chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Oropharyngeal pain, Pyrexia
Clinical narrative: scratchy throat,; Fever; bad sweats during the night; Headache; Fatigue; high blood pressure; heart rate Increased; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (high blood pressure), HEART RATE INCREASED (heart rate Increased), HYPERHIDROSIS (bad sweats during the night), OROPHARYNGEAL PAIN (scratchy throat,) and HEADACHE (Headache) in a 60-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.     Concomitant products included CARVEDILOL and LOSARTAN for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (high blood pressure) and HEART RATE INCREASED (heart rate Increased). On 11-Apr-2021, the patient experienced HYPERHIDROSIS (bad sweats during the night). 11-Apr-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 12-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (scratchy throat,) and PYREXIA (Fever). At the time of the report, BLOOD PRESSURE INCREASED (high blood pressure), HEART RATE INCREASED (heart rate Increased), HYPERHIDROSIS (bad sweats during the night), OROPHARYNGEAL PAIN (scratchy throat,), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood pressure measurement: 145/95 (High) 145/95 mmHg. On 10-Apr-2021, Heart rate: 95 (High) 95 bpm. On 12-Apr-2021, Blood pressure measurement: 174/97 (High) 174/97mmHg. On 12-Apr-2021, Heart rate: 71 (normal) 71 bpm.         Action taken with mRNA-1273 in response to the drug was not applicable. No treatment medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio increased
Clinical narrative: High INR 3.7; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO INCREASED (High INR 3.7) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced INTERNATIONAL NORMALISED RATIO INCREASED (High INR 3.7). At the time of the report, INTERNATIONAL NORMALISED RATIO INCREASED (High INR 3.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, International normalised ratio: 3.7 (High) INR is high at 3.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  Concomitant medications included Blood thinners. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: arm got swollen firm at injection site; red at the injection sight; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm got swollen firm at injection site), VACCINATION SITE ERYTHEMA (red at the injection sight) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE SWELLING (arm got swollen firm at injection site), VACCINATION SITE ERYTHEMA (red at the injection sight) and PYREXIA (fever). At the time of the report, VACCINATION SITE SWELLING (arm got swollen firm at injection site), VACCINATION SITE ERYTHEMA (red at the injection sight) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant medical history or concomitant medications provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Diarrhea; Fatigue; Chills; Body aches; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a female patient of an unknown age 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and PYREXIA (Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine were reported.  No treatment medicine were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; Fatigue; Chills; Body aches; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a female patient of an unknown age 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and PYREXIA (Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine were reported.  No treatment medicine were reported.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Pain in arm; inflammation; muscle soreness; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, INFLAMMATION, MYALGIA, and INJECTION SITE PAIN in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY, INFLAMMATION, MYALGIA, and INJECTION SITE PAIN. The patient was treated with ALEVE for Muscle soreness and Inflammation, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY, INFLAMMATION, MYALGIA, and INJECTION SITE PAIN outcome was unknown. Unknown          This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, MYALGIA, INFLAMMATION, and INJECTION SITE PAIN in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY, MYALGIA, INFLAMMATION, and INJECTION SITE PAIN. At the time of the report, PAIN IN EXTREMITY, MYALGIA, INFLAMMATION, and INJECTION SITE PAIN outcome was unknown. Unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date post 2nd dose of COVID-19, the patient reported that could not lift his arm up due to pain from the injection. The patient reported that he also felt inflammation and muscle soreness.   The patient reported that these symptoms are ongoing.   Treatment information included an unknown dosage of Aleve.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on full body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on full body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced RASH (Rash on full body). At the time of the report, RASH (Rash on full body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and FATIGUE (tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported). Concomitant products included OCRELIZUMAB.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (Fatigue) and FATIGUE (tired). At the time of the report, FATIGUE (Fatigue) and FATIGUE (tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: ear ache; swollen glands; uncontrollable vomiting; fatigue; sore arm; 103 fever; a little nausea; not feeling well; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), EAR PAIN (ear ache), MALAISE (not feeling well), HEADACHE (really bad headache) and LYMPHADENOPATHY (swollen glands) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (not feeling well), HEADACHE (really bad headache), PYREXIA (103 fever), NAUSEA (a little nausea) and FATIGUE (fatigue). On 22-Mar-2021, the patient experienced VOMITING (uncontrollable vomiting). On 23-Mar-2021, the patient experienced EAR PAIN (ear ache) and LYMPHADENOPATHY (swollen glands). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Mar-2021, VOMITING (uncontrollable vomiting) had resolved. On 23-Mar-2021, HEADACHE (really bad headache) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), EAR PAIN (ear ache), MALAISE (not feeling well), LYMPHADENOPATHY (swollen glands), PYREXIA (103 fever) and FATIGUE (fatigue) had resolved and NAUSEA (a little nausea) outcome was unknown.            This case was linked to -MODERNATX, INC.-MOD-2021-026134 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-026134:CROSS LINKED TO DOSE 1
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: ear ache; swollen glands; uncontrollable vomiting; fatigue; sore arm; 103 fever; a little nausea; not feeling well; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), EAR PAIN (ear ache), MALAISE (not feeling well), HEADACHE (really bad headache) and LYMPHADENOPATHY (swollen glands) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (not feeling well), HEADACHE (really bad headache), PYREXIA (103 fever), NAUSEA (a little nausea) and FATIGUE (fatigue). On 22-Mar-2021, the patient experienced VOMITING (uncontrollable vomiting). On 23-Mar-2021, the patient experienced EAR PAIN (ear ache) and LYMPHADENOPATHY (swollen glands). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Mar-2021, VOMITING (uncontrollable vomiting) had resolved. On 23-Mar-2021, HEADACHE (really bad headache) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), EAR PAIN (ear ache), MALAISE (not feeling well), LYMPHADENOPATHY (swollen glands), PYREXIA (103 fever) and FATIGUE (fatigue) had resolved and NAUSEA (a little nausea) outcome was unknown.            This case was linked to -MODERNATX, INC.-MOD-2021-026134 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-026134:CROSS LINKED TO DOSE 1
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pruritus, Rash
Clinical narrative: get itchy; a rash; really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired), INJECTION SITE PRURITUS (get itchy) and RASH (a rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Chickenpox.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (really tired). On 05-Apr-2021, the patient experienced INJECTION SITE PRURITUS (get itchy) and RASH (a rash). At the time of the report, FATIGUE (really tired), INJECTION SITE PRURITUS (get itchy) and RASH (a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Steroid and eczema cream.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Blistering rash; Rash on left arm; Fever; Left arm pain & swelling; Left arm pain & swelling; Frequent loose stools; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN IN EXTREMITY (Left arm pain & swelling), PERIPHERAL SWELLING (Left arm pain & swelling), DIARRHOEA (Frequent loose stools), RASH VESICULAR (Blistering rash) and RASH (Rash on left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insomnia since 28-May-2014 and Hyperlipidemia on 15-May-2014. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) from 28-Feb-2014 to an unknown date and ALPRAZOLAM from 15-May-2015 to an unknown date for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm pain & swelling), PERIPHERAL SWELLING (Left arm pain & swelling), DIARRHOEA (Frequent loose stools), RASH (Rash on left arm) and PYREXIA (Fever). On 06-Apr-2021, the patient experienced RASH VESICULAR (Blistering rash). At the time of the report, PAIN IN EXTREMITY (Left arm pain & swelling), PERIPHERAL SWELLING (Left arm pain & swelling), DIARRHOEA (Frequent loose stools), RASH VESICULAR (Blistering rash), RASH (Rash on left arm) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On 6-apr-2021 patient contacted office as her rash started blistering and was advised to see the dermatologist The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No treatment product information was provided   This case was linked to MOD-2021-044643 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: Blistering rash; Rash on left arm; Fever; Left arm pain & swelling; Left arm pain & swelling; Frequent loose stools; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN IN EXTREMITY (Left arm pain & swelling), PERIPHERAL SWELLING (Left arm pain & swelling), DIARRHOEA (Frequent loose stools), RASH VESICULAR (Blistering rash) and RASH (Rash on left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insomnia since 28-May-2014 and Hyperlipidemia on 15-May-2014. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) from 28-Feb-2014 to an unknown date and ALPRAZOLAM from 15-May-2015 to an unknown date for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm pain & swelling), PERIPHERAL SWELLING (Left arm pain & swelling), DIARRHOEA (Frequent loose stools), RASH (Rash on left arm) and PYREXIA (Fever). On 06-Apr-2021, the patient experienced RASH VESICULAR (Blistering rash). At the time of the report, PAIN IN EXTREMITY (Left arm pain & swelling), PERIPHERAL SWELLING (Left arm pain & swelling), DIARRHOEA (Frequent loose stools), RASH VESICULAR (Blistering rash), RASH (Rash on left arm) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On 6-apr-2021 patient contacted office as her rash started blistering and was advised to see the dermatologist The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No treatment product information was provided   This case was linked to MOD-2021-044643 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: can't  sleep, don't felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (can't  sleep, don't felt sleepy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (diabetes type 2), Blood pressure high and Arthritis. Concomitant products included LEVOTHYROXINE for Thyroid disorder, SITAGLIPTIN PHOSPHATE (JANUVIA) for Type 2 diabetes mellitus.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (can't  sleep, don't felt sleepy). At the time of the report, INSOMNIA (can't  sleep, don't felt sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not included. The other concomitant medication provided was blood pressure medicine.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), HYDROCHLOROTHIAZIDE, IRBESARTAN (AVALIDE), ATENOLOL (TENORMIN) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: slight pain at injection site; tiredness; muscle pain; chills; fever; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE PAIN (slight pain at injection site), FATIGUE (tiredness), MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (slight pain at injection site). an unknown date, the patient experienced FATIGUE (tiredness), MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, INJECTION SITE PAIN (slight pain at injection site), FATIGUE (tiredness), MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever) had resolved.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact
Clinical narrative: Direct skin exposure to vaccine/feeling liquid running down arm; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA SKIN CONTACT (Direct skin exposure to vaccine/feeling liquid running down arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced EXPOSURE VIA SKIN CONTACT (Direct skin exposure to vaccine/feeling liquid running down arm). At the time of the report, EXPOSURE VIA SKIN CONTACT (Direct skin exposure to vaccine/feeling liquid running down arm) had resolved.            Concomitant medications included birth control medications.  No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not Applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphonia, Fatigue, Headache, Movement disorder
Clinical narrative: Can barely lift or use her arms; Raspy voice; Fatigue; Headache; Chills; Swelling in the arm at the injection site; Red swelling that is itchy; Red swelling that burns; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Can barely lift or use her arms), DYSPHONIA (Raspy voice), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), HYDROCHLOROTHIAZIDE, IRBESARTAN (AVALIDE), ATENOLOL (TENORMIN) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MOVEMENT DISORDER (Can barely lift or use her arms), DYSPHONIA (Raspy voice), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE SWELLING (Swelling in the arm at the injection site), VACCINATION SITE PRURITUS (Red swelling that is itchy) and VACCINATION SITE PAIN (Red swelling that burns). At the time of the report, MOVEMENT DISORDER (Can barely lift or use her arms), DYSPHONIA (Raspy voice), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE SWELLING (Swelling in the arm at the injection site), VACCINATION SITE PRURITUS (Red swelling that is itchy) and VACCINATION SITE PAIN (Red swelling that burns) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Can barely lift or use her arms; Raspy voice; Fatigue; Headache; Chills; Swelling in the arm at the injection site; Red swelling that is itchy; Red swelling that burns; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Can barely lift or use her arms), DYSPHONIA (Raspy voice), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), HYDROCHLOROTHIAZIDE, IRBESARTAN (AVALIDE), ATENOLOL (TENORMIN) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MOVEMENT DISORDER (Can barely lift or use her arms), DYSPHONIA (Raspy voice), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE SWELLING (Swelling in the arm at the injection site), VACCINATION SITE PRURITUS (Red swelling that is itchy) and VACCINATION SITE PAIN (Red swelling that burns). At the time of the report, MOVEMENT DISORDER (Can barely lift or use her arms), DYSPHONIA (Raspy voice), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE SWELLING (Swelling in the arm at the injection site), VACCINATION SITE PRURITUS (Red swelling that is itchy) and VACCINATION SITE PAIN (Red swelling that burns) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: little fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (little fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (little fever) had resolved.            No concomitant medication was provided by the reporter.      Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Accident, Product dose omission issue
Clinical narrative: Accident after receiving first vaccine; had an accident and missed the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENT (Accident after receiving first vaccine) and PRODUCT DOSE OMISSION ISSUE (had an accident and missed the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-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 ACCIDENT (Accident after receiving first vaccine) and PRODUCT DOSE OMISSION ISSUE (had an accident and missed the second dose). At the time of the report, ACCIDENT (Accident after receiving first vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (had an accident and missed the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: left arm is uncontrollably twitching/Twitching now in the other arm, both calves and thighs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (left arm is uncontrollably twitching/Twitching now in the other arm, both calves and thighs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Lung disorder.    In March 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 MUSCLE TWITCHING (left arm is uncontrollably twitching/Twitching now in the other arm, both calves and thighs). At the time of the report, MUSCLE TWITCHING (left arm is uncontrollably twitching/Twitching now in the other arm, both calves and thighs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Patient stated that, after two and half weeks of receiving vaccine, she started noticing that her left arm muscle was uncontrollably twitching which was extended to another arm, both the calves and both thighs. The consumer reported that it was not painful, but  noticeable. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Infection, Injection site erythema, Injection site pain, Product dose omission issue
Clinical narrative: Has not received the 2nd vaccine; PAIN IN ARM; it was red and looked infected; she had a blister the size of her hand; looked infected; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (she had a blister the size of her hand), INFECTION (looked infected), PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine), INJECTION SITE PAIN (PAIN IN ARM) and INJECTION SITE ERYTHEMA (it was red and looked infected) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2004) for COVID-19 vaccination.     Concurrent medical conditions included Multiple allergies (Multiple food allergies to shrimp, pineapple, mango, and papaya).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced BLISTER (she had a blister the size of her hand), INFECTION (looked infected), INJECTION SITE PAIN (PAIN IN ARM) and INJECTION SITE ERYTHEMA (it was red and looked infected). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine). At the time of the report, BLISTER (she had a blister the size of her hand), INFECTION (looked infected), PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine), INJECTION SITE PAIN (PAIN IN ARM) and INJECTION SITE ERYTHEMA (it was red and looked infected) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment reported as blister was drained in the Emergency Room. No concomitant medications reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: tested for COVID; fever 100; aches and pains; cough; horrible sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains), COUGH (cough), OROPHARYNGEAL PAIN (horrible sore throat), COVID-19 (tested for COVID) and PYREXIA (fever 100) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplant since an unknown date.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN (aches and pains), COUGH (cough), OROPHARYNGEAL PAIN (horrible sore throat) and PYREXIA (fever 100). On 08-Apr-2021, the patient experienced COVID-19 (tested for COVID). The patient was treated with PARACETAMOL ongoing since an unknown date at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN (aches and pains), COUGH (cough), OROPHARYNGEAL PAIN (horrible sore throat), COVID-19 (tested for COVID) and PYREXIA (fever 100) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Treatment for the event include cough syrup.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 70-year-old female patient 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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. This case was linked to MOD-2021-074420 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 112A21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable. The reporter gave his mother 7up and water to help with the nausea.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Dizziness
Clinical narrative: super high blood pressure; extremely dizziness; nausea; chills; fever 103F; threw up; headache; body ache; This spontaneous case was reported by a physician and describes the occurrence of BLOOD PRESSURE INCREASED (super high blood pressure), PAIN (body ache), DIZZINESS (extremely dizziness), HEADACHE (headache) and NAUSEA (nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (body ache), HEADACHE (headache), CHILLS (chills), PYREXIA (fever 103F) and VOMITING (threw up). On 10-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (super high blood pressure), DIZZINESS (extremely dizziness) and NAUSEA (nausea). The patient was treated with MECLIZINE [MECLOZINE] at an unspecified dose and frequency; DICLOFENAC at an unspecified dose and frequency and TIZANIDINE for Dizziness, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (super high blood pressure) and DIZZINESS (extremely dizziness) had not resolved, PAIN (body ache), HEADACHE (headache), CHILLS (chills), PYREXIA (fever 103F) and VOMITING (threw up) had resolved and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 103°f (High) 103°F. On 10-Apr-2021, Blood pressure measurement: super high (High) super high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was on an unspecified blood pressure medicine as a concomitant product. Patient went to primary doctor, cardiologist, ENT and neurologist.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: super high blood pressure; extremely dizziness; nausea; chills; fever 103F; threw up; headache; body ache; This spontaneous case was reported by a physician and describes the occurrence of BLOOD PRESSURE INCREASED (super high blood pressure), PAIN (body ache), DIZZINESS (extremely dizziness), HEADACHE (headache) and NAUSEA (nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (body ache), HEADACHE (headache), CHILLS (chills), PYREXIA (fever 103F) and VOMITING (threw up). On 10-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (super high blood pressure), DIZZINESS (extremely dizziness) and NAUSEA (nausea). The patient was treated with MECLIZINE [MECLOZINE] at an unspecified dose and frequency; DICLOFENAC at an unspecified dose and frequency and TIZANIDINE for Dizziness, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (super high blood pressure) and DIZZINESS (extremely dizziness) had not resolved, PAIN (body ache), HEADACHE (headache), CHILLS (chills), PYREXIA (fever 103F) and VOMITING (threw up) had resolved and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 103°f (High) 103°F. On 10-Apr-2021, Blood pressure measurement: super high (High) super high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was on an unspecified blood pressure medicine as a concomitant product. Patient went to primary doctor, cardiologist, ENT and neurologist.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Adverse drug reaction, Headache
Clinical narrative: stomach ache; minor side effects; headaches; 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 ABDOMINAL PAIN UPPER (stomach ache), ADVERSE DRUG REACTION (minor side effects) and HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), ADVERSE DRUG REACTION (minor side effects) and HEADACHE (headaches). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), ADVERSE DRUG REACTION (minor side effects) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hypoaesthesia, Injection site pain, Nausea, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat started swelling), HYPOAESTHESIA (he started feeling numbness), PARAESTHESIA (he started feeling tingling), INJECTION SITE PAIN (arm soreness at the injection site) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Anxiety, COPD and Cardiovascular disorder. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, TADALAFIL (CIALIS) for Hypertension, APIXABAN (ELIQUIS) for an unknown indication. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PHARYNGEAL SWELLING (throat started swelling), HYPOAESTHESIA (he started feeling numbness) and PARAESTHESIA (he started feeling tingling). On 28-Jan-2021, the patient experienced INJECTION SITE PAIN (arm soreness at the injection site). On 01-Feb-2021, the patient experienced NAUSEA (nausea), DIARRHOEA (diarrhea) and SWELLING (my lower legs are swelling). On 31-Dec-2020, PHARYNGEAL SWELLING (throat started swelling), HYPOAESTHESIA (he started feeling numbness) and PARAESTHESIA (he started feeling tingling) had resolved. At the time of the report, INJECTION SITE PAIN (arm soreness at the injection site), NAUSEA (nausea), DIARRHOEA (diarrhea) and SWELLING (my lower legs are swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was given a "shot" of diphenhydramine and the event resolved. This case was linked to MOD-2021-017705.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat started swelling), HYPOAESTHESIA (he started feeling numbness), PARAESTHESIA (he started feeling tingling), INJECTION SITE PAIN (arm soreness at the injection site) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Anxiety, COPD and Cardiovascular disorder. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, TADALAFIL (CIALIS) for Hypertension, APIXABAN (ELIQUIS) for an unknown indication. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PHARYNGEAL SWELLING (throat started swelling), HYPOAESTHESIA (he started feeling numbness) and PARAESTHESIA (he started feeling tingling). On 28-Jan-2021, the patient experienced INJECTION SITE PAIN (arm soreness at the injection site). On 01-Feb-2021, the patient experienced NAUSEA (nausea), DIARRHOEA (diarrhea) and SWELLING (my lower legs are swelling). On 31-Dec-2020, PHARYNGEAL SWELLING (throat started swelling), HYPOAESTHESIA (he started feeling numbness) and PARAESTHESIA (he started feeling tingling) had resolved. At the time of the report, INJECTION SITE PAIN (arm soreness at the injection site), NAUSEA (nausea), DIARRHOEA (diarrhea) and SWELLING (my lower legs are swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was given a "shot" of diphenhydramine and the event resolved. This case was linked to MOD-2021-017705.