chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: cold symptoms; nasal congestion; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (cold symptoms) and NASAL CONGESTION (nasal congestion) 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 TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In 2017, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. In May 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold symptoms) and NASAL CONGESTION (nasal congestion). At the time of the report, NASOPHARYNGITIS (cold symptoms) and NASAL CONGESTION (nasal congestion) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient missed doses once every three weeks due to forgetting; unaware. The patient completed two doses of COVID vaccine Moderna (unknown, exact dates). the last COVID-19 vaccine was on May 2021 therapy, was held for one week for each dose with no symptoms were reported due to the vaccine/missed doses. Patient was getting over with cold symptoms (new-onset), nasal congestion on unknown dates and was improving. No other symptoms were noted. No treatment medication reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Arthralgia, Vaccination site pain
Clinical narrative: Alteration of allergy symptoms; Severe pain in the joints; Pain in the left elbow and inability to make heavy efforts, this arm was where they applied the two doses; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Alteration of allergy symptoms), ARTHRALGIA (Severe pain in the joints) and VACCINATION SITE PAIN (Pain in the left elbow and inability to make heavy efforts, this arm was where they applied the two doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient's diet was broad. He is strong.  Concurrent medical conditions included Hypertension.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Alteration of allergy symptoms), ARTHRALGIA (Severe pain in the joints) and VACCINATION SITE PAIN (Pain in the left elbow and inability to make heavy efforts, this arm was where they applied the two doses). At the time of the report, ALLERGY TO VACCINE (Alteration of allergy symptoms), ARTHRALGIA (Severe pain in the joints) and VACCINATION SITE PAIN (Pain in the left elbow and inability to make heavy efforts, this arm was where they applied the two doses) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.   Patient two months ago got the second dose of the modern vaccine and began to observe unwanted effects.  Reporter would like to be guided on what to do to eliminate intense pain in the elbow and how or what to do to eliminate the general pain.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to US-MODERNATX, INC.-MOD-2021-619952 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-619952:wife case
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHES AND PAINS FROM MODERNA BOOSTER COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ACHES AND PAINS FROM MODERNA BOOSTER COVID VACCINE) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Juvenile idiopathic arthritis.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 20-Aug-2021, the patient experienced PAIN (ACHES AND PAINS FROM MODERNA BOOSTER COVID VACCINE). At the time of the report, PAIN (ACHES AND PAINS FROM MODERNA BOOSTER COVID VACCINE) had not resolved.            No concomitant medication was reported. On 20 Aug 2021, the patient experienced ACHES AND PAINS FROM MODERNA BOOSTER COVID VACCINE. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of ACHES AND PAINS FROM MODERNA BOOSTER COVID VACCINE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Immunocompromised and Chronic myelogenous leukemia. 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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had resolved. No concomitant medications were reported. Patient had got stroke after one week of receiving Moderna COVID-19 vaccine. The primary physician spoke to patient about the Pfizer prophylactic treatment in immune compromised patients. Patient had enquired whether this treatment would be helpful for her or not. It was reported that patient was an immune compromised with leukemia (CML). 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 concerns an immunocompromised, female patient of unknown age with an underlying chronic myelogenous leukemia (CML), who experienced an unexpected, medically significant AESI Cerebrovascular accident 1 week after receiving a 2nd dose of mRNA-1273 vaccine. Outcome of the event was reported as resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's immunocompromised status and underlying CML remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns an immunocompromised, female patient of unknown age with an underlying chronic myelogenous leukemia (CML), who experienced an unexpected, medically significant AESI Cerebrovascular accident 1 week after receiving a 2nd dose of mRNA-1273 vaccine. Outcome of the event was reported as resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's immunocompromised status and underlying CML remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Somnolence
Clinical narrative: Achy; Sleepy; Second COVID shot kicked the butt for a day / knocked out for the day; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achy), SOMNOLENCE (Sleepy) and FEELING ABNORMAL (Second COVID shot kicked the butt for a day / knocked out for the day) 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 FESOTERODINE FUMARATE (TOVIAZ) for an unknown indication.    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 and FESOTERODINE FUMARATE (TOVIAZ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (Achy), SOMNOLENCE (Sleepy) and FEELING ABNORMAL (Second COVID shot kicked the butt for a day / knocked out for the day). At the time of the report, PAIN (Achy) and SOMNOLENCE (Sleepy) outcome was unknown and FEELING ABNORMAL (Second COVID shot kicked the butt for a day / knocked out for the day) had resolved.            No concomitant medications were reported.  The patient stated that the second COVID shot kicked the butt for a day and was not bad. It just knocked the patient out for the day, so the patient just hung around the house and took it easy. Patient experienced the same reaction with Shingrix vaccine that the patient got recently and had a rough half a day but then it was fine.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Fever; Flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of INFLUENZA LIKE ILLNESS (Flu like symptoms), the second episode of INFLUENZA LIKE ILLNESS (Flu like symptoms), the first episode of PYREXIA (Fever) and the second episode of PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced the first episode of INFLUENZA LIKE ILLNESS (Flu like symptoms) and the first episode of PYREXIA (Fever). In August 2021, the patient experienced the second episode of INFLUENZA LIKE ILLNESS (Flu like symptoms) and the second episode of PYREXIA (Fever). In August 2021, last episode of INFLUENZA LIKE ILLNESS (Flu like symptoms) and the last episode of PYREXIA (Fever) had resolved.            Concomitant medication was not reported.  In 2021, patient received 1st dose COVID-19 vaccine manufactured by Moderna. In 2021, patient received 2nd dose COVID-19 vaccine manufactured by Moderna. On 18-Aug-2021, patient received 3rd dose COVID-19 vaccine manufactured by Moderna. The patient had Moderna twice a month apart in 2021 and stated that most of them with Rheumatoid arthritis taking a biologic qualify for the third booster as immune suppressed. The patient got a note from Rheumatoid arthritis doctor stating that and four days ago on 18-Aug-2021, the patient got their third Moderna booster. Symptoms experienced were like the second shot. The patient had flu like symptoms and a slight fever for 24 hours. The patient glad they did this and still were a mask when they were in crowds. Treatment details were unknown.  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: COVID-19, Gastrointestinal disorder, Immunisation reaction, Nausea
Clinical narrative: Had third vaccination and had minimal reaction; Problems with small intestines; COVID; When went out for walking got nauseous; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Had third vaccination and had minimal reaction), GASTROINTESTINAL DISORDER (Problems with small intestines), COVID-19 (COVID) and NAUSEA (When went out for walking got nauseous) 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 an unknown indication.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-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) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had third vaccination and had minimal reaction), GASTROINTESTINAL DISORDER (Problems with small intestines), COVID-19 (COVID) and NAUSEA (When went out for walking got nauseous). At the time of the report, IMMUNISATION REACTION (Had third vaccination and had minimal reaction), GASTROINTESTINAL DISORDER (Problems with small intestines), COVID-19 (COVID) and NAUSEA (When went out for walking got nauseous) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  Strength of Humira was reported as 40 mg/ 0.4 ml.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of had third vaccination and had minimal reaction, when went out for walking got nauseous and COVID was not provided. The reporter's causality for the events of problems with small intestines with Humira 40mg/0.4ml (adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Follow-up was received: Narrative was updated.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Influenza like illness, Product dose omission issue, Pyrexia, Respiratory symptom
Clinical narrative: upper respiratory symptom; all sorts of flu like symptoms; fever; She was sick for exactly 8 weeks; and did not receive her second dose; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYMPTOM (upper respiratory symptom), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), ILLNESS (She was sick for exactly 8 weeks) and PRODUCT DOSE OMISSION ISSUE (and did not receive her second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RESPIRATORY SYMPTOM (upper respiratory symptom), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), ILLNESS (She was sick for exactly 8 weeks) and PRODUCT DOSE OMISSION ISSUE (and did not receive her second dose). At the time of the report, RESPIRATORY SYMPTOM (upper respiratory symptom), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), ILLNESS (She was sick for exactly 8 weeks) and PRODUCT DOSE OMISSION ISSUE (and did not receive her second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication information provided No concomitant medication information provided Patient sated that she received the Moderna COVID-19 vaccine last march2021 and developed upper respiratory symptoms, all sorts of flu like symptoms and fever. Patient was sick for exactly 8 weeks and did not receive her second dose. Patient's physician advised her to get the Pfizer COVID-19 vaccine. Patient wanted to know if she should restart her primary vaccination series. Patient was 56 years old when she received the Moderna COVID-19 vaccine. Patient was 57 years old at the time of reporting.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anaemia, Inflammation, Musculoskeletal stiffness
Clinical narrative: Inflammation; Anemia; Stiffness; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), ANAEMIA (Anemia) and MUSCULOSKELETAL STIFFNESS (Stiffness) 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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced INFLAMMATION (Inflammation), ANAEMIA (Anemia) and MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, INFLAMMATION (Inflammation) and MUSCULOSKELETAL STIFFNESS (Stiffness) outcome was unknown and ANAEMIA (Anemia) was resolving.     The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nasal congestion
Clinical narrative: Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced NASAL CONGESTION (Nasal congestion). At the time of the report, NASAL CONGESTION (Nasal congestion) outcome was unknown. Relevant concomitant medications were not reported.  In Dec-2021, the patient had nasal congestion for the last three days. She had got her booster dose of Moderna COVID-19 Vaccine on Saturday and woke up Sunday with nasal congestion. Treatment information was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Head cold) in an adult 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 an unknown indication. 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 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) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Head cold). At the time of the report, NASOPHARYNGITIS (Head cold) was resolving. No concomitant medication was reported. On an unknown date, the patient experienced HEAD COLD. COVID-19 VACCINE MODERNA (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for SKYRIZI (RISANKIZUMAB): The reporter's causality for the event(s) of HEAD COLD was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling cold, Orthosis user, Pyrexia, Swelling
Clinical narrative: BACK BRACE; Swelling; Feeling cold; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ORTHOSIS USER (BACK BRACE), SWELLING (Swelling), FEELING COLD (Feeling cold) and PYREXIA (Fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free,Solution for injection in pre-filled pen. In 2021, the patient experienced SWELLING (Swelling), FEELING COLD (Feeling cold) and PYREXIA (Fever). On an unknown date, the patient experienced ORTHOSIS USER (BACK BRACE). At the time of the report, ORTHOSIS USER (BACK BRACE) was resolving and SWELLING (Swelling), FEELING COLD (Feeling cold) and PYREXIA (Fever) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of BACK BRACE was not provided. The reporter's causality for the events of SWELLING, FEELING COLD and FEVER with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Psoriasis, Pyrexia, Skin irritation
Clinical narrative: Scalp irritation; Psoriasis flare-up; Fatigue; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Scalp irritation), PYREXIA (Low grade fever), PSORIASIS (Psoriasis flare-up) and FATIGUE (Fatigue) in a 31-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 Psoriatic plaque.    No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced PYREXIA (Low grade fever) and FATIGUE (Fatigue). On an unknown date, the patient experienced SKIN IRRITATION (Scalp irritation) and PSORIASIS (Psoriasis flare-up). At the time of the report, SKIN IRRITATION (Scalp irritation), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown and PSORIASIS (Psoriasis flare-up) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: Low Grade Fever.         The patient had occasionally dry scalp. He took first Moderna shot and had a low grade fever and fatigue. He did not agree to have physician contacted.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No treatment and concomitant information provided
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, SARS-CoV-2 test, Sinus disorder
Clinical narrative: Sinus disorder; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus disorder) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. On an unknown date, the patient experienced SINUS DISORDER (Sinus disorder) and FATIGUE (Fatigue). At the time of the report, SINUS DISORDER (Sinus disorder) was resolving and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On unknown dates, the patient experienced sinus issues and fatigue due to COVID vaccine and humira. on an unknown date, fatigue due to covid vaccine and humira resolved. 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: Blood pressure measurement, Blood test, Colonoscopy, Echocardiogram, Fatigue
Clinical narrative: Extreme Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Extreme Fatigue) 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 TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication.  The patient's past medical history included Asthma (onset before therapy and controlled), Heart murmur (leaky valve onset before therapy and controlled) and Acid reflux (esophageal) (resolved from  taking Motrin). Previously administered products included for Product used for unknown indication: Motrin. Past adverse reactions to the above products included No adverse event with Motrin. Concurrent medical conditions included Hypertension (Controlled with medication. Had 5 years ago.).  On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. In 2021, the patient experienced FATIGUE (Extreme Fatigue). The patient was treated with PREDNISONE (oral) at a dose of as needed only. In 2021, FATIGUE (Extreme Fatigue) had resolved.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 130/70. On an unknown date, Blood test: Normal. On an unknown date, Colonoscopy: Gastrointestinal bleeding from motrin.. On an unknown date, Echocardiogram: good with strong heart beat.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered FATIGUE (Extreme Fatigue) to be related.    Patient reported no break in therapy. When blood pressure in low, patient feels dizzy and nauseated. Patient had no missed doses of vaccine. Blood test was done for arthritis.  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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Felt ill; Fatigue; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt ill), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    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 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, Discontinued. On an unknown date, the patient experienced MALAISE (Felt ill), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MALAISE (Felt ill), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown and CHILLS (Chills) and HEADACHE (Headache) had resolved.            Concomitant Medication use information was not provided by reporter.  On unknown dates, the patient experienced felt chills, fatigue, felt ill, patient was not getting better on humira, felt headache and fever. on unknown dates, felt chills and felt headache resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality of humira for the event of felt chills, patient was not getting better on humira and felt headache with humira(adalimumab) was no reasonable possibility. Also, causality for the event of fatigue, felt ill and fever was not provided.  Treatment Medication use information was not provided 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICK) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 February 2021, the patient experienced ILLNESS (SICK). At the time of the report, ILLNESS (SICK) had not resolved.            Concomitant medication was not reported.  In Feb-2021 after second dose of vaccination patient got sick. 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.   This case was linked to MOD-2021-620150 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Non-significant follow up received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Crystal arthropathy, Osteoarthritis, Pneumonia
Clinical narrative: Pneumonia; Crystal arthropathy; Osteoarthritis; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an elderly 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), CRYSTAL ARTHROPATHY (Crystal arthropathy), OSTEOARTHRITIS (Osteoarthritis) and COVID-19 (COVID-19). At the time of the report, PNEUMONIA (Pneumonia) and COVID-19 (COVID-19) had resolved and CRYSTAL ARTHROPATHY (Crystal arthropathy) and OSTEOARTHRITIS (Osteoarthritis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication information was not provided by the reporter. On unknown dates, the patient experienced arthritis conditions not improved with humira/osteoarthritis, rheumatoid arthritis and crystal arthritis, covid and pneumonia. on unknown dates, covid and pneumonia resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an elderly female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 and the unexpected, serious (medically significant) event of Pneumonia, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. The events had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an elderly female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 and the unexpected, serious (medically significant) event of Pneumonia, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. The events had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Joint injury, Pain
Clinical narrative: Metallic taste; Fatigue; Injured hip while jogging; Painful; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (Injured hip while jogging), PAIN (Painful), DYSGEUSIA (Metallic taste) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2020, the patient experienced JOINT INJURY (Injured hip while jogging) and PAIN (Painful). On an unknown date, the patient experienced DYSGEUSIA (Metallic taste) and FATIGUE (Fatigue). At the time of the report, JOINT INJURY (Injured hip while jogging) had not resolved, PAIN (Painful) outcome was unknown and DYSGEUSIA (Metallic taste) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of INJURED HIP WHILE JOGGING, METALLIC TASTE and FATIGUE with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of PAINFUL was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: achy; Feel, tired; feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), FATIGUE (Feel, tired) and PYREXIA (feverish) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced PAIN (achy), FATIGUE (Feel, tired) and PYREXIA (feverish). At the time of the report, PAIN (achy), FATIGUE (Feel, tired) and PYREXIA (feverish) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site hypoaesthesia
Clinical narrative: Vaccination site hypoaesthesia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (Vaccination site hypoaesthesia) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE HYPOAESTHESIA (Vaccination site hypoaesthesia). At the time of the report, VACCINATION SITE HYPOAESTHESIA (Vaccination site hypoaesthesia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On unknown dates, the patient experienced pens were kept below recommended temperature in refrigerator for two days/readjust refrigerator and numbness on left side and left arm after COVID 19 vaccination. On an unknown date, numbness on left side and left arm after COVID 19 vaccination resolved. 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in a 35-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]) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved.            No concomitant medications were reported. On unknown dates patient had just started skyrizi when she got the covid vaccines and it seemed to be very slow in clearing, normally patient was very fast in clearing when she was on biologics. Patient experienced chronic plaque psoriasis flare/break out. On 30-Nov-2021 patient mentioned an issue with one Skyrizi syringe liquid was clear, colorless and the usual. Punger was not held when syringe was removed from the carton, not was when the needle guard was removed. Injection site that was selected was on her arm. Skin was squeezed to raise the injection site and syringe was placed at a 45-degree angle. Solution went all over the injection site. She had used her arm as the injection site. Patient had a pen misfire where the medication came out of her arm. Patient did not feel she got all the medication and went to physician. Patient was in a flare at the moment. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Follow up-narrative updated and event added
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bone densitometry, Bronchitis, Illness, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Sickness; Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021; Bronchitis; Flu-like illness; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), INFLUENZA LIKE ILLNESS (Flu-like illness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021) and ILLNESS (Sickness) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In 2022, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 UNK. In 2021, the patient experienced BRONCHITIS (Bronchitis) and INFLUENZA LIKE ILLNESS (Flu-like illness). On 30-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021). On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, BRONCHITIS (Bronchitis), INFLUENZA LIKE ILLNESS (Flu-like illness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021) and ILLNESS (Sickness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bone densitometry: Unknown. On an unknown date, Laboratory test: Unknown. On an unknown date, SARS-CoV-2 test: Positive.         No concomitant information provided.  No Treatment information 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 15-Feb-2022: Live Significant Follow Up Appended and new event sickness added , lab data added
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, SARS-CoV-2 test
Clinical narrative: Sickness; Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021; Bronchitis; Flu-like illness; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), INFLUENZA LIKE ILLNESS (Flu-like illness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021) and ILLNESS (Sickness) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In 2022, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 UNK. In 2021, the patient experienced BRONCHITIS (Bronchitis) and INFLUENZA LIKE ILLNESS (Flu-like illness). On 30-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021). On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, BRONCHITIS (Bronchitis), INFLUENZA LIKE ILLNESS (Flu-like illness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1- 20-JUN-2021  Dose-2-30-JUL-2021) and ILLNESS (Sickness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bone densitometry: Unknown. On an unknown date, Laboratory test: Unknown. On an unknown date, SARS-CoV-2 test: Positive.         No concomitant information provided.  No Treatment information 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 15-Feb-2022: Live Significant Follow Up Appended and new event sickness added , lab data added