chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Seizure
Clinical narrative: Experienced 5 seizures; Patient had Comirnaty and Moderna vaccine; Patient had Comirnaty and Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Experienced 5 seizures) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    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 and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Experienced 5 seizures) (seriousness criterion medically significant), INTERCHANGE OF VACCINE PRODUCTS (Patient had Comirnaty and Moderna vaccine) and COVID-19 IMMUNISATION (Patient had Comirnaty and Moderna vaccine). At the time of the report, SEIZURE (Experienced 5 seizures), INTERCHANGE OF VACCINE PRODUCTS (Patient had Comirnaty and Moderna vaccine) and COVID-19 IMMUNISATION (Patient had Comirnaty and Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment 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. Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Seizure (reported as experienced 5 seizures) after receiving a dose of mRNA-1273 vaccine on an unknown date and co-suspect drug Tozinameran. Latency cannot be assessed as the vaccination date and onset date of event were not provided. Clinical course and treatment details were not reported. The outcome of event was unknown. The co-suspect Tozinameran could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Seizure (reported as experienced 5 seizures) after receiving a dose of mRNA-1273 vaccine on an unknown date and co-suspect drug Tozinameran. Latency cannot be assessed as the vaccination date and onset date of event were not provided. Clinical course and treatment details were not reported. The outcome of event was unknown. The co-suspect Tozinameran could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: She stated that after recieving the first moderna vaccine she had allergic reaction to it; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (She stated that after recieving the first moderna vaccine she had allergic reaction to it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR;RITONAVIR tablet for an unknown indication.    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 and NIRMATRELVIR;RITONAVIR (unknown route) at an unspecified dose. On an unknown date, the patient experienced ALLERGY TO VACCINE (She stated that after recieving the first moderna vaccine she had allergic reaction to it). At the time of the report, ALLERGY TO VACCINE (She stated that after recieving the first moderna vaccine she had allergic reaction to it) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Relevant concomitant medications were not reported.  Patient received first dose of Moderna COVID-19 vaccine and experienced allergic reaction to it. Patient was afraid and not fully vaccinated.  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: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Gastrointestinal pain, Lymphadenopathy
Clinical narrative: Pain chest; Swollen lymph nodes; GI pain; Arthritic pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain chest), LYMPHADENOPATHY (Swollen lymph nodes), GASTROINTESTINAL PAIN (GI pain) and ARTHRALGIA (Arthritic pains) 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 Crohn's disease and 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 and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown Device. On an unknown date, the patient experienced CHEST PAIN (Pain chest), LYMPHADENOPATHY (Swollen lymph nodes), GASTROINTESTINAL PAIN (GI pain) and ARTHRALGIA (Arthritic pains). At the time of the report, CHEST PAIN (Pain chest), LYMPHADENOPATHY (Swollen lymph nodes), GASTROINTESTINAL PAIN (GI pain) and ARTHRALGIA (Arthritic pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. 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: Immunisation reaction
Clinical narrative: had a slight reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (had a slight reaction) 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 IMMUNISATION REACTION (had a slight reaction). At the time of the report, IMMUNISATION REACTION (had a slight reaction) outcome was unknown.            Patient had no bad reaction with Pfizer booster dose. Patient had arm was just a tiny bit sore for a day or two. 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.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    The patient's past medical history included Sinus infection (BELIEVED FROM CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE).   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 VACCINATION SITE PAIN (SORE ARM). At the time of the report, VACCINATION SITE PAIN (SORE ARM) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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, Chills, Fatigue, Pain in extremity
Clinical narrative: Fatigue; Chills; Hand pain; Painful hips; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Painful hips) in a 56-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.    No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 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) at an unspecified dose. In November 2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Painful hips). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Painful hips) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. the daily dose were reported as citrate free for the co-suspect drug. 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: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER CHILLS ON ALL THREE DOSES OF COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER CHILLS ON ALL THREE DOSES OF COVID VACCINE) in a 55-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.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (FEVER CHILLS ON ALL THREE DOSES OF COVID VACCINE). In 2021, PYREXIA (FEVER CHILLS ON ALL THREE DOSES OF COVID VACCINE) had resolved.            No concomitant medication was reported.   Treatment information was not provided. In 2021, patient received 3rd dose COVID-19 Vaccine manufactured by Moderna, because he was on Skyrizi, he was waiting for a week to pass before taking his next Skyrizi dose. 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: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse reaction; The caller received his 1st Pfizer BT Covid vaccine dose on 03Mar2021 and he received his 2nd Covid vaccine dose, which was Moderna on 01Apr2021; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (The caller received his 1st Pfizer BT Covid vaccine dose on 03Mar2021 and he received his 2nd Covid vaccine dose, which was Moderna on 01Apr2021), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Quadruple vessel bypass graft (quadruple bypass 6 years ago). Previously administered products included for Product used for unknown indication: Pfizer BT Covid vaccine on 03-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer BT Covid vaccine.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (The caller received his 1st Pfizer BT Covid vaccine dose on 03Mar2021 and he received his 2nd Covid vaccine dose, which was Moderna on 01Apr2021) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (The caller received his 1st Pfizer BT Covid vaccine dose on 03Mar2021 and he received his 2nd Covid vaccine dose, which was Moderna on 01Apr2021), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown. Not Provided          No Concomitant medications were reported. 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oropharyngeal discomfort, SARS-CoV-2 test
Clinical narrative: Felt like my throat was closing up on me; could not breathe and was gasping for air; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Felt like my throat was closing up on me) and DYSPNOEA (could not breathe and was gasping for air) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: depo provera. Past adverse reactions to the above products included No adverse event with depo provera.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Felt like my throat was closing up on me) and DYSPNOEA (could not breathe and was gasping for air). At the time of the report, OROPHARYNGEAL DISCOMFORT (Felt like my throat was closing up on me) and DYSPNOEA (could not breathe and was gasping for air) outcome was unknown.      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) (Unknown) was unknown.       No concomitant medication was reported.   Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  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, UNK
Symptoms: Arthralgia, Illness
Clinical narrative: Sick; Right hip pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) and ARTHRALGIA (Right hip pain) 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 and Ankylosing spondylitis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ) and Ankylosing spondylitis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first 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 ILLNESS (Sick) and ARTHRALGIA (Right hip pain). At the time of the report, ILLNESS (Sick) had resolved and ARTHRALGIA (Right hip pain) was resolving.            No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   The reporter's causality for the event(s) of right hip pain and sick with HUMIRA(ADALIMUMAB) 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: F
Vaccine: COVID19, UNK
Symptoms: Anaemia, Swelling, Therapeutic product effect decreased
Clinical narrative: Anemic; Swelling; HUMIRA STOPPED WORKING AFTER COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Anemic), SWELLING (Swelling) and THERAPEUTIC PRODUCT EFFECT DECREASED (HUMIRA STOPPED WORKING AFTER 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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PREDNISONE for an unknown indication.   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 ANAEMIA (Anemic), SWELLING (Swelling) and THERAPEUTIC PRODUCT EFFECT DECREASED (HUMIRA STOPPED WORKING AFTER COVID VACCINE). At the time of the report, ANAEMIA (Anemic), SWELLING (Swelling) and THERAPEUTIC PRODUCT EFFECT DECREASED (HUMIRA STOPPED WORKING AFTER COVID VACCINE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not 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
Symptoms: Hypertensive crisis
Clinical narrative: Hypertensive crisis; This spontaneous case was reported by a nurse and describes the occurrence of HYPERTENSIVE CRISIS (Hypertensive crisis) 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 HYPERTENSIVE CRISIS (Hypertensive crisis) (seriousness criterion medically significant). At the time of the report, HYPERTENSIVE CRISIS (Hypertensive crisis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious (medically significant) unexpected event hypertensive crisis, on an unknown date after the booster dose of mRNA-1273.  Patient receive treatment with blood pressure medications. Clinical course, diagnostic tests and additional treatment details were not provided. Event seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medications were reported.  The patient experienced hypertensive crisis from Moderna vaccine booster which could have caused a stroke.  Treatment information included that the patient was on blood pressure medications.   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 female patient of an unknown age with no reported medical history, who experienced the serious (medically significant) unexpected event hypertensive crisis, on an unknown date after the booster dose of mRNA-1273.  Patient receive treatment with blood pressure medications. Clinical course, diagnostic tests and additional treatment details were not provided. Event seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Hidradenitis
Clinical narrative: Occasional hidradenitis suppurativa flare.; Occasional hidradenitis suppurativa flare; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue), HIDRADENITIS (Occasional hidradenitis suppurativa flare.) and CONDITION AGGRAVATED (Occasional hidradenitis suppurativa flare) in a 75-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 Hidradenitis suppurativa.    The patient had a relevant medical history of had horrible issues all over the body.  Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe hidradenitis suppurativa).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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) Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. In February 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced HIDRADENITIS (Occasional hidradenitis suppurativa flare.) and CONDITION AGGRAVATED (Occasional hidradenitis suppurativa flare). In February 2021, FATIGUE (Fatigue) had resolved. At the time of the report, HIDRADENITIS (Occasional hidradenitis suppurativa flare.) and CONDITION AGGRAVATED (Occasional hidradenitis suppurativa flare) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  The reporter's causality for the event of fatigue with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event of occasional hidradenitis suppurativa flare with Humira(adalimumab)was a 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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received, Medical history, event information, reporter causality for event of fatigue updated. On 23-Dec-2021: Follow-up received, reporter causality for event Occasional hidradenitis suppurativa flare updated.
Sex: U
Vaccine: COVID19
Symptoms: Immunology test, Night sweats, Pyrexia
Clinical narrative: nights of hard sweating; fever`; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (nights of hard sweating) and PYREXIA (fever`) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (symptoms were tiredness, abrupt changes in pulse and shortness of breath.) and EBV infection (when patient was 24 years old which left me ailing for over 2 years.).    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 NIGHT SWEATS (nights of hard sweating) and PYREXIA (fever`). At the time of the report, NIGHT SWEATS (nights of hard sweating) and PYREXIA (fever`) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Immunology test: (Positive) positive.         No concomitant medication was reported.   Patient have been reading that the coronavirus could possible reactivate the EBV in the body and patient was convinced that the symptoms patient suffered were related to this. Unfortunately, no medical test has been able to prove this, only the fact that patient showed a positive Ig-G test and no antibodies after the fever from Covid-19 receded. Patient took second dose of Moderna vaccine and after a few nights of hard sweating and fever, patient situation improved dramatically. Patient could now run and cycle without any problems in pulse. Patient also have no signs of tiredness.  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.
Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 58-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 (Moderate to severe adult Crohn's disease).   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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). In September 2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of sore arm with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity  received in the Moderna  were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Musculoskeletal discomfort
Clinical narrative: moderate side effects; hip replacement surgery; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (moderate side effects) and MUSCULOSKELETAL DISCOMFORT (hip replacement surgery) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Shingles. Previously administered products included for Prophylactic vaccination: INFLUENZA VACCIN. Past adverse reactions to the above products included Vaccination adverse reaction with INFLUENZA VACCIN.   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 IMMUNISATION REACTION (moderate side effects) and MUSCULOSKELETAL DISCOMFORT (hip replacement surgery). At the time of the report, IMMUNISATION REACTION (moderate side effects) and MUSCULOSKELETAL DISCOMFORT (hip replacement surgery) outcome was unknown.            Pfizer covid-19 booster shot approximately 8 months after receiving 2 dose series of modern Covid-19 vaccine. The day after booster the patient spiked a fever ranging from 100.4-102 degrees. Two days after booster the patient developed a lump under her armpit to the side of her breast.  Patient also had a hip replacement surgery two weeks before the booster shot was received.  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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oxygen saturation, Oxygen saturation decreased, Vaccination site pain, Vaccination site rash
Clinical narrative: Low oxygen/oxygen dependent; Persistent dry cough; After covid booster shot had pain in arm; Rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (Low oxygen/oxygen dependent), COUGH (Persistent dry cough), VACCINATION SITE PAIN (After covid booster shot had pain in arm) and VACCINATION SITE RASH (Rash in the injection site) 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 Rheumatoid arthritis.    The patient's past medical history included COVID-19 from December 2020 to January 2021.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In October 2021, the patient experienced VACCINATION SITE PAIN (After covid booster shot had pain in arm) and VACCINATION SITE RASH (Rash in the injection site). On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Low oxygen/oxygen dependent) and COUGH (Persistent dry cough). At the time of the report, OXYGEN SATURATION DECREASED (Low oxygen/oxygen dependent) and VACCINATION SITE RASH (Rash in the injection site) was resolving and COUGH (Persistent dry cough) and VACCINATION SITE PAIN (After covid booster shot had pain in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: low.         No concomitant medications were provided. No treatment medications were provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of low oxygen/oxygen dependent, persistent dry cough and COVID 19 with Humira 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: CAUGHT A COLD OR SOMETHING SIMILAR; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (CAUGHT A COLD OR SOMETHING SIMILAR) in a 63-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.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (CAUGHT A COLD OR SOMETHING SIMILAR). At the time of the report, NASOPHARYNGITIS (CAUGHT A COLD OR SOMETHING SIMILAR) had not resolved.            No concomitant drugs were taken. 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Muscle spasms
Clinical narrative: Muscle spasm; patient received first dose on 10-Jun-2021 and second dose on 30-Jun-2021; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 10-Jun-2021 and second dose on 30-Jun-2021) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Crohn's (Outcome reported as not recovered.).   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-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) Solution for injection in pre-filled pen, Citrate Free. On 30-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 10-Jun-2021 and second dose on 30-Jun-2021). On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasm). The patient was treated with CEFIXIME (FLEXERIL [CEFIXIME]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Muscle spasm) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 10-Jun-2021 and second dose on 30-Jun-2021) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken for co-suspect ADALIMUMAB (HUMIRA) was reported as unknown with respect to the event Muscle spasm.  Primary reporter did not have the lot number information, because the packaging was discarded.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for the event muscle spasm with HUMIRA(ADALIMUMAB) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Live follow-up was received additional reporters causality of the event Muscle spasm was updated to not related from related, co-suspect drug dosing information updated, medical history was updated and narrative was updated.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Received the Moderna COVID-19 booster and experienced diarrhea after taking her Xejanz a few hours later; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Received the Moderna COVID-19 booster and experienced diarrhea after taking her Xejanz a few hours later) in a female 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 an unknown indication.    The patient's medical history was not reported.  Concomitant products included BUPROPION HCL, ESCITALOPRAM OXALATE (LEXAPRO), FOLIC ACID, FERROUS SULFATE, PROPRANOLOL HYDROCHLORIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SALBUTAMOL SULFATE (VENTOLIN HFA), HYDROXYCHLOROQUINE SULFATE, IBUPROFEN, TRAMADOL HCL and PREDNISONE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOFACITINIB CITRATE (XELJANZ) (Oral) 11 milligram once a day. On an unknown date, the patient experienced DIARRHOEA (Received the Moderna COVID-19 booster and experienced diarrhea after taking her Xejanz a few hours later). At the time of the report, DIARRHOEA (Received the Moderna COVID-19 booster and experienced diarrhea after taking her Xejanz a few hours later) had resolved.            The patient had 2 missed doses of Xeljanz when she was really sick and her MD was aware.   The patient was still taking her Xeljanz. It was reported she was still on Prednisone when she initially received Xeljanz. It was stated by her MD to complete therapy with Prednisone first before starting Xeljanz. Patient therefore had extra medication on hand due to starting later.  The patient had received Moderna COVID booster and experienced diarrhea after taking her Xejanz a few hours later. It was reported that the diarrhea only lasted that day.  No treatment information was provided by the reporter.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines). At the time of the report, COVID-19 (Breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient reported to Pfizer of their own experience then mentioned that their son had a breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 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  Company Comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of Breakthrough COVID-19. The reporter stated her son had a breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines. Exact date of vaccinations, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of Breakthrough COVID-19. The reporter stated her son had a breakthrough case of the Covid 19 virus after receiving the Moderna Covid 19 vaccines. Exact date of vaccinations, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Pain, Pain in extremity, Visual impairment
Clinical narrative: feeling like disoriented; aches and pains; Affecting vision; the aches and pains have gotten worse It's weird because I have like pinching needles on my left arm and leg and it kind of hurts; Dizzy; This spontaneous case was reported by a patient and describes the occurrence of DISORIENTATION (feeling like disoriented), PAIN (aches and pains), VISUAL IMPAIRMENT (Affecting vision), PAIN IN EXTREMITY (the aches and pains have gotten worse It's weird because I have like pinching needles on my left arm and leg and it kind of hurts) and DIZZINESS (Dizzy) 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 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced DISORIENTATION (feeling like disoriented), PAIN (aches and pains), VISUAL IMPAIRMENT (Affecting vision), PAIN IN EXTREMITY (the aches and pains have gotten worse It's weird because I have like pinching needles on my left arm and leg and it kind of hurts) and DIZZINESS (Dizzy). At the time of the report, DISORIENTATION (feeling like disoriented), VISUAL IMPAIRMENT (Affecting vision), PAIN IN EXTREMITY (the aches and pains have gotten worse It's weird because I have like pinching needles on my left arm and leg and it kind of hurts) and DIZZINESS (Dizzy) outcome was unknown and PAIN (aches and pains) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. 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.
Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache
Clinical narrative: FATIGUE AFTER FIRST COVID VACCINE; HEADACHE AFTER FIRST COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (FATIGUE AFTER FIRST COVID VACCINE) and HEADACHE (HEADACHE AFTER FIRST COVID VACCINE) in a 78-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) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 08-Feb-2021, the patient experienced FATIGUE (FATIGUE AFTER FIRST COVID VACCINE) and HEADACHE (HEADACHE AFTER FIRST COVID VACCINE). At the time of the report, FATIGUE (FATIGUE AFTER FIRST COVID VACCINE) and HEADACHE (HEADACHE AFTER FIRST COVID VACCINE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   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.   This case was linked to MOD-2021-631413 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: My arm was more sore from the booster (Moderna); Headache and fatigue were worse from the first two shots (Pfizer); Headache and fatigue were worse from the first two shots (Pfizer); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (My arm was more sore from the booster (Moderna)), HEADACHE (Headache and fatigue were worse from the first two shots (Pfizer)) and FATIGUE (Headache and fatigue were worse from the first two shots (Pfizer)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Two shots (Pfizer)), Pfizer (Two shots (Pfizer)), Pfizer (Two shots (Pfizer)), Pfizer (Two shots (Pfizer)), Pfizer (Two shots (Pfizer)) and Pfizer (Two shots (Pfizer)). Past adverse reactions to the above products included Fatigue with Pfizer and Pfizer; Headache with Pfizer and Pfizer; and Pain in arm with Pfizer and Pfizer.    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 PAIN (My arm was more sore from the booster (Moderna)), HEADACHE (Headache and fatigue were worse from the first two shots (Pfizer)) and FATIGUE (Headache and fatigue were worse from the first two shots (Pfizer)). At the time of the report, PAIN (My arm was more sore from the booster (Moderna)), HEADACHE (Headache and fatigue were worse from the first two shots (Pfizer)) and FATIGUE (Headache and fatigue were worse from the first two shots (Pfizer)) had resolved.            No concomitant medications were reported. 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Generalized aching/ body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Generalized aching/ body aches) 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 Psoriatic arthritis.    The patient's past medical history included COVID-19 on 12-Nov-2020. Concurrent medical conditions included Psoriatic arthritis.   On 12-Feb-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) at an unspecified dose. In February 2021, the patient experienced MYALGIA (Generalized aching/ body aches). At the time of the report, MYALGIA (Generalized aching/ body aches) outcome was unknown.        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.  No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.   This case was linked to MOD-2021-621454, MOD-2021-621451 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Pain
Clinical narrative: Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and FATIGUE (Tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylactic vaccination.    The patient's past medical history included Feeling abnormal (The patient reported that she had not been feeling good.). Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included WARFARIN SODIUM for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient received dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (Achy) and FATIGUE (Tired). At the time of the report, PAIN (Achy) and FATIGUE (Tired) outcome was unknown.            No treatment medication 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.