chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nauseous; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) and HEADACHE (Headache) 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 Ulcerative colitis.  No Medical History information was reported. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced NAUSEA (Nauseous) and HEADACHE (Headache). In February 2021, NAUSEA (Nauseous) and HEADACHE (Headache) had resolved. No concomitant medication information was reported. No treatment medication information was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fatigue
Clinical narrative: Ocassional pain in joints; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and ARTHRALGIA (Ocassional pain in joints) in a 67-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.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF, UNK. In 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ARTHRALGIA (Ocassional pain in joints). In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, ARTHRALGIA (Ocassional pain in joints) had not resolved.            No concomitant product was reported. No treatment information was reported. The reporter's causality for the event Arthralgia was reasonable possibility and for event Fatigue was no reasonable possibility with Humira. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) 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) for Crohn's disease.    No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. In February 2021, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  In February 2021, the patient experienced very sick after second covid shot. In 2021, the very sick after second covid shot resolved. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Depression, Feeling abnormal, Illness
Clinical narrative: Depressed down due to personal issues; Sickness; Felt miserable; weakness; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Depressed down due to personal issues), ILLNESS (Sickness), FEELING ABNORMAL (Felt miserable) and ASTHENIA (weakness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for an unknown indication.    No medical history was reported.  Concomitant products included FUROSEMIDE, LOSARTAN, TAMSULOSIN, DIAZEPAM, CYCLOBENZAPRINE, TRAZODONE, FERROUS SULFATE (FEROSUL), METOPROLOL and OMEPRAZOLE for an unknown indication.   On 11-Feb-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced DEPRESSION (Depressed down due to personal issues), ILLNESS (Sickness), FEELING ABNORMAL (Felt miserable) and ASTHENIA (weakness). At the time of the report, DEPRESSION (Depressed down due to personal issues) and ILLNESS (Sickness) had not resolved and FEELING ABNORMAL (Felt miserable) and ASTHENIA (weakness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The patient was sick after receiving the Moderna Covid Vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of weak, depressed down due to personal issues, sick and felt miserable was not provided for Rinvoq.  No treatment medication was reported.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Device malfunction, Fatigue, Injection site pain, Injection site pruritus
Clinical narrative: Night sweats; Fatigue; Chills; Injection site pain; Cold; Injection site itching; Device misfire; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE MALFUNCTION (Device misfire), NIGHT SWEATS (Night sweats), NASOPHARYNGITIS (Cold), INJECTION SITE PRURITUS (Injection site itching) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21E. and 046b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced DEVICE MALFUNCTION (Device misfire), NASOPHARYNGITIS (Cold), INJECTION SITE PRURITUS (Injection site itching), CHILLS (Chills) and INJECTION SITE PAIN (Injection site pain). In November 2021, the patient experienced NIGHT SWEATS (Night sweats) and FATIGUE (Fatigue). In 2021, DEVICE MALFUNCTION (Device misfire), INJECTION SITE PRURITUS (Injection site itching), CHILLS (Chills) and INJECTION SITE PAIN (Injection site pain) had resolved. At the time of the report, NIGHT SWEATS (Night sweats), NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of FATIGUE, NIGHT SWEATS and COLD was not provided. The reporter's causality for the event(s) of CHILLS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of DEVICE MISFIRE, INJECTION SITE ITCHINESS and INJECTION SITE PAIN with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis, Night sweats
Clinical narrative: Night sweats; Fatigue; Chills; Injection site pain; Cold; Injection site itching; Device misfire; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE MALFUNCTION (Device misfire), NIGHT SWEATS (Night sweats), NASOPHARYNGITIS (Cold), INJECTION SITE PRURITUS (Injection site itching) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21E. and 046b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced DEVICE MALFUNCTION (Device misfire), NASOPHARYNGITIS (Cold), INJECTION SITE PRURITUS (Injection site itching), CHILLS (Chills) and INJECTION SITE PAIN (Injection site pain). In November 2021, the patient experienced NIGHT SWEATS (Night sweats) and FATIGUE (Fatigue). In 2021, DEVICE MALFUNCTION (Device misfire), INJECTION SITE PRURITUS (Injection site itching), CHILLS (Chills) and INJECTION SITE PAIN (Injection site pain) had resolved. At the time of the report, NIGHT SWEATS (Night sweats), NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of FATIGUE, NIGHT SWEATS and COLD was not provided. The reporter's causality for the event(s) of CHILLS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of DEVICE MISFIRE, INJECTION SITE ITCHINESS and INJECTION SITE PAIN with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: The month due after the injection it was severally heavy to the point patient could not leave her house; have had big changes to menstruation/ It also became irregular and had some bleeding in the middle of cycle; This spontaneous case was reported by a patient and describes the occurrence of HEAVY MENSTRUAL BLEEDING (The month due after the injection it was severally heavy to the point patient could not leave her house) and MENSTRUATION IRREGULAR (have had big changes to menstruation/ It also became irregular and had some bleeding in the middle of cycle) in a female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (The month due after the injection it was severally heavy to the point patient could not leave her house) and MENSTRUATION IRREGULAR (have had big changes to menstruation/ It also became irregular and had some bleeding in the middle of cycle). At the time of the report, HEAVY MENSTRUAL BLEEDING (The month due after the injection it was severally heavy to the point patient could not leave her house) and MENSTRUATION IRREGULAR (have had big changes to menstruation/ It also became irregular and had some bleeding in the middle of cycle) outcome was unknown.            No concomitant medications were reported.   Patient have had big changes to her menstruation. The month due after the injection it was severally heavy to the point patient could not leave her house. It also became irregular and patient had some bleeding in the middle of her cycle. Her booster was moderna and the same thing was happening again.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Fatigue, Irritability
Clinical narrative: irritation; blisters on right arm; pain in right hips; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (irritation), BLISTER (blisters on right arm), ARTHRALGIA (pain in right hips) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IRRITABILITY (irritation), BLISTER (blisters on right arm), ARTHRALGIA (pain in right hips) and FATIGUE (Fatigue). At the time of the report, IRRITABILITY (irritation) outcome was unknown, BLISTER (blisters on right arm) and FATIGUE (Fatigue) had resolved and ARTHRALGIA (pain in right hips) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: COVID-19 antibody test negative; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative) outcome was unknown.            No Concomitant and Treatment Drug was provided by reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic reaction to covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction to covid vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis.    Concomitant products included LYSINE, ZINC, VITAMIN B12 [VITAMIN B12 NOS], CALCIUM, VITAMIN D [VITAMIN D NOS], CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), MELATONIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN, DULOXETINE HCL, GABAPENTIN and MAGNESIUM for an unknown indication.   In April 2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 75 milligram twice a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reaction to covid vaccine). At the time of the report, ALLERGY TO VACCINE (Allergic reaction to covid vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick for just one day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for just one day) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for just one day). At the time of the report, ILLNESS (Sick for just one day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was reported that patients daughter was ok. This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Parsley symptoms; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bells Parsley symptoms) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells Parsley symptoms) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells Parsley symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Patient was sitting in the ER due to facial dropping headaches along with many other Bells parsley symptoms. Facial dropping (PT: Facial paralysis) and headaches were the reported symptoms to event Bell's palsy.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a patient, concerning a female patient of an unknown age with no medical history reported, who experienced the expected serious (medically significant) adverse event of special interest Bell's palsy, reported as symptoms of Bell's palsy, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. It was reported that the patient went to emergency room due to facial drooping, headache, and symptoms of Bell's palsy. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a female patient of an unknown age with no medical history reported, who experienced the expected serious (medically significant) adverse event of special interest Bell's palsy, reported as symptoms of Bell's palsy, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. It was reported that the patient went to emergency room due to facial drooping, headache, and symptoms of Bell's palsy. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Pain, Pruritus, Vaccination site pain
Clinical narrative: SCALP HAD BEEN ITCHY/HEAD ITCHES VERY BAD/ Localised itching; Pain localised; VACCINE CAUSED SORE ARM; Head pain; took moderna dose-1 on  01-JAN-2020 and dose-2 on  01-MAR-2020; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (SCALP HAD BEEN ITCHY/HEAD ITCHES VERY BAD/ Localised itching), PAIN (Pain localised), VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM), HEADACHE (Head pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took moderna dose-1 on  01-JAN-2020 and dose-2 on  01-MAR-2020) 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 an unknown indication.    No Medical History information was reported.   On 01-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF, Solution for injection in pre-filled pen. On an unknown date, the patient experienced PRURITUS (SCALP HAD BEEN ITCHY/HEAD ITCHES VERY BAD/ Localised itching), PAIN (Pain localised), VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM), HEADACHE (Head pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took moderna dose-1 on  01-JAN-2020 and dose-2 on  01-MAR-2020). At the time of the report, PRURITUS (SCALP HAD BEEN ITCHY/HEAD ITCHES VERY BAD/ Localised itching) had not resolved, PAIN (Pain localised), HEADACHE (Head pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took moderna dose-1 on  01-JAN-2020 and dose-2 on  01-MAR-2020) outcome was unknown and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) had resolved.            No concomitant medication were reported. The patient experienced scalp had been itchy and noticed it started right before taking humira and vaccine caused sore arm.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up included events and narrative updated.
Age: 74.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Hidradenitis, Influenza like illness
Clinical narrative: Flu like symptoms; Fatigue; Hidradenitis suppurativa; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Ongoing. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Discontinued. In 2021, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication use information was not provided by reporter.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality of humira for the event(s) of fatigue and flu like symptoms was not provided. Also, causality for the event of hidradenitis suppurativa flare up with humira(adalimumab) was a reasonable possibility.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accident, Arthralgia, Fracture
Clinical narrative: Joint pain; Accident with dog; Broke in location where could not have surgery; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT (Accident with dog), FRACTURE (Broke in location where could not have surgery) and ARTHRALGIA (Joint pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced ACCIDENT (Accident with dog) and FRACTURE (Broke in location where could not have surgery). On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ACCIDENT (Accident with dog) and FRACTURE (Broke in location where could not have surgery) was resolving and ARTHRALGIA (Joint pain) had resolved.            No concomitant medication provided. No treatment information mentioned.  Patient took the booster dose of Moderna COVID vaccine. Experienced joint pain and in NOV2021, had an accident involving the dog and got a fracture in a location where they could not get surgery.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea exertional, Palpitations
Clinical narrative: Anaphylactic reaction; Chest Pain; Palpitations; SOB on exertion; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), CHEST PAIN (Chest Pain), PALPITATIONS (Palpitations) and DYSPNOEA EXERTIONAL (SOB on exertion). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown and CHEST PAIN (Chest Pain), PALPITATIONS (Palpitations) and DYSPNOEA EXERTIONAL (SOB on exertion) had not resolved.            Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) expected event anaphylactic reaction, on an unknown date after receiving the second dose of mRNA-1273. Patient also experienced chest pain, palpitations and dyspnoea exertional since vaccination.  Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Concomitant drugs not reported.  consumer reported that one of the fried developed myocarditis with Pfizer vaccine and there was also reporting of increased acute appendectomy in the ages between 12 to 30 with second dose.  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) expected event anaphylactic reaction, on an unknown date after receiving the second dose of mRNA-1273. Patient also experienced chest pain, palpitations and dyspnoea exertional since vaccination.  Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Headache, Illness, Neck pain, Pain
Clinical narrative: Psoriatic arthritis flare up; Pain in hands and feet with Humira (adalimumab); Sick; Swollen from neck to wrist; Vertigo; Redness from neck to wrist; Sore from neck to wrist; Felt achy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In January 2021, the patient experienced ILLNESS (Sick), SWELLING (Swollen from neck to wrist), VERTIGO (Vertigo), ERYTHEMA (Redness from neck to wrist), NECK PAIN (Sore from neck to wrist), PAIN (Felt achy) and HEADACHE (Headache). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in hands and feet with Humira (adalimumab)). In 2021, ILLNESS (Sick), SWELLING (Swollen from neck to wrist), VERTIGO (Vertigo), ERYTHEMA (Redness from neck to wrist), NECK PAIN (Sore from neck to wrist), PAIN (Felt achy) and HEADACHE (Headache) had resolved. At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) had not resolved and PAIN IN EXTREMITY (Pain in hands and feet with Humira (adalimumab)) outcome was unknown.            No concomitant medications were reported.   It was unknown if patient was enrolled in a Covid-19 vaccine trial.   The reporter's causality for the event(s) of sick, swollen from neck to wrist, vertigo, headache, redness from neck to wrist, sore from neck to wrist, felt achy and pain in hands and feet was not provided. The reporter's causality for the event(s) of psoriatic arthritis flare up with Humira(adalimumab) was a reasonable possibility.  No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Psoriatic arthropathy, Swelling, Vertigo
Clinical narrative: Psoriatic arthritis flare up; Pain in hands and feet with Humira (adalimumab); Sick; Swollen from neck to wrist; Vertigo; Redness from neck to wrist; Sore from neck to wrist; Felt achy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In January 2021, the patient experienced ILLNESS (Sick), SWELLING (Swollen from neck to wrist), VERTIGO (Vertigo), ERYTHEMA (Redness from neck to wrist), NECK PAIN (Sore from neck to wrist), PAIN (Felt achy) and HEADACHE (Headache). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in hands and feet with Humira (adalimumab)). In 2021, ILLNESS (Sick), SWELLING (Swollen from neck to wrist), VERTIGO (Vertigo), ERYTHEMA (Redness from neck to wrist), NECK PAIN (Sore from neck to wrist), PAIN (Felt achy) and HEADACHE (Headache) had resolved. At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) had not resolved and PAIN IN EXTREMITY (Pain in hands and feet with Humira (adalimumab)) outcome was unknown.            No concomitant medications were reported.   It was unknown if patient was enrolled in a Covid-19 vaccine trial.   The reporter's causality for the event(s) of sick, swollen from neck to wrist, vertigo, headache, redness from neck to wrist, sore from neck to wrist, felt achy and pain in hands and feet was not provided. The reporter's causality for the event(s) of psoriatic arthritis flare up with Humira(adalimumab) was a reasonable possibility.  No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: After received the COVID-19 booster shot arm became very swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (After received the COVID-19 booster shot arm became very swollen) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia.   On 10-May-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 16-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (After received the COVID-19 booster shot arm became very swollen). At the time of the report, VACCINATION SITE SWELLING (After received the COVID-19 booster shot arm became very swollen) had resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tiredness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Plaque psoriasis.   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., RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) had not resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: Chronic plaque psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Chronic plaque psoriasis flare-up) in a 48-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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 20-Sep-2021, 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) Citrate free, UNK. In 2021, the patient experienced PSORIASIS (Chronic plaque psoriasis flare-up). At the time of the report, PSORIASIS (Chronic plaque psoriasis flare-up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. The reporter's causality for the event with Humira was reasonable possibility. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal discomfort, Vaccination site haemorrhage, Weight bearing difficulty
Clinical narrative: SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT; BLOOD AFTER INJECTIONS; Shoulder discomfort; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT BEARING DIFFICULTY (SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT), VACCINATION SITE HAEMORRHAGE (BLOOD AFTER INJECTIONS) and MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to at an unspecified dose. On 25-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort). On an unknown date, the patient experienced WEIGHT BEARING DIFFICULTY (SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT) and VACCINATION SITE HAEMORRHAGE (BLOOD AFTER INJECTIONS). In 2021, MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort) had resolved. At the time of the report, WEIGHT BEARING DIFFICULTY (SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT) and VACCINATION SITE HAEMORRHAGE (BLOOD AFTER INJECTIONS) outcome was unknown.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT unknown onset and BLOOD AFTER INJECTIONS was not provided. The reporter's causality for the event(s) of SHOULDER DISCOMFORT AND LIFTING 75 TO 80 POUND OBJECT onset 25 Mar 2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Myalgia, Nasopharyngeal swab
Clinical narrative: Lower back pain; Muscle and joint pain.; Muscle and joint pain.; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain), MYALGIA (Muscle and joint pain.), ARTHRALGIA (Muscle and joint pain.) and FATIGUE (Fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced BACK PAIN (Lower back pain), MYALGIA (Muscle and joint pain.), ARTHRALGIA (Muscle and joint pain.) and FATIGUE (Fatigue). At the time of the report, BACK PAIN (Lower back pain), MYALGIA (Muscle and joint pain.), ARTHRALGIA (Muscle and joint pain.) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, Nasopharyngeal swab: (Negative) Negative.         No treatment medications were reported.  Since the vaccination, had the patient been tested for COVID-19?:Yes  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No treatment information was reported.  Company comment: This spontaneous case concerns an adult female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as date of vaccine and event onset date were not provided. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. On unknown date, patient received co-suspect Adalimumab for Crohn's disease and ulcerative colitis which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as date of vaccine and event onset date were not provided. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. On unknown date, patient received co-suspect Adalimumab for Crohn's disease and ulcerative colitis which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.