chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain/achiness all over body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/achiness all over body) in a 65-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 Psoriatic arthritis.    Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Dose 1 Route of administration was intramuscular) on 01-Feb-2022 and PFIZER BIONTECH COVID-19 VACCINE (Dose 2 Route of administration was intramuscular) on 22-Feb-2022. Past adverse reactions to the above products included General body pain with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In April 2022, the patient experienced PAIN (Pain/achiness all over body). At the time of the report, PAIN (Pain/achiness all over body) had not resolved.      No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: First primary series Moderna dose each time after the injection she experienced a red left arm that eventually resolved; First primary series Moderna dose each time after the injection she experienced a swollen left arm that eventually resolved; First primary series Moderna dose each time after the injection she experienced a sore left arm that eventually resolved; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (First primary series Moderna dose each time after the injection she experienced a red left arm that eventually resolved), VACCINATION SITE SWELLING (First primary series Moderna dose each time after the injection she experienced a swollen left arm that eventually resolved) and VACCINATION SITE PAIN (First primary series Moderna dose each time after the injection she experienced a sore left arm that eventually resolved) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 008B21A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu Vaccine (IM Vaccine (right deltoid)) on 24-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Blood pressure high (Started 25 years ago. She reported her HCP changed blood pressure medication a year ago.) and Thyroid disorder (Started 15 to 20 years ago).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (First primary series Moderna dose each time after the injection she experienced a red left arm that eventually resolved), VACCINATION SITE SWELLING (First primary series Moderna dose each time after the injection she experienced a swollen left arm that eventually resolved) and VACCINATION SITE PAIN (First primary series Moderna dose each time after the injection she experienced a sore left arm that eventually resolved). At the time of the report, VACCINATION SITE ERYTHEMA (First primary series Moderna dose each time after the injection she experienced a red left arm that eventually resolved), VACCINATION SITE SWELLING (First primary series Moderna dose each time after the injection she experienced a swollen left arm that eventually resolved) and VACCINATION SITE PAIN (First primary series Moderna dose each time after the injection she experienced a sore left arm that eventually resolved) had resolved.            Concomitant medications was not provided by the reporter. Caller mentioned that she had lost a lot of weight over a year ago due to a healthcare after taking a beta blocker medication. She reported she had lost 145 lbs. Treatment information was not provided.   This case was linked to MOD-2022-577895, MOD-2022-577896, MOD-2022-577806 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Weight decreased
Clinical narrative: Patient had lost a lot of weight over a year ago and reported that patient had lost 145 lbs.; Second Moderna primary dose each time after the injection patient experienced a red left arm; Second Moderna primary dose each time after the injection patient experienced a swollen left arm; Second Moderna primary dose each time after the injection she experienced a sore left arm; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT DECREASED (Patient had lost a lot of weight over a year ago and reported that patient had lost 145 lbs.), VACCINATION SITE ERYTHEMA (Second Moderna primary dose each time after the injection patient experienced a red left arm), VACCINATION SITE SWELLING (Second Moderna primary dose each time after the injection patient experienced a swollen left arm) and VACCINATION SITE PAIN (Second Moderna primary dose each time after the injection she experienced a sore left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Date was reported as 25 years ago Patient reported that patient  HCP changed the blood pressure medication a year ago.) and Thyroid disorder (Date was reported as 15 to 20 years ago.  There was no change in status such as improvement or worsening.).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced WEIGHT DECREASED (Patient had lost a lot of weight over a year ago and reported that patient had lost 145 lbs.), VACCINATION SITE ERYTHEMA (Second Moderna primary dose each time after the injection patient experienced a red left arm), VACCINATION SITE SWELLING (Second Moderna primary dose each time after the injection patient experienced a swollen left arm) and VACCINATION SITE PAIN (Second Moderna primary dose each time after the injection she experienced a sore left arm). At the time of the report, WEIGHT DECREASED (Patient had lost a lot of weight over a year ago and reported that patient had lost 145 lbs.) outcome was unknown and VACCINATION SITE ERYTHEMA (Second Moderna primary dose each time after the injection patient experienced a red left arm), VACCINATION SITE SWELLING (Second Moderna primary dose each time after the injection patient experienced a swollen left arm) and VACCINATION SITE PAIN (Second Moderna primary dose each time after the injection she experienced a sore left arm) had resolved.            On 24-Aug-2021, the patient received the Flu Vaccine (Intramuscular) in right deltoid.  No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2022-577887, MOD-2022-577896, MOD-2022-577806 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: first Moderna booster dose each time after the injection she experienced a red left arm; first Moderna booster dose each time after the injection she experienced a swollen left arm; first Moderna booster dose each time after the injection she experienced a sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (first Moderna booster dose each time after the injection she experienced a red left arm), VACCINATION SITE SWELLING (first Moderna booster dose each time after the injection she experienced a swollen left arm) and VACCINATION SITE PAIN (first Moderna booster dose each time after the injection she experienced a sore left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 024M20A and 008B21A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu Vaccine (Right deltoid) on 24-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Hypertension (25 years ago) and Thyroid disorder (15 to 20 years ago).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (first Moderna booster dose each time after the injection she experienced a red left arm), VACCINATION SITE SWELLING (first Moderna booster dose each time after the injection she experienced a swollen left arm) and VACCINATION SITE PAIN (first Moderna booster dose each time after the injection she experienced a sore left arm). At the time of the report, VACCINATION SITE ERYTHEMA (first Moderna booster dose each time after the injection she experienced a red left arm), VACCINATION SITE SWELLING (first Moderna booster dose each time after the injection she experienced a swollen left arm) and VACCINATION SITE PAIN (first Moderna booster dose each time after the injection she experienced a sore left arm) had resolved.            Concurrent medication included medication for high blood pressure. It was reported that patient's HCP changed her blood pressure medication a year ago. Treatment medication not reported.   This case was linked to MOD-2022-577887, MOD-2022-577895, MOD-2022-577806 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Migraine, Vomiting
Clinical narrative: COVID-19; Migraine; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), VOMITING (Vomiting) and COVID-19 (COVID-19) in a 28-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 and Psoriatic arthritis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In 2021, the patient experienced MIGRAINE (Migraine) and VOMITING (Vomiting). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, MIGRAINE (Migraine) and VOMITING (Vomiting) had resolved and COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided.  Company Comment: This spontaneous case concerns a 28-year-old, female patient with history of co-suspect administration of Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19, and other associated non-serious events. The event COVID-19 occurred on an unspecified date after receiving the first dose of the mRNA-1273 vaccine on an unspecified date in Oct2021. The other non-serious events occurred on unspecified dates in 2021 after receiving the first dose of the mRNA-1273 vaccine on an unspecified date in Oct2021. Treatment information was not provided. The outcome of the event COVID-19 was unknown, while the other non-serious events had resolved at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 28-year-old, female patient with history of co-suspect administration of Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19, and other associated non-serious events. The event COVID-19 occurred on an unspecified date after receiving the first dose of the mRNA-1273 vaccine on an unspecified date in Oct2021. The other non-serious events occurred on unspecified dates in 2021 after receiving the first dose of the mRNA-1273 vaccine on an unspecified date in Oct2021. Treatment information was not provided. The outcome of the event COVID-19 was unknown, while the other non-serious events had resolved at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/tested positive with a home test today; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/tested positive with a home test today) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Hypothyroidism and Allergy NOS. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 22-May-2022, the patient experienced COVID-19 (COVID-19/tested positive with a home test today). At the time of the report, COVID-19 (COVID-19/tested positive with a home test today) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: negative (Negative) felt good and tested negative with at home tests.. On 22-May-2022, SARS-CoV-2 test: positive (Positive) tested positive with a home test today.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that after completion of the 5 day course of paxlovid and 8 days total, He felt good and tested negative with at home tests.  It was reported that 7 days later he started to have symptoms including coughing, runny nose and slightly tired. Patient tested positive with a home test today and had persistent cough.  No treatment medication were reported. COMPANY COMMENT: This is an spontaneous case concerning a 68-years-old male patient with medical history of Hypothyroidism and Allergy NOS, Concomitant products included LEVOTHYROXINE for Hypothyroidism, RITONAVIR on 09-May-2022 for COVID-19 treatment who experienced the unexpected AESI event of COVID-19 156 days after  3rd  dose of  mRNA-1273 vaccine. On 22-May-2022, SARS-CoV-2 test: positive. 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 68-years-old male patient with medical history of Hypothyroidism and Allergy NOS, Concomitant products included LEVOTHYROXINE for Hypothyroidism, RITONAVIR on 09-May-2022 for COVID-19 treatment who experienced the unexpected AESI event of COVID-19 156 days after  3rd  dose of  mRNA-1273 vaccine. On 22-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in feet; Stomach pain; Bloated feeling; Feeling abnormal/did not feel right; Abnormal touch sensation/ hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), ABDOMINAL DISTENSION (Bloated feeling), FEELING ABNORMAL (Feeling abnormal/did not feel right), PARAESTHESIA (Abnormal touch sensation/ hard to touch) and HYPOAESTHESIA (Numbness in feet) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In April 2022, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), ABDOMINAL DISTENSION (Bloated feeling), FEELING ABNORMAL (Feeling abnormal/did not feel right) and PARAESTHESIA (Abnormal touch sensation/ hard to touch). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in feet). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), PARAESTHESIA (Abnormal touch sensation/ hard to touch) and HYPOAESTHESIA (Numbness in feet) had not resolved and ABDOMINAL DISTENSION (Bloated feeling) and FEELING ABNORMAL (Feeling abnormal/did not feel right) outcome was unknown.            Concomitant drugs were not reported. Patient said her feet had been numb ever since, might be something else, Patient had a lot going on. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment details were not reported. Causality for Rinvoq(upadacitinib): The reporter causality for the events of stomach pain and numb feet with rinvoq(upadacitinib) was no reasonable possibility. the reporter causality for the events of felt bloated, did not feel right and hard to touch was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dyspnoea, Psoriasis, Skin disorder, Skin erosion
Clinical narrative: Blistering; Breathing difficult; Raw skin; Skin disorder; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blistering), DYSPNOEA (Breathing difficult), SKIN EROSION (Raw skin), SKIN DISORDER (Skin disorder) and PSORIASIS (Psoriasis flare-up) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.   On 05-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced BLISTER (Blistering), DYSPNOEA (Breathing difficult), SKIN EROSION (Raw skin), SKIN DISORDER (Skin disorder) and PSORIASIS (Psoriasis flare-up). At the time of the report, BLISTER (Blistering), DYSPNOEA (Breathing difficult) and PSORIASIS (Psoriasis flare-up) had not resolved and SKIN EROSION (Raw skin) and SKIN DISORDER (Skin disorder) outcome was unknown.            It was reported that on an unknown date in 2022, the patient experienced trouble breathing. the patient still had plaque psoriasis flare up. She had spot on hands that were raw, blistering but not itching. she also got spot on bottom of feet. After taken covid booster of moderna in 2022, she was trouble breathing. It was unknown if she was enrolled in a covid-19 vaccine trial. Primary reporter does not had the lot number information, because the packaging was discarded. The reporter's causality for the event of blistering with skyrizi (risankizumab) was a reasonable possibility. the reporter's causality for the event of trouble breathing, spot on hands that were raw or spot on bottom of feet unknown onset, spot on hands that were raw or spot on bottom of feet unknown onset and plaque, psoriasis flare up was not provided.  No treatment information was reported.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash going in waves around trunk. Going down thighs today and up inner arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash going in waves around trunk. Going down thighs today and up inner arms) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer and Drug allergy (No drug was reported).    On 06-Dec-2021 at 12:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022 at 3:45 PM, the patient experienced RASH (Rash going in waves around trunk. Going down thighs today and up inner arms). At the time of the report, RASH (Rash going in waves around trunk. Going down thighs today and up inner arms) was resolving.            No concomitant medications were reported. It was reported that patient took Pfizer drug as a cosuspect for the treatment of COVID-19 with the start date as 21-MAY-2022 and end date as 25-MAY-2022 It was reported that patient was not the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient had previously received COVID-19 treatment. the event reported was Rash going in waves around trunk.Going down thighs today and up inner arms with Device Date as 25-May-2022 No treatment medications were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Psoriasis, Vaccination site pain
Clinical narrative: Fatigue; Vaccination site pain; Plaque psoriasis flare up on right hand, right forearm, elbows, ears and scalp; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and PSORIASIS (Plaque psoriasis flare up on right hand, right forearm, elbows, ears and scalp) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 20-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 15-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 08-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 experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and PSORIASIS (Plaque psoriasis flare up on right hand, right forearm, elbows, ears and scalp). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown and PSORIASIS (Plaque psoriasis flare up on right hand, right forearm, elbows, ears and scalp) had not resolved.            No concomitant medication were reported.   No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2022: Followup document contain, the event of "psoriasis flare up" was amended to "Plaque psoriasis flare up on right hand, right forearm, elbows, ears and scalp.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: 2nd dose admnistered on 07-May-2021 and booster administered on 01-Sep-2021; Felt like it set back runs high fever get chills; Felt like it set back runs high fever get chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Felt like it set back runs high fever get chills), CHILLS (Felt like it set back runs high fever get chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose admnistered on 07-May-2021 and booster administered on 01-Sep-2021) in a 57-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 Panuveitis.    No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-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) CF, prefilled pen. In 2021, the patient experienced PYREXIA (Felt like it set back runs high fever get chills) and CHILLS (Felt like it set back runs high fever get chills). On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose admnistered on 07-May-2021 and booster administered on 01-Sep-2021). In 2021, PYREXIA (Felt like it set back runs high fever get chills) and CHILLS (Felt like it set back runs high fever get chills) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose admnistered on 07-May-2021 and booster administered on 01-Sep-2021) outcome was unknown.            Concomitant medication information was not provided by the reporter.  The patient received 3rd, booster on 01-Sep-2021.  The reporter's causality for the events with Humira (Adalimumab) was no reasonable possibility.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Increased tendency to bruise
Clinical narrative: Seems to be bruising easily; More fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED TENDENCY TO BRUISE (Seems to be bruising easily) and FATIGUE (More fatigued) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.        Concurrent medical conditions included Ulcerative colitis.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-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) 1 dosage form. On an unknown date, the patient experienced INCREASED TENDENCY TO BRUISE (Seems to be bruising easily) and FATIGUE (More fatigued). At the time of the report, INCREASED TENDENCY TO BRUISE (Seems to be bruising easily) and FATIGUE (More fatigued) had not resolved.            No concomitant medications was provided. No treatment medications was provided.  It was unknown if patient was enrolled in COVID-19 Vaccine Trial.  The reporter's causality for the events seems to be bruising easily and more fatigued with Humira was a reasonable possibility.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa, Crohn's disease and Ulcerative colitis.    No Medical History information was reported.   On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, pre-filled pen. On an unknown date, the patient experienced SOMNOLENCE (Sleepy). At the time of the report, SOMNOLENCE (Sleepy) outcome was unknown.            No concomitant medications were provided by the reporter. It was unknown if the patient was enrolled in a COVID-19 Vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded. No treatment information was provided by the reporter.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Symptoms returned and antigen tests turned positive on 5/21. Pt still symptomatic on 5/25 with  positive antigen test; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Symptoms returned and antigen tests turned positive on 5/21. Pt still symptomatic on 5/25 with  positive antigen test) in a 40-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.        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 21-May-2022, the patient experienced COVID-19 (Symptoms returned and antigen tests turned positive on 5/21. Pt still symptomatic on 5/25 with  positive antigen test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Symptoms returned and antigen tests turned positive on 5/21. Pt still symptomatic on 5/25 with  positive antigen test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 21-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 25-May-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a 40-year-old male patient with no relevant medical history, who experienced the non-serious unexpected AESI COVID-19,  after receiving the second dose of mRNA-1273 on an unknown date. Patient was treated with Paxlovid for 5 days and symptoms returned with a positive antigen test.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medications information was reported.  Device date was reported as 25-May-2022.; Sender's Comments: Company comment: This is a spontaneous case concerning a 40-year-old male patient with no relevant medical history, who experienced the non-serious unexpected AESI COVID-19,  after receiving the second dose of mRNA-1273 on an unknown date. Patient was treated with Paxlovid for 5 days and symptoms returned with a positive antigen test.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dry mouth, Nausea
Clinical narrative: Dry mouth; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth) and NAUSEA (Nausea) 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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DRY MOUTH (Dry mouth) and NAUSEA (Nausea). At the time of the report, DRY MOUTH (Dry mouth) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported. The booster dose was administered on unknown date of 2022. It was reported that daily dose of HUMIRA was Citrate free. it was unknown if patient was enrolled in a COVID-19 Vaccine trial. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna Doses Administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Doses Administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Doses Administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Doses Administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 22 Apr 2022, the vial was initially stored in the refrigerator.The vial did not undergo any temperature excursions.  No treatment medication was reported.
Age: 27.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lymphadenopathy, Nasal congestion, Rhinalgia
Clinical narrative: painful and swollen Nasal congestion; Nasal congestion; Cervical lymphadenopathy; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINALGIA (painful and swollen Nasal congestion), NASAL CONGESTION (Nasal congestion) and LYMPHADENOPATHY (Cervical lymphadenopathy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Obesity and Allergy.   On 10-Dec-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 26-May-2022, the patient experienced RHINALGIA (painful and swollen Nasal congestion), NASAL CONGESTION (Nasal congestion) and LYMPHADENOPATHY (Cervical lymphadenopathy). At the time of the report, RHINALGIA (painful and swollen Nasal congestion), NASAL CONGESTION (Nasal congestion) and LYMPHADENOPATHY (Cervical lymphadenopathy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.  It was reported that patient was not taking any medications within 2 weeks of starting the COVID-19 treatment. Patient previously received COVID-19 vaccine. The start date of the events was reported as 26-May-2022 06:00.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Date on the vial was exp 17-May-2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Date on the vial was exp 17-May-2022) 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 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Date on the vial was exp 17-May-2022). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Date on the vial was exp 17-May-2022) outcome was unknown.            No concomitant medications were reported. The reporter mother had the booster but the date on the vial was expiry of 17-May-2022 and reporter further asked should this have been used and was worried. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: much stronger side effect,typical side effect; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (much stronger side effect,typical side effect) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (much stronger side effect,typical side effect). At the time of the report, IMMUNISATION REACTION (much stronger side effect,typical side effect) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant details were reported.  Patient had a much stronger side effect, typical side effect than her husband, but after more than 2 days it was gone.  No treatment details were reported.  Reporter declined providing information regarding the side effects because they were so minimal.   This case was linked to MOD-2022-578357, MOD-2022-578384 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: sweats; mild flu-like symptoms; aching; headaches; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills) in a female patient of an unknown age 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) (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 HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills) had resolved.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient did not have any pre-existing medical conditions. Patient experienced the events for 3 days. Patient did not take any medications for the events.   This case was linked to MOD-2022-577162 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Chills, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: sweats; mild flu-like symptoms; aching; headaches; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills) in a female patient of an unknown age 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) (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 HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills) had resolved.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient did not have any pre-existing medical conditions. Patient experienced the events for 3 days. Patient did not take any medications for the events.   This case was linked to MOD-2022-577162 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: sweats; mild flu-like symptoms; aching; headaches; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills) in a female patient of an unknown age 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) (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 HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headaches) and CHILLS (chills) had resolved.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient did not have any pre-existing medical conditions. Patient experienced the events for 3 days. Patient did not take any medications for the events.   This case was linked to MOD-2022-577162 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: received full booster dose/non immunocompromised individual received 3rd full dose instead of half dose; sweats; mild flu-like symptoms; aching; headache; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headache) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not have any pre-existing medical conditions.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. 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 an unknown date, the patient experienced HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headache), CHILLS (chills) and ACCIDENTAL OVERDOSE (received full booster dose/non immunocompromised individual received 3rd full dose instead of half dose). At the time of the report, HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headache) and CHILLS (chills) had resolved and ACCIDENTAL OVERDOSE (received full booster dose/non immunocompromised individual received 3rd full dose instead of half dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   It was reported that the patient received 3 full doses of the Moderna COVID-19 vaccine.   The patient did not take any medications for her symptoms.   This case was linked to MOD-2022-578392 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2022: Follow-up information received includes reporter details, patient details, suspect product information were updated and events were added.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Chills, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: received full booster dose/non immunocompromised individual received 3rd full dose instead of half dose; sweats; mild flu-like symptoms; aching; headache; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headache) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not have any pre-existing medical conditions.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. 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 an unknown date, the patient experienced HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headache), CHILLS (chills) and ACCIDENTAL OVERDOSE (received full booster dose/non immunocompromised individual received 3rd full dose instead of half dose). At the time of the report, HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headache) and CHILLS (chills) had resolved and ACCIDENTAL OVERDOSE (received full booster dose/non immunocompromised individual received 3rd full dose instead of half dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   It was reported that the patient received 3 full doses of the Moderna COVID-19 vaccine.   The patient did not take any medications for her symptoms.   This case was linked to MOD-2022-578392 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2022: Follow-up information received includes reporter details, patient details, suspect product information were updated and events were added.