chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product confusion, Wrong product administered
Clinical narrative: No Adverse Event; I was supposed to have a Moderna booter. I have symptoms from Pfizer.; At the booster clinic i was asked If i get Moderna or Pfizer. I n told them Moderna. Hmm I think they messed up; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (I was supposed to have a Moderna booter. I have symptoms from Pfizer.), PRODUCT CONFUSION (At the booster clinic i was asked If i get Moderna or Pfizer. I n told them Moderna. Hmm I think they messed up) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In November 2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced WRONG PRODUCT ADMINISTERED (I was supposed to have a Moderna booter. I have symptoms from Pfizer.) and PRODUCT CONFUSION (At the booster clinic i was asked If i get Moderna or Pfizer. I n told them Moderna. Hmm I think they messed up). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). The patient was treated with IBUPROFEN at an unspecified dose and frequency and TRAMADOL for Pain, at an unspecified dose and frequency. At the time of the report, WRONG PRODUCT ADMINISTERED (I was supposed to have a Moderna booter. I have symptoms from Pfizer.), PRODUCT CONFUSION (At the booster clinic i was asked If i get Moderna or Pfizer. I n told them Moderna. Hmm I think they messed up) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            Concomitant medication was not reported.  Patient received two previous doses of Moderna vaccine in January and experienced COVID-19. Two weeks ago, in Nov-2021, patient received Pfizer booster dose. Patient was supposed to have Moderna booster dose but received Pfizer dose. Patient was asked at booster clinic whether patient received Moderna or Pfizer dose? Patient replied Moderna. Patient think clinic had messed up vaccine. After receiving booster dose patient had terrible thigh, knee and calf pain. Tingling in foot. Ultrasound was performed showed no clots. Patient's lymph nodes of right side of neck popped up and neck was stiff. Patient's right leg was very painful. Patient cannot bear weight. Patient had Ibuprofen but it did not help. Patient's doctor prescribed small dose of Tramadol to get through this pain. Patient was nervous about stiffness and health.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620777 (Patient Link).
Sex: U
Vaccine: COVID19
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 a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported Patient had two Moderna vaccines in January. Had COVID-19 in july.  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.  CC: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced an unexpected, non-serious AESI COVID-19 after receiving a 2-dose primary series of mRNA-1273 vaccine. Event COVID-19 occurred approximately 6 months after vaccination with the primary series. Further details on the medical history, exact onset of event and vaccination dates, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.   This case was linked to MOD-2021-620776 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced an unexpected, non-serious AESI COVID-19 after receiving a 2-dose primary series of mRNA-1273 vaccine. Event COVID-19 occurred approximately 6 months after vaccination with the primary series. Further details on the medical history, exact onset of event and vaccination dates, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone scan, Cough, Investigation, Lymphadenopathy, Ultrasound Doppler
Clinical narrative: Cough; redness with third covid moderna vaccine; itchiness with third covid moderna vaccine; lymph node in neck; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), VACCINATION SITE ERYTHEMA (redness with third covid moderna vaccine), VACCINATION SITE PRURITUS (itchiness with third covid moderna vaccine) and LYMPHADENOPATHY (lymph node in neck) 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.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COUGH (Cough), VACCINATION SITE ERYTHEMA (redness with third covid moderna vaccine), VACCINATION SITE PRURITUS (itchiness with third covid moderna vaccine) and LYMPHADENOPATHY (lymph node in neck). At the time of the report, COUGH (Cough) was resolving and VACCINATION SITE ERYTHEMA (redness with third covid moderna vaccine), VACCINATION SITE PRURITUS (itchiness with third covid moderna vaccine) and LYMPHADENOPATHY (lymph node in neck) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Ultrasound Doppler: Normal. On an unknown date, Bone scan: -7. On an unknown date, Investigation: Cough not related to covid or flu related.         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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Cough; redness with third covid moderna vaccine; itchiness with third covid moderna vaccine; lymph node in neck; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), VACCINATION SITE ERYTHEMA (redness with third covid moderna vaccine), VACCINATION SITE PRURITUS (itchiness with third covid moderna vaccine) and LYMPHADENOPATHY (lymph node in neck) 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.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COUGH (Cough), VACCINATION SITE ERYTHEMA (redness with third covid moderna vaccine), VACCINATION SITE PRURITUS (itchiness with third covid moderna vaccine) and LYMPHADENOPATHY (lymph node in neck). At the time of the report, COUGH (Cough) was resolving and VACCINATION SITE ERYTHEMA (redness with third covid moderna vaccine), VACCINATION SITE PRURITUS (itchiness with third covid moderna vaccine) and LYMPHADENOPATHY (lymph node in neck) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Ultrasound Doppler: Normal. On an unknown date, Bone scan: -7. On an unknown date, Investigation: Cough not related to covid or flu related.         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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Rash
Clinical narrative: BREAK OUT and FUZZY; Skin breakout; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (BREAK OUT and FUZZY) and RASH (Skin breakout) 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 Psoriasis.    Concurrent medical conditions included Psoriasis (Moderate To Severe Chronic Plaque Psoriasis).   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 FEELING ABNORMAL (BREAK OUT and FUZZY) and RASH (Skin breakout). At the time of the report, FEELING ABNORMAL (BREAK OUT and FUZZY) had resolved and RASH (Skin breakout) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of Skin breakout and Fuzzy was reported as no reasonable possibility for Humira.  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.
Sex: M
Vaccine: COVID19
Symptoms: Lymphoedema, Post procedural complication, Vaccination site pain
Clinical narrative: SORE ARM WHEN GOT COVID-19 VACCINE; Lymphedema; LYMPHEDEMA DUE TO STOMACH SURGERY WHERE LYMPH NODE WAS REMOVED; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM WHEN GOT COVID-19 VACCINE), LYMPHOEDEMA (Lymphedema) and POST PROCEDURAL COMPLICATION (LYMPHEDEMA DUE TO STOMACH SURGERY WHERE LYMPH NODE WAS REMOVED) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa and Crohn's disease.    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) UNK, CF. On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM WHEN GOT COVID-19 VACCINE), LYMPHOEDEMA (Lymphedema) and POST PROCEDURAL COMPLICATION (LYMPHEDEMA DUE TO STOMACH SURGERY WHERE LYMPH NODE WAS REMOVED). At the time of the report, VACCINATION SITE PAIN (SORE ARM WHEN GOT COVID-19 VACCINE) had resolved and LYMPHOEDEMA (Lymphedema) and POST PROCEDURAL COMPLICATION (LYMPHEDEMA DUE TO STOMACH SURGERY WHERE LYMPH NODE WAS REMOVED) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not reported. The patient had lymphedema due to a stomach surgery where his lymph node was removed. Patient felt that his Humira had reached a plateau and was not really working. Patient physician asked him what he thought about stopping Humira to see if he saw any changes but he did not really want to try stopping it. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication were 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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Amylase, Blood pressure measurement, Cough, Diarrhoea
Clinical narrative: high blood pressure; Diarrhea; Cough; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ABDOMINAL DISCOMFORT (Upset stomach), HYPERTENSION (high blood pressure) and DIARRHOEA (Diarrhea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Mantle cell lymphoma.    Concurrent medical conditions included Blood pressure. Concomitant products included RAMIPRIL (ALTACE) for Blood pressure, RITUXIMAB (RITUXAN) for an unknown indication.   On 23-Oct-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced COUGH (Cough), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced HYPERTENSION (high blood pressure). At the time of the report, COUGH (Cough), ABDOMINAL DISCOMFORT (Upset stomach), HYPERTENSION (high blood pressure) and DIARRHOEA (Diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Amylase: elevated. On an unknown date, Blood pressure measurement: High. On an unknown date, Lipase: increased. On an unknown date, SARS-CoV-2 test: Negative.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The events of elevated lipase level, cough, upset stomach and diarrhea was not Provided. The reporter's causality for the events of elevated amylase level and high blood pressure with Imbruvica (ibrutinib) was a reasonable possibility.  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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Lipase, SARS-CoV-2 test
Clinical narrative: high blood pressure; Diarrhea; Cough; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ABDOMINAL DISCOMFORT (Upset stomach), HYPERTENSION (high blood pressure) and DIARRHOEA (Diarrhea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Mantle cell lymphoma.    Concurrent medical conditions included Blood pressure. Concomitant products included RAMIPRIL (ALTACE) for Blood pressure, RITUXIMAB (RITUXAN) for an unknown indication.   On 23-Oct-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced COUGH (Cough), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced HYPERTENSION (high blood pressure). At the time of the report, COUGH (Cough), ABDOMINAL DISCOMFORT (Upset stomach), HYPERTENSION (high blood pressure) and DIARRHOEA (Diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Amylase: elevated. On an unknown date, Blood pressure measurement: High. On an unknown date, Lipase: increased. On an unknown date, SARS-CoV-2 test: Negative.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The events of elevated lipase level, cough, upset stomach and diarrhea was not Provided. The reporter's causality for the events of elevated amylase level and high blood pressure with Imbruvica (ibrutinib) was a reasonable possibility.  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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Second Covid-19 vaccine caused her big reaction on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Second Covid-19 vaccine caused her big reaction on arm) in an adult 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.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE REACTION (Second Covid-19 vaccine caused her big reaction on arm). At the time of the report, VACCINATION SITE REACTION (Second Covid-19 vaccine caused her big reaction on arm) had resolved.            Concomitant medication was not provided. Treatment medication information was not provided by the reporter. On unknown date, the patient experienced rinvoq not helping like it did in the beginning, COPD/lung issues that have gotten worse since starting rinvoq, second covid-19 vaccine caused big reaction on arm and joints hurt. On unknown dates, after third covid-19 vaccine felt like autoimmune flared and second covid-19 vaccine caused big reaction on arm resolved. In Oct 2021 she stopped Rinvoq at physicians direction. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620784 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Pain aggravated / Increase in pain; Weakness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain aggravated / Increase in pain), ASTHENIA (Weakness) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In September 2021, the patient experienced PAIN (Pain aggravated / Increase in pain), ASTHENIA (Weakness) and PYREXIA (Fever). At the time of the report, PAIN (Pain aggravated / Increase in pain), ASTHENIA (Weakness) and PYREXIA (Fever) had not resolved.        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. Concomitant medications were not reported.  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, UNK
Symptoms: Injection site urticaria, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID AFTER TAKING VACCINATIONS; BROKE OUT IN HIVES AT THE INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (TESTED POSITIVE FOR COVID AFTER TAKING VACCINATIONS) and INJECTION SITE URTICARIA (BROKE OUT IN HIVES AT THE INJECTION SITE) 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.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (TESTED POSITIVE FOR COVID AFTER TAKING VACCINATIONS) and INJECTION SITE URTICARIA (BROKE OUT IN HIVES AT THE INJECTION SITE). At the time of the report, SARS-COV-2 TEST POSITIVE (TESTED POSITIVE FOR COVID AFTER TAKING VACCINATIONS) and INJECTION SITE URTICARIA (BROKE OUT IN HIVES AT THE INJECTION SITE) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   The reporter's causality for the event of tested positive for covid after taking vaccinations and broke out in hives at the injection site was not provided.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment 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: Arthralgia
Clinical narrative: Pain in joint involving shoulder region; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joint involving shoulder region) 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 Psoriasis.    Concurrent medical conditions included Psoriasis (moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Pain in joint involving shoulder region). At the time of the report, ARTHRALGIA (Pain in joint involving shoulder region) had not resolved.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of Pain in joint involving shoulder region was not provided for Humira.  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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Nausea, Vomiting
Clinical narrative: Injection site redness; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (Nausea) and VOMITING (Vomiting) 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.    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) Citrate Free. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received booster dose COVID-19 Vaccine manufactured by Moderna.  The reporter's causality for the event(s) of INJECTION SITE REDNESS, NAUSEA and VOMITING was not provided.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: Arthritic pains/took COVID booster shot and felt it affected rheumatoid arthritis and caused to feel pain in hands and legs; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arthritic pains/took COVID booster shot and felt it affected rheumatoid arthritis and caused to feel pain in hands and legs) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included COVID-19 (In 2020, the patient experienced COVID.) in 2020.   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 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. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced ARTHRALGIA (Arthritic pains/took COVID booster shot and felt it affected rheumatoid arthritis and caused to feel pain in hands and legs). At the time of the report, ARTHRALGIA (Arthritic pains/took COVID booster shot and felt it affected rheumatoid arthritis and caused to feel pain in hands and legs) had resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, patient received COVID-19 Vaccine manufactured by Moderna. The reporter's causality for the event of arthralgia was no reasonable possibility with HUMIRA.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved.            No concomitant medication information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna  were missed to be booked-in. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided.   This spontaneous case concerns an adult, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant Rheumatoid arthritis flare up after receiving a dose of mRNA-1273 vaccine. Outcome of the event was reported as not resolved. Patient received a 2-dose primary series of mRNA-1273 vaccine, given 26 days apart, followed by a 3rd dose on an unknown date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying condition of rheumatoid arthritis remains as a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns an adult, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant Rheumatoid arthritis flare up after receiving a dose of mRNA-1273 vaccine. Outcome of the event was reported as not resolved. Patient received a 2-dose primary series of mRNA-1273 vaccine, given 26 days apart, followed by a 3rd dose on an unknown date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying condition of rheumatoid arthritis remains as a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Rash; Swelling in her lymph nodes under her left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in her lymph nodes under her left arm) and RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   In 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a week. On 05-Aug-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced LYMPHADENOPATHY (Swelling in her lymph nodes under her left arm). On an unknown date, the patient experienced RASH (Rash). At the time of the report, LYMPHADENOPATHY (Swelling in her lymph nodes under her left arm) and RASH (Rash) was resolving.            No concomitant medication provided. No treatment information mentioned.  Patient would take Dupixent for treatment of Atopic dermatitis, initially 600 mg a week then reduced to 300 mg once a week. Got the Moderna booster dose, and experienced swelling in her lymph nodes under her left arm. Had the booster and got a rash as well. Was advised to stop dupixent for 2 weeks till rash was gone.  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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Pain in hip/on left side hip down to knee constant steady pain; Vaccination site pain/sore arm  at vaccine injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in hip/on left side hip down to knee constant steady pain) and VACCINATION SITE PAIN (Vaccination site pain/sore arm  at vaccine injection site) in a 51-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 Psoriatic arthritis.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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) Unknown. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/sore arm  at vaccine injection site). On an unknown date, the patient experienced ARTHRALGIA (Pain in hip/on left side hip down to knee constant steady pain). In 2021, VACCINATION SITE PAIN (Vaccination site pain/sore arm  at vaccine injection site) had resolved. At the time of the report, ARTHRALGIA (Pain in hip/on left side hip down to knee constant steady pain) had not resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of arthralgia and vaccination site pain was not provided with HUMIRA.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pruritus
Clinical narrative: ITCHINESS AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (ITCHINESS AT INJECTION SITE) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Knee surgery NOS (left knee). Concurrent medical conditions included Rheumatoid arthritis (moderate to severe rheumatoid arthritis). Concomitant products included MELOXICAM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (ITCHINESS AT INJECTION SITE). At the time of the report, VACCINATION SITE PRURITUS (ITCHINESS AT INJECTION SITE) had resolved.            The patient was taking meloxicam in conjunction with/HUMIRA.  Patient had events left knee surgery and non-serious itchiness at site for COVID 19 VACCINE with HUMIRA (ADALIMUMAB).  The reporter's causality for the event(s) of had left knee surgery was not provided. The reporter's causality for the event(s) of itchiness at injection site for covid 19 vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility. On unknown date patient had Knee operation and the outcome was Recovered/resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The formulation for Humira was reported as Solution for injection.   No treatment medications information 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
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Psoriasis
Clinical narrative: Psoriasis flare-up; Vaccination related malaise; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and IMMUNISATION REACTION (Vaccination related malaise) in a 59-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 Psoriasis.    Concurrent medical conditions included Psoriasis (Moderate To Severe Chronic Plaque Psoriasis).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 2021, the patient experienced PSORIASIS (Psoriasis flare-up) and IMMUNISATION REACTION (Vaccination related malaise). In 2021, IMMUNISATION REACTION (Vaccination related malaise) had resolved. At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient experienced plaque psoriasis flare up began with both elbows and legs and a little on back and sick for a day after Covid vaccinations.  The reporter's causality for the event of Psoriasis flare-up and Vaccination related malaise was not provided for Humira.  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.
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: breakthrough covid-19; This spontaneous case was reported by a patient and describes the occurrence of BREAKTHROUGH COVID-19 (breakthrough covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    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 BREAKTHROUGH COVID-19 (breakthrough covid-19). At the time of the report, BREAKTHROUGH COVID-19 (breakthrough covid-19) outcome was unknown.            No concomitant medications were reported.   No treatment medication was provided.  It had been reported that, the patient was fully vaccinated but unclear how many doses patient had received.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a patient of unknown age and gender with medical history reported as immunocompromised, who experienced the adverse event of special interest of breakthrough COVID-19 an unknown time after a dose of mRNA-1273. The reported medical history of being immunocompromised is a confounder. Information regarding vaccine schedule, clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with medical history reported as immunocompromised, who experienced the adverse event of special interest of breakthrough COVID-19 an unknown time after a dose of mRNA-1273. The reported medical history of being immunocompromised is a confounder. Information regarding vaccine schedule, clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Accident at work, Lethargy, Limb injury, Vaccination site pain
Clinical narrative: Accident at work; Foot injury; Lethargic; Vaccination site pain; This spontaneous case was reported by a non-health professional and describes the occurrence of ACCIDENT AT WORK (Accident at work), LIMB INJURY (Foot injury), LETHARGY (Lethargic) and VACCINATION SITE PAIN (Vaccination site pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ACCIDENT AT WORK (Accident at work), LIMB INJURY (Foot injury), LETHARGY (Lethargic) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ACCIDENT AT WORK (Accident at work) and LIMB INJURY (Foot injury) was resolving and LETHARGY (Lethargic) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.     Concomitant product use was not provided by the reporter.  On unknown dates, the patient experienced workman comp accident, ladder ran over foot on 7/7 and very lethargic and sore arm after taking Covid vaccine.   Patient reported workman comp accident, ladder ran over foot on 7/7. He was very lethargic and had sore arm after taking Covid vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality events of workman comp accident, ladder ran over foot on 7/7, very lethargic and sore arm after taking covid vaccine and workman comp accident, ladder ran over foot on 7/7 with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the events of very lethargic and sore arm after taking Covid vaccine unknown onset was not provided.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: It hurt to move it; i missed work; swelling in myleft arm; It hurt to move it; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (swelling in myleft arm), VACCINATION SITE PAIN (It hurt to move it), VACCINATION SITE MOVEMENT IMPAIRMENT (It hurt to move it) and IMPAIRED WORK ABILITY (i missed work) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis.    The patient's past medical history included Eosinophilic pneumonia chronic.   In May 2021, the patient started TOFACITINIB CITRATE (XELJANZ) (Oral) 5 milligram twice a day. In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE SWELLING (swelling in myleft arm), VACCINATION SITE PAIN (It hurt to move it), VACCINATION SITE MOVEMENT IMPAIRMENT (It hurt to move it) and IMPAIRED WORK ABILITY (i missed work). At the time of the report, VACCINATION SITE SWELLING (swelling in myleft arm), VACCINATION SITE PAIN (It hurt to move it), VACCINATION SITE MOVEMENT IMPAIRMENT (It hurt to move it) and IMPAIRED WORK ABILITY (i missed work) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. 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: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Little soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness in arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Prophylactic vaccination.    Previously administered products included for Prophylactic vaccination: Influenza vaccine (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE). Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.   On 29-Jan-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 20-Feb-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PAIN IN EXTREMITY (Little soreness in arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Little soreness in arm) outcome was unknown.            Patient took the primary doses of Pfizer vaccine initially, and then on 20FEB2021, took the Moderna booster. She reported a little soreness in her arm on 28SEP2021, following the administrations of the vaccines.  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