chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart has been racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart has been racing) 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 PALPITATIONS (heart has been racing). At the time of the report, PALPITATIONS (heart has been racing) outcome was unknown.            Action taken with drug is not applicable. No concomitant medication was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: very itchy skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy skin) 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 PRURITUS (very itchy skin). At the time of the report, PRURITUS (very itchy skin) outcome was unknown.            No laboratory data was provided.  Relevant concomitant medications were not reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; headache; fever; body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 antibody test positive since January 2021.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            no concomitant and  treatment drugs were provided.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeding disorder, Headache
Clinical narrative: was so sick; super bad intense headache for 2 days; muscle pain; joint pain; chills were horrible; nausea; couldn't eat; temperature of 102 for 2 days; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (super bad intense headache for 2 days), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills were horrible) and NAUSEA (nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia and Pre-diabetic.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced HEADACHE (super bad intense headache for 2 days), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills were horrible), NAUSEA (nausea), FEEDING DISORDER (couldn't eat) and PYREXIA (temperature of 102 for 2 days). On an unknown date, the patient experienced ILLNESS (was so sick). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (super bad intense headache for 2 days), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills were horrible), NAUSEA (nausea), FEEDING DISORDER (couldn't eat), PYREXIA (temperature of 102 for 2 days) and ILLNESS (was so sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) temperature of 102 for 2 days.  Her temperature broke after one day.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned   Additional information provided they provide lab data for body temp. and current conditions as a fibromyalgia and pre-diabetic  patient had super bad intense headache for 2 days, muscle pain, joint pain, chills were horrible; it lasted 2 days.  patient was over weight,
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Nausea, Pyrexia
Clinical narrative: was so sick; super bad intense headache for 2 days; muscle pain; joint pain; chills were horrible; nausea; couldn't eat; temperature of 102 for 2 days; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (super bad intense headache for 2 days), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills were horrible) and NAUSEA (nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia and Pre-diabetic.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced HEADACHE (super bad intense headache for 2 days), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills were horrible), NAUSEA (nausea), FEEDING DISORDER (couldn't eat) and PYREXIA (temperature of 102 for 2 days). On an unknown date, the patient experienced ILLNESS (was so sick). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (super bad intense headache for 2 days), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills were horrible), NAUSEA (nausea), FEEDING DISORDER (couldn't eat), PYREXIA (temperature of 102 for 2 days) and ILLNESS (was so sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) temperature of 102 for 2 days.  Her temperature broke after one day.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned   Additional information provided they provide lab data for body temp. and current conditions as a fibromyalgia and pre-diabetic  patient had super bad intense headache for 2 days, muscle pain, joint pain, chills were horrible; it lasted 2 days.  patient was over weight,
Sex: U
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: Tongue Sore; 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 GLOSSODYNIA (Tongue Sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GLOSSODYNIA (Tongue Sore). At the time of the report, GLOSSODYNIA (Tongue Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Medical History information was reported. No concomitant information was reported. Treatment information was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Overdue 2nd dose; 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 PRODUCT DOSE OMISSION ISSUE (Overdue 2nd dose) 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 15-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 PRODUCT DOSE OMISSION ISSUE (Overdue 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Overdue 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported . Treatment information was not provided.   The reporter mentioned that the patient has received the 1st dose on 15-April-2021 and it's been 52 days.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Possible AE: consumer is scheduled to receive 2nd dose passed 42nd day window; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Possible AE: consumer is scheduled to receive 2nd dose passed 42nd day window) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced OFF LABEL USE (Possible AE: consumer is scheduled to receive 2nd dose passed 42nd day window). On 04-Jun-2021, OFF LABEL USE (Possible AE: consumer is scheduled to receive 2nd dose passed 42nd day window) 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 reported.   Treatment information not reported.  Patient reported to pharmacist that 04-JUN-2021 would have been day 42 from 1st dose, but no proof of 1st dose.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (Rash) 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, 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 URTICARIA (Hives) and RASH (Rash). At the time of the report, URTICARIA (Hives) and RASH (Rash) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Action taken with respect to mRNA-1273 was not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Complex regional pain syndrome, Condition aggravated, Grip strength decreased, Joint swelling
Clinical narrative: diffficulty gripping things; The joints appear to larger than now; Arthritis worsened; CRSP worsened; CRSP worsened; Pinkie finger and the one next to it started hurting and is getting worse/began feeling pain in my right hand finger joints/Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of GRIP STRENGTH DECREASED (diffficulty gripping things), JOINT SWELLING (The joints appear to larger than now), ARTHRITIS (Arthritis worsened), COMPLEX REGIONAL PAIN SYNDROME (CRSP worsened) and CONDITION AGGRAVATED (CRSP worsened) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022b21a and 002c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulpha), Drug allergy (Diluadi), Drug allergy (Percocet), Asthma, Avascular necrosis, Seizures, Arthritis, Complex regional pain syndrome, Pain, Cancer, Depression, Blood pressure high and Sleep disorder. Concomitant products included AMLODIPINE for Blood pressure high, LETROZOLE for Cancer, FLUOXETINE HYDROCHLORIDE (FLOXETINE) for Depression, PARACETAMOL (TYLENOL) for Pain, TRAZODONE for Sleep disorder NOS.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced GRIP STRENGTH DECREASED (diffficulty gripping things), JOINT SWELLING (The joints appear to larger than now), ARTHRITIS (Arthritis worsened), COMPLEX REGIONAL PAIN SYNDROME (CRSP worsened), CONDITION AGGRAVATED (CRSP worsened) and VACCINATION SITE PAIN (Pinkie finger and the one next to it started hurting and is getting worse/began feeling pain in my right hand finger joints/Sore Arm). At the time of the report, GRIP STRENGTH DECREASED (diffficulty gripping things), JOINT SWELLING (The joints appear to larger than now), ARTHRITIS (Arthritis worsened), COMPLEX REGIONAL PAIN SYNDROME (CRSP worsened), CONDITION AGGRAVATED (CRSP worsened) and VACCINATION SITE PAIN (Pinkie finger and the one next to it started hurting and is getting worse/began feeling pain in my right hand finger joints/Sore Arm) had not resolved.            After second vaccination the patient began to feel pain in right hand and finger joints. It started with the pinkie finger and progressed to the four other fingers on that hand. The joints also appeared larger. She woke in the morning unable to use her right hand and fingers were in extreme pain. The patient used little exercises which decreased joint stiffness, but she now had difficulty gripping things, especially without pain.  No other treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Medical history updated, concomitant drugs, suspect dosage regimen and new events were added.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: diffficulty gripping things; The joints appear to larger than now; Arthritis worsened; CRSP worsened; CRSP worsened; Pinkie finger and the one next to it started hurting and is getting worse/began feeling pain in my right hand finger joints/Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of GRIP STRENGTH DECREASED (diffficulty gripping things), JOINT SWELLING (The joints appear to larger than now), ARTHRITIS (Arthritis worsened), COMPLEX REGIONAL PAIN SYNDROME (CRSP worsened) and CONDITION AGGRAVATED (CRSP worsened) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022b21a and 002c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulpha), Drug allergy (Diluadi), Drug allergy (Percocet), Asthma, Avascular necrosis, Seizures, Arthritis, Complex regional pain syndrome, Pain, Cancer, Depression, Blood pressure high and Sleep disorder. Concomitant products included AMLODIPINE for Blood pressure high, LETROZOLE for Cancer, FLUOXETINE HYDROCHLORIDE (FLOXETINE) for Depression, PARACETAMOL (TYLENOL) for Pain, TRAZODONE for Sleep disorder NOS.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced GRIP STRENGTH DECREASED (diffficulty gripping things), JOINT SWELLING (The joints appear to larger than now), ARTHRITIS (Arthritis worsened), COMPLEX REGIONAL PAIN SYNDROME (CRSP worsened), CONDITION AGGRAVATED (CRSP worsened) and VACCINATION SITE PAIN (Pinkie finger and the one next to it started hurting and is getting worse/began feeling pain in my right hand finger joints/Sore Arm). At the time of the report, GRIP STRENGTH DECREASED (diffficulty gripping things), JOINT SWELLING (The joints appear to larger than now), ARTHRITIS (Arthritis worsened), COMPLEX REGIONAL PAIN SYNDROME (CRSP worsened), CONDITION AGGRAVATED (CRSP worsened) and VACCINATION SITE PAIN (Pinkie finger and the one next to it started hurting and is getting worse/began feeling pain in my right hand finger joints/Sore Arm) had not resolved.            After second vaccination the patient began to feel pain in right hand and finger joints. It started with the pinkie finger and progressed to the four other fingers on that hand. The joints also appeared larger. She woke in the morning unable to use her right hand and fingers were in extreme pain. The patient used little exercises which decreased joint stiffness, but she now had difficulty gripping things, especially without pain.  No other treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Medical history updated, concomitant drugs, suspect dosage regimen and new events were added.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Myalgia, Vaccination site pruritus
Clinical narrative: Itchiness slightly below the injection site; Developed an allergic reaction; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Developed an allergic reaction), VACCINATION SITE PRURITUS (Itchiness slightly below the injection site) and MYALGIA (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included Malaria and Lymph node dissection (lymph nodes were removed due to cancer). Concurrent medical conditions included Cancer, Allergy (Very allergic NOS), Glaucoma, Allergy to antibiotic, Fruit allergy (Allergy to Mango) and Food allergy (Allergy to Chia). Concomitant products included COLECALCIFEROL (VITAMINS D3), VITAMIN C [ASCORBIC ACID], VITAMIN B1 NOS, VITAMIN B6, VITAMIN B12 [VITAMIN B12 NOS], CURCUMIN, FISH OIL, PROBIOTICS NOS, COLLAGEN, CLONAZEPAM (RIVOTRIL), LISINOPRIL and FAMOTIDINE (NOVATAC) for an unknown indication.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced MYALGIA (Sore arm). On 07-Jun-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness slightly below the injection site). In June 2021, the patient experienced ALLERGY TO VACCINE (Developed an allergic reaction). On 02-Jun-2021, MYALGIA (Sore arm) had resolved. At the time of the report, ALLERGY TO VACCINE (Developed an allergic reaction) and VACCINATION SITE PRURITUS (Itchiness slightly below the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included unspecified eye drops and glaucoma medication. No treatment medication was provided.   This case was linked to MOD-2021-270028 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received contains significant information: Event added: Developed an allergic reaction, medical history updated: Malaria, Allergy to Chia, Mango, Outcome of events updated On 28-Jul-2021: Follow up received contains No New Information
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Jul-2021. In 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.            The patient's concomitant medication was not reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Internal review on 20-Jul-2021 resulted in updates to the pregnancy details
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Candida infection, Chest X-ray, Colonoscopy, Computerised tomogram thorax, Dysgeusia
Clinical narrative: Candidiasis; Neoplasm of uncertain behavior; Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal), CANDIDA INFECTION (Candidiasis) and NEOPLASM (Neoplasm of uncertain behavior) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Diabetes. Concomitant products included OMEPRAZOLE, AMLODIPINE BESILATE, ATORVASTATIN CALCIUM ANHYDROUS, CARVEDILOL, LEVOTHYROXINE SODIUM (LEVOTHYROXINE NA), MONTELUKAST, LOSARTAN, COLECALCIFEROL (CHOLECALCIFEROL TEVA), METFORMIN, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE), BUDESONIDE;FORMOTEROL, FLUTICASONE PROPIONATE, IPRATROPIUM BROMIDE (IPRATROPIUM BR) and SILDENAFIL CITRATE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DYSGEUSIA (Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal). On 28-May-2021, the patient experienced NEOPLASM (Neoplasm of uncertain behavior). On an unknown date, the patient experienced CANDIDA INFECTION (Candidiasis). The patient was treated with DEXAMETHASONE on 22-Apr-2021 for Candidiasis, at a dose of Elx 0.5/5ml; NYSTATIN on 22-Apr-2021 for Candidiasis, at a dose of 450; FLUCONAZOLE on 05-May-2021 for Candidiasis, at a dose of 100 mg and GUAIFENESIN on 06-Apr-2021 for Sinus disorder, at a dose of 400 mg. At the time of the report, DYSGEUSIA (Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal) had not resolved and CANDIDA INFECTION (Candidiasis) and NEOPLASM (Neoplasm of uncertain behavior) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Chest X-ray: normal (normal) Normal. On 09-Apr-2021, Computerised tomogram thorax: normal (normal) Normal. On 30-Apr-2021, Colonoscopy: normal (normal) Normal. On 09-Jul-2021, Magnetic resonance imaging head: normal (normal) Normal.         Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains significant information- Demographics updated, medical history was added, relevant test results, concomitant and treatment medications were provided. Outcome was updated and additional events added.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Neoplasm
Clinical narrative: Candidiasis; Neoplasm of uncertain behavior; Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal), CANDIDA INFECTION (Candidiasis) and NEOPLASM (Neoplasm of uncertain behavior) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Diabetes. Concomitant products included OMEPRAZOLE, AMLODIPINE BESILATE, ATORVASTATIN CALCIUM ANHYDROUS, CARVEDILOL, LEVOTHYROXINE SODIUM (LEVOTHYROXINE NA), MONTELUKAST, LOSARTAN, COLECALCIFEROL (CHOLECALCIFEROL TEVA), METFORMIN, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE), BUDESONIDE;FORMOTEROL, FLUTICASONE PROPIONATE, IPRATROPIUM BROMIDE (IPRATROPIUM BR) and SILDENAFIL CITRATE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DYSGEUSIA (Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal). On 28-May-2021, the patient experienced NEOPLASM (Neoplasm of uncertain behavior). On an unknown date, the patient experienced CANDIDA INFECTION (Candidiasis). The patient was treated with DEXAMETHASONE on 22-Apr-2021 for Candidiasis, at a dose of Elx 0.5/5ml; NYSTATIN on 22-Apr-2021 for Candidiasis, at a dose of 450; FLUCONAZOLE on 05-May-2021 for Candidiasis, at a dose of 100 mg and GUAIFENESIN on 06-Apr-2021 for Sinus disorder, at a dose of 400 mg. At the time of the report, DYSGEUSIA (Sweet taste in mouth / Savory and vegetables taste sweet / Only sweet tastes normal) had not resolved and CANDIDA INFECTION (Candidiasis) and NEOPLASM (Neoplasm of uncertain behavior) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Chest X-ray: normal (normal) Normal. On 09-Apr-2021, Computerised tomogram thorax: normal (normal) Normal. On 30-Apr-2021, Colonoscopy: normal (normal) Normal. On 09-Jul-2021, Magnetic resonance imaging head: normal (normal) Normal.         Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains significant information- Demographics updated, medical history was added, relevant test results, concomitant and treatment medications were provided. Outcome was updated and additional events added.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse reaction after my second Moderna vacination; 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 VACCINATION COMPLICATION (adverse reaction after my second Moderna vacination) 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 VACCINATION COMPLICATION (adverse reaction after my second Moderna vacination). At the time of the report, VACCINATION COMPLICATION (adverse reaction after my second Moderna vacination) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  Concomitant product details was not reported.  Treatment details was not reported .
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia, Neck pain
Clinical narrative: Patient hasn't received 2nd dose; didn't feel good after 7 days of receiving 1st dose; had pain in the neck; started with fever; had body aches; had headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose), FEELING ABNORMAL (didn't feel good after 7 days of receiving 1st dose), NECK PAIN (had pain in the neck), PYREXIA (started with fever) and MYALGIA (had body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced FEELING ABNORMAL (didn't feel good after 7 days of receiving 1st dose), NECK PAIN (had pain in the neck), PYREXIA (started with fever), MYALGIA (had body aches), HEADACHE (had headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose) had resolved and FEELING ABNORMAL (didn't feel good after 7 days of receiving 1st dose), NECK PAIN (had pain in the neck), PYREXIA (started with fever), MYALGIA (had body aches), HEADACHE (had headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had antibody testing done on 21-May-2021 with results not provided.  No concomitant drugs were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia
Clinical narrative: Patient hasn't received 2nd dose; didn't feel good after 7 days of receiving 1st dose; had pain in the neck; started with fever; had body aches; had headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose), FEELING ABNORMAL (didn't feel good after 7 days of receiving 1st dose), NECK PAIN (had pain in the neck), PYREXIA (started with fever) and MYALGIA (had body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced FEELING ABNORMAL (didn't feel good after 7 days of receiving 1st dose), NECK PAIN (had pain in the neck), PYREXIA (started with fever), MYALGIA (had body aches), HEADACHE (had headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose) had resolved and FEELING ABNORMAL (didn't feel good after 7 days of receiving 1st dose), NECK PAIN (had pain in the neck), PYREXIA (started with fever), MYALGIA (had body aches), HEADACHE (had headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had antibody testing done on 21-May-2021 with results not provided.  No concomitant drugs were reported.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccinated a 13 year-old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 13 year-old) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024021A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 13 year-old). On 10-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 13 year-old) 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 drugs were reported. No treatment medications were reported.  It was reported that the pharmacist heard the information on the news that children between 12 to 16 years of age were eligible for vaccination but after the administration of the vaccine the pharmacist realized the information was about Pfizer vaccine and not Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Patient age updated.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 45 Days post First Vaccine, No Second Dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (45 Days post First Vaccine, No Second Dose yet) 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 and treatment medications were reported.    This case was linked to MOD-2021-213150 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Myalgia, Neck pain
Clinical narrative: pain in hands, and cheeks; pain went down to shoulders; pain in both sides of her neck, pain went down to shoulders, hands, and cheeks; feeling congested; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (pain in both sides of her neck, pain went down to shoulders, hands, and cheeks), FEELING ABNORMAL (feeling congested), MYALGIA (pain in hands, and cheeks) and ARTHRALGIA (pain went down to shoulders) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033CZA) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced NECK PAIN (pain in both sides of her neck, pain went down to shoulders, hands, and cheeks) and FEELING ABNORMAL (feeling congested). On an unknown date, the patient experienced MYALGIA (pain in hands, and cheeks) and ARTHRALGIA (pain went down to shoulders). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (pain in both sides of her neck, pain went down to shoulders, hands, and cheeks), FEELING ABNORMAL (feeling congested), MYALGIA (pain in hands, and cheeks) and ARTHRALGIA (pain went down to shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown   Reporter did not allow further contact
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient got the 1st dose of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got the 1st dose of the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got the 1st dose of the vaccine). On 03-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got the 1st dose of the vaccine) 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 drugs were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma symptoms (after 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma symptoms (after 2nd dose)) 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 18-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 ASTHMA (Asthma symptoms (after 2nd dose)). At the time of the report, ASTHMA (Asthma symptoms (after 2nd dose)) outcome was unknown.            Patient occasionally used rescue PII(36) but was using 2-3 times daily at the time of reporting.  Concomitant medication information was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) 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 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness). At the time of the report, PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Inappropriate schedule of product administration
Clinical narrative: on 3/26 I had the first vaccine shot followed by the second shot on 4/2; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (on 3/26 I had the first vaccine shot followed by the second shot on 4/2) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer since 25-Mar-2021.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (on 3/26 I had the first vaccine shot followed by the second shot on 4/2). On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (on 3/26 I had the first vaccine shot followed by the second shot on 4/2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Biopsy: her2 positive (Positive) HER2 positive.         It was reported that after the second shot of vaccine, another prognostic test was done and one of the markers which previously was HER2 positive was now HER2 negative.  No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Formication, Pain of skin, Product dose omission issue
Clinical narrative: Missed 2nd dose of Moderna vaccine on recommended interval; Lot of pain at injection site; Bruising on right shoulder/Bruising on back; Skin of back hurt; Feels like sunburn; something is moving on her back; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising on right shoulder/Bruising on back), PAIN OF SKIN (Skin of back hurt), BURNING SENSATION (Feels like sunburn), FORMICATION (something is moving on her back) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, HYDROXYZINE EMBONATE (HYDROXYZINE PAM) and DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced CONTUSION (Bruising on right shoulder/Bruising on back), PAIN OF SKIN (Skin of back hurt), BURNING SENSATION (Feels like sunburn), FORMICATION (something is moving on her back) and VACCINATION SITE PAIN (Lot of pain at injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, CONTUSION (Bruising on right shoulder/Bruising on back), PAIN OF SKIN (Skin of back hurt), BURNING SENSATION (Feels like sunburn), FORMICATION (something is moving on her back) and VACCINATION SITE PAIN (Lot of pain at injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval) had resolved.            It was reported that the patient consulted 2 dermatologists for the events.   This case was linked to MOD-2021-213234 (Dose1 case) (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Missed 2nd dose of Moderna vaccine on recommended interval; Lot of pain at injection site; Bruising on right shoulder/Bruising on back; Skin of back hurt; Feels like sunburn; something is moving on her back; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising on right shoulder/Bruising on back), PAIN OF SKIN (Skin of back hurt), BURNING SENSATION (Feels like sunburn), FORMICATION (something is moving on her back) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, HYDROXYZINE EMBONATE (HYDROXYZINE PAM) and DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced CONTUSION (Bruising on right shoulder/Bruising on back), PAIN OF SKIN (Skin of back hurt), BURNING SENSATION (Feels like sunburn), FORMICATION (something is moving on her back) and VACCINATION SITE PAIN (Lot of pain at injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, CONTUSION (Bruising on right shoulder/Bruising on back), PAIN OF SKIN (Skin of back hurt), BURNING SENSATION (Feels like sunburn), FORMICATION (something is moving on her back) and VACCINATION SITE PAIN (Lot of pain at injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval) had resolved.            It was reported that the patient consulted 2 dermatologists for the events.   This case was linked to MOD-2021-213234 (Dose1 case) (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Uproductive cougb/dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Uproductive cougb/dry cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced COUGH (Uproductive cougb/dry cough). At the time of the report, COUGH (Uproductive cougb/dry cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.