chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: twinge of a headache; mild swelling at injection site; pink at injection site; I feel a little unsettled; Fatigue; A spontaneous report was received from a 81 year old female patient, who received  Moderna's covid 19 vaccine (mRNA-1273) and experienced a twinge of a headache, mild swelling at injection site , injection site pink, little unsettled and fatigue.  The patient's medical history was not provided. Concomitant medications were reported.    On 17 Jan 2021 prior to the onset of event, the patient received first of two planned doses of mRNA-1273 (Batch NO:041LZ0A ) injection for prophylaxis of covid 19 infection.  On 17 Jan the patient experienced a twinge of a headache, mild swelling at injection site , injection site pink, little unsettled and fatigue .  No treatment information provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  Outcome of the event, a twinge of a headache, mild swelling at injection site , injection site pink, little unsettled and fatigue, not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Redness at the injection site; Swelling at the injection site; Hardness at the injection site; Tenderness at the injection site; Light rash at the injection site; A spontaneous report  was received from a consumer concerning a 45-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine site erythema, vaccine site swelling, vaccine site induration, vaccine site pain and vaccine site rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 6-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the left arm for prophylaxis of COVID-19 infection.  On 6-Jan-2021, the patient experienced vaccine site erythema, vaccine site swelling, vaccine site induration, vaccine site pain and vaccine site rash.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events (vaccine site erythema, vaccine site swelling, vaccine site induration, vaccine site pain and vaccine site rash) was ongoing.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness
Clinical narrative: Felt flu like symptoms; Later tested Positive for COVID-19; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt flu like symptoms) and COVID-19 (Later tested Positive for COVID-19) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt flu like symptoms) and COVID-19 (Later tested Positive for COVID-19). At the time of the report, INFLUENZA LIKE ILLNESS (Felt flu like symptoms) and COVID-19 (Later tested Positive for COVID-19) outcome was unknown. Not Provided      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.   Concomitant drugs were not reported.  Treatment information was not provided.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Vaccination site anaesthesia, Vaccination site movement impairment, Vaccination site paraesthesia
Clinical narrative: left arm paresthesia and tingling; Left arm numbness; difficult to bend over and do something with the arm; Nerve pain starts from her shoulder and extends down the left arm; A spontaneous report was received from a consumer concerning a 67-year old female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced lleft arm paresthesia, numbness and tingling and the nerve pain which starts from her shoulder and extends down the left arm and difficulty to bend over and do something with the arm.  The patient's medical history was provided as arthritis in lower back. Relevant concomitant medications reported was Robaxin.  Allergies reported included penicillin and Alpha-gal syndrome.  28-Dec-2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 026L20A) for prophylaxis of COVID-19 infection.  On an unknown date, five days after the first dose the patient experienced left arm paresthesia,numbness and tingling and the nerve pain which starts from her shoulder and extends down the left arm and difficulty to bend over and do something with the arm.  No Laboratory details provided but scheduled MRI of the cervical spine on 29-JAN-2021.  The treatment taken was reported as Gabapentin which was prescribed by primary HCP.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the experienced left arm paresthesia, numbness and tingling, nerve pain starts from shoulder and extends down the left arm and difficulty to bend over and do something with the arm  is not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Hyperhidrosis, Pain
Clinical narrative: PCR test for COVID-19 and it was positive; Lost of taste; Lost of smell; episode of heavy sweat; hypersensitivity in the torso and waist, I touch it and it hurts; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost of taste) and ANOSMIA (Lost of smell) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced ANOSMIA (Lost of smell). On 17-Jan-2021, the patient experienced AGEUSIA (Lost of taste). At the time of the report, AGEUSIA (Lost of taste) and ANOSMIA (Lost of smell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted covid after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted covid after the first dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical History).    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On 31-Dec-2020, the patient experienced COVID-19 (contracted covid after the first dose). At the time of the report, COVID-19 (contracted covid after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritus (feeling itchy) and nasal congestion (feels her nose and throat clogging) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 12, 2021, patient experienced pruritus (feeling itchy) and nasal congestion (feels her nose and throat clogging). At the time of the report, pruritus  (feeling itchy) and nasal congestion (feels her nose and throat clogging) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of exposure during pregnancy (pregnant) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unknown dosage form. Last menstrual period and estimated date of delivery not provided. On an unknown date, the patient experienced exposure during pregnancy (pregnant). At the time of the report, exposure during pregnancy (pregnant) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided. Sender's comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomachache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomachache). At the time of the report, ABDOMINAL PAIN UPPER (stomachache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site mass, Rash, Vaccination site pruritus
Clinical narrative: raised injection site; a little itchy injection site; broken up rash 2'x3'' about size of 2 eggs; Not feeling as good as normal until; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Not feeling as good as normal until) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Allergy (allergic to Latex, PCN).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced FATIGUE (Not feeling as good as normal until). On 15-Jan-2021, FATIGUE (Not feeling as good as normal until) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: tired; Fever; feeling bad; large oval knot at the site of the injection; chills; headache; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (feeling bad), INJECTION SITE MASS (large oval knot at the site of the injection), CHILLS (chills), PYREXIA (Fever) and FATIGUE (tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALSARTAN and FAMOTIDINE (PEPCID AC) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FEELING ABNORMAL (feeling bad), INJECTION SITE MASS (large oval knot at the site of the injection) and CHILLS (chills). On 14-Jan-2021, the patient experienced PYREXIA (Fever). On 15-Jan-2021, the patient experienced FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency and IBUPROFEN (ADVIL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling bad), INJECTION SITE MASS (large oval knot at the site of the injection), CHILLS (chills), PYREXIA (Fever) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature (Unknown-102°f): 102°f (High) Fever 102°F. On an unknown date, Body temperature (Unknown-101°f): 101°f (High) Fever 101°F.     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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Pyrexia
Clinical narrative: tired; Fever; feeling bad; large oval knot at the site of the injection; chills; headache; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (feeling bad), INJECTION SITE MASS (large oval knot at the site of the injection), CHILLS (chills), PYREXIA (Fever) and FATIGUE (tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALSARTAN and FAMOTIDINE (PEPCID AC) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FEELING ABNORMAL (feeling bad), INJECTION SITE MASS (large oval knot at the site of the injection) and CHILLS (chills). On 14-Jan-2021, the patient experienced PYREXIA (Fever). On 15-Jan-2021, the patient experienced FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency and IBUPROFEN (ADVIL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling bad), INJECTION SITE MASS (large oval knot at the site of the injection), CHILLS (chills), PYREXIA (Fever) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature (Unknown-102°f): 102°f (High) Fever 102°F. On an unknown date, Body temperature (Unknown-101°f): 101°f (High) Fever 101°F.     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.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever). At the time of the report, pyrexia (fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: whole body ached, could barely move; major headache; rash; throat got strectchy and kind of irritated; congested and runny nose; fever; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat got strectchy and kind of irritated), RHINORRHOEA (congested and runny nose), PYREXIA (fever), PAIN (whole body ached, could barely move) and HEADACHE (major headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03720KA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Cancer and Hypertension. Concomitant products included TAMOXIFEN for Cancer.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced THROAT IRRITATION (throat got strectchy and kind of irritated), RHINORRHOEA (congested and runny nose) and PYREXIA (fever). On 16-Jan-2021, the patient experienced PAIN (whole body ached, could barely move), HEADACHE (major headache) and RASH (rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, THROAT IRRITATION (throat got strectchy and kind of irritated), RHINORRHOEA (congested and runny nose), PYREXIA (fever), PAIN (whole body ached, could barely move), HEADACHE (major headache) and RASH (rash) 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.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: whole body ached, could barely move; major headache; rash; throat got strectchy and kind of irritated; congested and runny nose; fever; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat got strectchy and kind of irritated), RHINORRHOEA (congested and runny nose), PYREXIA (fever), PAIN (whole body ached, could barely move) and HEADACHE (major headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03720KA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy, Cancer and Hypertension. Concomitant products included TAMOXIFEN for Cancer.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced THROAT IRRITATION (throat got strectchy and kind of irritated), RHINORRHOEA (congested and runny nose) and PYREXIA (fever). On 16-Jan-2021, the patient experienced PAIN (whole body ached, could barely move), HEADACHE (major headache) and RASH (rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, THROAT IRRITATION (throat got strectchy and kind of irritated), RHINORRHOEA (congested and runny nose), PYREXIA (fever), PAIN (whole body ached, could barely move), HEADACHE (major headache) and RASH (rash) 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of arthralgia (sore arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history provided. On Jan 5, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On an unknown date, patient experienced arthralgia (sore arm). At the time of the report, arthralgia (sore arm) outcome: unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site was red) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site was red). At the time of the report, INJECTION SITE ERYTHEMA (Injection site was red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Movement disorder, Myalgia
Clinical narrative: severe flu like symptoms; muscle aches; couldn't move; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (severe flu like symptoms), MYALGIA (muscle aches) and MOVEMENT DISORDER (couldn't move) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (severe flu like symptoms), MYALGIA (muscle aches) and MOVEMENT DISORDER (couldn't move). At the time of the report, INFLUENZA LIKE ILLNESS (severe flu like symptoms), MYALGIA (muscle aches) and MOVEMENT DISORDER (couldn't move) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: injection site is red; injection site is swollen; injection site is hot to the touch; injection site is itchy; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site is red), INJECTION SITE SWELLING (injection site is swollen), INJECTION SITE WARMTH (injection site is hot to the touch), INJECTION SITE PRURITUS (injection site is itchy) and PAIN IN EXTREMITY (arm was sore) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZZ) for an unknown indication.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 17-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site is red), INJECTION SITE SWELLING (injection site is swollen), INJECTION SITE WARMTH (injection site is hot to the touch) and INJECTION SITE PRURITUS (injection site is itchy). The patient was treated with BACITRACIN at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (injection site is red), INJECTION SITE SWELLING (injection site is swollen), INJECTION SITE WARMTH (injection site is hot to the touch), INJECTION SITE PRURITUS (injection site is itchy) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: sore arm; Neck Pain; Shoulder Pain (Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NECK PAIN (Neck Pain) and INJECTION SITE PAIN (Shoulder Pain (Injection Site)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (Neck Pain) and INJECTION SITE PAIN (Shoulder Pain (Injection Site)). At the time of the report, PAIN IN EXTREMITY (sore arm), NECK PAIN (Neck Pain) and INJECTION SITE PAIN (Shoulder Pain (Injection Site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Pain in extremity
Clinical narrative: Face flushing; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FLUSHING (Face flushing) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 21-Jan-2021, the patient experienced FLUSHING (Face flushing). At the time of the report, PAIN IN EXTREMITY (Arm soreness) and FLUSHING (Face flushing) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a 38-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 23-Jun-2021. On an unknown date, the patient experienced PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, PREGNANCY (Pregnant) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (left arm was sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0252202A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (left arm was sore). At the time of the report, INJECTION SITE PAIN (left arm was sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness at injection site; Red bump (1/4inch in size) at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Red bump (1/4inch in size) at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Red bump (1/4inch in size) at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Red bump (1/4inch in size) at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Constipation, Vomiting
Clinical narrative: Pain on the back; Vomit; Severe pain in the stomach; Constipated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe pain in the stomach), CONSTIPATION (Constipated), BACK PAIN (Pain on the back) and VOMITING (Vomit) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe pain in the stomach), CONSTIPATION (Constipated) and VOMITING (Vomit). On 18-Jan-2021, the patient experienced BACK PAIN (Pain on the back). On 18-Jan-2021, ABDOMINAL PAIN UPPER (Severe pain in the stomach), CONSTIPATION (Constipated) and VOMITING (Vomit) outcome was unknown. At the time of the report, BACK PAIN (Pain on the back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Swelling, Vaccination site mass
Clinical narrative: Arm became red; Arm became swollen; Arm became warm; Arm became itchy; A little soreness around the injection site; Lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at the injection site), ERYTHEMA (Arm became red), SWELLING (Arm became swollen), FEELING HOT (Arm became warm) and PRURITUS (Arm became itchy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Hypothyroidism (mild hypothyroidism). Concomitant products included SOTALOL (SOTALOL AF [SOTALOL]), LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), LORAZEPAM (ATIVAN) and PRAVASTATIN for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE MASS (Lump at the injection site) and VACCINATION SITE PAIN (A little soreness around the injection site). On 17-Jan-2021, the patient experienced ERYTHEMA (Arm became red), SWELLING (Arm became swollen), FEELING HOT (Arm became warm) and PRURITUS (Arm became itchy). On 10-Jan-2021, VACCINATION SITE PAIN (A little soreness around the injection site) had resolved. On 17-Jan-2021, VACCINATION SITE MASS (Lump at the injection site) had resolved. At the time of the report, ERYTHEMA (Arm became red), SWELLING (Arm became swollen), FEELING HOT (Arm became warm) and PRURITUS (Arm became itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm became red; Arm became swollen; Arm became warm; Arm became itchy; A little soreness around the injection site; Lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at the injection site), ERYTHEMA (Arm became red), SWELLING (Arm became swollen), FEELING HOT (Arm became warm) and PRURITUS (Arm became itchy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Hypothyroidism (mild hypothyroidism). Concomitant products included SOTALOL (SOTALOL AF [SOTALOL]), LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), LORAZEPAM (ATIVAN) and PRAVASTATIN for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE MASS (Lump at the injection site) and VACCINATION SITE PAIN (A little soreness around the injection site). On 17-Jan-2021, the patient experienced ERYTHEMA (Arm became red), SWELLING (Arm became swollen), FEELING HOT (Arm became warm) and PRURITUS (Arm became itchy). On 10-Jan-2021, VACCINATION SITE PAIN (A little soreness around the injection site) had resolved. On 17-Jan-2021, VACCINATION SITE MASS (Lump at the injection site) had resolved. At the time of the report, ERYTHEMA (Arm became red), SWELLING (Arm became swollen), FEELING HOT (Arm became warm) and PRURITUS (Arm became itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: red mark on arm that itches after 8 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red mark on arm that itches after 8 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A.) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (red mark on arm that itches after 8 days). At the time of the report, ERYTHEMA (red mark on arm that itches after 8 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Dyspnoea, Heart rate increased, Pain in extremity
Clinical narrative: breathing was heavy; increased heart rate; bruising; chills; arm pain was so intense; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain was so intense), DYSPNOEA (breathing was heavy), HEART RATE INCREASED (increased heart rate), CONTUSION (bruising) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04112OA) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Mold and Cedar).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain was so intense). On an unknown date, the patient experienced DYSPNOEA (breathing was heavy), HEART RATE INCREASED (increased heart rate), CONTUSION (bruising) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm pain was so intense) was resolving and DYSPNOEA (breathing was heavy), HEART RATE INCREASED (increased heart rate), CONTUSION (bruising) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itching at the injection site; redness at the injection site; injection site swelle to the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (injection site swelle to the size of a silver dollar) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (injection site swelle to the size of a silver dollar). At the time of the report, INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (injection site swelle to the size of a silver dollar) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medication included unspecified medications for blood pressure and diabetes.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: grade 2 amount of redness; hurt; warm to the touch; itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (hurt), INJECTION SITE WARMTH (warm to the touch), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (grade 2 amount of redness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced INJECTION SITE PAIN (hurt), INJECTION SITE WARMTH (warm to the touch) and INJECTION SITE PRURITUS (itching). On 19-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (grade 2 amount of redness). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of UNK UNK, qd. On 14-Jan-2021, INJECTION SITE PAIN (hurt), INJECTION SITE WARMTH (warm to the touch) and INJECTION SITE PRURITUS (itching) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (grade 2 amount of redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment medication included claritin every day. She's not sure if she should take Benadryl or try ice pack.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: feels like she is going to die today; sore; red; warm to the touch; swelling in her shoulder and clavicle on the same side of the vaccination; pain in arm; a red circle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), INJECTION SITE ERYTHEMA (a red circle at the injection site), INJECTION SITE PAIN (sore), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (warm to the touch) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm) and INJECTION SITE ERYTHEMA (a red circle at the injection site). On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (sore), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm to the touch) and INJECTION SITE SWELLING (swelling in her shoulder and clavicle on the same side of the vaccination). On 19-Jan-2021, the patient experienced FEELING ABNORMAL (feels like she is going to die today). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. On 14-Jan-2021, PAIN IN EXTREMITY (pain in arm) and INJECTION SITE ERYTHEMA (a red circle at the injection site) had resolved. At the time of the report, INJECTION SITE PAIN (sore), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm to the touch), INJECTION SITE SWELLING (swelling in her shoulder and clavicle on the same side of the vaccination) and FEELING ABNORMAL (feels like she is going to die today) outcome was unknown. Not Provided   It was reported that patient took zyrtec but doesn't know if it worked or not.   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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: feels like she is going to die today; sore; red; warm to the touch; swelling in her shoulder and clavicle on the same side of the vaccination; pain in arm; a red circle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), INJECTION SITE ERYTHEMA (a red circle at the injection site), INJECTION SITE PAIN (sore), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (warm to the touch) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm) and INJECTION SITE ERYTHEMA (a red circle at the injection site). On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (sore), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm to the touch) and INJECTION SITE SWELLING (swelling in her shoulder and clavicle on the same side of the vaccination). On 19-Jan-2021, the patient experienced FEELING ABNORMAL (feels like she is going to die today). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. On 14-Jan-2021, PAIN IN EXTREMITY (pain in arm) and INJECTION SITE ERYTHEMA (a red circle at the injection site) had resolved. At the time of the report, INJECTION SITE PAIN (sore), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (warm to the touch), INJECTION SITE SWELLING (swelling in her shoulder and clavicle on the same side of the vaccination) and FEELING ABNORMAL (feels like she is going to die today) outcome was unknown. Not Provided   It was reported that patient took zyrtec but doesn't know if it worked or not.   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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant and received Moderna vaccine 2 doses; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna vaccine 2 doses) in a 36-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion (Miscarried on 07-May-2020) on 07-May-2020, Bipolar II disorder, Hyperandrogenism, ADHD and Nissen fundoplication (Linx , Nissen Fundoplication). Concomitant products included RHL G Immunoglobulin Injection, DOCUSATE SODIUM, ONDANSETRON, TRAZODONE HCL, FLUOXETINE HCL, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), QUETIAPINE FUMARATE (QUETIAPINE [QUETIAPINE FUMARATE]), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and IRON (SLOW RELEASE IRON) for an unknown indication, METFORMIN.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-May-2020 and the estimated date of delivery was 15-Feb-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna vaccine 2 doses). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-seventh week of the pregnancy.  On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna vaccine 2 doses) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2020, Pregnancy test: positive (Positive) Positive.         Treatment information was not provided. Ultrasound and Blood work were reported as Normal for an unknown date.  The number of fetuses was reported as 1 and had established prenatal care. The patient had no maternal history of subfertility. The patient had no complications or acute illness during this pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Itching all over the body; shingles infection.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (Itching all over the body) and HERPES ZOSTER (shingles infection.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching all over the body) and HERPES ZOSTER (shingles infection.). At the time of the report, PRURITUS (Itching all over the body) and HERPES ZOSTER (shingles infection.) outcome was unknown. Not Provided      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.   A patient is due for their second dose. Patient mentioned that soon after the first dose she had itching all over her body but didn't report it. She went to her primary Health Provider yesterday and they told her that they though the itching was due to a shingles infection.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: red bump at the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE SWELLING (red bump at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE SWELLING (red bump at the injection site). At the time of the report, VACCINATION SITE SWELLING (red bump at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.