chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Faeces discoloured, Fatigue
Clinical narrative: lower back aches that ache more than the rest of their body; Has had two episodes of loose bright orange stools; two episodes of loose bright orange stools; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back aches that ache more than the rest of their body), DIARRHOEA (Has had two episodes of loose bright orange stools), FAECES DISCOLOURED (two episodes of loose bright orange stools) and FATIGUE (Tiredness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced BACK PAIN (lower back aches that ache more than the rest of their body), DIARRHOEA (Has had two episodes of loose bright orange stools), FAECES DISCOLOURED (two episodes of loose bright orange stools) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, BACK PAIN (lower back aches that ache more than the rest of their body), DIARRHOEA (Has had two episodes of loose bright orange stools), FAECES DISCOLOURED (two episodes of loose bright orange stools) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort
Clinical narrative: had discomfort in his in his left arm; discomfort in left arm spread to chest from arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (had discomfort in his in his left arm) and CHEST DISCOMFORT (discomfort in left arm spread to chest from arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (had discomfort in his in his left arm) and CHEST DISCOMFORT (discomfort in left arm spread to chest from arm). At the time of the report, DISCOMFORT (had discomfort in his in his left arm) and CHEST DISCOMFORT (discomfort in left arm spread to chest from arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter. No lab data provided.   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeding disorder, Headache, Pain in extremity, Pyrexia
Clinical narrative: Couldn't eat anything; Dry heaves and gagging; pretty weak; Fever; Wicked, bad headache; Sore arm/pain in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/pain in arm), FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak) and PYREXIA (Fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood cholesterol abnormal, Acid reflux (oesophageal) and Blood pressure abnormal. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), EVOLOCUMAB (REPATHA) for Blood cholesterol abnormal, TELMISARTAN for Blood pressure abnormal.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm/pain in arm). On an unknown date, the patient experienced FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak), PYREXIA (Fever) and HEADACHE (Wicked, bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm/pain in arm), FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak), PYREXIA (Fever) and HEADACHE (Wicked, bad headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-302252.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Couldn't eat anything; Dry heaves and gagging; pretty weak; Fever; Wicked, bad headache; Sore arm/pain in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/pain in arm), FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak) and PYREXIA (Fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood cholesterol abnormal, Acid reflux (oesophageal) and Blood pressure abnormal. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), EVOLOCUMAB (REPATHA) for Blood cholesterol abnormal, TELMISARTAN for Blood pressure abnormal.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm/pain in arm). On an unknown date, the patient experienced FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak), PYREXIA (Fever) and HEADACHE (Wicked, bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm/pain in arm), FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak), PYREXIA (Fever) and HEADACHE (Wicked, bad headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-302252.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat; Congestion; Chills; Fevers; Lost my taste and smell; Lost my taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), AGEUSIA (Lost my taste and smell), ANOSMIA (Lost my taste and smell) and CHILLS (Chills) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced AGEUSIA (Lost my taste and smell). 28-Aug-2021, the patient experienced ANOSMIA (Lost my taste and smell). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), CHILLS (Chills) and PYREXIA (Fevers). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), CHILLS (Chills) and PYREXIA (Fevers) outcome was unknown and AGEUSIA (Lost my taste and smell) and ANOSMIA (Lost my taste and smell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient has adipose disease.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore throat; Congestion; Chills; Fevers; Lost my taste and smell; Lost my taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), AGEUSIA (Lost my taste and smell), ANOSMIA (Lost my taste and smell) and CHILLS (Chills) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced AGEUSIA (Lost my taste and smell). 28-Aug-2021, the patient experienced ANOSMIA (Lost my taste and smell). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), CHILLS (Chills) and PYREXIA (Fevers). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), CHILLS (Chills) and PYREXIA (Fevers) outcome was unknown and AGEUSIA (Lost my taste and smell) and ANOSMIA (Lost my taste and smell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient has adipose disease.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear swelling, Feeling abnormal, Feeling hot, Pruritus
Clinical narrative: It was awful in the beginning; her face swelled up,Cheek swelling; her ears swelled up; her nose swelled up; a rash,her chest had the rash,her arms had the rash; hives; it's burning and itching; it's burning and itching; her hand feels the heat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat) and FEELING ABNORMAL (It was awful in the beginning) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included APIXABAN (ELIQUIS) for Blood pressure, URSODIOL for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat) and RASH (a rash,her chest had the rash,her arms had the rash). On an unknown date, the patient experienced FEELING ABNORMAL (It was awful in the beginning), SWELLING FACE (her face swelled up,Cheek swelling), EAR SWELLING (her ears swelled up) and SWELLING (her nose swelled up). The patient was treated with PREDNISONE at an unspecified dose and frequency; MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency; DOXEPIN at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 180 mg. At the time of the report, URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat), FEELING ABNORMAL (It was awful in the beginning), SWELLING FACE (her face swelled up,Cheek swelling), EAR SWELLING (her ears swelled up), SWELLING (her nose swelled up) and RASH (a rash,her chest had the rash,her arms had the rash) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications Steroid shot and Pepcid were reported.  Patient visited primary care,dermatologist, allergist, all of them gave her different medications.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Swelling face, Urticaria
Clinical narrative: It was awful in the beginning; her face swelled up,Cheek swelling; her ears swelled up; her nose swelled up; a rash,her chest had the rash,her arms had the rash; hives; it's burning and itching; it's burning and itching; her hand feels the heat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat) and FEELING ABNORMAL (It was awful in the beginning) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included APIXABAN (ELIQUIS) for Blood pressure, URSODIOL for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat) and RASH (a rash,her chest had the rash,her arms had the rash). On an unknown date, the patient experienced FEELING ABNORMAL (It was awful in the beginning), SWELLING FACE (her face swelled up,Cheek swelling), EAR SWELLING (her ears swelled up) and SWELLING (her nose swelled up). The patient was treated with PREDNISONE at an unspecified dose and frequency; MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency; DOXEPIN at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 180 mg. At the time of the report, URTICARIA (hives), BURNING SENSATION (it's burning and itching), PRURITUS (it's burning and itching), FEELING HOT (her hand feels the heat), FEELING ABNORMAL (It was awful in the beginning), SWELLING FACE (her face swelled up,Cheek swelling), EAR SWELLING (her ears swelled up), SWELLING (her nose swelled up) and RASH (a rash,her chest had the rash,her arms had the rash) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications Steroid shot and Pepcid were reported.  Patient visited primary care,dermatologist, allergist, all of them gave her different medications.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: 1st Moderna vaccine on 7Jun2021/still get the 2nd vaccination; fatigue; shortness of breath / hard to breath; felt dizzy; had a feeling of heaviness; weakness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DYSPNOEA (shortness of breath / hard to breath), DIZZINESS (felt dizzy), FEELING ABNORMAL (had a feeling of heaviness) and ASTHENIA (weakness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced FATIGUE (fatigue), DYSPNOEA (shortness of breath / hard to breath), DIZZINESS (felt dizzy), FEELING ABNORMAL (had a feeling of heaviness) and ASTHENIA (weakness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st Moderna vaccine on 7Jun2021/still get the 2nd vaccination). At the time of the report, FATIGUE (fatigue), DYSPNOEA (shortness of breath / hard to breath), DIZZINESS (felt dizzy), FEELING ABNORMAL (had a feeling of heaviness) and ASTHENIA (weakness) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (1st Moderna vaccine on 7Jun2021/still get the 2nd vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided. Patient reported that she went to see a neurologist, but a diagnosis has not been determined.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st Moderna vaccine on 7Jun2021/still get the 2nd vaccination; fatigue; shortness of breath / hard to breath; felt dizzy; had a feeling of heaviness; weakness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DYSPNOEA (shortness of breath / hard to breath), DIZZINESS (felt dizzy), FEELING ABNORMAL (had a feeling of heaviness) and ASTHENIA (weakness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced FATIGUE (fatigue), DYSPNOEA (shortness of breath / hard to breath), DIZZINESS (felt dizzy), FEELING ABNORMAL (had a feeling of heaviness) and ASTHENIA (weakness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st Moderna vaccine on 7Jun2021/still get the 2nd vaccination). At the time of the report, FATIGUE (fatigue), DYSPNOEA (shortness of breath / hard to breath), DIZZINESS (felt dizzy), FEELING ABNORMAL (had a feeling of heaviness) and ASTHENIA (weakness) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (1st Moderna vaccine on 7Jun2021/still get the 2nd vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided. Patient reported that she went to see a neurologist, but a diagnosis has not been determined.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Fatigue, Magnetic resonance imaging heart, Ventricular extrasystoles
Clinical narrative: Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%; Extreme fatigue after 2nd dose , I slept for 20 hours; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%) and FATIGUE (Extreme fatigue after 2nd dose , I slept for 20 hours) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013220A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure high, LEVOTHYROXINE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Extreme fatigue after 2nd dose , I slept for 20 hours). On 11-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%). The patient was treated with METOPROLOL for Adverse event, at a dose of 1 dosage form. At the time of the report, VENTRICULAR EXTRASYSTOLES (Asymptomatic PVCs every 3rd heartbeat, Says she has worn a halter monitor 2x. The first time 15% PVCs 2nd time 21%) and FATIGUE (Extreme fatigue after 2nd dose , I slept for 20 hours) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Magnetic resonance imaging heart: abnormal (abnormal) Late gadolinium enhancement abnormal. On an unknown date, Electrocardiogram ambulatory: 15 % (abnormal) 15%PVCs and 21% (abnormal) 21%PVCs.         The patient reported that blood pressure has been elevated probably due to stress. On 02-Dec-2020, while blood donation patient did not have antibodies and hence declined every infection. The patient reported that on 11-Mar-2021 blood donation was denied due to PVCs which were asymptomatic to the patient and PVCs every 3rd heartbeat. The patient was informed to obtain timeline symptoms including cardiac laboratory values.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Oropharyngeal pain, Pain, Tinnitus
Clinical narrative: flu-like symptoms; A little achy; A little sore throat; Tired; Constant ringing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (A little achy), OROPHARYNGEAL PAIN (A little sore throat), TINNITUS (Constant ringing in both ears) and FATIGUE (Tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 024A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (A little achy), OROPHARYNGEAL PAIN (A little sore throat) and FATIGUE (Tired). In April 2021, the patient experienced TINNITUS (Constant ringing in both ears). The patient was treated with PARACETAMOL (TYLENOL) for Flu-like symptoms, at an unspecified dose and frequency. On 02-Apr-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (A little achy), OROPHARYNGEAL PAIN (A little sore throat) and FATIGUE (Tired) had resolved. At the time of the report, TINNITUS (Constant ringing in both ears) had not resolved.             Patient reported that she went to the doctor but they did not say anything, now she took  an appointment to look more into this problem.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Therapeutic product effect increased
Clinical narrative: extended second Moderna dose up to 90 days; efficacy is greater; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended second Moderna dose up to 90 days) and THERAPEUTIC PRODUCT EFFECT INCREASED (efficacy is greater) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended second Moderna dose up to 90 days) and THERAPEUTIC PRODUCT EFFECT INCREASED (efficacy is greater). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended second Moderna dose up to 90 days) and THERAPEUTIC PRODUCT EFFECT INCREASED (efficacy is greater) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reportedly, Caller had declined consent to document demographic details of the call.  Caller had stated that some people had extended their second Moderna COVID-19 dose up to 90 days. He had read that extending the second dose after the first dose for 2 to 3 months had shown greater.No additional detail provided. Consent not given for Safety follow-up.  Treatment product information was not provided.  Concomitant product use was not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Positive with coronavirus 10 days after 1st dose; It's been 36 days and did not receive 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive with coronavirus 10 days after 1st dose) and PRODUCT DOSE OMISSION ISSUE (It's been 36 days and did not receive 2nd dose of vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive with coronavirus 10 days after 1st dose) and PRODUCT DOSE OMISSION ISSUE (It's been 36 days and did not receive 2nd dose of vaccine). At the time of the report, COVID-19 (Positive with coronavirus 10 days after 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It's been 36 days and did not receive 2nd dose of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive with coronavirus 10 days after 1st dose.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported. Treatment medication were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: achiness; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     The patient's past medical history included Hip replacement on 28-Jul-2021.   On 08-Feb-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 an unknown date, the patient experienced PAIN (achiness) and PYREXIA (fever). At the time of the report, PAIN (achiness) and PYREXIA (fever) outcome was unknown.            Patient got a Hip Replacement surgery done on 28th july , she was in the hospital for a week and was taking antibiotics for almost a month , she wants to know when can she take her 3rd dose vaccine and if it will affect her surgery site  Concomitant medication was not provided treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: his wife had the same reactions also/worse reaction than the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (his wife had the same reactions also/worse reaction than the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (his wife had the same reactions also/worse reaction than the 2nd dose). At the time of the report, VACCINATION COMPLICATION (his wife had the same reactions also/worse reaction than the 2nd dose) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-137290, MOD21-137319 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-137290:Same reporter MOD21-137319:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Induration, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Her left hand is still swollen/Her right foot is also swollen now so she's not walking much/ if she goes 100 or 200 steps then it gets so swollen like a bulge; not walking much; over time it has gotten hard and it feels like a big rock; She is in so much pain that she can't sleep at night or put any weight on her left hand; She is in so much pain that she can't sleep at night or put any weight on her left hand; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Her left hand is still swollen/Her right foot is also swollen now so she's not walking much/ if she goes 100 or 200 steps then it gets so swollen like a bulge), GAIT DISTURBANCE (not walking much), INDURATION (over time it has gotten hard and it feels like a big rock), PAIN IN EXTREMITY (She is in so much pain that she can't sleep at night or put any weight on her left hand) and INSOMNIA (She is in so much pain that she can't sleep at night or put any weight on her left hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Her left hand is still swollen/Her right foot is also swollen now so she's not walking much/ if she goes 100 or 200 steps then it gets so swollen like a bulge), GAIT DISTURBANCE (not walking much), INDURATION (over time it has gotten hard and it feels like a big rock), PAIN IN EXTREMITY (She is in so much pain that she can't sleep at night or put any weight on her left hand) and INSOMNIA (She is in so much pain that she can't sleep at night or put any weight on her left hand). At the time of the report, PERIPHERAL SWELLING (Her left hand is still swollen/Her right foot is also swollen now so she's not walking much/ if she goes 100 or 200 steps then it gets so swollen like a bulge), GAIT DISTURBANCE (not walking much), INDURATION (over time it has gotten hard and it feels like a big rock), PAIN IN EXTREMITY (She is in so much pain that she can't sleep at night or put any weight on her left hand) and INSOMNIA (She is in so much pain that she can't sleep at night or put any weight on her left hand) outcome was unknown.            No Concomitant medications were provided. No Treatment medications were provided.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: COVID arm upper arm; very large rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm upper arm) and RASH (very large rash) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced RASH (very large rash). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm upper arm). At the time of the report, VACCINATION SITE REACTION (COVID arm upper arm) and RASH (very large rash) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Cheilitis, Dry mouth, Lip dry, Lip erythema, Oral mucosal erythema
Clinical narrative: inside of my mouth irritated; inside of my mouth so red; lips inside mouth red; lips inside mouth irratated; lips inside mouth dry; inside of my mouth so dry; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (inside of my mouth irritated), ORAL MUCOSAL ERYTHEMA (inside of my mouth so red), LIP ERYTHEMA (lips inside mouth red), CHEILITIS (lips inside mouth irratated) and LIP DRY (lips inside mouth dry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STOMATITIS (inside of my mouth irritated), ORAL MUCOSAL ERYTHEMA (inside of my mouth so red), LIP ERYTHEMA (lips inside mouth red), CHEILITIS (lips inside mouth irratated), LIP DRY (lips inside mouth dry) and DRY MOUTH (inside of my mouth so dry). At the time of the report, STOMATITIS (inside of my mouth irritated), ORAL MUCOSAL ERYTHEMA (inside of my mouth so red), LIP ERYTHEMA (lips inside mouth red), CHEILITIS (lips inside mouth irratated), LIP DRY (lips inside mouth dry) and DRY MOUTH (inside of my mouth so dry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: inside of my mouth irritated; inside of my mouth so red; lips inside mouth red; lips inside mouth irratated; lips inside mouth dry; inside of my mouth so dry; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (inside of my mouth irritated), ORAL MUCOSAL ERYTHEMA (inside of my mouth so red), LIP ERYTHEMA (lips inside mouth red), CHEILITIS (lips inside mouth irratated) and LIP DRY (lips inside mouth dry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STOMATITIS (inside of my mouth irritated), ORAL MUCOSAL ERYTHEMA (inside of my mouth so red), LIP ERYTHEMA (lips inside mouth red), CHEILITIS (lips inside mouth irratated), LIP DRY (lips inside mouth dry) and DRY MOUTH (inside of my mouth so dry). At the time of the report, STOMATITIS (inside of my mouth irritated), ORAL MUCOSAL ERYTHEMA (inside of my mouth so red), LIP ERYTHEMA (lips inside mouth red), CHEILITIS (lips inside mouth irratated), LIP DRY (lips inside mouth dry) and DRY MOUTH (inside of my mouth so dry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy spells). At the time of the report, DIZZINESS (Dizzy spells) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  The patient enquired if having dizzy spells was a common side effect.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Chills, Dysmenorrhoea, Haemorrhoids
Clinical narrative: menstruation; leg pain,foot pain; She had not menstruated in over 3 years before that; chills; vomiting; headache; fever; More than 36 days since caller got the first dose and still has not the second; missed dose; pain on her nipples; pain on her breasts; tenderness on her breasts; menstrual cramps; urinary track infection; hemorroids; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), URINARY TRACT INFECTION (urinary track infection), HAEMORRHOIDS (hemorroids) and NIPPLE PAIN (pain on her nipples) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Amenorrhea (amenorrhea.).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced URINARY TRACT INFECTION (urinary track infection) and HAEMORRHOIDS (hemorroids). In June 2021, the patient experienced NIPPLE PAIN (pain on her nipples), BREAST PAIN (pain on her breasts), BREAST TENDERNESS (tenderness on her breasts) and DYSMENORRHOEA (menstrual cramps). On an unknown date, the patient experienced MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), MENSTRUATION IRREGULAR (She had not menstruated in over 3 years before that), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache), PYREXIA (fever), PRODUCT DOSE OMISSION ISSUE (More than 36 days since caller got the first dose and still has not the second) and PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), URINARY TRACT INFECTION (urinary track infection), HAEMORRHOIDS (hemorroids), NIPPLE PAIN (pain on her nipples), BREAST PAIN (pain on her breasts), BREAST TENDERNESS (tenderness on her breasts), DYSMENORRHOEA (menstrual cramps), MENSTRUATION IRREGULAR (She had not menstruated in over 3 years before that), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache), PYREXIA (fever), PRODUCT DOSE OMISSION ISSUE (More than 36 days since caller got the first dose and still has not the second) and PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  Other treatment  Medication provided was antibiotics for UTI and  over the counter Cream for Hemorrhoids.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Added new event.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstrual disorder, Menstruation irregular, Nipple pain, Pain in extremity
Clinical narrative: menstruation; leg pain,foot pain; She had not menstruated in over 3 years before that; chills; vomiting; headache; fever; More than 36 days since caller got the first dose and still has not the second; missed dose; pain on her nipples; pain on her breasts; tenderness on her breasts; menstrual cramps; urinary track infection; hemorroids; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), URINARY TRACT INFECTION (urinary track infection), HAEMORRHOIDS (hemorroids) and NIPPLE PAIN (pain on her nipples) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Amenorrhea (amenorrhea.).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced URINARY TRACT INFECTION (urinary track infection) and HAEMORRHOIDS (hemorroids). In June 2021, the patient experienced NIPPLE PAIN (pain on her nipples), BREAST PAIN (pain on her breasts), BREAST TENDERNESS (tenderness on her breasts) and DYSMENORRHOEA (menstrual cramps). On an unknown date, the patient experienced MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), MENSTRUATION IRREGULAR (She had not menstruated in over 3 years before that), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache), PYREXIA (fever), PRODUCT DOSE OMISSION ISSUE (More than 36 days since caller got the first dose and still has not the second) and PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), URINARY TRACT INFECTION (urinary track infection), HAEMORRHOIDS (hemorroids), NIPPLE PAIN (pain on her nipples), BREAST PAIN (pain on her breasts), BREAST TENDERNESS (tenderness on her breasts), DYSMENORRHOEA (menstrual cramps), MENSTRUATION IRREGULAR (She had not menstruated in over 3 years before that), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache), PYREXIA (fever), PRODUCT DOSE OMISSION ISSUE (More than 36 days since caller got the first dose and still has not the second) and PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  Other treatment  Medication provided was antibiotics for UTI and  over the counter Cream for Hemorrhoids.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Added new event.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia, Urinary tract infection, Vomiting
Clinical narrative: menstruation; leg pain,foot pain; She had not menstruated in over 3 years before that; chills; vomiting; headache; fever; More than 36 days since caller got the first dose and still has not the second; missed dose; pain on her nipples; pain on her breasts; tenderness on her breasts; menstrual cramps; urinary track infection; hemorroids; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), URINARY TRACT INFECTION (urinary track infection), HAEMORRHOIDS (hemorroids) and NIPPLE PAIN (pain on her nipples) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Amenorrhea (amenorrhea.).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced URINARY TRACT INFECTION (urinary track infection) and HAEMORRHOIDS (hemorroids). In June 2021, the patient experienced NIPPLE PAIN (pain on her nipples), BREAST PAIN (pain on her breasts), BREAST TENDERNESS (tenderness on her breasts) and DYSMENORRHOEA (menstrual cramps). On an unknown date, the patient experienced MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), MENSTRUATION IRREGULAR (She had not menstruated in over 3 years before that), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache), PYREXIA (fever), PRODUCT DOSE OMISSION ISSUE (More than 36 days since caller got the first dose and still has not the second) and PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), URINARY TRACT INFECTION (urinary track infection), HAEMORRHOIDS (hemorroids), NIPPLE PAIN (pain on her nipples), BREAST PAIN (pain on her breasts), BREAST TENDERNESS (tenderness on her breasts), DYSMENORRHOEA (menstrual cramps), MENSTRUATION IRREGULAR (She had not menstruated in over 3 years before that), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache), PYREXIA (fever), PRODUCT DOSE OMISSION ISSUE (More than 36 days since caller got the first dose and still has not the second) and PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  Other treatment  Medication provided was antibiotics for UTI and  over the counter Cream for Hemorrhoids.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Added new event.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: foot numb from  shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (foot numb from  shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (foot numb from  shot). At the time of the report, HYPOAESTHESIA (foot numb from  shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided.