chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lymphatic disorder, Vaccination site haemorrhage
Clinical narrative: Blood at injection site; Moderna covid vaccine/left side of the body severe lymphatic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Blood at injection site) and LYMPHATIC DISORDER (Moderna covid vaccine/left side of the body severe lymphatic reaction) 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) solution for injection for Hidradenitis suppurativa and Rheumatoid arthritis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Blood at injection site) and LYMPHATIC DISORDER (Moderna covid vaccine/left side of the body severe lymphatic reaction). At the time of the report, VACCINATION SITE HAEMORRHAGE (Blood at injection site) and LYMPHATIC DISORDER (Moderna covid vaccine/left side of the body severe lymphatic reaction) outcome was unknown.            Issue with the pen where Humira medication did not come out of the pen and the needle did not prick skin.  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, UNK
Symptoms: Psoriasis
Clinical narrative: Psoriasis flare-up/plaque psoriasis out break in scalp; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/plaque psoriasis out break in scalp) 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.    patient had no known allergies. No relevant medical history was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/plaque psoriasis out break in scalp). At the time of the report, PSORIASIS (Psoriasis flare-up/plaque psoriasis out break in scalp) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On an unknown date, the patient experienced plaque psoriasis out break in scalp. On an unknown date, plaque psoriasis out break in scalp resolved. Moderna was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction
Clinical narrative: Heart attack; Stroke; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and CEREBROVASCULAR ACCIDENT (Stroke) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Vasculitis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were provided. The patient had an underlying autoimmune condition and vasculitis. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided.  Company comment: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of vasculitis, who experienced the unexpected serious (medically significant and hospitalization) AESIs of Myocardial infarction and Cerebrovascular accident after receiving a dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of events were not reported. Clinical course and treatment details were not reported. The outcome of events was unknown. Concurrent vasculitis could be considered as a risk factor for events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of vasculitis, who experienced the unexpected serious (medically significant and hospitalization) AESIs of Myocardial infarction and Cerebrovascular accident after receiving a dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of events were not reported. Clinical course and treatment details were not reported. The outcome of events was unknown. Concurrent vasculitis could be considered as a risk factor for events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction
Clinical narrative: Heart attack; Stroke; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and CEREBROVASCULAR ACCIDENT (Stroke) in a 52-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Vasculitis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were provided. The patient had an underlying autoimmune condition and vasculitis as medical history. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in. No treatment medicine were provided.  Company comment: This spontaneous case concerns a 52-year-old female patient, with concurrent medical history of vasculitis, who experienced the unexpected serious (medically significant and hospitalization) of Myocardial infarction and Cerebrovascular accident after receiving a dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of events were not reported. Clinical course and treatment details were not reported. The outcome of events was unknown. Concurrent vasculitis could be considered as a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 52-year-old female patient, with concurrent medical history of vasculitis, who experienced the unexpected serious (medically significant and hospitalization) of Myocardial infarction and Cerebrovascular accident after receiving a dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of events were not reported. Clinical course and treatment details were not reported. The outcome of events was unknown. Concurrent vasculitis could be considered as a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Menstrual disorder, Pain in extremity
Clinical narrative: Mentruation stuff; Sore arm; Bit tiredness; rough night afterwards with shivers; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Mentruation stuff), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Bit tiredness) and CHILLS (rough night afterwards with shivers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and 2) and PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and 2). Past adverse reactions to the above products included Headache with PFIZER BIONTECH COVID-19 VACCINE; Menstrual disorder NOS with PFIZER BIONTECH COVID-19 VACCINE; Pain in arm with PFIZER BIONTECH COVID-19 VACCINE; and Tiredness with PFIZER BIONTECH COVID-19 VACCINE.    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 MENSTRUAL DISORDER (Mentruation stuff), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Bit tiredness) and CHILLS (rough night afterwards with shivers). At the time of the report, MENSTRUAL DISORDER (Mentruation stuff), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Bit tiredness) outcome was unknown and HEADACHE (Headache) and CHILLS (rough night afterwards with shivers) had resolved.            With moderna patient also had rough night afterwards, with shivers and headache. Was really just for one night though. No information on concomitant medication were reported. 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
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation 4 months after Moderna; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation 4 months after Moderna) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation 4 months after Moderna) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation 4 months after Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns a patient of unspecified gender, aged 76 years with no reported medical history, experienced unexpected serious (medically significant) AESI of ATRIAL FIBRILLATION four months after a dose (dose number not specified) of mRNA-1273 vaccination. No further information on detailed clinical course, investigations and treatment was available in the report.  Outcome of the event was unknown at the time of report. Elderly age could be risk factor to the event.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2022-623722 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a patient of unspecified gender, aged 76 years with no reported medical history, experienced unexpected serious (medically significant) AESI of ATRIAL FIBRILLATION four months after a dose (dose number not specified) of mRNA-1273 vaccination. No further information on detailed clinical course, investigations and treatment was available in the report.  Outcome of the event was unknown at the time of report. Elderly age could be risk factor to the event.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. US-MODERNATX, INC.-MOD-2022-623722:This case refers 72 yr old who had Atrial fibrillation 4 months after Moderna(same reporter)
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION . At the time of the report, IMMUNISATION REACTION outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Patient reported her second vaccine shot which was Moderna was the worst one. . When she had the Biontech COVID booster, had no major side effects apart from a burning arm for 30 minutes after getting the shot.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke 4 months after Moderna) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke 4 months after Moderna) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke 4 months after Moderna) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication information was reported. No treatment medication information was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a 72yearold patient (unknown gender), with no medical history reported, who received a dose of mRNA-1273 vaccine and experienced the serious medically significant unexpected AESI of cerebrovascular accident. Although vaccination date and onset date of the event were not provided, the report mentioned the event occurred four months after vaccination. No further information has been provided for medical reviewing. Patient's age could be risk factor for the event. The benefitrisk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-623719 (E2B Linked Report). Sender's Comments: This spontaneous case concerns a 72yearold patient (unknown gender), with no medical history reported, who received a dose of mRNA-1273 vaccine and experienced the serious medically significant unexpected AESI of cerebrovascular accident. Although vaccination date and onset date of the event were not provided, the report mentioned the event occurred four months after vaccination. No further information has been provided for medical reviewing. Patient's age could be risk factor for the event. The benefitrisk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-623719:(same reporter).
Sex: M
Vaccine: COVID19, UNK
Symptoms: Decreased appetite, Hypoaesthesia, Influenza like illness, Pyrexia, Spinal X-ray
Clinical narrative: Appetite absent/ No appetite; Lumbar vertebra injury/ X-ray shows damage of Lumbar; Flu like symptoms; Numbness of extremities/ Numbness of feet and Arms; Fever/ temperature; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite absent/ No appetite), SPINAL COLUMN INJURY (Lumbar vertebra injury/ X-ray shows damage of Lumbar), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPOAESTHESIA (Numbness of extremities/ Numbness of feet and Arms) and PYREXIA (Fever/ temperature) 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 Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DECREASED APPETITE (Appetite absent/ No appetite), SPINAL COLUMN INJURY (Lumbar vertebra injury/ X-ray shows damage of Lumbar), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPOAESTHESIA (Numbness of extremities/ Numbness of feet and Arms) and PYREXIA (Fever/ temperature). At the time of the report, DECREASED APPETITE (Appetite absent/ No appetite), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever/ temperature) had resolved and SPINAL COLUMN INJURY (Lumbar vertebra injury/ X-ray shows damage of Lumbar) and HYPOAESTHESIA (Numbness of extremities/ Numbness of feet and Arms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Spinal X-ray: abnormal. On an unknown date, X-ray: Damage of lumbar.         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.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Live Significant Follow up included Event added. On 05-May-2022: Live Significant Follow up included event was removed and lab test added.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Spinal column injury, X-ray
Clinical narrative: Appetite absent/ No appetite; Lumbar vertebra injury/ X-ray shows damage of Lumbar; Flu like symptoms; Numbness of extremities/ Numbness of feet and Arms; Fever/ temperature; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite absent/ No appetite), SPINAL COLUMN INJURY (Lumbar vertebra injury/ X-ray shows damage of Lumbar), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPOAESTHESIA (Numbness of extremities/ Numbness of feet and Arms) and PYREXIA (Fever/ temperature) 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 Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DECREASED APPETITE (Appetite absent/ No appetite), SPINAL COLUMN INJURY (Lumbar vertebra injury/ X-ray shows damage of Lumbar), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPOAESTHESIA (Numbness of extremities/ Numbness of feet and Arms) and PYREXIA (Fever/ temperature). At the time of the report, DECREASED APPETITE (Appetite absent/ No appetite), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever/ temperature) had resolved and SPINAL COLUMN INJURY (Lumbar vertebra injury/ X-ray shows damage of Lumbar) and HYPOAESTHESIA (Numbness of extremities/ Numbness of feet and Arms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Spinal X-ray: abnormal. On an unknown date, X-ray: Damage of lumbar.         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.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Live Significant Follow up included Event added. On 05-May-2022: Live Significant Follow up included event was removed and lab test added.
Sex: U
Vaccine: COVID19
Symptoms: Lethargy, Nausea
Clinical narrative: Nausea; More lethargic; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and LETHARGY (More lethargic) 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 COVID-19 vaccination: Pfizer vaccine (Pfizer vaccine 2nd dose) and Pfizer vaccine (Pfizer vaccine 1st dose). Past adverse reactions to the above products included Illness with Pfizer vaccine and Pfizer vaccine.    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 NAUSEA (Nausea) and LETHARGY (More lethargic). At the time of the report, NAUSEA (Nausea) and LETHARGY (More lethargic) outcome was unknown.            No concomitant medicine were provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Incorrect route of product administration, Myalgia, Pain in extremity
Clinical narrative: Arm really sore; General aches and pains; Chills; Tired; Its put on my ass; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm really sore), MYALGIA (General aches and pains), CHILLS (Chills), FATIGUE (Tired) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Its put on my ass) 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 Drug use for unknown indication: Pfizer Comirnaty (Dose 1), Pfizer Comirnaty (Dose 3) and Pfizer Comirnaty (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer Comirnaty, Pfizer Comirnaty and Pfizer Comirnaty.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm really sore), MYALGIA (General aches and pains), CHILLS (Chills), FATIGUE (Tired) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Its put on my ass). At the time of the report, PAIN IN EXTREMITY (Arm really sore), MYALGIA (General aches and pains), CHILLS (Chills), FATIGUE (Tired) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Its put on my ass) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Patient took 3 doses of Comirnaty and felt fine. Took one dose of Moderna COVID vaccine, was put on his behind, and arm was really sore, chills, tired and general aches and pains.  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, Thrombosis, Walking disability
Clinical narrative: It actually causes spread.My left leg clotted up; Sicker; I will never be able to walk far again in my life because I am vaccinated with Moderna; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (It actually causes spread.My left leg clotted up) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) 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 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (It actually causes spread.My left leg clotted up) (seriousness criterion medically significant), ILLNESS (Sicker) and WALKING DISABILITY (I will never be able to walk far again in my life because I am vaccinated with Moderna). At the time of the report, THROMBOSIS (It actually causes spread.My left leg clotted up), ILLNESS (Sicker) and WALKING DISABILITY (I will never be able to walk far again in my life because I am vaccinated with Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) unexpected event Leg thrombosis, that occurred on an unknown date after an unspecified dose of mRNA-1273.  It was reported that "my left leg clotted up" and "I will never be able to walk far again in my entire life". Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list. Further information is not expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medication were reported.  Patient reported that this is not a vaccine it is a poison.  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. Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) unexpected event Leg thrombosis, that occurred on an unknown date after an unspecified dose of mRNA-1273.  It was reported that "my left leg clotted up" and "I will never be able to walk far again in my entire life". Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list. Further information is not expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Alot of side effects from Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Alot of side effects from Moderna vaccine) in a 71-year-old female patient who received mRNA-1273  for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Alot of side effects from Moderna vaccine). At the time of the report, IMMUNISATION REACTION (Alot of side effects from Moderna vaccine) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  No concomitant medication details were provided. No treatment medication details were provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Blood pressure measurement, Bursitis, Hypertension, Infection
Clinical narrative: Bursitis; Skin disorder, skin problem; Upper extremity dysfunction, hand problem; Blisters; Infection; Foot infection; Blood pressure high; Psoriasis flare-up/ breaking out with psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis), SKIN DISORDER (Skin disorder, skin problem), MUSCULOSKELETAL DISORDER (Upper extremity dysfunction, hand problem), BLISTER (Blisters) and INFECTION (Infection) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product  (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2022, the patient experienced PSORIASIS (Psoriasis flare-up/ breaking out with psoriasis). On an unknown date, the patient experienced BURSITIS (Bursitis), SKIN DISORDER (Skin disorder, skin problem), MUSCULOSKELETAL DISORDER (Upper extremity dysfunction, hand problem), BLISTER (Blisters), INFECTION (Infection), LOCALISED INFECTION (Foot infection) and HYPERTENSION (Blood pressure high). At the time of the report, BURSITIS (Bursitis), SKIN DISORDER (Skin disorder, skin problem), MUSCULOSKELETAL DISORDER (Upper extremity dysfunction, hand problem), BLISTER (Blisters), INFECTION (Infection), PSORIASIS (Psoriasis flare-up/ breaking out with psoriasis), LOCALISED INFECTION (Foot infection) and HYPERTENSION (Blood pressure high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High.         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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2022: Follow-up received wherein event psoriasis updated to psoriasis flare-up as well as reporter's causality and newevent (blood pressure high) added. Lab test added. Dose description of co suspect and narrative description updated.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Musculoskeletal disorder, Psoriasis, Skin disorder
Clinical narrative: Bursitis; Skin disorder, skin problem; Upper extremity dysfunction, hand problem; Blisters; Infection; Foot infection; Blood pressure high; Psoriasis flare-up/ breaking out with psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis), SKIN DISORDER (Skin disorder, skin problem), MUSCULOSKELETAL DISORDER (Upper extremity dysfunction, hand problem), BLISTER (Blisters) and INFECTION (Infection) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product  (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2022, the patient experienced PSORIASIS (Psoriasis flare-up/ breaking out with psoriasis). On an unknown date, the patient experienced BURSITIS (Bursitis), SKIN DISORDER (Skin disorder, skin problem), MUSCULOSKELETAL DISORDER (Upper extremity dysfunction, hand problem), BLISTER (Blisters), INFECTION (Infection), LOCALISED INFECTION (Foot infection) and HYPERTENSION (Blood pressure high). At the time of the report, BURSITIS (Bursitis), SKIN DISORDER (Skin disorder, skin problem), MUSCULOSKELETAL DISORDER (Upper extremity dysfunction, hand problem), BLISTER (Blisters), INFECTION (Infection), PSORIASIS (Psoriasis flare-up/ breaking out with psoriasis), LOCALISED INFECTION (Foot infection) and HYPERTENSION (Blood pressure high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High.         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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2022: Follow-up received wherein event psoriasis updated to psoriasis flare-up as well as reporter's causality and newevent (blood pressure high) added. Lab test added. Dose description of co suspect and narrative description updated.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: EFFECTS OF COVID VACCINATION/ARM WAS SORE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (EFFECTS OF COVID VACCINATION/ARM WAS SORE) in an elderly 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 Rheumatoid arthritis.    No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2022, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (EFFECTS OF COVID VACCINATION/ARM WAS SORE). At the time of the report, VACCINATION SITE PAIN (EFFECTS OF COVID VACCINATION/ARM WAS SORE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Patient's arm was sore after her first Moderna vaccination. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-632605.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Extreme fatigue, muscle aches, headache, nauseous,  chills
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site, joint aches, chills, fatigue and slight nausea.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Pain and swelling at injection site, joint aches, chills, fatigue and slight nausea.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: patient received original Pfizer vaccine booster instead of requested Pfizer bivalent booster
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Creatinine renal clearance, Glomerular filtration rate decreased, Hyperlipidaemia, Hypertension
Clinical narrative: I have developed moderately severe kidney disease.  My tubules show extensive damage.  I have received annual physicals for years and my kidneys have been healthy until last years labs, after getting the vaccine.  I have no risk factors- no hypertension, no diabetes, no heart or lung disease.   I do have PAC's, hence the bystolic.  And, I have hyperlipidemia, regulated with diet and crestor.   I eat well, am of ideal weight.  I work out throughout the week and and am a very active 60 year old.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Renal disorder, Renal failure, Renal tubular disorder, Supraventricular extrasystoles
Clinical narrative: I have developed moderately severe kidney disease.  My tubules show extensive damage.  I have received annual physicals for years and my kidneys have been healthy until last years labs, after getting the vaccine.  I have no risk factors- no hypertension, no diabetes, no heart or lung disease.   I do have PAC's, hence the bystolic.  And, I have hyperlipidemia, regulated with diet and crestor.   I eat well, am of ideal weight.  I work out throughout the week and and am a very active 60 year old.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received original Pfizer Covid-19 vaccine instead of Pfizer bivalent vaccine requested
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Rash, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: unable to develop antibodies after receiving covid vaccine/COVID-19 antibody test negative; Psoriasis aggravated/worsened plaque psoriasis/plaque psoriasis exploded; Rash; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (unable to develop antibodies after receiving covid vaccine/COVID-19 antibody test negative) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia and Plaque psoriasis.   In March 2017, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (unable to develop antibodies after receiving covid vaccine/COVID-19 antibody test negative) (seriousness criterion medically significant), PSORIASIS (Psoriasis aggravated/worsened plaque psoriasis/plaque psoriasis exploded) and RASH (Rash). The patient was treated with GUSELKUMAB (TREMFYA) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (unable to develop antibodies after receiving covid vaccine/COVID-19 antibody test negative) outcome was unknown, PSORIASIS (Psoriasis aggravated/worsened plaque psoriasis/plaque psoriasis exploded) had not resolved and RASH (Rash) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: (Negative) negative.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  The reporter's causality for imbruvica(ibrutinib) for the event(s) of worsened plaque psoriasis/plaque psoriasis exploded, unable to develop antibodies after receiving covid vaccine and rash 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Developed Bells palsy.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Heart rate increased
Clinical narrative: Rapid heart rate
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pt presented with headache 15 minutes after first COVID vaccine.  Comfort measures offered.  BP 122/74 O2 98% Temp 98.5 P 88.  Tylenol 325 2 tabs po given with good results within 10 minutes of administering.  Follow up call to patient positive. No resumption of pain as of 9/24/2022
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Nausea, Pruritus
Clinical narrative: Itchy palms (started 9/20), low grade nausea/lack of appetite (started a day after vaccination), diarrhea (started 9/13), extreme fatigue (9/21 - 9/22).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Fatigue, extreme shortness of breath, and rapid heart rate, particularly when excel using
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, X-ray
Clinical narrative: Fatigue, extreme shortness of breath, and rapid heart rate, particularly when excel using
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Fatigue, Upper respiratory tract infection
Clinical narrative: COVID-19; Upper respiratory infection; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) and FATIGUE (Fatigue) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced COVID-19 (COVID-19) and UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection). At the time of the report, COVID-19 (COVID-19), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. It was reported that the patient had two upper respiratory infections. He had COVID. In Mar-2021 he experienced fatigue followed by his Covid vaccine.  The reporter's causality for the event(s) of covid and fatigue was not provided. The reporter's causality for the event of upper respiratory infections with Skyrizi (risankizumab) was a reasonable possibility.  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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ocular rosacea, Tinnitus
Clinical narrative: Tinnitus was acting up; Ocular rosacea was also worse; Left hand was hurting with psoriatic arthritis; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus was acting up), OCULAR ROSACEA (Ocular rosacea was also worse) and ARTHRALGIA (Left hand was hurting with psoriatic arthritis) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (Tinnitus was acting up), OCULAR ROSACEA (Ocular rosacea was also worse) and ARTHRALGIA (Left hand was hurting with psoriatic arthritis). At the time of the report, TINNITUS (Tinnitus was acting up), OCULAR ROSACEA (Ocular rosacea was also worse) and ARTHRALGIA (Left hand was hurting with psoriatic arthritis) had not resolved.            It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  It was reported that after getting COVID booster shot her tinnitus was acting up, her left hand was hurting with psoriatic arthritis and her ocular rosacea was also worse. Patient got the booster shot in her left arm. Patient stated normally her right hand could act up with psoriatic arthritis but not left. Her skin was getting better.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Bronchitis, Insomnia, Pain
Clinical narrative: Pain; Difficulty sleeping; Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INSOMNIA (Difficulty sleeping) and BRONCHITIS (Bronchitis) in a 51-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 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2021, the patient experienced BRONCHITIS (Bronchitis). On an unknown date, the patient experienced PAIN (Pain) and INSOMNIA (Difficulty sleeping). In February 2022, BRONCHITIS (Bronchitis) had resolved. At the time of the report, PAIN (Pain) and INSOMNIA (Difficulty sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: The value was 104/abnormal..         On an unknown date, the patient experienced could not stay on the same sleep schedule because of pain. In September 2021, the patient experienced sick/temperature 104. In September 2021, the sick/temperature 104 resolved. In December 2021, the patient experienced bronchitis. In February 2022, the bronchitis resolved.  The patient after the second covid vaccine was sick and 104 temperature for four days.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.