chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Tightness in the chest; Vaccine spilled; Re-vaccinated patient; Vaccine spilled; Body aches; Severe fatigue; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Tightness in the chest), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine spilled), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Re-vaccinated patient), UNDERDOSE (Vaccine spilled) and PAIN (Body aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history provided).    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 CHEST DISCOMFORT (Tightness in the chest), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine spilled), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Re-vaccinated patient), UNDERDOSE (Vaccine spilled), PAIN (Body aches) and FATIGUE (Severe fatigue). On 03-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine spilled), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Re-vaccinated patient) and UNDERDOSE (Vaccine spilled) had resolved. At the time of the report, CHEST DISCOMFORT (Tightness in the chest) and PAIN (Body aches) had not resolved and FATIGUE (Severe fatigue) 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.   There was no concomitant list.  Treatment medication not provided.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Less than 0.5ml of 2nd dose administered; Syringe connection issue; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Less than 0.5ml of 2nd dose administered) and DEVICE CONNECTION ISSUE (Syringe connection issue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction (No reported medical history).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3. On 25-Mar-2021, the patient experienced UNDERDOSE (Less than 0.5ml of 2nd dose administered) and DEVICE CONNECTION ISSUE (Syringe connection issue). On 25-Mar-2021, UNDERDOSE (Less than 0.5ml of 2nd dose administered) and DEVICE CONNECTION ISSUE (Syringe connection issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. This report refers to a case of Underdose and Device connection issue, for mRNA-1273, lot # unknown,  with no associated AEs.; Sender's Comments: This report refers to a case of Underdose and Device connection issue, for mRNA-1273, lot # unknown,  with no associated AEs.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Made me sick for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Made me sick for a couple of days) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007DZ10) for COVID-19 vaccination.     The patient's past medical history included COVID-19, Pneumonia in December 2020 and Hospitalization (was hospitalized for COVID-19 and pneumonia). Concurrent medical conditions included Blood cholesterol abnormal and Heart disease, unspecified.    On 23-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 ILLNESS (Made me sick for a couple of days). At the time of the report, ILLNESS (Made me sick for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information was received on 11 May 2021, patient hung up when asked to provide email address so no new information was received.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth ) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth ). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. Patient's arm was hot, she applied something cold to it, then was fine.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Heaviness in arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heaviness in arm) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced LIMB DISCOMFORT (Heaviness in arm). On 18-Mar-2021, LIMB DISCOMFORT (Heaviness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. The patient did not receive any treatment.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: got real nauseated; vomited three times; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (got real nauseated) and VOMITING (vomited three times) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart failure. Concurrent medical conditions included Blood pressure high.    On 22-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 NAUSEA (got real nauseated) and VOMITING (vomited three times). At the time of the report, NAUSEA (got real nauseated) and VOMITING (vomited three times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medicine.  Patient vomited 3 times. Vomit was completely liquid and kind of yellow. Patient then went to lay down and staid in bed for 4-5 hours.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. he had been having problems with his arm hurting every day. The pain was  greater in the morning and seems to improved  but not resolved by the evenings. He also noted that his pain was  worse with lying down.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Sensory loss, Vaccination site swelling
Clinical narrative: dizziness; Sensation loss; Sensation loss; Sensation loss; fatigue; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), the first episode of SENSORY LOSS (Sensation loss), the second episode of SENSORY LOSS (Sensation loss), the third episode of SENSORY LOSS (Sensation loss) and FATIGUE (fatigue) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (dizziness), the first episode of SENSORY LOSS (Sensation loss), the second episode of SENSORY LOSS (Sensation loss), the third episode of SENSORY LOSS (Sensation loss), FATIGUE (fatigue) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, DIZZINESS (dizziness), the last episode of SENSORY LOSS (Sensation loss), FATIGUE (fatigue) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided. On 24Mar2021, he started experiencing fatigue, dizziness, decreased sensation not quite numbness or tingling, a sensation in between on the left side of face. Vaccine was administered on the left arm. Roof of his mouth and around his lips had decreased sensation as well. His left arm was swollen but not red at the injection site. He did not use anything to treat his symptoms.   Caller provided consent to follow up with her.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal pain, Muscle spasms
Clinical narrative: severe painful colon cramping; Severe Spasms; Diarrhea/ really bad for 24 hours could not even make it to the hospital due to the diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (severe painful colon cramping), MUSCLE SPASMS (Severe Spasms) and DIARRHOEA (Diarrhea/ really bad for 24 hours could not even make it to the hospital due to the diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced GASTROINTESTINAL PAIN (severe painful colon cramping), MUSCLE SPASMS (Severe Spasms) and DIARRHOEA (Diarrhea/ really bad for 24 hours could not even make it to the hospital due to the diarrhea). On 25-Feb-2021, GASTROINTESTINAL PAIN (severe painful colon cramping), MUSCLE SPASMS (Severe Spasms) and DIARRHOEA (Diarrhea/ really bad for 24 hours could not even make it to the hospital due to the diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Doctor prescribed muscle relaxers to take 12 hours before receiving the 2nd dose and she received the 2nd dose 25 Mar 2021. First dose reaction was so bad that on a scale of 1 to 10 she had a 15 reaction.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Reporters address added. Second dose information added. Reporters first name updated. Reporter type and occupation were updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dry mouth, Migraine
Clinical narrative: Dry mouth; Migraine headaches; Dizziness; Weak; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), MIGRAINE (Migraine headaches), DIZZINESS (Dizziness), ASTHENIA (Weak) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for an unknown indication.    On 24-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 DRY MOUTH (Dry mouth), MIGRAINE (Migraine headaches), DIZZINESS (Dizziness), ASTHENIA (Weak) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DRY MOUTH (Dry mouth), MIGRAINE (Migraine headaches), DIZZINESS (Dizziness), ASTHENIA (Weak) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: tooth abscess; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH ABSCESS (tooth abscess) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 24-Feb-2021, the patient experienced TOOTH ABSCESS (tooth abscess). At the time of the report, TOOTH ABSCESS (tooth abscess) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes antibiotic for tooth abscess.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: Rash on her left ankle which then went to her right ankle, hands and wrist looked like little red raised bumps; Hands and wrist looked like little red raised bumps; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash on her left ankle which then went to her right ankle, hands and wrist looked like little red raised bumps) and PERIPHERAL SWELLING (Hands and wrist looked like little red raised bumps) in a 59-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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Rash on her left ankle which then went to her right ankle, hands and wrist looked like little red raised bumps) and PERIPHERAL SWELLING (Hands and wrist looked like little red raised bumps). At the time of the report, RASH ERYTHEMATOUS (Rash on her left ankle which then went to her right ankle, hands and wrist looked like little red raised bumps) and PERIPHERAL SWELLING (Hands and wrist looked like little red raised bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient reported that the AEs did not occur because of the vaccine.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Oxygen saturation, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Sinus infection; Nose running wild; Running a slight fever between 99°F and 100°F; Vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), SINUSITIS (Sinus infection), RHINORRHOEA (Nose running wild), PYREXIA (Running a slight fever between 99°F and 100°F) and VOMITING (Vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 01-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 DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On an unknown date, the patient experienced SINUSITIS (Sinus infection), RHINORRHOEA (Nose running wild) and PYREXIA (Running a slight fever between 99°F and 100°F). The patient was treated with AZITHROMYCIN for Sinus infection, at an unspecified dose and frequency. On 08-Mar-2021, VOMITING (Vomiting) had resolved. At the time of the report, DIARRHOEA (Diarrhea), SINUSITIS (Sinus infection), RHINORRHOEA (Nose running wild) and PYREXIA (Running a slight fever between 99°F and 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, SARS-CoV-2 test positive: Positive. On an unknown date, Oxygen saturation: 97 Inconclusive. On an unknown date, Pyrexia: 99°f (Low) slight fever between 99°F and 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included Tussan, Advil and Azithromycin tabet.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Vomiting
Clinical narrative: Sinus infection; Nose running wild; Running a slight fever between 99°F and 100°F; Vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), SINUSITIS (Sinus infection), RHINORRHOEA (Nose running wild), PYREXIA (Running a slight fever between 99°F and 100°F) and VOMITING (Vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 01-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 DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On an unknown date, the patient experienced SINUSITIS (Sinus infection), RHINORRHOEA (Nose running wild) and PYREXIA (Running a slight fever between 99°F and 100°F). The patient was treated with AZITHROMYCIN for Sinus infection, at an unspecified dose and frequency. On 08-Mar-2021, VOMITING (Vomiting) had resolved. At the time of the report, DIARRHOEA (Diarrhea), SINUSITIS (Sinus infection), RHINORRHOEA (Nose running wild) and PYREXIA (Running a slight fever between 99°F and 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, SARS-CoV-2 test positive: Positive. On an unknown date, Oxygen saturation: 97 Inconclusive. On an unknown date, Pyrexia: 99°f (Low) slight fever between 99°F and 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included Tussan, Advil and Azithromycin tabet.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: 2 inch diameter redness below injection site; A bit sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (2 inch diameter redness below injection site) and VACCINATION SITE PAIN (A bit sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (2 inch diameter redness below injection site). 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (A bit sore). At the time of the report, VACCINATION SITE ERYTHEMA (2 inch diameter redness below injection site) and VACCINATION SITE PAIN (A bit sore) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nauseous) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and LAMOTRIGINE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Spinal stenosis.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Gingival bleeding, Gingivitis, Nausea
Clinical narrative: Bleeding from her gums; Felt she has gingivitis; Dizziness; Shortness of breath; Heart racing; Rash on injection site; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL BLEEDING (Bleeding from her gums), GINGIVITIS (Felt she has gingivitis), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath) and PALPITATIONS (Heart racing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart racing), VACCINATION SITE RASH (Rash on injection site) and NAUSEA (Nauseous). On 25-Mar-2021, the patient experienced GINGIVAL BLEEDING (Bleeding from her gums) and GINGIVITIS (Felt she has gingivitis). The patient was treated with PENICILLIN NOS (PENICILLIN [PENICILLIN NOS]) at an unspecified dose and frequency. On 24-Mar-2021, DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart racing) and NAUSEA (Nauseous) had resolved. At the time of the report, GINGIVAL BLEEDING (Bleeding from her gums), GINGIVITIS (Felt she has gingivitis) and VACCINATION SITE RASH (Rash on injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vaccination site rash
Clinical narrative: Bleeding from her gums; Felt she has gingivitis; Dizziness; Shortness of breath; Heart racing; Rash on injection site; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL BLEEDING (Bleeding from her gums), GINGIVITIS (Felt she has gingivitis), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath) and PALPITATIONS (Heart racing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart racing), VACCINATION SITE RASH (Rash on injection site) and NAUSEA (Nauseous). On 25-Mar-2021, the patient experienced GINGIVAL BLEEDING (Bleeding from her gums) and GINGIVITIS (Felt she has gingivitis). The patient was treated with PENICILLIN NOS (PENICILLIN [PENICILLIN NOS]) at an unspecified dose and frequency. On 24-Mar-2021, DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart racing) and NAUSEA (Nauseous) had resolved. At the time of the report, GINGIVAL BLEEDING (Bleeding from her gums), GINGIVITIS (Felt she has gingivitis) and VACCINATION SITE RASH (Rash on injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: No appetite; Brain fog; Lot of exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), FEELING ABNORMAL (Brain fog) and FATIGUE (Lot of exhaustion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, LEVOTHYROXINE, PROPRANOLOL and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DECREASED APPETITE (No appetite), FEELING ABNORMAL (Brain fog) and FATIGUE (Lot of exhaustion). At the time of the report, DECREASED APPETITE (No appetite) and FEELING ABNORMAL (Brain fog) had not resolved and FATIGUE (Lot of exhaustion) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Tooth infection, Toothache
Clinical narrative: Infection; Bad toothache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOOTHACHE (Bad toothache) and TOOTH INFECTION (Infection) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced TOOTHACHE (Bad toothache). On an unknown date, the patient experienced TOOTH INFECTION (Infection). At the time of the report, TOOTHACHE (Bad toothache) and TOOTH INFECTION (Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included unspecified Antibiotics.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itchy; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy) and INJECTION SITE RASH (Rash at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Itchy) and INJECTION SITE RASH (Rash at the injection site). At the time of the report, INJECTION SITE PRURITUS (Itchy) and INJECTION SITE RASH (Rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm hurt) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (Lymph nodes taken out of her right arm). Concurrent medical conditions included Cancer.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (My arm hurt). On 18-Mar-2021, PAIN IN EXTREMITY (My arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not receive any treatment
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Vaccination site pain, White blood cell count
Clinical narrative: arm became is extremely red covering an area of half a palm of a hand; very itchy; itchiness started, but came and went; left arm was a little achy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness started, but came and went), INJECTION SITE ERYTHEMA (arm became is extremely red covering an area of half a palm of a hand), INJECTION SITE PRURITUS (very itchy) and VACCINATION SITE PAIN (left arm was a little achy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: pneumococcal shot. Concomitant products included VITAMIN D NOS, MECOBALAMIN (VITAMIN B12 [MECOBALAMIN]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm was a little achy). On 17-Mar-2021, the patient experienced PRURITUS (itchiness started, but came and went). On 23-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (arm became is extremely red covering an area of half a palm of a hand) and INJECTION SITE PRURITUS (very itchy). On 17-Mar-2021, VACCINATION SITE PAIN (left arm was a little achy) outcome was unknown. At the time of the report, PRURITUS (itchiness started, but came and went), INJECTION SITE ERYTHEMA (arm became is extremely red covering an area of half a palm of a hand) and INJECTION SITE PRURITUS (very itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 2,8 (Low) 2,8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Rhinorrhoea
Clinical narrative: Runny nose; Some achiness; glands on the left side were swollen/swollen glands in neck; Mild Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), PAIN (Some achiness), LYMPHADENOPATHY (glands on the left side were swollen/swollen glands in neck) and HEADACHE (Mild Headache) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Polymyalgia rheumatica (Currently in Remission Since June 2020) in October 2020, Blood pressure high and GERD. Concurrent medical conditions included Hypothyroidism since 1991, Sulfonamide allergy, Drug allergy (Dorzolamide), Latex allergy and Fructose. Concomitant products included PIROXICAM (MAXIDENE), TIMOLOL MALEATE (LOTENSIN [TIMOLOL MALEATE]) and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Blood pressure high, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for GERD.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RHINORRHOEA (Runny nose), PAIN (Some achiness), LYMPHADENOPATHY (glands on the left side were swollen/swollen glands in neck) and HEADACHE (Mild Headache). At the time of the report, RHINORRHOEA (Runny nose) had not resolved, PAIN (Some achiness) outcome was unknown and LYMPHADENOPATHY (glands on the left side were swollen/swollen glands in neck) and HEADACHE (Mild Headache) had resolved.            Concomitant medication also included : Thyroid Compound Med (ongoing)  (oral) 88/28 mcg for hypothyroidism. Patient stated that  only other possible complicating factor might be that patient  had had an epidural injection 2 weeks prior to final Moderna Vaccine injection.  Patient called that doctor's office who  told  that the Epidural could not possibly have been a factor.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Patient demographics, medical history, vaccination facility details, dose details, concomitant medications and events  added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Pyrexia
Clinical narrative: Very nervous; Fluctuating fever; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Very nervous) and PYREXIA (Fluctuating fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced NERVOUSNESS (Very nervous). 22-Mar-2021, the patient experienced PYREXIA (Fluctuating fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, NERVOUSNESS (Very nervous) and PYREXIA (Fluctuating fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Pyrexia: 101 (High) fever highest is reported as 101 and lowest being 99.1.         No relevant concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad headache after the 2nd shot of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache after the 2nd shot of vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-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 25-Mar-2021, the patient experienced HEADACHE (Bad headache after the 2nd shot of vaccine). At the time of the report, HEADACHE (Bad headache after the 2nd shot of vaccine) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Fast heart beat (105 BPM); This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart beat (105 BPM)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 HEART RATE INCREASED (Fast heart beat (105 BPM)). On 01-Mar-2021, HEART RATE INCREASED (Fast heart beat (105 BPM)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Heart rate: 105 (High) 105 BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Inflammation, Myalgia, Neck pain
Clinical narrative: Neck pain; all over body inflammation; Shoulder Pain; Pain in the legs muscles/the pain is similar to Polymyalgia Rheumatica that she had a few years ago; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), INFLAMMATION (all over body inflammation), ARTHRALGIA (Shoulder Pain), MYALGIA (Pain in the legs muscles/the pain is similar to Polymyalgia Rheumatica that she had a few years ago) and HEADACHE (Headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Polymyalgia rheumatica (Recurrence after 7 Years of having disease under control) since 02-Jan-2012. Concurrent medical conditions included Drug allergy (Sulfa Drugs), Glaucoma since 15-May-1990, Hypothyroidism since 01-Jun-1965 and Seasonal allergy (allergies). Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 15-Feb-2010 to an unknown date for Allergy, LATANOPROST (LATANOPROST-OPTIC) from 15-May-1990 to an unknown date for Glaucoma, LEVOTHYROXINE from 01-Jun-1965 to an unknown date for Hypothyroidism, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FISH OIL from 10-Feb-1995 to an unknown date and VITAMIN D NOS from 01-May-2002 to an unknown date for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced NECK PAIN (Neck pain), INFLAMMATION (all over body inflammation), ARTHRALGIA (Shoulder Pain), MYALGIA (Pain in the legs muscles/the pain is similar to Polymyalgia Rheumatica that she had a few years ago) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form; IBUPROFEN at a dose of UNK dosage form and PREDNISONE on 04-Apr-2021 for Pain, at a dose of 5 mg twice a day. On 25-May-2021, NECK PAIN (Neck pain), INFLAMMATION (all over body inflammation), ARTHRALGIA (Shoulder Pain), MYALGIA (Pain in the legs muscles/the pain is similar to Polymyalgia Rheumatica that she had a few years ago) and HEADACHE (Headaches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   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 02-Jul-2021: Significant follow-up, New event updated- all over body inflammation, all events outcome updated to Recovered/Resolved and concomitant drugs added. On 06-Jul-2021: ADR: FU 3 and FU 4 - no new information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Eye swelling, Limb discomfort, Pain
Clinical narrative: Legs felt very heavy like they weighed 500 pounds; hurt all over; chills; Eyes became swollen; Face became swollen; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes became swollen), LIMB DISCOMFORT (Legs felt very heavy like they weighed 500 pounds), PAIN (hurt all over), SWELLING FACE (Face became swollen) and CHILLS (chills) in a 54-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 24-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 EYE SWELLING (Eyes became swollen) and SWELLING FACE (Face became swollen). On 25-Mar-2021, the patient experienced LIMB DISCOMFORT (Legs felt very heavy like they weighed 500 pounds), PAIN (hurt all over) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Eyes became swollen), LIMB DISCOMFORT (Legs felt very heavy like they weighed 500 pounds), PAIN (hurt all over), SWELLING FACE (Face became swollen) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Legs felt very heavy like they weighed 500 pounds; hurt all over; chills; Eyes became swollen; Face became swollen; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes became swollen), LIMB DISCOMFORT (Legs felt very heavy like they weighed 500 pounds), PAIN (hurt all over), SWELLING FACE (Face became swollen) and CHILLS (chills) in a 54-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 24-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 EYE SWELLING (Eyes became swollen) and SWELLING FACE (Face became swollen). On 25-Mar-2021, the patient experienced LIMB DISCOMFORT (Legs felt very heavy like they weighed 500 pounds), PAIN (hurt all over) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Eyes became swollen), LIMB DISCOMFORT (Legs felt very heavy like they weighed 500 pounds), PAIN (hurt all over), SWELLING FACE (Face became swollen) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Sinusitis, Tachycardia
Clinical narrative: heart rate was flying; measured 113; usually resting rate is 60; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart rate was flying; measured 113; usually resting rate is 60) and SINUSITIS (sinus infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) from 2017 to an unknown date and CARVEDILOL from 2019 to an unknown date for Blood pressure high, ATORVASTATIN from 2017 to an unknown date for Cholesterol, FINASTERIDE from 2018 to an unknown date for Hair loss, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced TACHYCARDIA (heart rate was flying; measured 113; usually resting rate is 60) and SINUSITIS (sinus infection). The patient was treated with AZITHROMYCIN (Z-PAK) for Sinus infection, at an unspecified dose and frequency. On 24-Mar-2021, TACHYCARDIA (heart rate was flying; measured 113; usually resting rate is 60) had resolved. On 07-Apr-2021, SINUSITIS (sinus infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 113 (High) 113.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: (Follow up  received on 12 May 2021) patient demographics, vaccination facility details added. Concomitant medication, events updated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: noticed a nodule right below the left side of the neck below the cheek; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (noticed a nodule right below the left side of the neck below the cheek) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included ACEBUTOLOL HYDROCHLORIDE and ENALAPRIL MALEATE for Hypertension, POTASSIUM CHLORIDE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced NODULE (noticed a nodule right below the left side of the neck below the cheek). At the time of the report, NODULE (noticed a nodule right below the left side of the neck below the cheek) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported include steroid. Treatment for the event included