chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness
Clinical narrative: Jaw issue/jaw joint was restricted; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Jaw issue/jaw joint was restricted) 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 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced JOINT STIFFNESS (Jaw issue/jaw joint was restricted). At the time of the report, JOINT STIFFNESS (Jaw issue/jaw joint was restricted) outcome was unknown.            It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter. No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: COVID-19; Runny nose; Sore throat; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) 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) 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) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). At the time of the report, COVID-19 (COVID-19), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) had not resolved.            Concomitant product use was not provided by the reporter.  On unknown dates, the patient experienced covid vaccine caused sore arm, covid vaccine caused runny nose, covid vaccine caused sore throat, covid vaccine caused fatigue and covid-19. 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.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Migraine
Clinical narrative: Migraines was not unusual headache with second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines was not unusual headache with second vaccine) 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 ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   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) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, CF (1 in 1 week). In April 2021, the patient experienced MIGRAINE (Migraines was not unusual headache with second vaccine). At the time of the report, MIGRAINE (Migraines was not unusual headache with second vaccine) outcome was unknown.            No concomitant medication details were provided. No treatment medication details were provided.   Dosage form for HUMIRA was reported as Solution for injection in pre-filled pen.  The reporter's causality for the event of migraine with HUMIRA was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter contact for lot number information was unsuccessful.   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-2022-620824.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain
Clinical narrative: Very mild side effects from the vaccine; Body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Very mild side effects from the vaccine) and PAIN (Body ache) 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 (PAXLOVID) for an unknown indication.    Concomitant products included LEVOTHYROXINE 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 NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (Very mild side effects from the vaccine) and PAIN (Body ache). At the time of the report, IMMUNISATION REACTION (Very mild side effects from the vaccine) outcome was unknown and PAIN (Body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Patient was prescribed Paxlovid that she started two days ago and having some horrible side effects from it including pelvic and stomach pain and then she guess, GERD and as well as horrible the worst taste in her mouth that she ever had in her life that will not go away. She have taken today's dose and she don't want to take this medication any more and she guess they can be feel worse than the COVID (Further clarification unknown) she was looking for guidance on that.  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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Illness, Inappropriate schedule of product administration
Clinical narrative: COVID-19; Inappropriate schedule of vaccine administered; sickness; feels bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness), FEELING ABNORMAL (feels bad), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 57-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 Ankylosing spondylitis and Ulcerative colitis.    Concurrent medical conditions included Ankylosing spondylitis and Ulcerative colitis (Moderate to severe ulcerative colitis).   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-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) UNK, Citrate Free. In 2021, the patient experienced ILLNESS (sickness) and FEELING ABNORMAL (feels bad). On 01-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In January 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, ILLNESS (sickness), FEELING ABNORMAL (feels bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and COVID-19 (COVID-19) 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 events of sickness, feels bad and COVID-19 was not reported for Humira.  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.
Sex: F
Vaccine: COVID19
Symptoms: Mallet finger, Pain
Clinical narrative: Drop finger in digits of hands; Pain; This spontaneous case was reported by a consumer and describes the occurrence of MALLET FINGER (Drop finger in digits of hands) and PAIN (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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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) CF. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced MALLET FINGER (Drop finger in digits of hands) and PAIN (Pain). At the time of the report, MALLET FINGER (Drop finger in digits of hands) and PAIN (Pain) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration
Clinical narrative: Pain in joint involving hand/Pain in Knuckles; Patient took first dose of Moderna on 23-Mar-2021, second dose on 15-Nov-2021.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joint involving hand/Pain in Knuckles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose of Moderna on 23-Mar-2021, second dose on 15-Nov-2021.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-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 15-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose of Moderna on 23-Mar-2021, second dose on 15-Nov-2021.). On an unknown date, the patient experienced ARTHRALGIA (Pain in joint involving hand/Pain in Knuckles). At the time of the report, ARTHRALGIA (Pain in joint involving hand/Pain in Knuckles) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose of Moderna on 23-Mar-2021, second dose on 15-Nov-2021.) outcome was unknown.      No treatment medication details were provided.   Dosage form for HUMIRA was reported as Solution for injection in pre-filled pen.  The reporter's causality for the event Arthralgia was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trail.  Primary reporter contact for lot number information was unsuccessful.  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-2022-620881 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer, Chills, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: oral bumps at times but not painful; occasional diarrhea; Chills; fever; body ache; This spontaneous case was reported by a health care professional and describes the occurrence of APHTHOUS ULCER (oral bumps at times but not painful), DIARRHOEA (occasional diarrhea), CHILLS (Chills), PYREXIA (fever) and MYALGIA (body ache) 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 PALBOCICLIB (IBRANCE) for Breast cancer.    No Medical History information was reported.   In September 2020, the patient started PALBOCICLIB (IBRANCE) (Oral) 125 milligram once a day. 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, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (fever) and MYALGIA (body ache). On an unknown date, the patient experienced APHTHOUS ULCER (oral bumps at times but not painful) and DIARRHOEA (occasional diarrhea). In April 2021, CHILLS (Chills), PYREXIA (fever) and MYALGIA (body ache) had resolved. At the time of the report, APHTHOUS ULCER (oral bumps at times but not painful) and DIARRHOEA (occasional diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell count: lower red blood count but stable. On an unknown date, White blood cell count: lower white blood count but stable.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 28-Oct-2021, patient experienced another episode of chills, fever and body ache after the mRNA-1273 (Moderna COVID-19 Vaccine) for couple of days (resolved on an unknown date of Oct-2021).  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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Red blood cell count, White blood cell count
Clinical narrative: oral bumps at times but not painful; occasional diarrhea; Chills; fever; body ache; This spontaneous case was reported by a health care professional and describes the occurrence of APHTHOUS ULCER (oral bumps at times but not painful), DIARRHOEA (occasional diarrhea), CHILLS (Chills), PYREXIA (fever) and MYALGIA (body ache) 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 PALBOCICLIB (IBRANCE) for Breast cancer.    No Medical History information was reported.   In September 2020, the patient started PALBOCICLIB (IBRANCE) (Oral) 125 milligram once a day. 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, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (fever) and MYALGIA (body ache). On an unknown date, the patient experienced APHTHOUS ULCER (oral bumps at times but not painful) and DIARRHOEA (occasional diarrhea). In April 2021, CHILLS (Chills), PYREXIA (fever) and MYALGIA (body ache) had resolved. At the time of the report, APHTHOUS ULCER (oral bumps at times but not painful) and DIARRHOEA (occasional diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell count: lower red blood count but stable. On an unknown date, White blood cell count: lower white blood count but stable.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 28-Oct-2021, patient experienced another episode of chills, fever and body ache after the mRNA-1273 (Moderna COVID-19 Vaccine) for couple of days (resolved on an unknown date of Oct-2021).  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.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 53-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 Crohn's disease.    The patient's past medical history included Post procedural inflammation (FISSURE SURGERY WHICH WAS INFLAMMED) in 2017 and Surgery in 2017.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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) UNK, Citrate Free. On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. Patient was not feeling very well, went bathroom a lot and experienced blood/blood in stool and humira was not working. Patient had bad diarrhea, fever and blood in stool. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was unknown if patient was enrolled in a COVID-19 vaccine Trial. 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.   This case was linked to MOD-2022-624833 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Cough, Dyspnoea
Clinical narrative: (asthma symptoms worse; cough; Chest discomfort; shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of ASTHMA ((asthma symptoms worse), COUGH (cough), CHEST DISCOMFORT (Chest discomfort) and DYSPNOEA (shortness of breath) in a 33-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) solution for injection for Asthma.    CHRONIC MIGRAINE WO AURA NT INTRCT WO STAT MIGR. ALLERGIES.  Concurrent medical conditions included Sesame allergy, Allergy to plants, Allergy to animal, Allergy to molds and Pollen allergy. Concomitant products included ALBUTEROL SULFATE and MONTELUKAST SODIUM (SINGULAIR) for Asthma, COVID-19 VACCINE for Prophylactic vaccination, FISH OIL, GABAPENTIN (GRALISE), CLONAZEPAM (KLONOPIN), LAMOTRIGINE (LAMICTAL), ESOMEPRAZOLE MAGNESIUM (NEXIUM EBB), NORTRIPTYLINE, SERTRALINE, TRIAMCINOLONE, CYANOCOBALAMIN (VITAMINA B12), VITAMIN D3, RANITIDINE HYDROCHLORIDE (ZANTAC) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 04-Jun-2021, the patient started DUPILUMAB (DUPIXENT) (unknown route) 300 milligram. 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 ASTHMA ((asthma symptoms worse), COUGH (cough), CHEST DISCOMFORT (Chest discomfort) and DYSPNOEA (shortness of breath). At the time of the report, ASTHMA ((asthma symptoms worse), COUGH (cough), CHEST DISCOMFORT (Chest discomfort) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Suspect product Dupixent was 150 mg/ml in strength with these 2 events attributed to it: Drug ineffective and Product use issue. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided. She had her leg death 18 years ago. She was bipolar, never should had taken Zoloft in first place and she had never been suicidal with other drugs. She was on medication, and she was mentally stable and then took Chantix and cut herself 15 years ago. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Platelet count
Clinical narrative: Experiencing heavy hair loss to the point; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Experiencing heavy hair loss to the point) 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.    The patient's past medical history included Essential thrombocythemia (Had ET for 16 years). Concurrent medical conditions included Hair loss (Significant hair loss at the beginning but it let up after the first year.).   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Experiencing heavy hair loss to the point). At the time of the report, ALOPECIA (Experiencing heavy hair loss to the point) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: Staying between 700 to 900..         Patient was on HU for 14 years. 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: U
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericarditis, Thrombosis with thrombocytopenia syndrome
Clinical narrative: Thrombosis with thrombocytopenia syndrome (TTS); myocarditis; percarditis; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Thrombosis with thrombocytopenia syndrome (TTS)), MYOCARDITIS (myocarditis) and PERICARDITIS (percarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) 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.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Thrombosis with thrombocytopenia syndrome (TTS)) (seriousness criteria death and medically significant), MYOCARDITIS (myocarditis) (seriousness criterion medically significant) and PERICARDITIS (percarditis) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was Thrombosis with thrombocytopenia syndrome. It is unknown if an autopsy was performed. At the time of death, MYOCARDITIS (myocarditis) and PERICARDITIS (percarditis) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. Thrombosis with thrombocytopenia syndrome (TTS) moderna and 9 deaths were reported and so far 3 confirmed cases associated with Moderna. No treatment details reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact; Reported Cause(s) of Death: Thrombosis with thrombocytopenia syndrome
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Injection site pain, Nasal congestion, Neck pain
Clinical narrative: RIGHT NECK AND BACK WAS SORE; RIGHT NECK AND BACK WAS SORE; ARM SORENESS AT INJECTION SITE; Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (RIGHT NECK AND BACK WAS SORE), NECK PAIN (RIGHT NECK AND BACK WAS SORE), NASAL CONGESTION (Nasal congestion) and INJECTION SITE PAIN (ARM SORENESS AT 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.    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) at an unspecified dose. In September 2021, the patient experienced NASAL CONGESTION (Nasal congestion). On an unknown date, the patient experienced BACK PAIN (RIGHT NECK AND BACK WAS SORE), NECK PAIN (RIGHT NECK AND BACK WAS SORE) and INJECTION SITE PAIN (ARM SORENESS AT INJECTION SITE). At the time of the report, BACK PAIN (RIGHT NECK AND BACK WAS SORE), NECK PAIN (RIGHT NECK AND BACK WAS SORE) and INJECTION SITE PAIN (ARM SORENESS AT INJECTION SITE) had resolved and NASAL CONGESTION (Nasal congestion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  On an unknown date, the patient experienced arm soreness at injection site/right neck and back was sore. In Sep-2021, the patient experienced nasal congestion. 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.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Decreased appetite, Dysphonia, Feeling abnormal
Clinical narrative: Lost his appetite; Really flat out and it hit him hard; He might have had the flu and Covid at the same time; Still sound hoarse; Tested positive for Covid after receiving Moderna Covid/high fever for several days of 103 and whole body chills; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid after receiving Moderna Covid/high fever for several daysof 103 and whole body chills), DECREASED APPETITE (Lost his appetite), FEELING ABNORMAL (Really flat out and it hit him hard), INFLUENZA (He might have had the flu and Covid at the same time) and DYSPHONIA (Still sound hoarse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21BRAVO NDC, 045BRAVO21A NDC and 008BRAVO212A NDC) for COVID-19 prophylaxis.     Concurrent medical conditions included High cholesterol and Sleep apnea syndrome (Some kind of sleep apnea condition).   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, the patient experienced COVID-19 (Tested positive for Covid after receiving Moderna Covid/high fever for several daysof 103 and whole body chills). On an unknown date, the patient experienced DECREASED APPETITE (Lost his appetite), FEELING ABNORMAL (Really flat out and it hit him hard), INFLUENZA (He might have had the flu and Covid at the same time) and DYSPHONIA (Still sound hoarse). At the time of the report, COVID-19 (Tested positive for Covid after receiving Moderna Covid/high fever for several daysof 103 and whole body chills), DECREASED APPETITE (Lost his appetite), FEELING ABNORMAL (Really flat out and it hit him hard), INFLUENZA (He might have had the flu and Covid at the same time) and DYSPHONIA (Still sound hoarse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: (Positive) Positive. On 26-Apr-2022, SARS-CoV-2 test: (Positive) Positive for Covid. On an unknown date, Body temperature: high fever for several days of 103.         No concomitant medications were reported. Based on the symptoms, the nurse practitioner the patient might have had the flu and Covid at the same time. The patient was trying to get treatments and was very dissatisfied with his care. The patient did still sound hoarse and still not feeling 100 percent. He didn't have a fever anymore. The reporter was not sure if the patient had the flu or not. 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
Symptoms: Influenza, SARS-CoV-2 test
Clinical narrative: Lost his appetite; Really flat out and it hit him hard; He might have had the flu and Covid at the same time; Still sound hoarse; Tested positive for Covid after receiving Moderna Covid/high fever for several days of 103 and whole body chills; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid after receiving Moderna Covid/high fever for several daysof 103 and whole body chills), DECREASED APPETITE (Lost his appetite), FEELING ABNORMAL (Really flat out and it hit him hard), INFLUENZA (He might have had the flu and Covid at the same time) and DYSPHONIA (Still sound hoarse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21BRAVO NDC, 045BRAVO21A NDC and 008BRAVO212A NDC) for COVID-19 prophylaxis.     Concurrent medical conditions included High cholesterol and Sleep apnea syndrome (Some kind of sleep apnea condition).   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, the patient experienced COVID-19 (Tested positive for Covid after receiving Moderna Covid/high fever for several daysof 103 and whole body chills). On an unknown date, the patient experienced DECREASED APPETITE (Lost his appetite), FEELING ABNORMAL (Really flat out and it hit him hard), INFLUENZA (He might have had the flu and Covid at the same time) and DYSPHONIA (Still sound hoarse). At the time of the report, COVID-19 (Tested positive for Covid after receiving Moderna Covid/high fever for several daysof 103 and whole body chills), DECREASED APPETITE (Lost his appetite), FEELING ABNORMAL (Really flat out and it hit him hard), INFLUENZA (He might have had the flu and Covid at the same time) and DYSPHONIA (Still sound hoarse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: (Positive) Positive. On 26-Apr-2022, SARS-CoV-2 test: (Positive) Positive for Covid. On an unknown date, Body temperature: high fever for several days of 103.         No concomitant medications were reported. Based on the symptoms, the nurse practitioner the patient might have had the flu and Covid at the same time. The patient was trying to get treatments and was very dissatisfied with his care. The patient did still sound hoarse and still not feeling 100 percent. He didn't have a fever anymore. The reporter was not sure if the patient had the flu or not. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry eye, Inappropriate schedule of product administration, Myalgia, Oropharyngeal pain
Clinical narrative: First Dose of Moderna Vaccine was administered on 09-Mar-2021 and second dose of Moderna vaccine was administered on 01-Apr-2021; Dry eyes; STUNG; SORE THROAT; Felt Dizzy; COVID SHOT CAUSED SORE MUSCLE; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry eyes), PAIN (STUNG), OROPHARYNGEAL PAIN (SORE THROAT), DIZZINESS (Felt Dizzy) and MYALGIA (COVID SHOT CAUSED SORE MUSCLE) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Rheumatoid arthritis. Concomitant products included INFLUENZA VACCINE for Flu vaccination.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose of Moderna Vaccine was administered on 09-Mar-2021 and second dose of Moderna vaccine was administered on 01-Apr-2021). In 2021, the patient experienced DRY EYE (Dry eyes), PAIN (STUNG), OROPHARYNGEAL PAIN (SORE THROAT), DIZZINESS (Felt Dizzy) and MYALGIA (COVID SHOT CAUSED SORE MUSCLE). At the time of the report, DRY EYE (Dry eyes), PAIN (STUNG), OROPHARYNGEAL PAIN (SORE THROAT), DIZZINESS (Felt Dizzy), MYALGIA (COVID SHOT CAUSED SORE MUSCLE) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose of Moderna Vaccine was administered on 09-Mar-2021 and second dose of Moderna vaccine was administered on 01-Apr-2021) outcome was unknown.    Concomitant product use was not provided by the reporter. In 2021, the patient experienced that Moderna covid vaccine shot caused sore muscle, stung, felt dizzy, dry eyes, and sore throat.  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. This case was linked to MOD-2021-624984 (Patient Link).   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: First Dose of Moderna Vaccine was administered on 09-Mar-2021 and second dose of Moderna vaccine was administered on 01-Apr-2021; Dry eyes; STUNG; SORE THROAT; Felt Dizzy; COVID SHOT CAUSED SORE MUSCLE; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry eyes), PAIN (STUNG), OROPHARYNGEAL PAIN (SORE THROAT), DIZZINESS (Felt Dizzy) and MYALGIA (COVID SHOT CAUSED SORE MUSCLE) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Rheumatoid arthritis. Concomitant products included INFLUENZA VACCINE for Flu vaccination.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose of Moderna Vaccine was administered on 09-Mar-2021 and second dose of Moderna vaccine was administered on 01-Apr-2021). In 2021, the patient experienced DRY EYE (Dry eyes), PAIN (STUNG), OROPHARYNGEAL PAIN (SORE THROAT), DIZZINESS (Felt Dizzy) and MYALGIA (COVID SHOT CAUSED SORE MUSCLE). At the time of the report, DRY EYE (Dry eyes), PAIN (STUNG), OROPHARYNGEAL PAIN (SORE THROAT), DIZZINESS (Felt Dizzy), MYALGIA (COVID SHOT CAUSED SORE MUSCLE) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose of Moderna Vaccine was administered on 09-Mar-2021 and second dose of Moderna vaccine was administered on 01-Apr-2021) outcome was unknown.    Concomitant product use was not provided by the reporter. In 2021, the patient experienced that Moderna covid vaccine shot caused sore muscle, stung, felt dizzy, dry eyes, and sore throat.  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. This case was linked to MOD-2021-624984 (Patient Link).   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 008B21-2A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Healthy without cold or anything the month of December.  Concurrent medical conditions included Hypothyroidism since 2013, Allergy (she 5 years old) and Asthma (she 5 years old). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Allergy to animal, LEVOTHYROXINE for Hypothyroidism.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, SARS-CoV-2 antibody test: SARS COV2 total AB value 1615.0, standard- 0.0 to0.7 SARS COVID total interep value positive, standard negative. On 10-Jan-2022, SARS-CoV-2 test: (Negative) Negative, deep runny nose. On 12-Jan-2022, SARS-CoV-2 test: (Positive) Positive. On 17-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         It was reported that patient's toddler got covid and slept in her bed with her fever and sneezed on us. Patient hoped Pfizer quickly starts trials on 0 to 5 ages with a new formula to address omnicron better now that hers had omnicron. It was reported that got booster due to travel and as she had a toddler.  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 US-MODERNATX, INC.-MOD-2022-625499 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Live follow-up received with no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-625499:Husband case
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) 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 TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH 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.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         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.   This case was linked to US-MODERNATX, INC.-MOD-2022-625471 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Live follow-up received with additional no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-625471:Wife case
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in an 8-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Fibrosis, Lung cancer stage IV (fibrosis that caused stage 4 lung cancer), Non-smoker and Chemotherapy (undergoing chemo).   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Company comment: This is a spontaneous case concerning a 8-decade-old male  patient with Lung cancer stage IV undergoing chemotherapy, who experienced the non-serious unexpected event of COVID-19 (AESI), on an unknown date after the third dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Patient had fatigue and cough and was not hospitalized.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Concomitant product use was not provided by the reporter.  Patient had cough,  tiredness were considered as symptoms of Covid-19. patient had less fatigue and more cough. It was hard to distinguish what was omicron and what was just his general condition (cough and tiredness). It was also reported that patient had similar symptoms as reporter and 2 or 3 days behind reporter. next round of chemotherapy was put by a week.  Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a 8-decade-old male  patient with Lung cancer stage IV undergoing chemotherapy, who experienced the non-serious unexpected event of COVID-19 (AESI), on an unknown date after the third dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Patient had fatigue and cough and was not hospitalized.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.