chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by an other and describes the occurrence of TINNITUS (Tinnitus) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history ).    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 TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dysphonia, Fatigue, Vaccination site pain
Clinical narrative: hoarness /voice was really raspy; pain at the injection site; FATIGUE; weakness; loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (hoarness /voice was really raspy), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (FATIGUE), ASTHENIA (weakness) and DECREASED APPETITE (loss of appetite) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Hypertension and Arthritis. Concomitant products included GABAPENTIN, LOSARTAN, MELOXICAM and CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPHONIA (hoarness /voice was really raspy), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (FATIGUE), ASTHENIA (weakness) and DECREASED APPETITE (loss of appetite). At the time of the report, DYSPHONIA (hoarness /voice was really raspy), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (FATIGUE), ASTHENIA (weakness) and DECREASED APPETITE (loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia
Clinical narrative: Patient noticed loss of voice after receiving the 2nd shot of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Patient noticed loss of voice after receiving the 2nd shot of Moderna vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced APHONIA (Patient noticed loss of voice after receiving the 2nd shot of Moderna vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, APHONIA (Patient noticed loss of voice after receiving the 2nd shot of Moderna vaccine) was resolving.            Concomitant medications included Blood pressure medication, Diabetic medication, Post liver transplant medication and Cholesterol medication.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22-JUN-2021 contains no new information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine, Blood glucose, Blood sodium, Leukocytosis, White blood cell count
Clinical narrative: High white blood count when she got her blood works done; This spontaneous case was reported by a consumer and describes the occurrence of LEUKOCYTOSIS (High white blood count when she got her blood works done) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0BM204 and 05A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced LEUKOCYTOSIS (High white blood count when she got her blood works done). At the time of the report, LEUKOCYTOSIS (High white blood count when she got her blood works done) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood creatine: high (High) high. In February 2021, Blood glucose: low (Low) Low. In February 2021, Blood sodium: low (Low) low. In February 2021, White blood cell count: high (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt weird 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt weird 3-4 days) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included OXYCODONE and ALPRAZOLAM (XANAX) for an unknown indication.   On 19-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt weird 3-4 days). At the time of the report, FEELING ABNORMAL (felt weird 3-4 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided.   This case was linked to MOD-2021-053415 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeding) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced EPISTAXIS (Nose bleeding). At the time of the report, EPISTAXIS (Nose bleeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore throat; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (low grade fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (low grade fever). On 24-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (TYLENOL) on 23-Mar-2021 at a dose of UNK dosage form, tid. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Feeling abnormal, Hyperhidrosis, Hypersensitivity
Clinical narrative: signs of a severe allergic reaction; felt strange; racing heartbeat; extremely dizzy; sweating a little bit; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy), HYPERHIDROSIS (sweating a little bit), HYPERSENSITIVITY (signs of a severe allergic reaction), FEELING ABNORMAL (felt strange) and TACHYCARDIA (racing heartbeat) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (extremely dizzy), HYPERHIDROSIS (sweating a little bit), FEELING ABNORMAL (felt strange) and TACHYCARDIA (racing heartbeat). On an unknown date, the patient experienced HYPERSENSITIVITY (signs of a severe allergic reaction). At the time of the report, DIZZINESS (extremely dizzy), HYPERHIDROSIS (sweating a little bit), HYPERSENSITIVITY (signs of a severe allergic reaction), FEELING ABNORMAL (felt strange) and TACHYCARDIA (racing heartbeat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood pressure measurement: 136 (High) blood pressure went up (136 over something).     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 medication was reported by the reporter. No treatment was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: signs of a severe allergic reaction; felt strange; racing heartbeat; extremely dizzy; sweating a little bit; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy), HYPERHIDROSIS (sweating a little bit), HYPERSENSITIVITY (signs of a severe allergic reaction), FEELING ABNORMAL (felt strange) and TACHYCARDIA (racing heartbeat) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (extremely dizzy), HYPERHIDROSIS (sweating a little bit), FEELING ABNORMAL (felt strange) and TACHYCARDIA (racing heartbeat). On an unknown date, the patient experienced HYPERSENSITIVITY (signs of a severe allergic reaction). At the time of the report, DIZZINESS (extremely dizzy), HYPERHIDROSIS (sweating a little bit), HYPERSENSITIVITY (signs of a severe allergic reaction), FEELING ABNORMAL (felt strange) and TACHYCARDIA (racing heartbeat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood pressure measurement: 136 (High) blood pressure went up (136 over something).     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 medication was reported by the reporter. No treatment was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Musculoskeletal discomfort, Musculoskeletal stiffness, Neck pain
Clinical narrative: Left side felt stiff/neck was stiff; Could barely move her neck; pain in her neck; pain back of ear area; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Left side felt stiff/neck was stiff), MUSCULOSKELETAL DISCOMFORT (Could barely move her neck), NECK PAIN (pain in her neck) and EAR PAIN (pain back of ear area) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Left side felt stiff/neck was stiff), MUSCULOSKELETAL DISCOMFORT (Could barely move her neck), NECK PAIN (pain in her neck) and EAR PAIN (pain back of ear area). At the time of the report, MUSCULOSKELETAL STIFFNESS (Left side felt stiff/neck was stiff), MUSCULOSKELETAL DISCOMFORT (Could barely move her neck), NECK PAIN (pain in her neck) and EAR PAIN (pain back of ear area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: No specific follow-up information recorded.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LOSARTAN, TAMSULOSIN, DOXAZOSIN, TRAZODONE, OXYBUTYNIN, DESVENLAFAXINE and AMPHETAMINE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information received on 20-May-2021 contains non-significant information.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose after 45 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 45 days) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 45 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 45 days) had resolved.            No concomitant medication was reported by the reporter. No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Swelling face
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), and describes the occurrence of pruritus (face itching), erythematous rash (red rash on face) and face swelling (swelling in the face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. March 2021, patient experienced pruritus (face itching), erythematous rash (red rash on face) and face swelling (swelling in the face). At the time of the report, pruritus (face itching), erythematous rash (red rash on face) and face swelling (swelling in the face) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported. Treatment included: allergy medicine. Patient is fine now. She went to a doctor to get medicine for her side effects. It took about two weeks before the side effects went away. Most recent follow-up information incorporated above included: On May 18, 2021: Outcome of all the events updated from unknown to recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Vaccination site pain
Clinical narrative: The nurse spoke to her and said the needle broke off but she was able to give the entire dose.; getting injected she had a sharp pain and her arm still hurts.; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (The nurse spoke to her and said the needle broke off but she was able to give the entire dose.) and VACCINATION SITE PAIN (getting injected she had a sharp pain and her arm still hurts.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01Bz11A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (The nurse spoke to her and said the needle broke off but she was able to give the entire dose.) and VACCINATION SITE PAIN (getting injected she had a sharp pain and her arm still hurts.). At the time of the report, DEVICE CONNECTION ISSUE (The nurse spoke to her and said the needle broke off but she was able to give the entire dose.) had resolved and VACCINATION SITE PAIN (getting injected she had a sharp pain and her arm still hurts.) outcome was unknown.            This report refers to a case of syringe connection issue for mRNA-1273, lot #01Bz11A  with vaccination site pain.; Sender's Comments: This report refers to a case of syringe connection issue for mRNA-1273, lot #01Bz11A  with vaccination site pain.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hypoaesthesia, Sensory disturbance, Vaccination site pain
Clinical narrative: Numbness down her left arm; Pressure in her left side of the chest.; Weird sensation that she has never had before.; Pain at the site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness down her left arm), CHEST DISCOMFORT (Pressure in her left side of the chest.), SENSORY DISTURBANCE (Weird sensation that she has never had before.) and VACCINATION SITE PAIN (Pain at the site) in a 64-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site). On 26-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness down her left arm), CHEST DISCOMFORT (Pressure in her left side of the chest.) and SENSORY DISTURBANCE (Weird sensation that she has never had before.). At the time of the report, HYPOAESTHESIA (Numbness down her left arm), CHEST DISCOMFORT (Pressure in her left side of the chest.), SENSORY DISTURBANCE (Weird sensation that she has never had before.) and VACCINATION SITE PAIN (Pain at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash itching; Severe rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Rash itching) and RASH (Severe rash all over body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (Rash itching) and RASH (Severe rash all over body). At the time of the report, PRURITUS (Rash itching) and RASH (Severe rash all over body) outcome was unknown.            No Concomitant medications were reported. Patient consulted dermatologist and seeking treatment but treatment information was not reported.  The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-059450, MOD-2021-059458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up information received on 18-JUN-2021. Reporter's address and email id was updated. It contains non significant information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: FU received on 22-Jun-2021 , Contains No New Information
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) and chills (shivering, chills) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037A21B) for COVID-19 immunization. No medical history reported. On Mar 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 20, 2021, patient experienced pain in extremity (sore arm) and chills (shivering, chills). At the time of the report, pain in extremity (sore arm) and chills (shivering, chills) outcome: unknown. 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Gastrooesophageal reflux disease, Headache, Hyperhidrosis
Clinical narrative: Horrible migraine headache; Headache is killing me, very bad headache; Nausea; Chills; Acid reflux; Sweat; Earache; Pain in feet, Pain in legs; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), HYPERHIDROSIS (Sweat), EAR PAIN (Earache), PAIN IN EXTREMITY (Pain in feet, Pain in legs) and MIGRAINE (Horrible migraine headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine NOS (had regular migraine attacks).    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), HYPERHIDROSIS (Sweat), EAR PAIN (Earache), PAIN IN EXTREMITY (Pain in feet, Pain in legs), NAUSEA (Nausea) and CHILLS (Chills). On 26-Mar-2021, the patient experienced MIGRAINE (Horrible migraine headache) and HEADACHE (Headache is killing me, very bad headache). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), HYPERHIDROSIS (Sweat), EAR PAIN (Earache), PAIN IN EXTREMITY (Pain in feet, Pain in legs), MIGRAINE (Horrible migraine headache), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache is killing me, very bad headache) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up information received on 22-Jun-2021 contains non significant information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain in extremity
Clinical narrative: Horrible migraine headache; Headache is killing me, very bad headache; Nausea; Chills; Acid reflux; Sweat; Earache; Pain in feet, Pain in legs; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), HYPERHIDROSIS (Sweat), EAR PAIN (Earache), PAIN IN EXTREMITY (Pain in feet, Pain in legs) and MIGRAINE (Horrible migraine headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine NOS (had regular migraine attacks).    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), HYPERHIDROSIS (Sweat), EAR PAIN (Earache), PAIN IN EXTREMITY (Pain in feet, Pain in legs), NAUSEA (Nausea) and CHILLS (Chills). On 26-Mar-2021, the patient experienced MIGRAINE (Horrible migraine headache) and HEADACHE (Headache is killing me, very bad headache). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), HYPERHIDROSIS (Sweat), EAR PAIN (Earache), PAIN IN EXTREMITY (Pain in feet, Pain in legs), MIGRAINE (Horrible migraine headache), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache is killing me, very bad headache) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up information received on 22-Jun-2021 contains non significant information.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Papule, Rash
Clinical narrative: Rashes over abdomen, both legs, both elbows and Hands; Small bumps and redness over rashes; Small bumps and redness over rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes over abdomen, both legs, both elbows and Hands), PAPULE (Small bumps and redness over rashes) and ERYTHEMA (Small bumps and redness over rashes) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced RASH (Rashes over abdomen, both legs, both elbows and Hands), PAPULE (Small bumps and redness over rashes) and ERYTHEMA (Small bumps and redness over rashes). At the time of the report, RASH (Rashes over abdomen, both legs, both elbows and Hands), PAPULE (Small bumps and redness over rashes) and ERYTHEMA (Small bumps and redness over rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is taking blood pressure pill as concomitant medication but not specified. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia (fibral myalgia) and Rheumatoid arthritis.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Lymph node pain, Pain in extremity, Sciatica
Clinical narrative: severe sciatic nerve pain; uncontrolled hypertension; L leg pain; L arm pain; lymph node pain; lymph node numbness; This spontaneous case was reported by a pharmacist and describes the occurrence of SCIATICA (severe sciatic nerve pain), HYPERTENSION (uncontrolled hypertension), PAIN IN EXTREMITY (L leg pain), PAIN IN EXTREMITY (L arm pain) and LYMPH NODE PAIN (lymph node pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN, METFORMIN, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN/HYDROCHLOROTHIAZIDE) and INSULIN GLARGINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced SCIATICA (severe sciatic nerve pain), HYPERTENSION (uncontrolled hypertension), PAIN IN EXTREMITY (L leg pain), PAIN IN EXTREMITY (L arm pain), LYMPH NODE PAIN (lymph node pain) and HYPOAESTHESIA (lymph node numbness). The patient was treated with HYDRALAZINE ongoing from 14-Mar-2021 for Adverse event, at an unspecified dose and frequency; MORPHINE ongoing from 14-Mar-2021 for Adverse event, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing from 14-Mar-2021 at an unspecified dose and frequency. On 17-Mar-2021, SCIATICA (severe sciatic nerve pain), LYMPH NODE PAIN (lymph node pain) and HYPOAESTHESIA (lymph node numbness) had resolved. At the time of the report, HYPERTENSION (uncontrolled hypertension), PAIN IN EXTREMITY (L leg pain) and PAIN IN EXTREMITY (L arm pain) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional initial On 26-Jun-2021: F/U-2 : Hospital records; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Invalid dose administered from a vial that had been punctured and administered for a period greater than 6 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Invalid dose administered from a vial that had been punctured and administered for a period greater than six hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid dose administered from a vial that had been punctured and administered for a period greater than six hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Invalid dose administered from a vial that had been punctured and administered for a period greater) 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 were reported. No treatment related information has been reported.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Expired Vaccine Used for mRNA-1273 (Lot #: Unknown)  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches; She was feeling feverish; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (She was feeling feverish) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 26-Mar-2021 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (Body aches), PYREXIA (She was feeling feverish) and CHILLS (Chills). At the time of the report, PAIN (Body aches), PYREXIA (She was feeling feverish) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Received 1st dose of Moderna and 2nd dose of Pfizer Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received 1st dose of Moderna and 2nd dose of Pfizer Covid-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received 1st dose of Moderna and 2nd dose of Pfizer Covid-19 Vaccine). On 26-Mar-2021, WRONG PRODUCT ADMINISTERED (Received 1st dose of Moderna and 2nd dose of Pfizer Covid-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  This report refers to a case of wrong product administered for mRNA-1273 with no associated AEs.; Sender's Comments: This report refers to a case of wrong product administered for mRNA-1273 with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Heavy flu-like symptoms for about 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Heavy flu-like symptoms for about 12 hours) 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 INFLUENZA LIKE ILLNESS (Heavy flu-like symptoms for about 12 hours). At the time of the report, INFLUENZA LIKE ILLNESS (Heavy flu-like symptoms for about 12 hours) outcome was unknown.            No concomitant drugs were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Nasopharyngitis, Pyrexia
Clinical narrative: cold chills; Cold chills; fever of 102.1; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold chills), CHILLS (Cold chills) and PYREXIA (fever of 102.1) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METFORMIN for an unknown indication.    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 NASOPHARYNGITIS (cold chills), CHILLS (Cold chills) and PYREXIA (fever of 102.1). On 27-Feb-2021, NASOPHARYNGITIS (cold chills), CHILLS (Cold chills) and PYREXIA (fever of 102.1) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102.1 High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient called 911 for the symptoms but was not taken to the hospital.   This case was linked to MOD-2021-059479 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: cold chills; Cold chills; fever of 102.1; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold chills), CHILLS (Cold chills) and PYREXIA (fever of 102.1) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METFORMIN for an unknown indication.    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 NASOPHARYNGITIS (cold chills), CHILLS (Cold chills) and PYREXIA (fever of 102.1). On 27-Feb-2021, NASOPHARYNGITIS (cold chills), CHILLS (Cold chills) and PYREXIA (fever of 102.1) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102.1 High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient called 911 for the symptoms but was not taken to the hospital.   This case was linked to MOD-2021-059479 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Nasopharyngitis, Pyrexia
Clinical narrative: Her arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her arm is really sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 010A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METFORMIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Her arm is really sore). At the time of the report, VACCINATION SITE PAIN (Her arm is really sore) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-059473.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her arm is really sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 010A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METFORMIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Her arm is really sore). At the time of the report, VACCINATION SITE PAIN (Her arm is really sore) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-059473.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: Elevated blood pressure; Fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure) and HEART RATE INCREASED (Fast heart rate) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included LABETALOL, POTASSIUM, HYDROCHLOROTHIAZIDE, RAMIPRIL and CLONIDINE for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure) and HEART RATE INCREASED (Fast heart rate). At the time of the report, BLOOD PRESSURE INCREASED (Elevated blood pressure) and HEART RATE INCREASED (Fast heart rate) outcome was unknown.            The patient went to an urgent care clinic and had a call in to her doctor. She would be having major neck surgery in April and needed to know if the vaccine could have caused the elevated blood pressure and faster heart rate. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness; Believe has 101 temperature feels hot; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), PYREXIA (Believe has 101 temperature feels hot), CHILLS (Chills) and HEADACHE (Headache) 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 25-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness), PYREXIA (Believe has 101 temperature feels hot), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm soreness), PYREXIA (Believe has 101 temperature feels hot), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101.         Concomitant product use was not provided by the reporter. Treatment included cold pak.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021 contains non-significant information.