chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) 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.   This case was linked to MOD-2021-237447 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of administered expired product (administration of expired vaccine) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006C21A) for COVID-19 immunization. No medical history reported. On Jun 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 8, 2021, patient administered expired product (administration of expired vaccine). On Jun 8, 2021, administered expired product (administration of expired vaccine) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. This case linked to MOD-2021-237307 (patient link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Product administered at inappropriate site, Wrong technique in device usage process
Clinical narrative: Given to me on my back just underneath my shoulder; my 2nd vaccination was not right/ it wasn't like it's supposed to be; it burned like crazy for a few minutes; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (my 2nd vaccination was not right/ it wasn't like it's supposed to be), BURNING SENSATION (it burned like crazy for a few minutes) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given to me on my back just underneath my shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 010M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and DENOSUMAB (PROLIA) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (my 2nd vaccination was not right/ it wasn't like it's supposed to be) and BURNING SENSATION (it burned like crazy for a few minutes). On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given to me on my back just underneath my shoulder). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (my 2nd vaccination was not right/ it wasn't like it's supposed to be), BURNING SENSATION (it burned like crazy for a few minutes) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given to me on my back just underneath my shoulder) outcome was unknown.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 30-year-old male 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) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for Vaccine exposure via breast milk.     No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. The mother's last menstrual period was on 18-Aug-2020 and the estimated date of delivery was 25-May-2021. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). The delivery occurred on an unknown date, which was reported as Full-term. For neonate 1, the birth weight was 3600 grams (7lbs 15oz). The outcome was reported as Term Birth w/o Complications. At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) had resolved. Unknown          No concomitant products were reported. There were no pregnancy related complication or other acute illnesses.  No treatment information provided.   This case was linked to MOD-2021-010771 (Parent-Child Link).   See case MOD-2021-010771 for details regarding the Parent case.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.   This case was linked to MOD-2021-237427 (Patient Link).
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-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 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 08-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) 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 provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) 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 HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were reported. no treatment drugs were reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Inappropriate schedule of product administration, Magnetic resonance imaging, Pain, Peripheral swelling
Clinical narrative: He did not get his second dose until two months later on 23-Mar2021; he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf; Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He did not get his second dose until two months later on 23-Mar2021), PERIPHERAL SWELLING (he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf) and PAIN (Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received second 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 (He did not get his second dose until two months later on 23-Mar2021), PERIPHERAL SWELLING (he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf) and PAIN (Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He did not get his second dose until two months later on 23-Mar2021) had resolved, PERIPHERAL SWELLING (he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf) had not resolved and PAIN (Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.         No treatment medication information has been provided by the reporter. No concomitant medication information has been provided by the reporter.   This case was linked to MOD-2021-042428 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-06-2021: Contains no new information
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: He did not get his second dose until two months later on 23-Mar2021; he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf; Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He did not get his second dose until two months later on 23-Mar2021), PERIPHERAL SWELLING (he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf) and PAIN (Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received second 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 (He did not get his second dose until two months later on 23-Mar2021), PERIPHERAL SWELLING (he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf) and PAIN (Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He did not get his second dose until two months later on 23-Mar2021) had resolved, PERIPHERAL SWELLING (he had no change,Bottom line is his left foot is not back to normal/swelling procedded to lf ankle and back of calf) had not resolved and PAIN (Some days he hasn't hardly any pain and some days it's considerable/pain proceeded to lf ankle and back of calf) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.         No treatment medication information has been provided by the reporter. No concomitant medication information has been provided by the reporter.   This case was linked to MOD-2021-042428 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-06-2021: Contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore Arm; Headache; 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 PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) 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 PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) was resolving.            Concomitant Medication was not provided. Treatment Medication was not provided. patient is feeling fine now.   This case was linked to MOD-2021-237491 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After having the shots in May of this year the allergies have been reducing to where Ican now spend all day outside wit; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After having the shots in May of this year the allergies have been reducing to where Ican now spend all day outside wit) 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 Allergy NOS (Patient had severe allergies for over 30 years and never being able to spend more than a couple of hours outside without non stop sneezing.).    In May 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 THERAPEUTIC RESPONSE UNEXPECTED (After having the shots in May of this year the allergies have been reducing to where Ican now spend all day outside wit). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After having the shots in May of this year the allergies have been reducing to where Ican now spend all day outside wit) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm
Clinical narrative: had a tumor on his neck; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM (had a tumor on his neck) 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 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 NEOPLASM (had a tumor on his neck). At the time of the report, NEOPLASM (had a tumor on his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by reporter. No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm) 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 MYALGIA (Sore Arm). At the time of the report, MYALGIA (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-237486 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-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 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: Missed second dose in recommended time frame; 3 shot pain in thigh muscle; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose in recommended time frame) and MYALGIA (3 shot pain in thigh muscle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL and AMLODIPINE for Hypertension, LORAZEPAM for Sleeping sickness, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for Supplementation therapy.    On 04-May-2021, the patient received second 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 (Missed second dose in recommended time frame) and MYALGIA (3 shot pain in thigh muscle). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose in recommended time frame) outcome was unknown and MYALGIA (3 shot pain in thigh muscle) had resolved.            This case was linked to MOD-2021-211621 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Hypersensitivity, Rash
Clinical narrative: broke out on his chest and back, like pimple; allergy; broke out on his chest and back, like rash; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (broke out on his chest and back, like pimple), HYPERSENSITIVITY (allergy) and RASH (broke out on his chest and back, like rash) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B214) for COVID-19 vaccination.     No medical history was reported by  the reporter.  Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACNE (broke out on his chest and back, like pimple), HYPERSENSITIVITY (allergy) and RASH (broke out on his chest and back, like rash). At the time of the report, ACNE (broke out on his chest and back, like pimple), HYPERSENSITIVITY (allergy) and RASH (broke out on his chest and back, like rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned that patient received a steroid shot for allergy possibly on the same day as his Moderna COVID 19 vaccine.    This case was linked to MOD-2021-237502 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Myalgia, Vaccination site joint pain
Clinical narrative: joint pain on the injection site from the right upper arm up to in between her elbow; Very uncomfortable; Muscle pain on the injection site from the right upper arm up to in between her elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (joint pain on the injection site from the right upper arm up to in between her elbow), DISCOMFORT (Very uncomfortable) and MYALGIA (Muscle pain on the injection site from the right upper arm up to in between her elbow) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B2HA and 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Drug allergy (allergies to Benadryl) and Sulfonamide allergy (allergies to Sulfa drugs). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and LORATADINE (CLARITIN [LORATADINE]) for Asthma.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE JOINT PAIN (joint pain on the injection site from the right upper arm up to in between her elbow), DISCOMFORT (Very uncomfortable) and MYALGIA (Muscle pain on the injection site from the right upper arm up to in between her elbow). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Muscle pain and Vaccination site joint pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE JOINT PAIN (joint pain on the injection site from the right upper arm up to in between her elbow), DISCOMFORT (Very uncomfortable) and MYALGIA (Muscle pain on the injection site from the right upper arm up to in between her elbow) outcome was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours) had resolved. Not Provided      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 Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021 and Patient's Initial updated. On 16-Aug-2021: Non significant Follow up received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I have had side effects from my moderna vaccine since March 2021; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (I have had side effects from my moderna vaccine since March 2021) 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 VACCINATION COMPLICATION (I have had side effects from my moderna vaccine since March 2021). At the time of the report, VACCINATION COMPLICATION (I have had side effects from my moderna vaccine since March 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received vaccine 12 hours after the vial was punctured) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 051C21A) for COVID-19 immunization. No medical history reported. On Jun 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 19, 2021, patient administered expired product (received vaccine 12 hours after the vial was punctured). At the time of the report, administered expired product (received vaccine 12 hours after the vial was punctured) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: large lymph node under the armpit of the arm where she got the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (large lymph node under the armpit of the arm where she got the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-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 VACCINATION SITE LYMPHADENOPATHY (large lymph node under the armpit of the arm where she got the vaccine). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (large lymph node under the armpit of the arm where she got the vaccine) outcome was unknown.            No concomitant medications and treatment information were reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received the vaccine  from vial  12 hours after the vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the vaccine  from vial  12 hours after the vial was punctured) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the vaccine  from vial  12 hours after the vial was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the vaccine  from vial  12 hours after the vial was punctured) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shaking and it seems to be getting worse; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking and it seems to be getting worse) 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 26-Jun-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 TREMOR (shaking and it seems to be getting worse). At the time of the report, TREMOR (shaking and it seems to be getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were  reported  No treatment medication were provided
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 antibody test
Clinical narrative: Extreme fatigue for a couple of weeks; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue for a couple of weeks) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014M20A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Food allergy (Onion), Food allergy (garlic), Food allergy (spices), Drug allergy (anastazole), Allergy to metals (pyridium), Non-Hodgkin's lymphoma (CLL-SLL x 7 years) and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (Extreme fatigue for a couple of weeks). At the time of the report, FATIGUE (Extreme fatigue for a couple of weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, SARS-CoV-2 antibody test: negative negative (Negative) Sars Cov 2 serology ab IGG/IGM/ IA- negative.         Patient had similar symptoms when she had a flu shot. No concomitant information was reported. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received and contains non-significant information(AE contact information).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: received a expired dose; was administered an additional dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a expired dose) and EXTRA DOSE ADMINISTERED (was administered an additional dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a expired dose) and EXTRA DOSE ADMINISTERED (was administered an additional dose). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (received a expired dose) and EXTRA DOSE ADMINISTERED (was administered an additional dose) 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 information was provided.  A pharmacy had administered 3 doses of Moderna covid-19 vaccine to patient which had been punctured and stored at room temperature for between 18-24 hours. The vaccine had been punctured on 10MAY2021 and left on the counter overnight before 3 doses were administered the following day on 11MAY2021. All doses were administered from 1, 10 dose vial lot number 031B21A. The facility then determined that this vaccine had "expired" and administered an additional dose of vaccine. The dose had been stored within the recommended conditions, administered the same day, lot number 031B21A. The concerning dose of vaccine had not experienced any previous temperature excursions.   Patient had not experienced any known symptoms since receiving 3 doses of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Patient demographics and dates of dose updated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Headache
Clinical narrative: heart pain; Shoulder pain; headache; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST PAIN (heart pain), ARTHRALGIA (Shoulder pain) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Irritable bowel syndrome, Latex allergy, Allergy to metals (nickel) and Drug allergy (bactrim). Concomitant products included SENNOSIDE A+B (CLEARLAX [SENNOSIDE A+B]) for Constipation, ESTRADIOL (ESTRACE) and VITAMIN D NOS for an unknown indication.    On 14-Apr-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (heart pain), ARTHRALGIA (Shoulder pain) and HEADACHE (headache). At the time of the report, CHEST PAIN (heart pain) was resolving, ARTHRALGIA (Shoulder pain) outcome was unknown and HEADACHE (headache) had not 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.   Patient reported at follow up, has now had an "ekg" and a chest x-ray, no results provided. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received and Event outcome updated and patient information updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle tightness, Muscular weakness, Pain in extremity
Clinical narrative: The same day of the injection only had the front of the leg tight; just little arm pain but 1 or 2 days only; Can't hold anything, her arm is so week to her elbow; a lot of chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (The same day of the injection only had the front of the leg tight), PAIN IN EXTREMITY (just little arm pain but 1 or 2 days only), MUSCULAR WEAKNESS (Can't hold anything, her arm is so week to her elbow) and CHILLS (a lot of chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder since 1989. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MUSCLE TIGHTNESS (The same day of the injection only had the front of the leg tight), PAIN IN EXTREMITY (just little arm pain but 1 or 2 days only), MUSCULAR WEAKNESS (Can't hold anything, her arm is so week to her elbow) and CHILLS (a lot of chills). On 27-Feb-2021, MUSCLE TIGHTNESS (The same day of the injection only had the front of the leg tight) and CHILLS (a lot of chills) had resolved. At the time of the report, PAIN IN EXTREMITY (just little arm pain but 1 or 2 days only) and MUSCULAR WEAKNESS (Can't hold anything, her arm is so week to her elbow) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment was taken by the patient for the adverse events.   This case was linked to MOD-2021-237500 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose from a vial that had been punctered more than 12 hours ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that had been punctered more than 12 hours ago) 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 EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that had been punctered more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that had been punctered more than 12 hours ago) 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 drug was not reported. Treatment medication was not reported.  It was reported that vaccine was administered after puncturing for more than 12 hours.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: No second dose after 2 Months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No second dose after 2 Months) 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 PRODUCT DOSE OMISSION ISSUE (No second dose after 2 Months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose after 2 Months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea after my second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea after my second dose) 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 DIARRHEA (Diarrhea after my second dose). At the time of the report, DIARRHEA (Diarrhea after my second dose) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Skin warm, Vaccination site pain, Vaccination site warmth
Clinical narrative: Vaccine site is hot to touch; Warm to touch; Arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccine site is hot to touch), SKIN WARM (Warm to touch) and VACCINATION SITE PAIN (Arm is red) 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 VACCINATION SITE WARMTH (Vaccine site is hot to touch), SKIN WARM (Warm to touch) and VACCINATION SITE PAIN (Arm is red). At the time of the report, VACCINATION SITE WARMTH (Vaccine site is hot to touch), SKIN WARM (Warm to touch) and VACCINATION SITE PAIN (Arm is red) outcome was unknown.            No relevant concomitant medications reported. No treatment medications reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Expired product administered
Clinical narrative: unable to breath; Anxiety; invalid dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (invalid dose), DYSPNOEA (unable to breath) and ANXIETY (Anxiety) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Drug allergy. Concomitant products included TRIAMTERENE, CARVEDILOL, SIMVASTATIN, ALLOPURINOL and LAMOTRIGINE for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (invalid dose) and ANXIETY (Anxiety). On an unknown date, the patient experienced DYSPNOEA (unable to breath). On 25-Jun-2021, ANXIETY (Anxiety) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (invalid dose) had resolved and DYSPNOEA (unable to breath) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19-JUL-2021 contains: Added Patient demographics- Height, weight; Added medical history- Allergies; Added dose 2 information- Route of administration, Anatomical location; Added Concomitant medications; Added event- Anxiety, Dyspnea;
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Headache, Peripheral swelling, Pyrexia
Clinical narrative: post nasal drip; Headache that comes and goes; 105 Fever; Has taste of pennies in his mouth; Lost sense of taste; Sinuses burned very badly all day like he had salt in his sinuses; Arm swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up), SINUSITIS (Sinuses burned very badly all day like he had salt in his sinuses), PYREXIA (105 Fever), HEADACHE (Headache that comes and goes) and DYSGEUSIA (Has taste of pennies in his mouth) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0388821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm swelled up). On 12-Apr-2021, the patient experienced SINUSITIS (Sinuses burned very badly all day like he had salt in his sinuses). On 19-Apr-2021, the patient experienced PYREXIA (105 Fever), HEADACHE (Headache that comes and goes), DYSGEUSIA (Has taste of pennies in his mouth) and AGEUSIA (Lost sense of taste). On an unknown date, the patient experienced UPPER-AIRWAY COUGH SYNDROME (post nasal drip). On 19-Apr-2021, PYREXIA (105 Fever) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm swelled up), HEADACHE (Headache that comes and goes), DYSGEUSIA (Has taste of pennies in his mouth), AGEUSIA (Lost sense of taste) and UPPER-AIRWAY COUGH SYNDROME (post nasal drip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.