chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: All the patients who received a vaccine which was more than 30 days in the refrigerator; All the patients who received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (All the patients who received a vaccine which was more than 30 days in the refrigerator) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (All the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (All the patients who received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (All the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (All the patients who received a vaccine which was more than 30 days in the refrigerator) 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.   No concomitants were provided. No treatment was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: arms are itching a lot no; minor itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (minor itching) and PRURITUS (arms are itching a lot no) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRURITUS (minor itching). In August 2021, the patient experienced PRURITUS (arms are itching a lot no). At the time of the report, PRURITUS (minor itching) and PRURITUS (arms are itching a lot no) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the patient who received a vaccine which was more than 25 days in the refrigerator; the patient who received a vaccine which was more than 25 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the patient who received a vaccine which was more than 25 days in the refrigerator) and PRODUCT STORAGE ERROR (the patient who received a vaccine which was more than 25 days in the refrigerator) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the patient who received a vaccine which was more than 25 days in the refrigerator) and PRODUCT STORAGE ERROR (the patient who received a vaccine which was more than 25 days in the refrigerator). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (the patient who received a vaccine which was more than 25 days in the refrigerator) and PRODUCT STORAGE ERROR (the patient who received a vaccine which was more than 25 days in the refrigerator) 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.   No concomitant information was provided by the reporter.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Groin pain, Pain in extremity
Clinical narrative: groin pain; thigh pain first one side and then the other; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (groin pain) and PAIN IN EXTREMITY (thigh pain first one side and then the other) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (groin pain) and PAIN IN EXTREMITY (thigh pain first one side and then the other). At the time of the report, GROIN PAIN (groin pain) and PAIN IN EXTREMITY (thigh pain first one side and then the other) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  Treatment medication was not provided
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: All the patients who received a vaccine which was more than 30 days in the refrigerator; All the patients who received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (All the patients who received a vaccine which was more than 30 days in the refrigerator) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (All the patients who received a vaccine which was more than 30 days in the refrigerator). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (All the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (All the patients who received a vaccine which was more than 30 days in the refrigerator) 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 medications were not reported by the reporter. Treatment drugs were not reported by the reporter.  The patient received a vaccine which was more than 25 days in the refrigerator.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: all the patients who received a vaccine which was more than 30 days in the refrigerator; all the patients who received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) 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.; Sender's Comments: This report refers to a case of EXPIRED PRODUCT ADMINISTERED, and PRODUCT STORAGE ERROR, in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination with no associated Adverse events.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Bronchitis, Chest pain, Cough
Clinical narrative: Bronchitis; Occasional cough; Sweaty; Sinus infection; ear infection; Burning pain on left ear; Chest pain; Eyes swelling; Face swelling; Throat swelling; Difficulty breathing; No taste; No smell; Vomiting; Fatigue; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection) and EAR PAIN (ear infection) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Perianal abscess (Due to Crohn's) and Ileostomy (Ileostomy placed prior to receiving vaccination.) in February 2021. Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic (Cipro), Drug allergy (Zofran), Drug allergy (Chlorophyl) and Crohn's disease.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she had been in and out of the hospital due to perianal abscesses and was diagnosed with Crohn's disease. She also mentioned that she currently has an ileostomy bag that was placed in February of 2021 due to her disease.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  further information has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear pain, Eye swelling, Fatigue, Hyperhidrosis
Clinical narrative: Bronchitis; Occasional cough; Sweaty; Sinus infection; ear infection; Burning pain on left ear; Chest pain; Eyes swelling; Face swelling; Throat swelling; Difficulty breathing; No taste; No smell; Vomiting; Fatigue; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection) and EAR PAIN (ear infection) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Perianal abscess (Due to Crohn's) and Ileostomy (Ileostomy placed prior to receiving vaccination.) in February 2021. Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic (Cipro), Drug allergy (Zofran), Drug allergy (Chlorophyl) and Crohn's disease.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she had been in and out of the hospital due to perianal abscesses and was diagnosed with Crohn's disease. She also mentioned that she currently has an ileostomy bag that was placed in February of 2021 due to her disease.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  further information has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngeal swelling, Pyrexia, Sinusitis, Swelling face
Clinical narrative: Bronchitis; Occasional cough; Sweaty; Sinus infection; ear infection; Burning pain on left ear; Chest pain; Eyes swelling; Face swelling; Throat swelling; Difficulty breathing; No taste; No smell; Vomiting; Fatigue; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection) and EAR PAIN (ear infection) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Perianal abscess (Due to Crohn's) and Ileostomy (Ileostomy placed prior to receiving vaccination.) in February 2021. Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic (Cipro), Drug allergy (Zofran), Drug allergy (Chlorophyl) and Crohn's disease.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she had been in and out of the hospital due to perianal abscesses and was diagnosed with Crohn's disease. She also mentioned that she currently has an ileostomy bag that was placed in February of 2021 due to her disease.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  further information has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Bronchitis; Occasional cough; Sweaty; Sinus infection; ear infection; Burning pain on left ear; Chest pain; Eyes swelling; Face swelling; Throat swelling; Difficulty breathing; No taste; No smell; Vomiting; Fatigue; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection) and EAR PAIN (ear infection) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Perianal abscess (Due to Crohn's) and Ileostomy (Ileostomy placed prior to receiving vaccination.) in February 2021. Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic (Cipro), Drug allergy (Zofran), Drug allergy (Chlorophyl) and Crohn's disease.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she had been in and out of the hospital due to perianal abscesses and was diagnosed with Crohn's disease. She also mentioned that she currently has an ileostomy bag that was placed in February of 2021 due to her disease.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: all the patients who received a vaccine which was more than 30 days in the refrigerator; all the patients who received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-126929 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose 2 weeks after 1st; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 2 weeks after 1st) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Denied) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 2 weeks after 1st). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 2 weeks after 1st) 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.   No concomitant medication were reported No treatment medication were reported   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Tasting and smelling rubber after the vaccine; smelling rubber after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Tasting and smelling rubber after the vaccine) and PAROSMIA (smelling rubber after the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (Tasting and smelling rubber after the vaccine) and PAROSMIA (smelling rubber after the vaccine). At the time of the report, TASTE DISORDER (Tasting and smelling rubber after the vaccine) and PAROSMIA (smelling rubber after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe pain where the shot was administered/It's worse than a broken arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain where the shot was administered/It's worse than a broken arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced VACCINATION SITE PAIN (Severe pain where the shot was administered/It's worse than a broken arm). At the time of the report, VACCINATION SITE PAIN (Severe pain where the shot was administered/It's worse than a broken arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment  was provided.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) 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.   No concomitant medications were provided. No treatments were provided. HCP has provided demographics for all the patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021). For this patient, the number of days that have passed were 9.   This case was linked to MOD-2021-278394 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Illness, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; felt off/dazed; low grade temp; chills; Was sick for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick for a day and a half), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (felt off/dazed), PYREXIA (low grade temp) and CHILLS (chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IDELALISIB tablet for Mantle cell lymphoma.    Concurrent medical conditions included Mantle cell lymphoma.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient started IDELALISIB (Oral) 100 mg twice a day. On 20-May-2021, 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 ILLNESS (Was sick for a day and a half), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (felt off/dazed), PYREXIA (low grade temp) and CHILLS (chills). At the time of the report, ILLNESS (Was sick for a day and a half) had resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (felt off/dazed), PYREXIA (low grade temp) and CHILLS (chills) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Colon cancer, Large intestinal obstruction
Clinical narrative: Diagnosed with Colon cancer; Colon obstruction; This spontaneous case was reported by a consumer and describes the occurrence of COLON CANCER (Diagnosed with Colon cancer) and LARGE INTESTINAL OBSTRUCTION (Colon obstruction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLON CANCER (Diagnosed with Colon cancer) (seriousness criterion medically significant) and LARGE INTESTINAL OBSTRUCTION (Colon obstruction) (seriousness criterion medically significant). The patient was treated with Surgery (emergency surgery due to colon obstruction) for Large intestinal obstruction. At the time of the report, COLON CANCER (Diagnosed with Colon cancer) and LARGE INTESTINAL OBSTRUCTION (Colon obstruction) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information included chemo treatment for colon cancer. Patient had two cycles of chemotherapy recently.  Company Comment : Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/the number of days that have passed were 11) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/the number of days that have passed were 11). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/the number of days that have passed were 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased, Product dose omission issue, Vaccination site bruising, Vaccination site swelling
Clinical narrative: bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath; low platelets; bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath; did not get the 2nd dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath), PRODUCT DOSE OMISSION ISSUE (did not get the 2nd dose of the vaccine), PLATELET COUNT DECREASED (low platelets) and VACCINATION SITE SWELLING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibroids and Hysterectomy. Concurrent medical conditions included Liver disorder.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the 2nd dose of the vaccine). On an unknown date, the patient experienced VACCINATION SITE BRUISING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath), PLATELET COUNT DECREASED (low platelets) and VACCINATION SITE SWELLING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath). On 16-Aug-2021, PRODUCT DOSE OMISSION ISSUE (did not get the 2nd dose of the vaccine) had resolved. At the time of the report, VACCINATION SITE BRUISING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath), PLATELET COUNT DECREASED (low platelets) and VACCINATION SITE SWELLING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 38,000 (Low) 38,000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  The reporter reported that the primary care doctor thought it was clot and advised the patient to take aspirin but patient did not take as she was suffering from unspecified liver disease.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded- However chronic liver disease could be a confounder. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Pyrexia
Clinical narrative: stuff nose; fever; fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of NASAL CONGESTION (stuff nose), PYREXIA (fever) and FATIGUE (fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (stuff nose), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, NASAL CONGESTION (stuff nose), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy sites on my back and thighs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy sites on my back and thighs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy sites on my back and thighs). At the time of the report, PRURITUS (itchy sites on my back and thighs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Concomitant medication was not provided.  Patient stated that he had two shots and started with itchy sites on back and thighs.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I am vaccinated and have contracted covid; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I am vaccinated and have contracted covid) and DRUG INEFFECTIVE (Drug ineffective) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I am vaccinated and have contracted covid) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (I am vaccinated and have contracted covid) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Biopsy, Computerised tomogram, Diagnostic aspiration, Nasopharyngitis
Clinical narrative: had a little bit of a cold dissipated over a couple of days; left shoulder pain; felt a mass in his left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (had a little bit of a cold dissipated over a couple of days), SKIN MASS (felt a mass, left arm pit), and ARTHRALGIA (left shoulder pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff tear and Surgery (Spine) in January 2021.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced SKIN MASS (felt a mass in his left arm pit) (seriousness criterion medically significant). On an unknown date, the patient experienced NASOPHARYNGITIS (had a little bit of a cold dissipated over a couple of days) (seriousness criterion medically significant) and ARTHRALGIA (left shoulder pain) (seriousness criterion medically significant). The patient was treated with Surgery (On 11-Aug-2021,surgical excision of the lymph node which was the size of an egg (6cm x 3cm x 3cm)) for Skin mass. At the time of the report, NASOPHARYNGITIS (had a little bit of a cold dissipated over a couple of days), SKIN MASS (felt a mass, left arm pit), and ARTHRALGIA (left shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Biopsy: negative Biopsy of surgically excised lymph node was negative. In June 2021, Computerised tomogram: abnormal showed a mass. In June 2021, Diagnostic aspiration: inconclusive for lymphoma were inconclusive. In June 2021, Ultrasound scan: abnormal ultrasound biopsy that looked like lymphoma.         Relevant concomitant medications were not provided. Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. No further information is expected. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Skin mass, Ultrasound scan
Clinical narrative: had a little bit of a cold dissipated over a couple of days; left shoulder pain; felt a mass in his left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (had a little bit of a cold dissipated over a couple of days), SKIN MASS (felt a mass, left arm pit), and ARTHRALGIA (left shoulder pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff tear and Surgery (Spine) in January 2021.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced SKIN MASS (felt a mass in his left arm pit) (seriousness criterion medically significant). On an unknown date, the patient experienced NASOPHARYNGITIS (had a little bit of a cold dissipated over a couple of days) (seriousness criterion medically significant) and ARTHRALGIA (left shoulder pain) (seriousness criterion medically significant). The patient was treated with Surgery (On 11-Aug-2021,surgical excision of the lymph node which was the size of an egg (6cm x 3cm x 3cm)) for Skin mass. At the time of the report, NASOPHARYNGITIS (had a little bit of a cold dissipated over a couple of days), SKIN MASS (felt a mass, left arm pit), and ARTHRALGIA (left shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Biopsy: negative Biopsy of surgically excised lymph node was negative. In June 2021, Computerised tomogram: abnormal showed a mass. In June 2021, Diagnostic aspiration: inconclusive for lymphoma were inconclusive. In June 2021, Ultrasound scan: abnormal ultrasound biopsy that looked like lymphoma.         Relevant concomitant medications were not provided. Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. No further information is expected. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received covid vaccine no.1 in April. He recieved 2nd dose last week.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received covid vaccine no.1 in April. He recieved 2nd dose last week.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received covid vaccine no.1 in April. He recieved 2nd dose last week.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received covid vaccine no.1 in April. He recieved 2nd dose last week.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Diagnosed with Extreme Vertigo, when she sat on the toilet the room started spinning, when she turned to the left while lying in the bed, the room started spinning; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Diagnosed with Extreme Vertigo, when she sat on the toilet the room started spinning, when she turned to the left while lying in the bed, the room started spinning) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced VERTIGO (Diagnosed with Extreme Vertigo, when she sat on the toilet the room started spinning, when she turned to the left while lying in the bed, the room started spinning) (seriousness criterion disability). The patient was treated with MECLIZINE HCL for Vertigo, at a dose of 12.5 mg. At the time of the report, VERTIGO (Diagnosed with Extreme Vertigo, when she sat on the toilet the room started spinning, when she turned to the left while lying in the bed, the room started spinning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Neither medical history, nor concomitant medication were provided. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Neither medical history, nor concomitant medication were provided. Further information has been requested.