chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Influenza like illness, Rheumatoid arthritis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), IMMUNISATION REACTION (Vaccination adverse reaction) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 59-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. The patient's past medical history included Rheumatoid arthritis. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), IMMUNISATION REACTION (Vaccination adverse reaction) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and IMMUNISATION REACTION (Vaccination adverse reaction) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. Concomitant medications were not reported. On unknown date, Patient experienced Rheumatoid arthritis flare up on right ankle. No treatment information was provided. Company Comment: This is a spontaneous case concerning a 59-year-old male patient with medical history of rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up on right ankle), on unknown date after receiving a dose of mRNA-1273 vaccine. Date of vaccination, onset date of the event, clinical course and diagnostic tests were not provided in the case. The outcome of the event was unknown at the time of the report. The patient is receiving Adalimumab daily for rheumatoid arthritis. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 59-year-old male patient with medical history of rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up on right ankle), on unknown date after receiving a dose of mRNA-1273 vaccine. Date of vaccination, onset date of the event, clinical course and diagnostic tests were not provided in the case. The outcome of the event was unknown at the time of the report. The patient is receiving Adalimumab daily for rheumatoid arthritis. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Dysgeusia
Clinical narrative: COVID-19; Metallic taste; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DYSGEUSIA (Metallic taste) and DIARRHOEA (Diarrhea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Avastin. Past adverse reactions to the above products included Allergy with Avastin. Concurrent medical conditions included Thoracic outlet syndrome, Diabetes, Gout and Hypertension. Concomitant products included METFORMIN from 01-Jun-2017 to an unknown date, LOSARTAN from 01-Jan-2006 to an unknown date, ALLOPURINOL from 01-Jan-2006 to an unknown date, ACETYLSALICYLIC ACID (ASPIRINE) from 01-Jun-2013 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022, the patient experienced DYSGEUSIA (Metallic taste) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown and DYSGEUSIA (Metallic taste) and DIARRHOEA (Diarrhea) was resolving.            Patient took other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  From 28-May-2022 to 29-May-2022, the patient treated with unspecified medication(batch lot number FY6826) for COVID-19.  CC: This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred unknown days after a dose of mRNA-1273 vaccine administration, given as the third dose. Patient also reported the non-serious events metallic taste and diarrhea which occurred 207 days after the mRNA-1273 vaccine administration. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred unknown days after a dose of mRNA-1273 vaccine administration, given as the third dose. Patient also reported the non-serious events metallic taste and diarrhea which occurred 207 days after the mRNA-1273 vaccine administration. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Vaccination site erythema, Vaccination site induration
Clinical narrative: injection site reaction; Flu-like symptoms; very mild achiness; mild pruritus; oblong in shape with a hard center; reddened area 2.5 to 3 inches; minimal pain; very mild fatigue; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (injection site reaction), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (very mild achiness), VACCINATION SITE PRURITUS (mild pruritus) and VACCINATION SITE INDURATION (oblong in shape with a hard center) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 089M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.   On 25-May-2022, the patient received fourth 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. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, the patient experienced VACCINATION SITE REACTION (injection site reaction), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (very mild achiness), VACCINATION SITE PRURITUS (mild pruritus), VACCINATION SITE INDURATION (oblong in shape with a hard center), VACCINATION SITE ERYTHEMA (reddened area 2.5 to 3 inches), VACCINATION SITE PAIN (minimal pain) and FATIGUE (very mild fatigue). On 27-May-2022, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (very mild achiness) and FATIGUE (very mild fatigue) had resolved. At the time of the report, VACCINATION SITE REACTION (injection site reaction), VACCINATION SITE PRURITUS (mild pruritus), VACCINATION SITE INDURATION (oblong in shape with a hard center), VACCINATION SITE ERYTHEMA (reddened area 2.5 to 3 inches) and VACCINATION SITE PAIN (minimal pain) outcome was unknown.            Patient had no known health history related to the reaction. The fourth Moderna dose was the last dose as the previous dose. Flu-like symptoms, very mild fatigue and achiness started around noon on 26-May-2022.The patient had no loss of mobility. The patient did not seek medical treatment.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: injection site reaction; Flu-like symptoms; very mild achiness; mild pruritus; oblong in shape with a hard center; reddened area 2.5 to 3 inches; minimal pain; very mild fatigue; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (injection site reaction), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (very mild achiness), VACCINATION SITE PRURITUS (mild pruritus) and VACCINATION SITE INDURATION (oblong in shape with a hard center) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 089M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.   On 25-May-2022, the patient received fourth 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. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, the patient experienced VACCINATION SITE REACTION (injection site reaction), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (very mild achiness), VACCINATION SITE PRURITUS (mild pruritus), VACCINATION SITE INDURATION (oblong in shape with a hard center), VACCINATION SITE ERYTHEMA (reddened area 2.5 to 3 inches), VACCINATION SITE PAIN (minimal pain) and FATIGUE (very mild fatigue). On 27-May-2022, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (very mild achiness) and FATIGUE (very mild fatigue) had resolved. At the time of the report, VACCINATION SITE REACTION (injection site reaction), VACCINATION SITE PRURITUS (mild pruritus), VACCINATION SITE INDURATION (oblong in shape with a hard center), VACCINATION SITE ERYTHEMA (reddened area 2.5 to 3 inches) and VACCINATION SITE PAIN (minimal pain) outcome was unknown.            Patient had no known health history related to the reaction. The fourth Moderna dose was the last dose as the previous dose. Flu-like symptoms, very mild fatigue and achiness started around noon on 26-May-2022.The patient had no loss of mobility. The patient did not seek medical treatment.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: SPEECH WAS BELLS PALSY SIMILAR TO A STROKE; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (SPEECH WAS BELLS PALSY SIMILAR TO A STROKE) in a 75-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 Psoriatic arthritis.    No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced BELL'S PALSY (SPEECH WAS BELLS PALSY SIMILAR TO A STROKE) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (SPEECH WAS BELLS PALSY SIMILAR TO A STROKE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.  Company Comment: This spontaneous case concerns a 75-year-old, male patient with history of co-suspect administration of Humira (adalimumab) for Psoriatic Arthritis, who experienced the expected, serious (medically significant) AESI of Bell's palsy. The event occurred on an unspecified date in 2021 after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient experienced 'speech was Bell's palsy similar to a Stroke'. No further details were provided. Treatment information was also not provided. The outcome of the event was unknown at the time of the report. The event was considered not related to the mRNA-1273 vaccine as per the reporter's assessment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old, male patient with history of co-suspect administration of Humira (adalimumab) for Psoriatic Arthritis, who experienced the expected, serious (medically significant) AESI of Bell's palsy. The event occurred on an unspecified date in 2021 after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient experienced 'speech was Bell's palsy similar to a Stroke'. No further details were provided. Treatment information was also not provided. The outcome of the event was unknown at the time of the report. The event was considered not related to the mRNA-1273 vaccine as per the reporter's assessment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Respiration abnormal
Clinical narrative: haven't been feeling 100% himself; he felt like his breath was leaving him; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (haven't been feeling 100% himself) and RESPIRATION ABNORMAL (he felt like his breath was leaving him) in a 34-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient does not have allergies to medications, food and other products. Patient never had COVID positive test or diagnosis. No information relating to mentioned AE and both Acute and Chronic similar past. The patient not experienced similar event in the past.    On 26-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (haven't been feeling 100% himself) and RESPIRATION ABNORMAL (he felt like his breath was leaving him). At the time of the report, FEELING ABNORMAL (haven't been feeling 100% himself) and RESPIRATION ABNORMAL (he felt like his breath was leaving him) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid-19) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Promethazine. Past adverse reactions to the above products included Allergy with Promethazine. Concurrent medical conditions included Crohn's, Autoimmune thyroiditis and Soy allergy (Soy). Concomitant products included AZATHIOPRINE for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2022, SARS-CoV-2 test: positive (Positive) Rebound COVID.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Paxlovid course Device Date : 30-May-2022  Company Comment: This spontaneous case concerns a 39-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 15th May 2022 to 20th May 2022 for Covid-19. A week after completing the treatment with paxlovid patient had a rebound covid. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 39-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 15th May 2022 to 20th May 2022 for Covid-19. A week after completing the treatment with paxlovid patient had a rebound covid. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: low grade fever; chills; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M204) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue). In February 2021, PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. The patient experienced low grade fever, chills, and fatigue which lasted for 36 to 48 hours.  No treatment medications were provided.   This case was linked to MOD-2021-023951, MOD-2022-580236 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fever; chills; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 014M204) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). In October 2021, PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The chills, fever and fatigue were lasted for 24 hours.  No treatment information was provided by the reporter.  The patient received her second Moderna COVID-19 vaccine booster dose on 12-Apr-2022 (lot number 002M21A and expiration date was not available). The patient received the vaccine in her left arm and the patient reported no side effects after second booster dose.   This case was linked to MOD-2022-580230, MOD-2021-023951 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Headache; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and ARTHRALGIA (Shoulder pain) in an elderly female patient who received mRNA-1273 (Spikevax) 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 an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, CF. On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization) and ARTHRALGIA (Shoulder pain) (seriousness criterion hospitalization). The patient was hospitalized for 6 days due to ARTHRALGIA and HEADACHE. The patient was treated with Rehabilitation therapy for Arthralgia. At the time of the report, HEADACHE (Headache) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication reported.   It was unknown if the patient had been enrolled in COVID-19 vaccine trial.  Reporter stated she was in rehab in 2022.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication reported.  The reporter causality for the product Humira had not been reported for the events headache and shoulder pain. COMPANY COMMENT: This is an spontaneous case concerning a female patient with medical history of Co-suspect product included non-company product ADALIMUMAB solution for injection for Rheumatoid arthritis. who experienced the unexpected events of ARTHRALGIA and HEADACHE unknown days after a  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 1949 born female patient with medical history of Co-suspect product included non-company product ADALIMUMAB solution for injection for Rheumatoid arthritis. who experienced the unexpected events of ARTHRALGIA and HEADACHE unknown days after a  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: pains; elevated temperature; muscle aches; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), BODY TEMPERATURE INCREASED (elevated temperature), MYALGIA (muscle aches), PYREXIA (fever) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939969) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Sensitivity to penicillin).    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pains), BODY TEMPERATURE INCREASED (elevated temperature), MYALGIA (muscle aches), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, PAIN (pains), BODY TEMPERATURE INCREASED (elevated temperature), MYALGIA (muscle aches), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.            It was reported that patient received a Tetanus shot in her right arm on 05-May-2022 as an IM injection. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-580253 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: severe allergic reaction to booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALLERGY TO VACCINE (severe allergic reaction to booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (severe allergic reaction to booster). At the time of the report, ALLERGY TO VACCINE (severe allergic reaction to booster) outcome was unknown.            No concomitant information was reported. It was reported that patient had received booster dose of vaccine. No treatment information was provided.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Feeling abnormal, Influenza like illness, Migraine
Clinical narrative: Felt terrible; Migraines; Felt like had flu; Temperature drops; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible), MIGRAINE (Migraines), INFLUENZA LIKE ILLNESS (Felt like had flu), BODY TEMPERATURE DECREASED (Temperature drops) and PYREXIA (Fever) in a 61-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 Psoriatic arthritis.    Previously administered products included for Product used for unknown indication: NIACIN, DILAUDID and CODEINE. Past adverse reactions to the above products included Drug allergy with CODEINE, DILAUDID and NIACIN. Concurrent medical conditions included Drug allergy (Dilaudid, manifested by stop breathing), Drug allergy (Niacin, manifested by stop breathing) and Drug allergy (Codeine, manifested by stop breathing).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2022, received fourth 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, Citrate Free. On 15-May-2022, the patient experienced FEELING ABNORMAL (Felt terrible), MIGRAINE (Migraines), INFLUENZA LIKE ILLNESS (Felt like had flu), BODY TEMPERATURE DECREASED (Temperature drops), PYREXIA (Fever) and MYALGIA (Body aches). On 15-May-2022, FEELING ABNORMAL (Felt terrible), MIGRAINE (Migraines), INFLUENZA LIKE ILLNESS (Felt like had flu), BODY TEMPERATURE DECREASED (Temperature drops), PYREXIA (Fever) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, Body temperature: temperature drops (Low) Temperature drops.         No concomitant medications were reported. The patient received 2nd booster on 15-May-2022. The reporter causality for the events Felt terrible, Migraine, Felt like had flu, Fever, Body aches and Temperature drops with Humira was reported as no reasonable possibility. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Felt terrible; Migraines; Felt like had flu; Temperature drops; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible), MIGRAINE (Migraines), INFLUENZA LIKE ILLNESS (Felt like had flu), BODY TEMPERATURE DECREASED (Temperature drops) and PYREXIA (Fever) in a 61-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 Psoriatic arthritis.    Previously administered products included for Product used for unknown indication: NIACIN, DILAUDID and CODEINE. Past adverse reactions to the above products included Drug allergy with CODEINE, DILAUDID and NIACIN. Concurrent medical conditions included Drug allergy (Dilaudid, manifested by stop breathing), Drug allergy (Niacin, manifested by stop breathing) and Drug allergy (Codeine, manifested by stop breathing).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2022, received fourth 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, Citrate Free. On 15-May-2022, the patient experienced FEELING ABNORMAL (Felt terrible), MIGRAINE (Migraines), INFLUENZA LIKE ILLNESS (Felt like had flu), BODY TEMPERATURE DECREASED (Temperature drops), PYREXIA (Fever) and MYALGIA (Body aches). On 15-May-2022, FEELING ABNORMAL (Felt terrible), MIGRAINE (Migraines), INFLUENZA LIKE ILLNESS (Felt like had flu), BODY TEMPERATURE DECREASED (Temperature drops), PYREXIA (Fever) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, Body temperature: temperature drops (Low) Temperature drops.         No concomitant medications were reported. The patient received 2nd booster on 15-May-2022. The reporter causality for the events Felt terrible, Migraine, Felt like had flu, Fever, Body aches and Temperature drops with Humira was reported as no reasonable possibility. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Pyrexia
Clinical narrative: patient could not do much of anything; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMPAIRED WORK ABILITY (patient could not do much of anything) and PYREXIA (fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had not been diagnosed or tested positive with COVID-19.  The patient's past medical history included Skin cancer. Concurrent medical conditions included Nasal allergy (Nasal allergies). Concomitant products included METOPROLOL, ATORVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], FISH OIL, MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], CIMETIDINE (CREATE [CIMETIDINE]) and CREATININE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMPAIRED WORK ABILITY (patient could not do much of anything) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Fever, at an unspecified dose and frequency. At the time of the report, IMPAIRED WORK ABILITY (patient could not do much of anything) and PYREXIA (fever) outcome was unknown.            Concomitant medications included Create (D) and creatinine monohydrate.  The patient and the reporter were glad that they both received the vaccinations.   This case was linked to MOD-2022-580263, MOD-2022-580266, MOD-2022-580267.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: couldn't do much of anything; fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't do much of anything) and PYREXIA (fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no COVID + test or diagnosis.  Concurrent medical conditions included Nasal allergy and Skin cancer. Concomitant products included METOPROLOL, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], ARGININE, HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, VALINE (CREATE [ARGININE;HISTIDINE;ISOLEUCINE;LEUCINE;LYSINE;METHIONINE;PHENYLALANINE;THREONINE;VALINE]) and CREATINE MONOHYDRATE for an unknown indication.   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) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (couldn't do much of anything) and PYREXIA (fever). At the time of the report, MOBILITY DECREASED (couldn't do much of anything) and PYREXIA (fever) outcome was unknown.            Concomitant medications included Create (D) No treatment was reported   This case was linked to MOD-2022-580263, MOD-2022-580265, MOD-2022-580267 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMPAIRED WORK ABILITY (couldn't do much of anything) and PYREXIA (fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Nasal allergy (Nasal) and Skin cancer. Concomitant products included METOPROLOL, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, VITAMIN D NOS and CREATININE for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, the patient experienced IMPAIRED WORK ABILITY (couldn't do much of anything) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date at an unspecified dose and frequency. On 30-May-2022, PYREXIA (fever) had resolved. At the time of the report, IMPAIRED WORK ABILITY (couldn't do much of anything) outcome was unknown. Concomitant medications also included Create (D). The patient had never been diagnosed with/ tested positive for COVID-19. The patient had received first booster dose of Moderna vaccine on 12-Oct-2021. The patient took second booster dose on 27-May-2022 both at the same facility. This case was linked to MOD-2022-580263, MOD-2022-580265, MOD-2022-580266 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in the lower abdomen/colon.; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clot in the lower abdomen/colon.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (blood clot in the lower abdomen/colon.) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot in the lower abdomen/colon.) outcome was unknown.            No concomitant medication was reported.    Patient got her first booster on 21-Nov-2021 and 10 days later she got a blood clot in the lower abdomen/colon. No treatment information was reported.  Company Comment: This spontaneous case concerns a female patient with unknown age , with no medical history reported , who experienced Serious  ( medically significant ) , unexpected. AESI of thrombosis which occurred 10 days post vaccination with the 3rd dose of mRNA-1273 vaccine . The information regarding the 1st and 2nd dose of Covid 19 vaccine of this patient was not reported. The thrombosis was described as blood clot in the lower abdomen /colon.The details surrounding the event  like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the event was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report   This case was linked to MOD-2022-580280 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient with unknown age , with no medical history reported , who experienced Serious  ( medically significant ) , unexpected. AESI of thrombosis which occurred 10 days post vaccination with the 3rd dose of mRNA-1273 vaccine . The information regarding the 1st and 2nd dose of Covid 19 vaccine of this patient was not reported. The thrombosis was described as blood clot in the lower abdomen /colon.The details surrounding the event  like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the event was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Feeling unwell; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-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. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). On an unknown date, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) outcome was unknown and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information provided. No treatment medication information provided.  Company comment: This spontaneous case concerns a 52 years old female patient, with no medical history reported, who experienced the unexpected non serious AESI event SARS Cov2 test positive. Additionally non serious event malaise is also reported. Event SARS Cov2 test positive occurred 5 months 20 days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 24-May-2022.  The current pandemic situation of COVID 19 may remain as confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52 years old female patient, with no medical history reported, who experienced the unexpected non serious AESI event SARS Cov2 test positive. Additionally non serious event malaise is also reported. Event SARS Cov2 test positive occurred 5 months 20 days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 24-May-2022.  The current pandemic situation of COVID 19 may remain as confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage; They used two vials from the freezer after 30 days to administer them to 4 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients) and PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients) and PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No treatment drug was reported.  Reporter stated that it was notified to them that their upright freezer (two separate doors for freezer and fridge) was not good to use after 30 days. They normally pull the vials out before the 30 days to thaw. Reporter further stated that they wanted to have a stand alone freezer because of an automatic defrost cycle on some two door freezer/fridge combinations. The vial was initially stored in the refrigerator on 17-May-2022 (1 vial) and 19-May-2022 (1 vial). The temperature had not gone out of range at all, no temperature excursion happened. The patient received booster dose. Reporter further stated that the patients had not contacted them about any problems.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Prednisone. Past adverse reactions to the above products included Allergy with Prednisone. Concurrent medical conditions included Blood pressure high and Overweight.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: negative (Negative) Rebound after testing negative on 27/5.         Concomitant medication was not reported. Rebound COVID-19 on 30-May-2022 and was not recovered. The patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously had received a COVID-19 vaccine. The device date was 30-May-2022.  Company comment-This spontaneous case concerns a 34-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 21st to 26th May2022. She had a rebound covid 19 after testing negative and completion of Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 21st to 26th May2022. She had a rebound covid 19 after testing negative and completion of Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after the first and second Moderna Covid-19 vaccines in the prmary series.  vaccine; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue after the first and second Moderna Covid-19 vaccines in the prmary series.  vaccine) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after the first and second Moderna Covid-19 vaccines in the prmary series.  vaccine). At the time of the report, FATIGUE (Fatigue after the first and second Moderna Covid-19 vaccines in the prmary series.  vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment was reported   This case was linked to MOD-2022-580294, MOD-2022-580295 (Patient Link).   Reporter did not allow further contact