chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Pain
Clinical narrative: I have been having unexpained pain all over my body; have a general feeling of unwell; particularly my joints; I am always tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I have been having unexpained pain all over my body), MALAISE (have a general feeling of unwell), ARTHRALGIA (particularly my joints) and FATIGUE (I am always tired) 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.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (I have been having unexpained pain all over my body), MALAISE (have a general feeling of unwell), ARTHRALGIA (particularly my joints) and FATIGUE (I am always tired). The patient was treated with Physical therapy for Pain; Physical therapy for Malaise; Physical therapy for Arthralgia and Physical therapy for Fatigue. At the time of the report, PAIN (I have been having unexpained pain all over my body), MALAISE (have a general feeling of unwell), ARTHRALGIA (particularly my joints) and FATIGUE (I am always tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. It was reported that patient was very active prior to injections and progression was very fast. No improvement even after physical therapy, medication helped a little in beginning but are no longer very effective.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Tingling from his right shoulder to the fingers of the right arm; Recurring pain in his right arm exactly where he got the shot; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling from his right shoulder to the fingers of the right arm) and VACCINATION SITE PAIN (Recurring pain in his right arm exactly where he got the shot) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 021B21A-1) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient 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 VACCINATION SITE PARAESTHESIA (Tingling from his right shoulder to the fingers of the right arm) and VACCINATION SITE PAIN (Recurring pain in his right arm exactly where he got the shot). At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling from his right shoulder to the fingers of the right arm) and VACCINATION SITE PAIN (Recurring pain in his right arm exactly where he got the shot) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022; No Adverse event; Received expired  2nd dose after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022).    No concomitant product use was provided.  The patient received 2nd dose (6-11 year) beyond 30 days in the refrigerator.  The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day.  The vial did not undergo any temperature excursion.  No treatment medication was provided.  This case is created for pediatric patient 1   This case was linked to US-MODERNATX, INC.-MOD-2022-636327, US-MODERNATX, INC.-MOD-2022-636330 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-636327:Paediatric patient -2 US-MODERNATX, INC.-MOD-2022-636330:Paediatric patient -3
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Breaking out in sores on elbows/Twice on right elbow, which went away, but now on the left elbow; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Breaking out in sores on elbows/Twice on right elbow, which went away, but now on the left elbow) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Breaking out in sores on elbows/Twice on right elbow, which went away, but now on the left elbow). At the time of the report, ARTHRALGIA (Breaking out in sores on elbows/Twice on right elbow, which went away, but now on the left elbow) had not resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse event; Incorrect product or dosage is administered, resulting in a lower than authorized dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Incorrect product or dosage is administered, resulting in a lower than authorized dose) and NO ADVERSE EVENT (no adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2022, the patient experienced UNDERDOSE (Incorrect product or dosage is administered, resulting in a lower than authorized dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (Incorrect product or dosage is administered, resulting in a lower than authorized dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Incorrect product or dosage is administered, resulting in a lower than authorized dose).    No concomitant medications were reported.  6 year old patient was administered a first dose of the Moderna COVID19 vaccine for 6 months to 5 years old.  No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypersensitivity, Laboratory test
Clinical narrative: Cannot walk because feet are impacted by ulcers; Allergic reactions because delayed response of immune system; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (Cannot walk because feet are impacted by ulcers) and HYPERSENSITIVITY (Allergic reactions because delayed response of immune system) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F214, 006B21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics (Doxycycline, Augmentin) and Drug allergy (Lisinopril). Concomitant products included AZILSARTAN KAMEDOXOMIL (EDARBI), HYDROCHLOROTHIAZIDE, ATORVASTATIN and VITAMIN D NOS for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-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 GAIT DISTURBANCE (Cannot walk because feet are impacted by ulcers) and HYPERSENSITIVITY (Allergic reactions because delayed response of immune system). The patient was treated with TACROLIMUS (topical) at a dose of 1 % percent (Tacrolimus 1%). At the time of the report, GAIT DISTURBANCE (Cannot walk because feet are impacted by ulcers) and HYPERSENSITIVITY (Allergic reactions because delayed response of immune system) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Laboratory test: concomitant medication were not causing symptoms..         Patient not tested positive to Covid-19. Patient states that patient also had a body rash a couple of months ago.  The doctors also did test to know if the concomitant medication might be causing these symptoms and proved they were not causing them. As treatment some other medications were also used, but the patient did not know the names of these.   This case was linked to MOD-2022-636334 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Had four shots of the Moderna vaccine and got Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Had four shots of the Moderna vaccine and got Covid) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, 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. In 2022, the patient experienced COVID-19 (Had four shots of the Moderna vaccine and got Covid). At the time of the report, COVID-19 (Had four shots of the Moderna vaccine and got Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were provided. Reporter stated that her mother had four shots of the Moderna vaccine and got Covid and got it confirmed. Reporter said it was mild. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 79-year-old female with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of fourth dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. SARS-CoV-2 test was Positive on an unknown date in 2022. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. 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 79-year-old female with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of fourth dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. SARS-CoV-2 test was Positive on an unknown date in 2022. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First Dose received on 05-MAR-2021 amd Second dose on 12-APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose received on 05-MAR-2021 amd Second dose on 12-APR-2021) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Patient was taking Humira (adalimumab) through subcutaneous route.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose received on 05-MAR-2021 amd Second dose on 12-APR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose received on 05-MAR-2021 amd Second dose on 12-APR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2022-636460 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose administered on 19Aug2020 and second dose on 12Oct2020; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 19Aug2020 and second dose on 12Oct2020) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2020, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 19Aug2020 and second dose on 12Oct2020). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 19Aug2020 and second dose on 12Oct2020) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant drug information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment drug information was reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Drug interaction
Clinical narrative: FLARE UP; HUMIRA STOPPED WORKING; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP) and DRUG INTERACTION (HUMIRA STOPPED WORKING) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis, Rheumatoid arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis, Rheumatoid arthritis and Plaque psoriasis.   In June 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UP) and DRUG INTERACTION (HUMIRA STOPPED WORKING). At the time of the report, CONDITION AGGRAVATED (FLARE UP) had resolved and DRUG INTERACTION (HUMIRA STOPPED WORKING) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Patient began having psoriasis; This spontaneous case was reported by an other health care professional and describes the occurrence of PSORIASIS (Patient began having psoriasis) in an 8-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 028L20A, 007B21A and 056M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (About 20 years ago). Past adverse reactions to the above products included Autoimmune disorder with Flu shot.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-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 23-Apr-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 PSORIASIS (Patient began having psoriasis). At the time of the report, PSORIASIS (Patient began having psoriasis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 1st booster dose. No concomitant medications were reported. Patient not had COVID. It was stated that patient has funny immune system. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Got it worse symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got it worse symptoms) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got it worse symptoms). At the time of the report, VACCINATION COMPLICATION (Got it worse symptoms) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient got it worse symptoms for a few days. No concomitant product reported. No treatment medication reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Inappropriate schedule of product discontinuation, Joint stiffness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (PAIN AND STIFFNESS IN FINGER JOINTS), INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (SKIPPED HUMIRA INJECTION DATE ON RECEIVING THE COVID BOOSTER DOSE/DID) and ARTHRALGIA (PAIN AND STIFFNESS IN FINGER JOINTS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-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 an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced JOINT STIFFNESS (PAIN AND STIFFNESS IN FINGER JOINTS), INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (SKIPPED HUMIRA INJECTION DATE ON RECEIVING THE COVID BOOSTER DOSE/DID) and ARTHRALGIA (PAIN AND STIFFNESS IN FINGER JOINTS). At the time of the report, JOINT STIFFNESS (PAIN AND STIFFNESS IN FINGER JOINTS) and ARTHRALGIA (PAIN AND STIFFNESS IN FINGER JOINTS) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (SKIPPED HUMIRA INJECTION DATE ON RECEIVING THE COVID BOOSTER DOSE/DID) had resolved. No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the events of Inappropriate schedule of product discontinuation, Joint stiffness, Pain in joint was assessed as Not related for cosuspect humira. No treatment medications were reported. Reporter did not allow further contact.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Myalgia, Pain, Pyrexia
Clinical narrative: Felt sick; Aches / Pains; Fever; Chills; Muscle aches; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Felt sick), PAIN (Aches / Pains), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, 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 an unknown date, the patient experienced ILLNESS (Felt sick), PAIN (Aches / Pains), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle aches). At the time of the report, ILLNESS (Felt sick), PAIN (Aches / Pains), PYREXIA (Fever) and CHILLS (Chills) had resolved and MYALGIA (Muscle aches) outcome was unknown.            No concomitant product reported by reporter.  Patient got the first and second shot for Moderna but not it was not clear if patient mentioned his first and second booster shot is from Pfizer or Moderna. It was reported that patient experienced muscle aches and normal side effects of the vaccine.   It was reported that patient received 4 moderna COVID-19 vaccine and experienced aches, pains, fever, chills, and he felt sick for a day or two afterwards.  No treatment medication reported by reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: Low-grade fever/Fever 101; Nausea; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Low-grade fever/Fever 101) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low-grade fever/Fever 101) and NAUSEA (Nausea). At the time of the report, PYREXIA (Low-grade fever/Fever 101) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Low-grade and 101.         No concomitant medications were reported. It was reported that the patient ethnicity was provided. The patient had a reaction to Moderna shots. The patient woke up with nausea with the first one and had a low-grade fever. The patient had fever 101 with second shot. The doctor who was overseeing that and said for patient to not take another one because it could have been one of the derivatives in it and they had not known which one. No treatment medications were reported.   This case was linked to MOD-2022-636749 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Allergy to vaccine, Arthritis
Clinical narrative: Triggered severe arthritis inflammation; Allergic reaction to COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Triggered severe arthritis inflammation) and ALLERGY TO VACCINE (Allergic reaction to COVID vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) pre filled pen. In 2020, the patient experienced ALLERGY TO VACCINE (Allergic reaction to COVID vaccine). On an unknown date, the patient experienced ARTHRITIS (Triggered severe arthritis inflammation). At the time of the report, ARTHRITIS (Triggered severe arthritis inflammation) was resolving and ALLERGY TO VACCINE (Allergic reaction to COVID vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided. Reporters causality for Humira with respect to the events, allergy to vaccine and arthritis aggravated were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Company comment- This spontaneous case concerns a 55-year-old female patient with relevant medical condition of Rheumatoid arthritis treated with Adalimumab (reported as co-suspect), who experienced the unexpected non-serious AESI arthritis (reported as arthritis aggravated). A first dose of mRNA-1273 vaccine was administered. Latency unknown as the onset date of the events was not specified. Details of symptoms, clinical course, investigation reports and treatment were not provided. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient with relevant medical condition of Rheumatoid arthritis treated with Adalimumab (reported as co-suspect), who experienced the unexpected non-serious AESI arthritis (reported as arthritis aggravated). A first dose of mRNA-1273 vaccine was administered. Latency unknown as the onset date of the events was not specified. Details of symptoms, clinical course, investigation reports and treatment were not provided. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Could be related to Guillain-Barre syndrome; [Numbness/tingling of L arm from shoulder to fingertips] followed by weakness of that arm; Numbness/tingling of L arm from shoulder to fingertips; numbness/tingling of R hand and R food; numbness/tingling down both forearms; Pain of L wrist that shot up about 1/4 of forearm; This serious initial spontaneous safety report was received by Novavax on 26-AUG-2022 from a consumer.  A male of 18 years was vaccinated with intramuscular Nuvaxovid 10 µg/ml suspect Covid-19 vaccine primary dose 1 on 19-AUG-2022 in the left arm at a hospital.  The following medical history was reported: Hypersensitivity to amoxicillin, Anxiety, Asthma, Ehlers-Danlos syndrome, Hepatic steatosis, Irritable bowel syndrome, Migraine, and Scoliosis.  No concomitant medications were reported.  On 24-AUG-2022, reported as day 5 after vaccine, the individual experienced numbness/tingling of L (left) arm from shoulder to fingertips (PT: Hypoaesthesia) (Serious: Medically Significant) followed by weakness of that arm (PT: Muscular weakness) (Serious: Medically Significant) that lasted 1/2 day along with numbness/tingling of R (right) hand and R food (PT: Hypoaesthesia) (Serious: Medically Significant) which only lasted briefly. On 26-AUG-2022, reported as 2 days later, the individual experienced numbness/tingling down both forearms (PT: Hypoaesthesia) (Serious: Medically Significant) which lasted about 1/2 hour, followed by pain of L wrist that shot up about 1/4 of forearm (PT: Arthralgia) (Serious: Medically Significant). The reporter scheduled an appointment with the primary care doctor and was awaiting a call back from the neurologist to get an appointment so it was yet to determine if there will be treatment or hospitalization. The reporter stated the concern was to watch for any signs that could be related to Guillain-Barre syndrome (PT: Guillain-Barre syndrome) (Serious: Medically Significant) at the time of reporting.  At the time of reporting, the event outcome of Muscular weakness was recovered/resolved and event stop date was 24-AUG-2022, Hypoaesthesia was recovered/resolved and event stop date was 26-AUG-2022, and Guillain-Barre syndrome and Arthralgia were unknown.; Sender's Comments: This male of an unspecified age experienced: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness and Arthralgia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The events Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness and Arthralgia were reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events were assessed as Possible.
Age: 41.0
Sex: U
Vaccine: COVID19, HEP
Symptoms: Adverse event, Chest pain, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Lightheadedness; Accelerated heart rate; Chest pain; Adverse event NOS; This serious initial spontaneous safety report was received by Novavax on 27-AUG-2022 from a consumer.     A female of 41 years was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 16-JUL-2022, and intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 2 on 19-AUG-2022.  The following secondary suspect medications were reported: Hepatitis B [Hepatitis B Vaccine] on 10-AUG-2022.  No medical history was reported.  No concomitant medications were reported.  On 19-AUG-2022, after vaccination, the individual experienced adverse event nos (PT: Adverse event) (Serious: Medically Significant). On 19-AUG-2022, three hours after vaccination, the individual experienced lightheadedness (PT: Dizziness) (Serious: Medically Significant) and accelerated heart rate (PT: Heart rate increased) (Serious: Medically Significant). On 19-AUG-2022, the individual also experienced chest pain (PT: Chest pain) (Serious: Medically Significant) in the center of the chest. The individual went to emergency room on 20-AUG-2022 for continued symptoms. Symptoms lasted for several days.  Relevant lab tests included: Heart rate (Result: up to 100-120 bpm, baseline is reported as 80 bpm; 19-AUG-2022).  At the time of reporting, the event outcomes of Adverse event, Dizziness, Heart rate increased and Chest pain were recovering/resolving.; Sender's Comments: This female of an unspecified age experienced: Adverse event, Chest pain, Dizziness and Heart rate increased after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The events Adverse event, Chest pain, Dizziness and Heart rate increased were reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events were assessed as Possible.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Overdose
Clinical narrative: GI disturbance; inadvertently received 5 times the normal dose of the Pfizer Covid 19 maroon cap for his second dose; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team. The reporter is the parent.  A 2-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2022 as dose 2 (maroon cap), 15 ug single (Lot number: FT9142) at the age of 2 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FT9142), administration date: 28Jul2022, when the patient was 2-year-old, for COVID-19 Immunization.  The following information was reported: OVERDOSE (non-serious) with onset 19Aug2022, outcome "unknown", described as "inadvertently received 5 times the normal dose of the Pfizer Covid 19 maroon cap for his second dose"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "GI disturbance".  Additional information: Serious criteria reported as no. Doctor stated that instead of 3mcg the patient received 15 mcg. The doctor was seeking any information available on this happening. Higher-than-authorized dose volume. Poor training was the contributing factors to the medication error.The medication error didn't affected the patient or consumer with clinical consequences. The reporter said there have been no adverse events experienced by the patient. The reporter felt the overdose event occurred due to poor training. Upon follow-up on 29Aug2022, the patient seemed to have done very well following the vaccine overdose. He never had any injection site reaction, and there was a small chance that the GI disturbance he experienced was related to the vaccine, but it is hard to say with a 2 year old. The patient was exposed to covid Wednesday 24Aug2022, and tested positive yesterday 28Aug2022 via PCR test, and was doing quite well. He has some Covid symptoms but nothing too bad. The patient has a runny nose and a cough (upper respiratory, not a lower chest cough) so the physician felt he was relatively well protected from more severe Covid symptom by getting the vaccine.  No follow-up attempts are possible. No further information is expected.  Follow-up(22Aug2022): This is a Follow-up spontaneous report from a contactable Physician in response to HCP telephonic follow-up activity.  Updated information included: Vaccine facility information added; additional information updated.  Follow-up (29Aug2022): This is a spontaneous follow-up report received from a contactable Physician. This physician reported in response to HCP telephonic follow-up activity which included that:  Updated information included: New event added and clinical course updated.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: Fi1b2d) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Lot number: 007m20a), in right arm and on 13Mar2021 as dose 2, single (Lot number: 048a21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; IBUPROFEN; GUAIFENESIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Negative test adter lastt dose; (unspecified date) Positive, notes: indication: Treatment of COVID-19; (23Aug2022) Negative, notes: Negative test 2 days after last dose; (25Aug2022) Positive, notes: Positive test 4 days after last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Negative test adter lastt dose. Negative test 2 days after last dose. Sore throat 3days after last paxlovid dose. Positive test 4 days after last dose.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; COVID Rebound; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group.  A female patient received BNT162b2 (BNT162B2), on 05May2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 09Aug2022, outcome "not recovered", described as "COVID Rebound"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient had all the same symptoms 4 days prior reporter with the same vacation history, Paxlovid & rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound with nasal congestion, cough, sneezing. Patient had all the same symptoms 4 days prior to reporter with the same vacation history, Paxlovid & rebound.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Papilloedema
Clinical narrative: swollen optic nerve and lost 50% vision in one eye; swollen optic nerve and lost 50% vision in one eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: BLINDNESS (medically significant), PAPILLOEDEMA (medically significant), outcome "unknown" and all described as "swollen optic nerve and lost 50% vision in one eye".  Clinical information: Caller stated, after receiving Pfizer Covid vaccine booster, he experienced swollen optic nerve and lost 50% vision in one eye. Caller was seeking information on any other cases.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Lichen planus
Clinical narrative: autoimmune disease; Hypertrophic Lichen Planus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 16:00 as dose 2, single (Lot number: Ff8841), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulpha" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; IBUPROFEN. Vaccination history included: BNT162b2 (Dose number 1, lot number Ff8841 Administration time 16:00, vaccine location-Right arm), administration date: 26Oct2021, when the patient was 58-year-old, for COVID-19 Immunization. The following information was reported: LICHEN PLANUS (disability, medically significant) with onset 01Dec2021 at 12:00, outcome "not recovered", described as "Hypertrophic Lichen Planus"; AUTOIMMUNE DISORDER (disability, medically significant) with onset 01Dec2021 at 12:00, outcome "not recovered", described as "autoimmune disease". The events "autoimmune disease" and "hypertrophic lichen planus" required emergency room visit. Therapeutic measures were taken as a result of autoimmune disorder, lichen planus. Clinical information: Ae treatment: Clobestasol propionate cream usp 0.05%, Prednisone. No covid prior vaccination and post vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Reporting a Paxlovid Rebound: On 15Aug tested positive again & on 16Aug symptoms reoccurred. Restarted isolation/masking. Tested positive again 16Aug & 19Aug.; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2022, outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 15Aug2022, outcome "unknown", described as "Reporting a Paxlovid Rebound: On 15Aug tested positive again & on 16Aug symptoms reoccurred. Restarted isolation/masking. Tested positive again 16Aug & 19Aug.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) Positive; (10Aug2022) Negative; (13Aug2022) Negative; (15Aug2022) Positive; (16Aug2022) Positive; (19Aug2022) Positive; (22Aug2022) Negative; (25Aug2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Patient was double boosted & take precautions for Covid19 exposure. Tested positive for Covid19 on 05Aug2022 & began Paxlovid same day. By 09Aug2022 symptoms had resolved. Tested negative on 10Aug2022 and 13Aug2022. Reporting a Paxlovid Rebound: On 15Aug2022 tested positive again & on 16Aug2022 symptoms reoccurred. Restarted isolation/masking. Tested positive again 16Aug2022 & 19Aug2022. By 22Aug2022 symptoms began to lessen & tested negative. Tested negative again 25Aug2022.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; NASONEX; ALBUTEROL [SALBUTAMOL]; PULMICORT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  Clinical information: It was reported that, female patient who was diagnosed with COVID-19 and had pre-existing conditions called stating that she was put on Paxlovid. Caller stated that she had other medications that she takes. Supplements Herbs or vitamins Nasal spray steroid (Flonase or Nasonex) Inhaler Albuterol Pulmicort (budesonide).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Menstrual cycle off since taking covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4515151-00 (AbbVie).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "Menstrual cycle off since taking covid vaccine".  Additional information: On unknown dates, the patient experienced menstrual cycle off since taking covid vaccine and patient still had minor plaque psoriasis breakouts. Pfizer BioNTech COVID-19 vaccine (TOZINAMERAN) was also considered suspect. The patient still had minor breakouts and stubborn spots. She used topical ointment for those spots. Her menstrual cycle was off since she took COVID vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by patient was not related to covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.