chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Moderna One kicked me like an angry mule; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Moderna One kicked me like an angry mule) 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 (second dose) and Pfizer (first dose). Past adverse reactions to the above products included No adverse reaction 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 (Moderna One kicked me like an angry mule). At the time of the report, IMMUNISATION REACTION (Moderna One kicked me like an angry mule) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment drugs were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: arm  soreness from COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm  soreness from COVID-19 vaccination) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    Previously administered products included for Product used for unknown indication: LEVAQUIN. Past adverse reactions to the above products included No adverse event with LEVAQUIN. Concurrent medical conditions included Sulfonamide allergy, Non-smoker and Abstains from alcohol. Concomitant products included ATORVASTATIN for High cholesterol, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Indigestion.   In 2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (arm  soreness from COVID-19 vaccination). In February 2021, VACCINATION SITE PAIN (arm  soreness from COVID-19 vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.   The patient was hospitalized for unknown reason. Patient was not enrolled in a COVID-19 Vaccine Trial. In August 2021, the patient experienced possible inflammation/inflammation all over body and increased from 94 to 152 caused by the Humira.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622389 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Arm soreness from COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   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) at an unspecified dose. In 2021, the patient experienced PAIN IN EXTREMITY (Arm soreness from COVID-19 vaccine). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and PAIN IN EXTREMITY (Arm soreness from COVID-19 vaccine) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  company comment  This spontaneous case reported by a consumer, concerns a 62 year old  female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series.  On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 62 year old  female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series.  On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: Inappropriate schedule of product administration; Generalized aching; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN (Generalized aching) and PYREXIA (Fever). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). At the time of the report, PAIN (Generalized aching), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna were missed to be booked-in.
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Joint injury, Vaccination site swelling
Clinical narrative: MODERNA BOOSTER VACCINE/SWOLLEN ARM; INJURY/KNEE CAP HURT; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (INJURY/KNEE CAP HURT) and VACCINATION SITE SWELLING (MODERNA BOOSTER VACCINE/SWOLLEN ARM) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    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 ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In September 2021, the patient experienced JOINT INJURY (INJURY/KNEE CAP HURT). On an unknown date, the patient experienced VACCINATION SITE SWELLING (MODERNA BOOSTER VACCINE/SWOLLEN ARM). At the time of the report, JOINT INJURY (INJURY/KNEE CAP HURT) had not resolved and VACCINATION SITE SWELLING (MODERNA BOOSTER VACCINE/SWOLLEN ARM) had resolved.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Reporter causality for Knee injury was related and vaccination site swelling was not related with Humira
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient had the first dose of the Moderna COVID-19 vaccine last 01MAR2021. Caller mentioned he had a hospital situation; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient had the first dose of the Moderna COVID-19 vaccine last 01MAR2021. Caller mentioned he had a hospital situation) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-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 IMMUNISATION REACTION (Patient had the first dose of the Moderna COVID-19 vaccine last 01MAR2021. Caller mentioned he had a hospital situation). At the time of the report, IMMUNISATION REACTION (Patient had the first dose of the Moderna COVID-19 vaccine last 01MAR2021. Caller mentioned he had a hospital situation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  It was reported that patient had the first dose of the Moderna COVID-19 vaccine on 01-MAR-2021 and experienced a hospital situation.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: WORSENING OF PSORIASIS; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (WORSENING OF PSORIASIS) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product  (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 2021, the patient experienced PSORIASIS (WORSENING OF PSORIASIS). At the time of the report, PSORIASIS (WORSENING OF PSORIASIS) outcome was unknown.            No concomitant medications were reported. Patient reported worsening of Psoriasis after COVID vaccines 1st   dose in Mar-2021 and 2nd dose on Apr-2021. The patient had improvement in psoriasis on scalp for several months but psoriasis on abdomen did not improve. She stated that recently in 2021, her scalp psoriasis recurred and spread down the back of her neck. She was ordered by physician to discontinues Skyrizi treatment due to loss of efficacy.  Patient reported worsening of Psoriasis after COVID vaccines 1st   dose in Mar-2021 and 2nd dose on Apr-2021. 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   No treatment information was reported.   Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Pyrexia
Clinical narrative: Low Grade fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low Grade fever) and CHILLS (Chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 12-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (Low Grade fever) and CHILLS (Chills). At the time of the report, PYREXIA (Low Grade fever) and CHILLS (Chills) outcome was unknown.            No concomitant products were reported.  On unknown dates, the patient experienced bruise on thigh, going threw menopause, forgetfulness, anxiety, plaque psoriasis flare up, headache and fatigue. In 2021, the patient experienced low grade fever, chills and feeling like having the flu. Moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. The patient had headache and fatigue three to five hours after injection. previous injection caused bruise on thigh. going threw menopause. She had forgetfulness. had itchy scalp, anxiety. it was unknown if she was enrolled in a covid-19 vaccine trial. On 12-Mar-2021, she received 1st dose covid-19 vaccine manufactured by moderna. On 09-Apr-2201, she received 2nd dose covid-19 vaccine manufactured by moderna and 2nd shot caused low grade fever and chills. She described it as feeling like having the flu for 14 hours.  Causality for skyrizi  The reporter's causality for the event (s) of bruise on thigh, plaque psoriasis flare up, headache and fatigue with skyrizi  was a reasonable possibility. The reporter's causality for the event(s) of going threw menopause, forgetfulness, anxiety, low grade fever, chills and feeling like having the flu with skyrizi was no reasonable possibility.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna
Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Joint swelling, Pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Knee swelling; Hand swelling/ swelling looks like half a baseball on hand; Swelling/ fingers get larger and toes get larger like sausages; Painful feet/ feet had been feeling like marbles on bottom; Pain/ pain occurs after extended periods of use/ random pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling), PERIPHERAL SWELLING (Hand swelling/ swelling looks like half a baseball on hand), PAIN (Pain/ pain occurs after extended periods of use/ random pain), SWELLING (Swelling/ fingers get larger and toes get larger like sausages) and PAIN IN EXTREMITY (Painful feet/ feet had been feeling like marbles on bottom) in a 68-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 an unknown indication.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN (Pain/ pain occurs after extended periods of use/ random pain) and PAIN IN EXTREMITY (Painful feet/ feet had been feeling like marbles on bottom). On 17-Dec-2021, the patient experienced JOINT SWELLING (Knee swelling), PERIPHERAL SWELLING (Hand swelling/ swelling looks like half a baseball on hand) and SWELLING (Swelling/ fingers get larger and toes get larger like sausages). At the time of the report, JOINT SWELLING (Knee swelling) and SWELLING (Swelling/ fingers get larger and toes get larger like sausages) had not resolved and PERIPHERAL SWELLING (Hand swelling/ swelling looks like half a baseball on hand), PAIN (Pain/ pain occurs after extended periods of use/ random pain) and PAIN IN EXTREMITY (Painful feet/ feet had been feeling like marbles on bottom) outcome was unknown.      Concomitant medication 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.  No information regarding treatment medication was provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cystitis, Psoriasis
Clinical narrative: Psoriasis flare-up; Bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and CYSTITIS (Bladder infection) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up) and CYSTITIS (Bladder infection). At the time of the report, PSORIASIS (Psoriasis flare-up) and CYSTITIS (Bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Pain
Clinical narrative: FLARE UP VERY OCCASIONALLY; Fatigue; BODY ACHES; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP VERY OCCASIONALLY), FATIGUE (Fatigue) and PAIN (BODY ACHES) 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 Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UP VERY OCCASIONALLY), FATIGUE (Fatigue) and PAIN (BODY ACHES). At the time of the report, CONDITION AGGRAVATED (FLARE UP VERY OCCASIONALLY) had resolved and FATIGUE (Fatigue) and PAIN (BODY ACHES) was resolving.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter causality with Humira was provided as Not Related to all the events.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: Pain in arm/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm/sore arm) 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.    Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received first 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm/sore arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm/sore arm) had resolved.            On an unknown date, the patient experienced sore arm. On an unknown date, it was 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, UNK
Symptoms: Eyelid ptosis, Illness, Psoriasis, Pyrexia
Clinical narrative: plaque psoriasis flare ups on back and leg; droopy problem with both eyes lids top and bottom; Sick; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (plaque psoriasis flare ups on back and leg), EYELID PTOSIS (droopy problem with both eyes lids top and bottom), ILLNESS (Sick) and PYREXIA (Fever) 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 Plaque psoriasis.    No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (plaque psoriasis flare ups on back and leg), EYELID PTOSIS (droopy problem with both eyes lids top and bottom), ILLNESS (Sick) and PYREXIA (Fever). At the time of the report, PSORIASIS (plaque psoriasis flare ups on back and leg) had not resolved and EYELID PTOSIS (droopy problem with both eyes lids top and bottom), ILLNESS (Sick) and PYREXIA (Fever) outcome was unknown.            Concomitant medication was not reported.  The patient had a droopy problem with both eyes lids top and bottom. She tried to get plastic surgery on both her eyes to correct the droopy problem, but her eye specialist was worried about her taking SKYRIZI and infection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 21.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Foot fracture, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Abdominal distress/ Abdominal distress due to school related stress; Broken foot/ Broke left foot; Injection site itching/ itchy injections; Injection site inflammation/ Inflamed injections; Fever; Injection site pain/ painful injections; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Abdominal distress/ Abdominal distress due to school related stress), FOOT FRACTURE (Broken foot/ Broke left foot), INJECTION SITE PRURITUS (Injection site itching/ itchy injections), INJECTION SITE INFLAMMATION (Injection site inflammation/ Inflamed injections) and PYREXIA (Fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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) Citrate free. In 2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching/ itchy injections), INJECTION SITE INFLAMMATION (Injection site inflammation/ Inflamed injections), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain/ painful injections). In December 2021, the patient experienced ABDOMINAL DISCOMFORT (Abdominal distress/ Abdominal distress due to school related stress) and FOOT FRACTURE (Broken foot/ Broke left foot). At the time of the report, ABDOMINAL DISCOMFORT (Abdominal distress/ Abdominal distress due to school related stress), FOOT FRACTURE (Broken foot/ Broke left foot), INJECTION SITE PRURITUS (Injection site itching/ itchy injections), INJECTION SITE INFLAMMATION (Injection site inflammation/ Inflamed injections), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain/ painful injections) outcome was unknown.     This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medication was not provided.  No information regarding treatment medication was provided.
Age: 21.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: Abdominal distress/ Abdominal distress due to school related stress; Broken foot/ Broke left foot; Injection site itching/ itchy injections; Injection site inflammation/ Inflamed injections; Fever; Injection site pain/ painful injections; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Abdominal distress/ Abdominal distress due to school related stress), FOOT FRACTURE (Broken foot/ Broke left foot), INJECTION SITE PRURITUS (Injection site itching/ itchy injections), INJECTION SITE INFLAMMATION (Injection site inflammation/ Inflamed injections) and PYREXIA (Fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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) Citrate free. In 2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching/ itchy injections), INJECTION SITE INFLAMMATION (Injection site inflammation/ Inflamed injections), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain/ painful injections). In December 2021, the patient experienced ABDOMINAL DISCOMFORT (Abdominal distress/ Abdominal distress due to school related stress) and FOOT FRACTURE (Broken foot/ Broke left foot). At the time of the report, ABDOMINAL DISCOMFORT (Abdominal distress/ Abdominal distress due to school related stress), FOOT FRACTURE (Broken foot/ Broke left foot), INJECTION SITE PRURITUS (Injection site itching/ itchy injections), INJECTION SITE INFLAMMATION (Injection site inflammation/ Inflamed injections), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain/ painful injections) outcome was unknown.     This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medication was not provided.  No information regarding treatment medication was provided.
Age: 32.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Influenza like illness
Clinical narrative: FLARE; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and CONDITION AGGRAVATED (FLARE) in a 32-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 Crohn's disease and Ulcerative colitis.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, CONDITION AGGRAVATED (FLARE) was resolving.            Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medication information was provided.  It was reported that the patient was sick for 3 weeks after the Moderna vaccine second dose. Patient experienced achy, crabby and arm hurt after Pfizer booster dose.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: I-narrative supplement was updated. Action taken was updated.
Age: 46.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dizziness
Clinical narrative: Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 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) Daily dose: Citrate free, Solution for injection in pre-filled pen. In 2021, the patient experienced DIZZINESS (Lightheaded). In 2021, DIZZINESS (Lightheaded) had resolved.            Concomitant Drugs were not reported.  On 15-Nov-2021, the patient experienced event when went to put injection foot slipped and needle came out and medicine went down leg( Device use error) with Humira, the reported causality for this event was reasonable possibility with drug Humira.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided by the reporter.  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.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Plaque psoriasis.    No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 15-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In July 2021, the patient experienced COVID-19 (COVID-19). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatic nerve injury
Clinical narrative: Feels first dose may have affected sciatic nerve as it was painful; This spontaneous case was reported by a patient and describes the occurrence of SCIATIC NERVE INJURY (Feels first dose may have affected sciatic nerve as it was painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C12A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Mar-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 SCIATIC NERVE INJURY (Feels first dose may have affected sciatic nerve as it was painful). At the time of the report, SCIATIC NERVE INJURY (Feels first dose may have affected sciatic nerve as it was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622718.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  No other issue 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: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Achy; Cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and PAIN (Achy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-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) Daily dose, Solution for injection in pre-filled pen. On 25-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASOPHARYNGITIS (Cold). On an unknown date, the patient experienced PAIN (Achy). At the time of the report, NASOPHARYNGITIS (Cold) and PAIN (Achy) had resolved.            Concomitant Drugs were not reported.  The reporter's causality for the events of Cold and Achy with HUMIRA(Adalimumab) was no reasonable possibility.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dysstasia, Feeling abnormal, Nausea, Vertigo
Clinical narrative: cold sweats; couldn't stand more than 15 sec; Knocked out; Felt like she was either going to sleep and waking up or passing out and waking up after the second dose; extreme nausea; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), DYSSTASIA (couldn't stand more than 15 sec), FEELING ABNORMAL (Knocked out), VERTIGO (Felt like she was either going to sleep and waking up or passing out and waking up after the second dose) and NAUSEA (extreme nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A and C12A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLD SWEAT (cold sweats), DYSSTASIA (couldn't stand more than 15 sec), FEELING ABNORMAL (Knocked out), VERTIGO (Felt like she was either going to sleep and waking up or passing out and waking up after the second dose) and NAUSEA (extreme nausea). At the time of the report, COLD SWEAT (cold sweats), DYSSTASIA (couldn't stand more than 15 sec), FEELING ABNORMAL (Knocked out), VERTIGO (Felt like she was either going to sleep and waking up or passing out and waking up after the second dose) and NAUSEA (extreme nausea) 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.   This case was linked to MOD-2021-622692 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow up received contains no new information added.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Super high Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Super high Fever) 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 BIONTECH COVID-19 VACCINE (got Pfizer in April) and PFIZER BIONTECH COVID-19 VACCINE (got Pfizer in March). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PYREXIA (Super high Fever). At the time of the report, PYREXIA (Super high Fever) had resolved.            Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hyperhidrosis, Malaise, Psoriasis, Rash macular, Vomiting
Clinical narrative: Psoriasis flare-up; face blotchy; Vomiting; Ill; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Ill), HYPERHIDROSIS (Sweating), PSORIASIS (Psoriasis flare-up), VOMITING (Vomiting) and RASH MACULAR (face blotchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2021, the patient experienced MALAISE (Ill), HYPERHIDROSIS (Sweating) and VOMITING (Vomiting). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up) and RASH MACULAR (face blotchy). At the time of the report, MALAISE (Ill), HYPERHIDROSIS (Sweating) and VOMITING (Vomiting) outcome was unknown and PSORIASIS (Psoriasis flare-up) and RASH MACULAR (face blotchy) had not resolved.            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 causality for the event skin blotches and Psoriasis flare-up for  Humira was reported as reasonable possibility. The causality for the event Ill feeling, Vomiting, Sweating for  Humira was reported as  no reasonable possibility.  The treatment medication was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Accidental overdose, Vaccination site nodule, Vaccination site pain
Clinical narrative: Had a knot and it was tender for 2 to 3 days; Had a knot and it was tender for 2 to 3 days; Patient got full dose instead of half dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Had a knot and it was tender for 2 to 3 days), VACCINATION SITE PAIN (Had a knot and it was tender for 2 to 3 days) and ACCIDENTAL OVERDOSE (Patient got full dose instead of half dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product SUNITINIB MALATE (SUTENT) for Secondary malignant neoplasm of kidney.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and SUNITINIB MALATE (SUTENT) (unknown route) 37.5 milligram. On an unknown date, the patient experienced VACCINATION SITE NODULE (Had a knot and it was tender for 2 to 3 days), VACCINATION SITE PAIN (Had a knot and it was tender for 2 to 3 days) and ACCIDENTAL OVERDOSE (Patient got full dose instead of half dose). At the time of the report, VACCINATION SITE NODULE (Had a knot and it was tender for 2 to 3 days) and VACCINATION SITE PAIN (Had a knot and it was tender for 2 to 3 days) had resolved and ACCIDENTAL OVERDOSE (Patient got full dose instead of half dose) outcome 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.  Pateint stated that patient and his wife received moderna booster few days ago. Patient will go for his next scan soon. This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna