chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Fibromyalgia, Inappropriate schedule of product administration
Clinical narrative: Fibromyalgia/fibromyalgia pain in ankles; Patient took first dose on 01-Mar-2021 and second dose on 22-Mar-2021; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia/fibromyalgia pain in ankles), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 01-Mar-2021 and second dose on 22-Mar-2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    There was no reported medical history.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia/fibromyalgia pain in ankles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 01-Mar-2021 and second dose on 22-Mar-2021). In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, FIBROMYALGIA (Fibromyalgia/fibromyalgia pain in ankles) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 01-Mar-2021 and second dose on 22-Mar-2021) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.  Formulation for HUMIRA was given as Solution for injection in pre-filled pen.  The reporter's causality for the events of fibromyalgia and fatigue was not provided with HUMIRA (ADALIMUMAB).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Secretion discharge, Vaginal infection
Clinical narrative: Vaginitis; Cough; MUCUS IN CHEST; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL INFECTION (Vaginitis), COUGH (Cough) and SECRETION DISCHARGE (MUCUS IN CHEST) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VAGINAL INFECTION (Vaginitis), COUGH (Cough) and SECRETION DISCHARGE (MUCUS IN CHEST). At the time of the report, VAGINAL INFECTION (Vaginitis) was resolving and COUGH (Cough) and SECRETION DISCHARGE (MUCUS IN CHEST) outcome was unknown.            Concomitant medication was not reported.  On an unknown date, patient experienced inflammation in vagina area and buttock area felt like had homolids/there was itching and burning, bad cough and mucus in chest. 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.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: Ringing in ears; 1st dose on 3/22/2021 and second dose on 4/12/2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 3/22/2021 and second dose on 4/12/2021) and TINNITUS (Ringing in ears) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Family history included Hypertension since an unknown date, Aneurysm cerebral, Thyroid cancer since an unknown date, Ovarian cancer since an unknown date and Cervical cancer since an unknown date. Concurrent medical conditions included Aortic aneurysm since 2009.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 3/22/2021 and second dose on 4/12/2021). On an unknown date, the patient experienced TINNITUS (Ringing in ears). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 3/22/2021 and second dose on 4/12/2021) and TINNITUS (Ringing in ears) outcome was unknown.            No concomitant medications were reported. It was reported that after 2 hrs of shot patient experienced ringing in ears. It was worse. 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: 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 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 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 were reported.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to US-MODERNATX, INC.-MOD-2021-621568 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-621568:
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE) 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 Psoriatic arthritis.    There was no reported medical history.  Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HEADACHE (HEADACHE). At the time of the report, HEADACHE (HEADACHE) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Skin discolouration, Skin disorder, Vaccination site mass, Vaccination site pain
Clinical narrative: Spot on left arm/little tiny pink things on skin; Spot on left arm/little tiny pink things on skin; Covid 19 vaccination made arm sore; Both covid 19 vaccine caused knot on a arm; Head hurt so bad/Headache from nerve ending; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Spot on left arm/little tiny pink things on skin), SKIN DISCOLOURATION (Spot on left arm/little tiny pink things on skin), VACCINATION SITE PAIN (Covid 19 vaccination made arm sore), VACCINATION SITE MASS (Both covid 19 vaccine caused knot on a arm) and HEADACHE (Head hurt so bad/Headache from nerve ending) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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) (unknown route) Solution for injection in pre-filled pen. On an unknown date, the patient experienced SKIN DISORDER (Spot on left arm/little tiny pink things on skin), SKIN DISCOLOURATION (Spot on left arm/little tiny pink things on skin), VACCINATION SITE PAIN (Covid 19 vaccination made arm sore), VACCINATION SITE MASS (Both covid 19 vaccine caused knot on a arm) and HEADACHE (Head hurt so bad/Headache from nerve ending). At the time of the report, SKIN DISORDER (Spot on left arm/little tiny pink things on skin), SKIN DISCOLOURATION (Spot on left arm/little tiny pink things on skin), VACCINATION SITE MASS (Both covid 19 vaccine caused knot on a arm) and HEADACHE (Head hurt so bad/Headache from nerve ending) outcome was unknown and VACCINATION SITE PAIN (Covid 19 vaccination made arm sore) 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   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received from safety contains Significant follow up- Event updated.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Head discomfort, Nausea, Pyrexia
Clinical narrative: Chills; Fever; Nauseous; Felt like i got in the head with a shovel; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nauseous) and HEAD DISCOMFORT (Felt like i got in the head with a shovel) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER and PFIZER. Past adverse reactions to the above products included No adverse event with PFIZER and PFIZER.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose 3. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nauseous) and HEAD DISCOMFORT (Felt like i got in the head with a shovel). At the time of the report, CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nauseous) and HEAD DISCOMFORT (Felt like i got in the head with a shovel) outcome was unknown. 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.  No treatment and concomitant medication provided.  It was reported that patient got first and second Pfizer shots without any side effects.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Headache, Musculoskeletal pain, Pain in extremity
Clinical narrative: Upset tummy; Back pains; Aching arms, both; Pains across the shoulder blades; Headache; Aching arms, both and yet jabbed in the rights.; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Upset tummy), BACK PAIN (Back pains), PAIN IN EXTREMITY (Aching arms, both), MUSCULOSKELETAL PAIN (Pains across the shoulder blades) and HEADACHE (Headache) in a  patient of an unknown age and gender 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 15-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ABDOMINAL DISCOMFORT (Upset tummy), BACK PAIN (Back pains), PAIN IN EXTREMITY (Aching arms, both), MUSCULOSKELETAL PAIN (Pains across the shoulder blades), HEADACHE (Headache) and VACCINATION SITE PAIN (Aching arms, both and yet jabbed in the rights.). At the time of the report, ABDOMINAL DISCOMFORT (Upset tummy), BACK PAIN (Back pains), PAIN IN EXTREMITY (Aching arms, both), MUSCULOSKELETAL PAIN (Pains across the shoulder blades), HEADACHE (Headache) and VACCINATION SITE PAIN (Aching arms, both and yet jabbed in the rights.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was provided.  It was mentioned that patient got vaccine yesterday morning and issues that occurred from it.  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: Vaccination site pain
Clinical narrative: Upset tummy; Back pains; Aching arms, both; Pains across the shoulder blades; Headache; Aching arms, both and yet jabbed in the rights.; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Upset tummy), BACK PAIN (Back pains), PAIN IN EXTREMITY (Aching arms, both), MUSCULOSKELETAL PAIN (Pains across the shoulder blades) and HEADACHE (Headache) in a  patient of an unknown age and gender 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 15-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ABDOMINAL DISCOMFORT (Upset tummy), BACK PAIN (Back pains), PAIN IN EXTREMITY (Aching arms, both), MUSCULOSKELETAL PAIN (Pains across the shoulder blades), HEADACHE (Headache) and VACCINATION SITE PAIN (Aching arms, both and yet jabbed in the rights.). At the time of the report, ABDOMINAL DISCOMFORT (Upset tummy), BACK PAIN (Back pains), PAIN IN EXTREMITY (Aching arms, both), MUSCULOSKELETAL PAIN (Pains across the shoulder blades), HEADACHE (Headache) and VACCINATION SITE PAIN (Aching arms, both and yet jabbed in the rights.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was provided.  It was mentioned that patient got vaccine yesterday morning and issues that occurred from it.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Condition aggravated, Eye pruritus, Vaccination site pain
Clinical narrative: Unknown flare ups; Itchiness in eye; Back pain; Arm sorness with pfizer injection shots; Arm sorness with moderna injection shots; Pain on knees; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Unknown flare ups), EYE PRURITUS (Itchiness in eye), BACK PAIN (Back pain), VACCINATION SITE PAIN (Arm sorness with pfizer injection shots) and VACCINATION SITE PAIN (Arm sorness with moderna injection shots) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Panuveitis and Ankylosing spondylitis.    No Medical History information was reported.   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., dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (Unknown flare ups), EYE PRURITUS (Itchiness in eye), BACK PAIN (Back pain), VACCINATION SITE PAIN (Arm sorness with pfizer injection shots), VACCINATION SITE PAIN (Arm sorness with moderna injection shots) and ARTHRALGIA (Pain on knees). At the time of the report, CONDITION AGGRAVATED (Unknown flare ups), EYE PRURITUS (Itchiness in eye), BACK PAIN (Back pain) and ARTHRALGIA (Pain on knees) had not resolved and VACCINATION SITE PAIN (Arm sorness with pfizer injection shots) and VACCINATION SITE PAIN (Arm sorness with moderna injection shots) had resolved.            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 UNKNOWN FLARE UPS, ARM SORNESS WITH PFIZER INJECTION SHOTS, ARM SORNESS WITH MODERNA INJECTION SHOTS, ITCHINESS IN EYE, BACK PAIN and PAIN ON KNEES with HUMIRA(ADALIMUMAB) was no reasonable possibility and with PFIZER BIONTECH COVID-19 VACCINE was not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Respiratory tract congestion
Clinical narrative: PATIENT HAD CHILLS AND STUFF; PATIENT HAD CHILLS AND STUFF; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (PATIENT HAD CHILLS AND STUFF) and CHILLS (PATIENT HAD CHILLS AND STUFF) in a 24-year-old male 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.    No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In March 2021, the patient experienced RESPIRATORY TRACT CONGESTION (PATIENT HAD CHILLS AND STUFF) and CHILLS (PATIENT HAD CHILLS AND STUFF). In 2021, RESPIRATORY TRACT CONGESTION (PATIENT HAD CHILLS AND STUFF) and CHILLS (PATIENT HAD CHILLS AND STUFF) 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.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt yucky; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt yucky) in a 25-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 Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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) 1 in 1 wk. In 2021, the patient experienced MALAISE (Felt yucky). At the time of the report, MALAISE (Felt yucky) was resolving.            No relevant concomitant medications were reported. On an unknown date, the patient experienced humira was not lasting/ prescribed weekly dose. Therapeutic response shortened was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.  The reporter's causality for the event(s) in aspect for Humira of humira was not lasting/ prescribed weekly dose with  humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of felt yucky 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.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Didn't feel well for a day after the booster; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Didn't feel well for a day after the booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse effect with Pfizer and Pfizer. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Didn't feel well for a day after the booster). At the time of the report, IMMUNISATION REACTION (Didn't feel well for a day after the booster) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox we missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Breakout; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Breakout) 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 RASH (Breakout). At the time of the report, RASH (Breakout) outcome was unknown. Not Provided      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.  The concomitant medication was not reported.  The caller reported that someone from her church had the same symptoms post covid 19 vaccination and has a current condition of lupus.  The treatment medication was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pruritus, Pyrexia, Stress, Vaccination site pain
Clinical narrative: Pruritus aggravated; Stress; Fever; Vaccination site pain /achiness after covid vaccine; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Pruritus aggravated), STRESS (Stress), PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain /achiness after covid vaccine) and FATIGUE (Fatigue) in a 52-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 Psoriatic arthritis.    The patient's past medical history included COVID-19 from January 2021 to 2021.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-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) 1 dosage form. In 2021, the patient experienced PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain /achiness after covid vaccine) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRURITUS (Pruritus aggravated) and STRESS (Stress). In 2021, PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain /achiness after covid vaccine) and FATIGUE (Fatigue) had resolved. At the time of the report, PRURITUS (Pruritus aggravated) and STRESS (Stress) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of INCREASED ITCHING DUE TO STRESS unknown onset and INCREASED ITCHING DUE TO STRESS unknown onset was not provided. The reporter's causality for the event(s) of FEVER AFTER COVID VACCINE, COVID-19, ACHINESS AFTER COVID VACCINE and FATIGUE AFTER COVID VACCINE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021); fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)) and MYALGIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Asthma.    The patient's past medical history, medical treatments and family history were not provided.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (unknown route) via pre-filled pen. On 16-Nov-2021, the patient experienced PYREXIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)) and MYALGIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)). At the time of the report, PYREXIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)) and MYALGIA (fever and body aches post her moderna covid vaccine yesterday (16-Nov-2021)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced events while being treated with Dupilumab and Elasomeran.  On 16-NOV-2021 the patient experienced fever and body aches post her Moderna COVID vaccine yesterday(16-Nov-2021), (unknown latency) following the first dose intake and Elasomeran.  It was not reported if the patient received a corrective treatment for the events.  Treatment medications were not provided.  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: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: violently ill; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (violently ill) 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 (violently ill). At the time of the report, ILLNESS (violently ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was reported that they were thinking this may have been a latent reaction.  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: Lymphadenopathy
Clinical narrative: Swelling of lymph node under left armpit after covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph node under left armpit after covid vaccine) 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (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 LYMPHADENOPATHY (Swelling of lymph node under left armpit after covid vaccine). At the time of the report, LYMPHADENOPATHY (Swelling of lymph node under left armpit after covid vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   It was reported that Humira was not effective.  The reporter's causality for the event(s) of Humira was not effective was not provided. The reporter's causality for the event(s) of Swelling of lymph node under left armpit after COVID vaccine 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.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: violently ill; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (violently ill) 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 ILLNESS (violently ill). At the time of the report, ILLNESS (violently ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On an unknown date, reporters friend was violently ill.  It was reported that they were thinking this may have been a latent reaction. 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: Illness
Clinical narrative: violently ill; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (violently ill) 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 ILLNESS (violently ill). At the time of the report, ILLNESS (violently ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On an unknown date, reporterd neighbour was violently ill.  It was reported that they were thinking this may have been a latent reaction.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Sluggishness
Clinical narrative: Unilateral leg pain/right leg throbbing; Fatigue; Sluggishness/felt sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness/felt sluggish), PAIN IN EXTREMITY (Unilateral leg pain/right leg throbbing) and FATIGUE (Fatigue) 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 Plaque psoriasis.    No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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) Citrate free. In 2021, the patient experienced SLUGGISHNESS (Sluggishness/felt sluggish) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Unilateral leg pain/right leg throbbing). At the time of the report, SLUGGISHNESS (Sluggishness/felt sluggish), PAIN IN EXTREMITY (Unilateral leg pain/right leg throbbing) and FATIGUE (Fatigue) had not resolved.            No concomitant medications were reported.   On an unknown date, the patient experienced right leg throbbing. In 2021, the patient experienced felt sluggish and fatigue. Moderna vaccine was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Immunisation reaction, Syncope
Clinical narrative: faint during his workout; black marks on his finger knuckles; While he excersises, he stays out of air; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (faint during his workout) 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.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (faint during his workout) (seriousness criterion medically significant), IMMUNISATION REACTION (black marks on his finger knuckles) and DYSPNOEA EXERTIONAL (While he excersises, he stays out of air). At the time of the report, SYNCOPE (faint during his workout), IMMUNISATION REACTION (black marks on his finger knuckles) and DYSPNOEA EXERTIONAL (While he excersises, he stays out of air) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information 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.  Company comment. This spontaneous case concerns a male patient of unknown age, with no medical history reported, who received the first dose of mRNA  1273 vaccine and experienced the serious medically significant unexpected event of syncope. Exact vaccination date and onset date of the event was not provided; hence latency and temporal association cannot be properly assessed. The report mentioned the patient presented exertional dyspnoea and faint during his workout. No further clinical information was available for medical reviewing. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who received the first dose of mRNA  1273 vaccine and experienced the serious medically significant unexpected event of syncope. Exact vaccination date and onset date of the event was not provided; hence latency and temporal association cannot be properly assessed. The report mentioned the patient presented exertional dyspnoea and faint during his workout. No further clinical information was available for medical reviewing. The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm from the third for about three hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm from the third for about three hours) 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 Pancreatic exocrine insufficiency.    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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and PANCREATIN (CREON) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm from the third for about three hours). At the time of the report, PAIN IN EXTREMITY (sore arm from the third for about three hours) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Exhaustion from watching granddaughter.; Sore arm from covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm from covid-19 vaccine.) and FATIGUE (Exhaustion from watching granddaughter.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 30-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore arm from covid-19 vaccine.). On an unknown date, the patient experienced FATIGUE (Exhaustion from watching granddaughter.). At the time of the report, VACCINATION SITE PAIN (Sore arm from covid-19 vaccine.) and FATIGUE (Exhaustion from watching granddaughter.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.  The reporter's causality for the event(s) of Sore arm from covid-19 vaccine and Exhaustion from watching granddaughter with Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The patient developed allergic reactions in which her lip and chin filler got swollen on fourth day post vaccination. Patient was informed that she was not eligible for second Moderna vaccine and she should wait and get Pfizer vaccine.  The treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives after second covid vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives after second covid vaccine.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   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. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced URTICARIA (Broke out in hives after second covid vaccine.). At the time of the report, URTICARIA (Broke out in hives after second covid vaccine.) outcome was unknown.            No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   The reporter's causality of Humira for the event(s) of broke out in hives after second COVID vaccine 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: Abdominal pain upper, Diarrhoea, Intentional product misuse, Mobility decreased, Myalgia
Clinical narrative: Intentional product misuse / PATIENT WAS NOT TAKING CREON MEDICATION AS RECOMMENDED; Stomach pain; Diarrhea; Muscle pain; Mobility decreased /Count not hardly move; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT MISUSE (Intentional product misuse / PATIENT WAS NOT TAKING CREON MEDICATION AS RECOMMENDED), MOBILITY DECREASED (Mobility decreased /Count not hardly move), ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and MYALGIA (Muscle pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 016B21A) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for Pancreatic insufficiency.    Previously administered products included for Product used for unknown indication: AUGMENTIN. Past adverse reactions to the above products included Vomiting with AUGMENTIN. Concurrent medical conditions included Drug allergy (manifested by vomiting) and Pancreatic insufficiency.   In October 2020, the patient started PANCREATIN (CREON) (Oral) 1 dosage form. On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced MOBILITY DECREASED (Mobility decreased /Count not hardly move) and MYALGIA (Muscle pain). On 26-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced INTENTIONAL PRODUCT MISUSE (Intentional product misuse / PATIENT WAS NOT TAKING CREON MEDICATION AS RECOMMENDED). In May 2021, MOBILITY DECREASED (Mobility decreased /Count not hardly move) and MYALGIA (Muscle pain) had resolved. At the time of the report, INTENTIONAL PRODUCT MISUSE (Intentional product misuse / PATIENT WAS NOT TAKING CREON MEDICATION AS RECOMMENDED) outcome was unknown, ABDOMINAL PAIN UPPER (Stomach pain) had not resolved and DIARRHOEA (Diarrhea) was resolving.            No concomitant medications were reported.  The patient only eat small amount of food so she would only need to take one pill in order for her not to completely run out of medication. She had not gotten her refill and only 10 capsule left and having the adverse event because she was not taking the medication as recommended.  No treatment medications were reported.  The reporter's causality for the event(s) of MISUSE/PATIENT WAS NOT TAKING CREON MEDICATION AS RECOMMENDED and COUNT NOT HARDLY MOVE was not provided. The reporter's causality for the event(s) of SEVERE DIARRHEA, STOMACH PAIN and MUSCLE PAIN with CREON(PANCREATIN) was no reasonable possibility.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Infected with Delta SARS-COV-2 Variant; Vaccine breakthrough cases; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Infected with Delta SARS-COV-2 Variant) and VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough cases) 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 COVID-19 (Infected with Delta SARS-COV-2 Variant) and VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough cases). At the time of the report, COVID-19 (Infected with Delta SARS-COV-2 Variant) and VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough cases) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was reported by the reporter.