chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Influenza like illness, Limb discomfort, Movement disorder
Clinical narrative: started feeling like flu; Arm started to hurt; Red like the size of a 1/2 dollar; Nodule; Very hot; Trouble raising her arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm started to hurt), ERYTHEMA (Red like the size of a 1/2 dollar), NODULE (Nodule), FEELING HOT (Very hot) and MOVEMENT DISORDER (Trouble raising her arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 25-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 LIMB DISCOMFORT (Arm started to hurt), ERYTHEMA (Red like the size of a 1/2 dollar), NODULE (Nodule), FEELING HOT (Very hot) and MOVEMENT DISORDER (Trouble raising her arm). On 28-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (started feeling like flu). At the time of the report, LIMB DISCOMFORT (Arm started to hurt), ERYTHEMA (Red like the size of a 1/2 dollar), NODULE (Nodule), FEELING HOT (Very hot), MOVEMENT DISORDER (Trouble raising her arm) and INFLUENZA LIKE ILLNESS (started feeling like flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: started feeling like flu; Arm started to hurt; Red like the size of a 1/2 dollar; Nodule; Very hot; Trouble raising her arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm started to hurt), ERYTHEMA (Red like the size of a 1/2 dollar), NODULE (Nodule), FEELING HOT (Very hot) and MOVEMENT DISORDER (Trouble raising her arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 25-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 LIMB DISCOMFORT (Arm started to hurt), ERYTHEMA (Red like the size of a 1/2 dollar), NODULE (Nodule), FEELING HOT (Very hot) and MOVEMENT DISORDER (Trouble raising her arm). On 28-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (started feeling like flu). At the time of the report, LIMB DISCOMFORT (Arm started to hurt), ERYTHEMA (Red like the size of a 1/2 dollar), NODULE (Nodule), FEELING HOT (Very hot), MOVEMENT DISORDER (Trouble raising her arm) and INFLUENZA LIKE ILLNESS (started feeling like flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on front side above her stomach towards left side, after receiving second dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on front side above her stomach towards left side, after receiving second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LANSOPRAZOLE and ATORVASTATIN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash on front side above her stomach towards left side, after receiving second dose). On 30-Apr-2021, RASH (Rash on front side above her stomach towards left side, after receiving second dose) had resolved. Not Provided          Treatment information was not provided.  Action taken with the mRNA-1273 in response to the event is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Additional information received, Updated the outcome of the event updated as recovered. On 25-Jun-2021: No new information
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Red band on Biceps measured 6.5" X 3" today; Stiff Injection Site; Burning/Stinging sensation at the injection site; Sore Injection Site/Burning/Stinging sensation at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red band on Biceps measured 6.5" X 3" today), VACCINATION SITE MOVEMENT IMPAIRMENT (Stiff Injection Site), INJECTION SITE WARMTH (Burning/Stinging sensation at the injection site) and VACCINATION SITE PAIN (Sore Injection Site/Burning/Stinging sensation at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-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) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced ERYTHEMA (Red band on Biceps measured 6.5" X 3" today), VACCINATION SITE MOVEMENT IMPAIRMENT (Stiff Injection Site), INJECTION SITE WARMTH (Burning/Stinging sensation at the injection site) and VACCINATION SITE PAIN (Sore Injection Site/Burning/Stinging sensation at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red band on Biceps measured 6.5" X 3" today), VACCINATION SITE MOVEMENT IMPAIRMENT (Stiff Injection Site), INJECTION SITE WARMTH (Burning/Stinging sensation at the injection site) and VACCINATION SITE PAIN (Sore Injection Site/Burning/Stinging sensation at the injection site) outcome was unknown. Not Provided          No concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash macular, Swelling
Clinical narrative: Red spot; Swollen  spot; Hot spot; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spot), SWELLING (Swollen  spot) and FEELING HOT (Hot spot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced RASH MACULAR (Red spot), SWELLING (Swollen  spot) and FEELING HOT (Hot spot). At the time of the report, RASH MACULAR (Red spot), SWELLING (Swollen  spot) and FEELING HOT (Hot spot) was resolving.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: In Telephone Contact Report (TCR) has no new information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Pain in extremity
Clinical narrative: redness below the injection site; injection was not administered in the deltoid muscle; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection was not administered in the deltoid muscle), PAIN IN EXTREMITY (sore arm) and INJECTION SITE ERYTHEMA (redness below the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection was not administered in the deltoid muscle) and PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness below the injection site). On 09-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection was not administered in the deltoid muscle) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and INJECTION SITE ERYTHEMA (redness below the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment was reported for the events.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Initial additional information received on 04-May-2021 included event of injection site erythema and updated outcome.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance
Clinical narrative: Stabbing pain in his back; he can barely walk because of his pain; This spontaneous case was reported by a non-health professional and describes the occurrence of BACK PAIN (Stabbing pain in his back) and GAIT DISTURBANCE (he can barely walk because of his pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced BACK PAIN (Stabbing pain in his back) and GAIT DISTURBANCE (he can barely walk because of his pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Stabbing pain in his back) and GAIT DISTURBANCE (he can barely walk because of his pain) had not resolved.            The reporter confirmed the patient does not take any concomitant medications.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warm to the touch; More tired than usual; Three inch pink patch under the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE ERYTHEMA (Three inch pink patch under the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SOTALOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE ERYTHEMA (Three inch pink patch under the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE ERYTHEMA (Three inch pink patch under the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not take any medication as treatment for the events. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills
Clinical narrative: upset stomach; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills) 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) dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. /unknown.  Concomitant product use was not provided/unknown by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 2x2 inch red patch on that arm, but it is 4 inches down from where she got the vaccine; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine  second dose on Thursday a( 18 Feb 2021)nd now she  have a 2x2 inch red patch on that arm, but it is 4 inches down from where she got the vaccine. The injection site itself is perfectly fine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an 18 FEB 2021, prior to the onset of events, the patient received their second  of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On an unspecified date, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, after second dose of vaccine, the patient experienced ongoing red patch . No treatment medication was reported. MIS making attempts to reach reporter for additional information. No additional information at this time.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, is unknown; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria
Clinical narrative: Hard time to Urinate; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Hard time to Urinate) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer. Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DYSURIA (Hard time to Urinate). At the time of the report, DYSURIA (Hard time to Urinate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Itchy spots; Rash on knees; Joint Aches; Extreme Fatigue; Headache; Body aches; Teeth Chattering, chills; Fever; Flooding of "metallic" sensation; Sore Arm; Dizziness; Hives on chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAROSMIA (Flooding of "metallic" sensation), PAIN IN EXTREMITY (Sore Arm), DIZZINESS (Dizziness), URTICARIA (Hives on chest) and PRURITUS (Itchy spots) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis since an unknown date. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAROSMIA (Flooding of "metallic" sensation), PAIN IN EXTREMITY (Sore Arm), DIZZINESS (Dizziness), URTICARIA (Hives on chest), ARTHRALGIA (Joint Aches), FATIGUE (Extreme Fatigue), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Teeth Chattering, chills) and PYREXIA (Fever). On 19-Feb-2021, the patient experienced PRURITUS (Itchy spots) and RASH (Rash on knees). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, Joint ache, sore arm, Chills, Pain in extremity and Fatigue, at an unspecified dose and frequency. At the time of the report, PAROSMIA (Flooding of "metallic" sensation), PAIN IN EXTREMITY (Sore Arm), DIZZINESS (Dizziness), URTICARIA (Hives on chest), PRURITUS (Itchy spots), RASH (Rash on knees), ARTHRALGIA (Joint Aches), FATIGUE (Extreme Fatigue), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Teeth Chattering, chills) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has consulted her immunologist prior to vaccination and recommended take have it.  Also insisted to have 2 dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Parosmia, Pruritus, Pyrexia
Clinical narrative: Itchy spots; Rash on knees; Joint Aches; Extreme Fatigue; Headache; Body aches; Teeth Chattering, chills; Fever; Flooding of "metallic" sensation; Sore Arm; Dizziness; Hives on chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAROSMIA (Flooding of "metallic" sensation), PAIN IN EXTREMITY (Sore Arm), DIZZINESS (Dizziness), URTICARIA (Hives on chest) and PRURITUS (Itchy spots) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis since an unknown date. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAROSMIA (Flooding of "metallic" sensation), PAIN IN EXTREMITY (Sore Arm), DIZZINESS (Dizziness), URTICARIA (Hives on chest), ARTHRALGIA (Joint Aches), FATIGUE (Extreme Fatigue), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Teeth Chattering, chills) and PYREXIA (Fever). On 19-Feb-2021, the patient experienced PRURITUS (Itchy spots) and RASH (Rash on knees). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, Joint ache, sore arm, Chills, Pain in extremity and Fatigue, at an unspecified dose and frequency. At the time of the report, PAROSMIA (Flooding of "metallic" sensation), PAIN IN EXTREMITY (Sore Arm), DIZZINESS (Dizziness), URTICARIA (Hives on chest), PRURITUS (Itchy spots), RASH (Rash on knees), ARTHRALGIA (Joint Aches), FATIGUE (Extreme Fatigue), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Teeth Chattering, chills) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has consulted her immunologist prior to vaccination and recommended take have it.  Also insisted to have 2 dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Itchy spots; Rash on knees; Joint Aches; Extreme Fatigue; Headache; Body aches; Teeth Chattering, chills; Fever; Flooding of "metallic" sensation; Sore Arm; Dizziness; Hives on chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAROSMIA (Flooding of "metallic" sensation), PAIN IN EXTREMITY (Sore Arm), DIZZINESS (Dizziness), URTICARIA (Hives on chest) and PRURITUS (Itchy spots) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis since an unknown date. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAROSMIA (Flooding of "metallic" sensation), PAIN IN EXTREMITY (Sore Arm), DIZZINESS (Dizziness), URTICARIA (Hives on chest), ARTHRALGIA (Joint Aches), FATIGUE (Extreme Fatigue), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Teeth Chattering, chills) and PYREXIA (Fever). On 19-Feb-2021, the patient experienced PRURITUS (Itchy spots) and RASH (Rash on knees). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, Joint ache, sore arm, Chills, Pain in extremity and Fatigue, at an unspecified dose and frequency. At the time of the report, PAROSMIA (Flooding of "metallic" sensation), PAIN IN EXTREMITY (Sore Arm), DIZZINESS (Dizziness), URTICARIA (Hives on chest), PRURITUS (Itchy spots), RASH (Rash on knees), ARTHRALGIA (Joint Aches), FATIGUE (Extreme Fatigue), HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Teeth Chattering, chills) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has consulted her immunologist prior to vaccination and recommended take have it.  Also insisted to have 2 dose.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 16 years old and received the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 16 years old and received the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 16 years old and received the vaccine). On 08-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 16 years old and received the vaccine) had resolved. Unknown          no concomitant medications reported. no treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Additional information received on 11-MAR-2021, No new information found.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old d female) for mRNA-1273 (lot number 013A21A) with no associated AEs reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Chills, Dizziness, Fatigue, Headache
Clinical narrative: light dizziness; light sweating; dizziness; sweating profusely; sore arm; temp of 95; headache; exhausted; chills / Teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp of 95), DIZZINESS (dizziness), HYPERHIDROSIS (sweating profusely) and DIZZINESS (light dizziness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had COVID-19 about 6 weeks ago (prior to vaccination).).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp of 95), HEADACHE (headache), FATIGUE (exhausted) and CHILLS (chills / Teeth chattering). On 07-Mar-2021, the patient experienced DIZZINESS (dizziness) and HYPERHIDROSIS (sweating profusely). On 09-Mar-2021, the patient experienced DIZZINESS (light dizziness) and HYPERHIDROSIS (light sweating). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Pain, at an unspecified dose and frequency. On 04-Mar-2021, PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp of 95), HEADACHE (headache), FATIGUE (exhausted) and CHILLS (chills / Teeth chattering) had resolved. On 07-Mar-2021, DIZZINESS (dizziness) and HYPERHIDROSIS (sweating profusely) had resolved. On 09-Mar-2021, DIZZINESS (light dizziness) and HYPERHIDROSIS (light sweating) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity
Clinical narrative: light dizziness; light sweating; dizziness; sweating profusely; sore arm; temp of 95; headache; exhausted; chills / Teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp of 95), DIZZINESS (dizziness), HYPERHIDROSIS (sweating profusely) and DIZZINESS (light dizziness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had COVID-19 about 6 weeks ago (prior to vaccination).).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp of 95), HEADACHE (headache), FATIGUE (exhausted) and CHILLS (chills / Teeth chattering). On 07-Mar-2021, the patient experienced DIZZINESS (dizziness) and HYPERHIDROSIS (sweating profusely). On 09-Mar-2021, the patient experienced DIZZINESS (light dizziness) and HYPERHIDROSIS (light sweating). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Pain, at an unspecified dose and frequency. On 04-Mar-2021, PAIN IN EXTREMITY (sore arm), BODY TEMPERATURE ABNORMAL (temp of 95), HEADACHE (headache), FATIGUE (exhausted) and CHILLS (chills / Teeth chattering) had resolved. On 07-Mar-2021, DIZZINESS (dizziness) and HYPERHIDROSIS (sweating profusely) had resolved. On 09-Mar-2021, DIZZINESS (light dizziness) and HYPERHIDROSIS (light sweating) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Itchy; "Looked like it had bee sting"; "Rashy"; "Super" red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING ("Looked like it had bee sting"), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH ("Rashy") and VACCINATION SITE ERYTHEMA ("Super" red) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010AZ(orL)IA) for COVID-19 vaccination.     The patient's past medical history included Celiac disease. Concurrent medical conditions included Gluten intolerance.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE SWELLING ("Looked like it had bee sting"), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH ("Rashy") and VACCINATION SITE ERYTHEMA ("Super" red). At the time of the report, VACCINATION SITE SWELLING ("Looked like it had bee sting"), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH ("Rashy") and VACCINATION SITE ERYTHEMA ("Super" red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment details not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: all the side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (all the side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (all the side effects). At the time of the report, VACCINATION COMPLICATION (all the side effects) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the events.     Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: lump around injection site; redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE MASS (lump around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site). At the time of the report, VACCINATION SITE MASS (lump around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included applying ice packs topically.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Feeling Sick; Pains; Shaking; Vertigo; Dizziness; Sore throat; Aches; Severe headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling Sick), PAIN (Pains), TREMOR (Shaking), VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DESVENLAFAXINE SUCCINATE (PRISTIQ) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 09-Mar-2021 at 10:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MALAISE (Feeling Sick), PAIN (Pains), TREMOR (Shaking), VERTIGO (Vertigo), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Aches), HEADACHE (Severe headache) and NAUSEA (Nausea). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling Sick), PAIN (Pains), TREMOR (Shaking), VERTIGO (Vertigo), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Aches), HEADACHE (Severe headache) and NAUSEA (Nausea) outcome was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Tremor, Vertigo
Clinical narrative: Feeling Sick; Pains; Shaking; Vertigo; Dizziness; Sore throat; Aches; Severe headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling Sick), PAIN (Pains), TREMOR (Shaking), VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DESVENLAFAXINE SUCCINATE (PRISTIQ) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 09-Mar-2021 at 10:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MALAISE (Feeling Sick), PAIN (Pains), TREMOR (Shaking), VERTIGO (Vertigo), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Aches), HEADACHE (Severe headache) and NAUSEA (Nausea). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling Sick), PAIN (Pains), TREMOR (Shaking), VERTIGO (Vertigo), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Aches), HEADACHE (Severe headache) and NAUSEA (Nausea) outcome was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Mammogram
Clinical narrative: Right boob is bigger than the other one, looks swollen; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Right boob is bigger than the other one, looks swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) and FENOFIBRATE.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced BREAST SWELLING (Right boob is bigger than the other one, looks swollen). At the time of the report, BREAST SWELLING (Right boob is bigger than the other one, looks swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Mammogram: unremarkable. unremarkable..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment was reported for the events.
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Psychogenic seizure
Clinical narrative: PNES (psychogenic nonepileptic spells); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PSYCHOGENIC SEIZURE (PNES (psychogenic nonepileptic spells)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PSYCHOGENIC SEIZURE (PNES (psychogenic nonepileptic spells)). The patient was treated with LORAZEPAM (ATIVAN) on 03-Feb-2021 for Convulsions, at a dose of 1 dosage form and EPINEPHRINE on 03-Feb-2021 for Convulsions, at a dose of 1 dosage form. At the time of the report, PSYCHOGENIC SEIZURE (PNES (psychogenic nonepileptic spells)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Electroencephalogram: pnes (abnormal) PNES (psychogenic nonepileptic spells).         Patient began having major convulsions within 10 minutes of receiving second dose, and was transported to the emergency room (ER). On 03-MAR-2021, patient's neurologist diagnosed with PNES (psychogenic non epileptic spells) requiring CBT (Cognitive behavioral therapy).   This case was linked to MOD-2021-046737 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swollen; arm was very itchy; redness, going from her shoulder down to her elbow; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen), VACCINATION SITE PRURITUS (arm was very itchy), VACCINATION SITE ERYTHEMA (redness, going from her shoulder down to her elbow) and HEADACHE (severe headaches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swollen), VACCINATION SITE PRURITUS (arm was very itchy), VACCINATION SITE ERYTHEMA (redness, going from her shoulder down to her elbow) and HEADACHE (severe headaches). At the time of the report, VACCINATION SITE SWELLING (swollen), VACCINATION SITE PRURITUS (arm was very itchy), VACCINATION SITE ERYTHEMA (redness, going from her shoulder down to her elbow) and HEADACHE (severe headaches) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Had no appetite; Experienced overwhelming weakness; No energy at all, fatigue was getting worse; Became breathless; She had anxiety about this; Stayed awake the entire night because she was afraid she would go to sleep and not wake up again; Very sleepy, stayed in bed until 2:00 PM; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Became breathless), ANXIETY (She had anxiety about this), INSOMNIA (Stayed awake the entire night because she was afraid she would go to sleep and not wake up again), SOMNOLENCE (Very sleepy, stayed in bed until 2:00 PM) and DECREASED APPETITE (Had no appetite) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Emphysema.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SOMNOLENCE (Very sleepy, stayed in bed until 2:00 PM). On 03-Mar-2021, the patient experienced DYSPNOEA (Became breathless), ANXIETY (She had anxiety about this) and INSOMNIA (Stayed awake the entire night because she was afraid she would go to sleep and not wake up again). On 04-Mar-2021, the patient experienced DECREASED APPETITE (Had no appetite), ASTHENIA (Experienced overwhelming weakness) and FATIGUE (No energy at all, fatigue was getting worse). On 10-Mar-2021, DYSPNOEA (Became breathless), ANXIETY (She had anxiety about this), INSOMNIA (Stayed awake the entire night because she was afraid she would go to sleep and not wake up again), SOMNOLENCE (Very sleepy, stayed in bed until 2:00 PM), DECREASED APPETITE (Had no appetite), ASTHENIA (Experienced overwhelming weakness) and FATIGUE (No energy at all, fatigue was getting worse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment medications was not provided by the reporter
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Somnolence
Clinical narrative: Had no appetite; Experienced overwhelming weakness; No energy at all, fatigue was getting worse; Became breathless; She had anxiety about this; Stayed awake the entire night because she was afraid she would go to sleep and not wake up again; Very sleepy, stayed in bed until 2:00 PM; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Became breathless), ANXIETY (She had anxiety about this), INSOMNIA (Stayed awake the entire night because she was afraid she would go to sleep and not wake up again), SOMNOLENCE (Very sleepy, stayed in bed until 2:00 PM) and DECREASED APPETITE (Had no appetite) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Emphysema.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SOMNOLENCE (Very sleepy, stayed in bed until 2:00 PM). On 03-Mar-2021, the patient experienced DYSPNOEA (Became breathless), ANXIETY (She had anxiety about this) and INSOMNIA (Stayed awake the entire night because she was afraid she would go to sleep and not wake up again). On 04-Mar-2021, the patient experienced DECREASED APPETITE (Had no appetite), ASTHENIA (Experienced overwhelming weakness) and FATIGUE (No energy at all, fatigue was getting worse). On 10-Mar-2021, DYSPNOEA (Became breathless), ANXIETY (She had anxiety about this), INSOMNIA (Stayed awake the entire night because she was afraid she would go to sleep and not wake up again), SOMNOLENCE (Very sleepy, stayed in bed until 2:00 PM), DECREASED APPETITE (Had no appetite), ASTHENIA (Experienced overwhelming weakness) and FATIGUE (No energy at all, fatigue was getting worse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment medications was not provided by the reporter
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Shingles; Developed 2 small red blisters on left side of her cheek and buttock, progressing to the left side of body; Rash about 7-8" long starts on left buttock and follows her back; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), BLISTER (Developed 2 small red blisters on left side of her cheek and buttock, progressing to the left side of body) and RASH (Rash about 7-8" long starts on left buttock and follows her back) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) and LEVONORGESTREL (MIRENA) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, the patient experienced HERPES ZOSTER (Shingles) and BLISTER (Developed 2 small red blisters on left side of her cheek and buttock, progressing to the left side of body). In March 2021, the patient experienced RASH (Rash about 7-8" long starts on left buttock and follows her back). At the time of the report, HERPES ZOSTER (Shingles), BLISTER (Developed 2 small red blisters on left side of her cheek and buttock, progressing to the left side of body) and RASH (Rash about 7-8" long starts on left buttock and follows her back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She indicated she has a reddish color with blisters in a straight line or string that starts on her butt cheecks and follows back as well. On 08-Mar-2021, the patient went to see her physician. On 10-Mar-2021, her physician diagnosed her with shingles. Treatment included doxycycline, triamcinolone, valacyclovir and gabapentin.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Unable to make the second appointment; missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to make the second appointment) and PRODUCT DOSE OMISSION ISSUE (missed second dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ANAGRELIDE, VITAMIN D3, ZINC, OLMESARTAN MEDOXOMIL (BENICAR), NIFEDIPINE, ATENOLOL and LORAZEPAM for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to make the second appointment) and PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to make the second appointment) had resolved and PRODUCT DOSE OMISSION ISSUE (missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated no side effects were experienced due to the vaccine. The patient also reported having heart issues for years and was unable to make the second appointment.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Significant follow-up information received. Added missed second dose as an event.