chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got pretty sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got pretty sick) in a 35-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got pretty sick). At the time of the report, ILLNESS (got pretty sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient takes medications daily but did not wish to report the names of the medications.  Treatment information was not provided.  Patient has no known drug or food allergies.   This case was linked to MOD-2021-404755, MOD-2021-404759 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (arm soreness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 025C21A) for COVID-19 immunization. Concurrent medical conditions included Vitamin D deficiency. Concomitant products included Vitamin D 2000 (calcium carbonate/cholecalciferol) for Vitamin D deficiency. On May 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced myalgia (arm soreness). At the time of the report, myalgia (arm soreness) resolved. No concomitant medication or treatment information reported. This case linked to MOD-2021-400021, MOD-2021-404753 (patient link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain on both arms where she had her 1st and 2nd shots; This spontaneous case was reported by a physician assistant and describes the occurrence of VACCINATION SITE PAIN (pain on both arms where she had her 1st and 2nd shots) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-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 VACCINATION SITE PAIN (pain on both arms where she had her 1st and 2nd shots). At the time of the report, VACCINATION SITE PAIN (pain on both arms where she had her 1st and 2nd shots) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   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.   This case was linked to MOD-2021-404628 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain on both arms where she had her 1st and 2nd shots; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN IN EXTREMITY (pain on both arms where she had her 1st and 2nd shots) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-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 PAIN IN EXTREMITY (pain on both arms where she had her 1st and 2nd shots). At the time of the report, PAIN IN EXTREMITY (pain on both arms where she had her 1st and 2nd shots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-404628, MOD-2021-404746 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; doses given after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (doses given after temperature excursion) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (doses given after temperature excursion). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion). On 28-Nov-2021, PRODUCT STORAGE ERROR (doses given after temperature excursion) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Gastrooesophageal reflux disease, Throat irritation
Clinical narrative: metallic taste in their mouth; esophageal reflux; burning in the throat.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in the throat.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A20A) for COVID-19 vaccination.     Concomitant products included VERAPAMIL for Hypertension.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in the throat.). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse reaction, at an unspecified dose and frequency and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in the throat.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-404760 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; doses given after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (doses given after temperature excursion) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (doses given after temperature excursion). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion). On 28-Nov-2021, PRODUCT STORAGE ERROR (doses given after temperature excursion) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-403721 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided   This case was linked to MOD-2021-403721 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Gastrooesophageal reflux disease, Gingival swelling, Nasal congestion, Rash
Clinical narrative: swelling of their gums and nasal passages; swelling of their gums; metallic taste in their mouth; esophageal reflux; burning in the throat; rash behind the ears and the upper neck; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (swelling of their gums and nasal passages), GINGIVAL SWELLING (swelling of their gums), DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in the throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-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 NASAL CONGESTION (swelling of their gums and nasal passages), GINGIVAL SWELLING (swelling of their gums), DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux), THROAT IRRITATION (burning in the throat) and RASH (rash behind the ears and the upper neck). At the time of the report, NASAL CONGESTION (swelling of their gums and nasal passages) outcome was unknown and GINGIVAL SWELLING (swelling of their gums), DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux), THROAT IRRITATION (burning in the throat) and RASH (rash behind the ears and the upper neck) had resolved.            Concomitant medication was not provided. Treatment information was not provided.  It was reported that the symptoms have decreased since March but the nasal passages remain the worse and they were the last thing going away .   This case was linked to MOD-2021-404751 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: swelling of their gums and nasal passages; swelling of their gums; metallic taste in their mouth; esophageal reflux; burning in the throat; rash behind the ears and the upper neck; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (swelling of their gums and nasal passages), GINGIVAL SWELLING (swelling of their gums), DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux) and THROAT IRRITATION (burning in the throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-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 NASAL CONGESTION (swelling of their gums and nasal passages), GINGIVAL SWELLING (swelling of their gums), DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux), THROAT IRRITATION (burning in the throat) and RASH (rash behind the ears and the upper neck). At the time of the report, NASAL CONGESTION (swelling of their gums and nasal passages) outcome was unknown and GINGIVAL SWELLING (swelling of their gums), DYSGEUSIA (metallic taste in their mouth), GASTROOESOPHAGEAL REFLUX DISEASE (esophageal reflux), THROAT IRRITATION (burning in the throat) and RASH (rash behind the ears and the upper neck) had resolved.            Concomitant medication was not provided. Treatment information was not provided.  It was reported that the symptoms have decreased since March but the nasal passages remain the worse and they were the last thing going away .   This case was linked to MOD-2021-404751 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: vaccine administered to patient after 21st puncture of vial; 2nd dose administered >36 days after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (vaccine administered to patient after 21st puncture of vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered >36 days after 1st dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered >36 days after 1st dose). On 02-Dec-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (vaccine administered to patient after 21st puncture of vial). On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered >36 days after 1st dose) had resolved. On 02-Dec-2021, PRODUCT ADMINISTRATION ERROR (vaccine administered to patient after 21st puncture of vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug was reported.  No treatment drug was reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was a little cramped; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little cramped) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A, 016B21A and 030H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU. Past adverse reactions to the above products included Adverse event with FLU. Concurrent medical conditions included Heart disease, unspecified.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Arm was a little cramped). At the time of the report, VACCINATION SITE PAIN (Arm was a little cramped) outcome was unknown.            No concomitant medications was reported.  Patient stated that she felt the way she did with the flu several years ago with absolutely no energy whatsoever, and arm pain.  She has a history of a heart condition, and has been using hand sanitizer more regularly.   No treatment medications was reported.    This case was linked to MOD-2021-404779 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a lot of pain in the muscle where he got the injection left deltoid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a lot of pain in the muscle where he got the injection left deltoid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced VACCINATION SITE PAIN (a lot of pain in the muscle where he got the injection left deltoid). At the time of the report, VACCINATION SITE PAIN (a lot of pain in the muscle where he got the injection left deltoid) outcome was unknown.            Concomitant product use was not provided by the reporter.    No treatment information was provided.   This case was linked to MOD-2021-404841 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by a respiratory therapist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The facility had a 20 minute excursion in the freezer that their Moderna  COVID-19 vials were stored in  No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pruritus ("improving as of today") and vaccination site pain (left sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 022C21A) for COVID-19 immunization. No medical history reported. On Dec 1, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced  vaccination site pruritus ("improving as of today") and vaccination site pain (left sore arm). At the time of the report, vaccination site pruritus ("improving as of today"): not resolved and vaccination site pain (left sore arm): resolving. No concomitant medications reported. Patient had experienced symptoms in Dec 2021. Patient's treatment medications included nighttime medications to help her sleep.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses given after temperature excursion; Doses given after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Doses given after temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Doses given after temperature excursion). On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion). On 28-Nov-2021, PRODUCT STORAGE ERROR (Doses given after temperature excursion) had resolved. On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Excursion in freezer for 20 minutes happened on 28 Nov 2021.  No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-403721, MOD-2021-404722 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-403721 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test
Clinical narrative: Death; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) and COVID-19 (COVID-19) 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 second 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. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and COVID-19 (COVID-19) (seriousness criterion death). The reported cause of death was covid-19. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 test Positive..         No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter; Reported Cause(s) of Death: COVID-19
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia
Clinical narrative: numbness in the arms,numbness in the feet , numbness in the hands; difficulty breathing.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in the arms,numbness in the feet , numbness in the hands) and DYSPNOEA (difficulty breathing.) 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 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced HYPOAESTHESIA (numbness in the arms,numbness in the feet , numbness in the hands) and DYSPNOEA (difficulty breathing.). At the time of the report, HYPOAESTHESIA (numbness in the arms,numbness in the feet , numbness in the hands) and DYSPNOEA (difficulty breathing.) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-404773 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Discomfort, Fatigue, Feeling abnormal
Clinical narrative: but this time coldness came along with extreme fatigue; brain fog this time as well; uncomfortable; it was similar to bones in hands and feet; muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips; Hurt, Pain, hurt only if she put her arm up and touched the shot area; extreme fatigue; heavy-duty body ache like as if she was hit by a truck which was across the shoulders, spine and was also affecting her joints; with headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (but this time coldness came along with extreme fatigue), FEELING ABNORMAL (brain fog this time as well), DISCOMFORT (uncomfortable), BONE PAIN (it was similar to bones in hands and feet) and MYALGIA (muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 031M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vision abnormal NOS (bad vision even before the first dose of moderna vaccine).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-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 experienced FEELING COLD (but this time coldness came along with extreme fatigue), FEELING ABNORMAL (brain fog this time as well), DISCOMFORT (uncomfortable), BONE PAIN (it was similar to bones in hands and feet), MYALGIA (muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips), VACCINATION SITE PAIN (Hurt, Pain, hurt only if she put her arm up and touched the shot area), FATIGUE (extreme fatigue), ARTHRALGIA (heavy-duty body ache like as if she was hit by a truck which was across the shoulders, spine and was also affecting her joints) and HEADACHE (with headaches). At the time of the report, FEELING COLD (but this time coldness came along with extreme fatigue), FEELING ABNORMAL (brain fog this time as well), DISCOMFORT (uncomfortable), BONE PAIN (it was similar to bones in hands and feet), MYALGIA (muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips), VACCINATION SITE PAIN (Hurt, Pain, hurt only if she put her arm up and touched the shot area), FATIGUE (extreme fatigue), ARTHRALGIA (heavy-duty body ache like as if she was hit by a truck which was across the shoulders, spine and was also affecting her joints) and HEADACHE (with headaches) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported. Patient had visited dentist to have her teeth cleaned.   This case was linked to MOD-2021-404868 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Myalgia, Vaccination site pain
Clinical narrative: but this time coldness came along with extreme fatigue; brain fog this time as well; uncomfortable; it was similar to bones in hands and feet; muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips; Hurt, Pain, hurt only if she put her arm up and touched the shot area; extreme fatigue; heavy-duty body ache like as if she was hit by a truck which was across the shoulders, spine and was also affecting her joints; with headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (but this time coldness came along with extreme fatigue), FEELING ABNORMAL (brain fog this time as well), DISCOMFORT (uncomfortable), BONE PAIN (it was similar to bones in hands and feet) and MYALGIA (muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 031M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vision abnormal NOS (bad vision even before the first dose of moderna vaccine).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-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 experienced FEELING COLD (but this time coldness came along with extreme fatigue), FEELING ABNORMAL (brain fog this time as well), DISCOMFORT (uncomfortable), BONE PAIN (it was similar to bones in hands and feet), MYALGIA (muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips), VACCINATION SITE PAIN (Hurt, Pain, hurt only if she put her arm up and touched the shot area), FATIGUE (extreme fatigue), ARTHRALGIA (heavy-duty body ache like as if she was hit by a truck which was across the shoulders, spine and was also affecting her joints) and HEADACHE (with headaches). At the time of the report, FEELING COLD (but this time coldness came along with extreme fatigue), FEELING ABNORMAL (brain fog this time as well), DISCOMFORT (uncomfortable), BONE PAIN (it was similar to bones in hands and feet), MYALGIA (muscle hurt, and heavy-duty body ache, across the shoulders, spine and hips), VACCINATION SITE PAIN (Hurt, Pain, hurt only if she put her arm up and touched the shot area), FATIGUE (extreme fatigue), ARTHRALGIA (heavy-duty body ache like as if she was hit by a truck which was across the shoulders, spine and was also affecting her joints) and HEADACHE (with headaches) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported. Patient had visited dentist to have her teeth cleaned.   This case was linked to MOD-2021-404868 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Flushing, Headache
Clinical narrative: Flushed; HEADACHE; Fatigue; chills; This spontaneous case was reported by a nurse and describes the occurrence of FLUSHING (Flushed), HEADACHE (HEADACHE), FATIGUE (Fatigue) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary sarcoidosis on 15-Jun-2015. Concurrent medical conditions included Iodine allergy, Penicillin allergy, Drug allergy (Sulfa drug allergy), Drug allergy (Compazine) and Food allergy (Shell fish). Concomitant products included MOMETASONE FUROATE (NASONEX) from 15-Jun-2000 to an unknown date for Allergy, POTASSIUM from 01-Jun-1990 to an unknown date for Hypokalemia, CYANOCOBALAMIN (B 12) from 15-Jun-2015 to an unknown date for Nutritional support, PREDNISONE from 15-Jun-2015 to an unknown date and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 01-Jun-2019 to an unknown date for Pulmonary sarcoidosis.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FLUSHING (Flushed), HEADACHE (HEADACHE), FATIGUE (Fatigue) and CHILLS (chills). In February 2021, FATIGUE (Fatigue) and CHILLS (chills) had resolved. At the time of the report, FLUSHING (Flushed) and HEADACHE (HEADACHE) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that she was fatigued for 3 days with chills no fever.  No treatment drugs were reported
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised had a 0.25 instead of 0.50 ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised had a 0.25 instead of 0.50 ml) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Immunocompromised.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 01-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised had a 0.25 instead of 0.50 ml). On 01-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised had a 0.25 instead of 0.50 ml) had resolved.            No concomitant informations were reported. No treatment informations were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Stress, Vomiting
Clinical narrative: it was the stress from  having a fever; he has 101°F fever; This morning he also vomited a little but it was bile, stated it was the stress from having a fever. Just a little bile this morning; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (it was the stress from  having a fever), PYREXIA (he has 101°F fever) and VOMITING (This morning he also vomited a little but it was bile, stated it was the stress from having a fever. Just a little bile this morning) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Advanced prostate cancer since September 2021 and Immunocompromised.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced STRESS (it was the stress from  having a fever), PYREXIA (he has 101°F fever) and VOMITING (This morning he also vomited a little but it was bile, stated it was the stress from having a fever. Just a little bile this morning). At the time of the report, STRESS (it was the stress from  having a fever), PYREXIA (he has 101°F fever) and VOMITING (This morning he also vomited a little but it was bile, stated it was the stress from having a fever. Just a little bile this morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: 101°f (High) Fever.         Concomitant medication was not provided.  patient has 101°F fever, wanted to know if that could possibly be from the moderna shot. Morning also he vomited a little but it was bile, stated it was the stress from having a fever. Just a little bile this morning.  Treatment information was not provided.   This case was linked to MOD-2021-403905 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Influenza like illness
Clinical narrative: she feels like she is having the flu; headache; feeling horrible, feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (she feels like she is having the flu), FEELING ABNORMAL (feeling horrible, feeling terrible) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 039B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (feeling horrible, feeling terrible). On 29-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (she feels like she is having the flu) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (she feels like she is having the flu), FEELING ABNORMAL (feeling horrible, feeling terrible) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concimtant drugs were reported.   This case was linked to MOD-2021-402920 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Mood altered, Myalgia, Neck pain
Clinical narrative: (forehead and neck pain); mind isn't right/little bit crazy/feels congested; She isn't in the mood to do anything; headache (forehead and neck pain); body aches; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN ((forehead and neck pain)), FEELING ABNORMAL (mind isn't right/little bit crazy/feels congested), MOOD ALTERED (She isn't in the mood to do anything), HEADACHE (headache (forehead and neck pain)) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced NECK PAIN ((forehead and neck pain)), FEELING ABNORMAL (mind isn't right/little bit crazy/feels congested), MOOD ALTERED (She isn't in the mood to do anything), HEADACHE (headache (forehead and neck pain)) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK PAIN ((forehead and neck pain)), FEELING ABNORMAL (mind isn't right/little bit crazy/feels congested), MOOD ALTERED (She isn't in the mood to do anything), HEADACHE (headache (forehead and neck pain)) and MYALGIA (body aches) outcome was unknown.      Concomitant medications were not provided.   This case was linked to MOD-2021-403180, MOD-2021-403181 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills after one of the vaccinations; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills after one of the vaccinations) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant in July 2021. Concurrent medical conditions included Multiple myeloma (was diagnosed with Multiple Myeloma Cancer prior to receiving his two doses of Moderna Covid-19 vaccine).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-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 CHILLS (chills after one of the vaccinations). At the time of the report, CHILLS (chills after one of the vaccinations) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.  The patient had chills after one of the vaccinations. The patient did not remember which vaccination that was.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac discomfort
Clinical narrative: Heart issues; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (Heart issues) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISCOMFORT (Heart issues). At the time of the report, CARDIAC DISCOMFORT (Heart issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-403371 (Patient Link).