On an unknown date, the patient experienced SLEEP APNOEA SYNDROME (Sleep apnea). At the time of the report, SLEEP APNOEA SYNDROME (Sleep apnea) had not resolved and INFLUENZA LIKE ILLNESS (Influenza like illness) had resolved.            No concomitant products were reported.  On an unknown date, the patient experienced sleep apnea. In 2021, the patient experienced felt like flu after second vaccination. in 2021, the felt like flu after second vaccination resolved. Moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 01-May-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 30-May-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna. Causality for humira (adalimumab) The reporter's causality for the event (s) of sleep apnea and felt like flu after second vaccination was not  provided.  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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: symptoms earlier and tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (symptoms earlier and tested positive for COVID) 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 29-Sep-2021, the patient experienced COVID-19 (symptoms earlier and tested positive for COVID). At the time of the report, COVID-19 (symptoms earlier and tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported. No treatment information was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine (unknown dose number and schedule of vaccination). SARS-CoV-2 test was positive as on 29-Sep-2021. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was unknown. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine (unknown dose number and schedule of vaccination). SARS-CoV-2 test was positive as on 29-Sep-2021. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was unknown. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Age: 21.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Alopecia; Flu like symptoms; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Alopecia), INFLUENZA LIKE ILLNESS (Flu like symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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) Solution for injection in pre-filled pen. On 24-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced ALOPECIA (Alopecia) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, ALOPECIA (Alopecia) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Concomitant medication was not reported.  On an unknown date, it was reported Humira was not as effective. Treatment details 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medications were reported. It was reported that patient had flu like symptoms with 2nd dose of vaccine, but he did not experienced anything permanent like tinnitus. 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: Illness, Mobility decreased, Vaccination site erythema, Vaccination site warmth
Clinical narrative: she got it and it is real red and hot where they gave it to her at referring to the location of the body; real sick; cant even get out bed; she got it and it is real red and hot where they gave it to her at referring to the location of the body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (she got it and it is real red and hot where they gave it to her at referring to the location of the body), ILLNESS (real sick), MOBILITY DECREASED (cant even get out bed) and VACCINATION SITE ERYTHEMA (she got it and it is real red and hot where they gave it to her at referring to the location of the body) 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 WARMTH (she got it and it is real red and hot where they gave it to her at referring to the location of the body), ILLNESS (real sick), MOBILITY DECREASED (cant even get out bed) and VACCINATION SITE ERYTHEMA (she got it and it is real red and hot where they gave it to her at referring to the location of the body). At the time of the report, VACCINATION SITE WARMTH (she got it and it is real red and hot where they gave it to her at referring to the location of the body), ILLNESS (real sick), MOBILITY DECREASED (cant even get out bed) and VACCINATION SITE ERYTHEMA (she got it and it is real red and hot where they gave it to her at referring to the location of the body) outcome was unknown.        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
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gastric disorder, Headache, Myalgia
Clinical narrative: Headaches after covid vaccine; Body aches after covid vaccine; stomach issues; This spontaneous case was reported by a patient and describes the occurrence of GASTRIC DISORDER (stomach issues), HEADACHE (Headaches after covid vaccine) and MYALGIA (Body aches after covid vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Ankylosing spondylitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe) and Ankylosing spondylitis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. In 2021, the patient experienced GASTRIC DISORDER (stomach issues) and MYALGIA (Body aches after covid vaccine). On an unknown date, the patient experienced HEADACHE (Headaches after covid vaccine). At the time of the report, GASTRIC DISORDER (stomach issues) had not resolved and HEADACHE (Headaches after covid vaccine) and MYALGIA (Body aches after covid vaccine) had resolved.            No concomitant medications were reported.  On an unknown date, the patient experienced headaches. At the time of the report, headaches had not resolved. The reporter causality for the event of headaches was no reasonable possibility with Moderna COVID-19 vaccine.  No treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of headaches was not provided. the reporter's causality for the events of body aches after covid vaccine and headaches after covid vaccine with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event of stomach issues with Humira(adalimumab) was reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received, Event and dose information and narrative updated.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Drug interaction
Clinical narrative: PERCEIVED HUMIRA FAILED THERAPY; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (PERCEIVED HUMIRA FAILED THERAPY) 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 Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous). On an unknown date, the patient experienced DRUG INTERACTION (PERCEIVED HUMIRA FAILED THERAPY). At the time of the report, DRUG INTERACTION (PERCEIVED HUMIRA FAILED THERAPY) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled pen.   No concomitant medication was reported.   On an unknown date, the patient experienced PERCEIVED HUMIRA FAILED THERAPY.  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 mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: had problems; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (had problems) 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 (had problems). At the time of the report, IMMUNISATION REACTION (had problems) 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.   No concomitant medication was reported. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-621593:
Sex: F
Vaccine: COVID19
Symptoms: Tendon rupture
Clinical narrative: Tendon rupture; This spontaneous case was reported by a consumer and describes the occurrence of TENDON RUPTURE (Tendon rupture) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    There was no reported medical history.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced TENDON RUPTURE (Tendon rupture). At the time of the report, TENDON RUPTURE (Tendon rupture) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       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.  Patient had a torn tendon in her knee. It was unknown if patient was enrolled in a COVID-19 Vaccine trial.   Concomitant drugs were not reported. No treatment medication reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Night sweats, Pain, Thyroid mass
Clinical narrative: Thyroid nodule; Night sweats; Dry eyes; Pain; This spontaneous case was reported by a consumer and describes the occurrence of THYROID MASS (Thyroid nodule), NIGHT SWEATS (Night sweats), DRY EYE (Dry eyes) and PAIN (Pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. In 2021, the patient experienced THYROID MASS (Thyroid nodule), NIGHT SWEATS (Night sweats), DRY EYE (Dry eyes) and PAIN (Pain). At the time of the report, THYROID MASS (Thyroid nodule), NIGHT SWEATS (Night sweats), DRY EYE (Dry eyes) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of THYROID NODULE, NIGHT SWEATS, DRY EYES and PAIN was not provided for Humira. 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.