chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Menstrual disorder, Migraine, Rhinorrhoea
Clinical narrative: Pain in heart; very bad running nose; Period all messed up day and length and flow; Frequent migrane; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Pain in heart), RHINORRHOEA (very bad running nose), MENSTRUAL DISORDER (Period all messed up day and length and flow) and MIGRAINE (Frequent migrane) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis ((7 years ago approximately)), Drug allergy (Ciprofloxacin), Drug allergy (Glycine-bactrim allergy), Drug allergy (Sulfa allergy), Fruit allergy (Lemons allergy) and Gluten sensitivity (Gluten sensitivity (Autoimmune disorder) (7 years ago approximately)(). Concomitant products included COLECALCIFEROL (VIT D3) and VITAMIN B12 NOS for an unknown indication.    On 07-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Pain in heart), RHINORRHOEA (very bad running nose), MENSTRUAL DISORDER (Period all messed up day and length and flow) and MIGRAINE (Frequent migrane). At the time of the report, ANGINA PECTORIS (Pain in heart), RHINORRHOEA (very bad running nose), MENSTRUAL DISORDER (Period all messed up day and length and flow) and MIGRAINE (Frequent migrane) outcome was unknown.            No treatment informations were reported. Patient has been taking Echinacea for the past 4 years.   This case was linked to MOD-2021-363416 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2021: Follow up received contains significant information- Reporter information, Patient details, Events, concomitant medications, medical history updated.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Sleep disorder
Clinical narrative: cannot breathe everytime he lays flat/gasping for air every 20mins when sleeping; cannot sleep continuously; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (cannot breathe everytime he lays flat/gasping for air every 20mins when sleeping) and SLEEP DISORDER (cannot sleep continuously) 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-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (cannot breathe everytime he lays flat/gasping for air every 20mins when sleeping) and SLEEP DISORDER (cannot sleep continuously). At the time of the report, DYSPNOEA (cannot breathe everytime he lays flat/gasping for air every 20mins when sleeping) and SLEEP DISORDER (cannot sleep continuously) had not resolved.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Vaccination site swelling
Clinical narrative: Lump is still there until now.; Her left arm was swollen for a week or so.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Lump is still there until now.) and VACCINATION SITE SWELLING (Her left arm was swollen for a week or so.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced INJECTION SITE MASS (Lump is still there until now.) and VACCINATION SITE SWELLING (Her left arm was swollen for a week or so.). At the time of the report, INJECTION SITE MASS (Lump is still there until now.) had not resolved and VACCINATION SITE SWELLING (Her left arm was swollen for a week or so.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that 10days after she had a lump on her arm and her left arm was swollen for a week or so. Patient's 2nd dose of Moderna vaccine is scheduled but she said she will not probably get it. No concomitant medications were mentioned. No treatment details were reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Myalgia, Pyrexia, Vomiting
Clinical narrative: Diarrhea all day (more than 20 times); Body aches; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea all day (more than 20 times)), MYALGIA (Body aches), PYREXIA (Fever) and VOMITING (Vomiting) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011S211A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021, the patient experienced DIARRHOEA (Diarrhea all day (more than 20 times)), MYALGIA (Body aches), PYREXIA (Fever) and VOMITING (Vomiting). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea all day (more than 20 times)), MYALGIA (Body aches), PYREXIA (Fever) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Fever; Chills; 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 PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills) had not resolved.            No concomitant information was reported. No treatment information was reported. Reporter has stated that patient was asked whether they could take Tylenol after the booster dose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Off label use
Clinical narrative: Patient confirmed she is not immunocompromised; 0.5ml for her booster dose/We were given too much, I don't think the nurse in there did it, she did not fill out my husband's; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Patient confirmed she is not immunocompromised) and ACCIDENTAL OVERDOSE (0.5ml for her booster dose/We were given too much, I don't think the nurse in there did it, she did not fill out my husband's) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02IF21A, 01FB21A and 030I21A) 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 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 23-Oct-2021, the patient experienced OFF LABEL USE (Patient confirmed she is not immunocompromised) and ACCIDENTAL OVERDOSE (0.5ml for her booster dose/We were given too much, I don't think the nurse in there did it, she did not fill out my husband's). On 23-Oct-2021, OFF LABEL USE (Patient confirmed she is not immunocompromised) and ACCIDENTAL OVERDOSE (0.5ml for her booster dose/We were given too much, I don't think the nurse in there did it, she did not fill out my husband's) had resolved.            Concomitant medications were not provided.  Patient called to report that she was given 0.5ml for her booster dose instead of only 0.25ml. Patient was aware of the difference between the third dose and the booster dose.   Treatment information was not provided.   This case was linked to MOD-2021-361840 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got COVID after receiving the first dose of Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got COVID after receiving the first dose of Moderna Vaccine) 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 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I got COVID after receiving the first dose of Moderna Vaccine). At the time of the report, COVID-19 (I got COVID after receiving the first dose of Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Patient received monoclonal antibodies as treatment .   Reporter did not allow further contact; Sender's Comments: This case concerns a patient, unknown age and gender, with no disclosed medical history, who experienced the serious, unexpected, event of Covid-19. The event occurred  on unknown day after first dose of Moderna vaccine. The rechallenge is not applicable as only first dose details were given and patient received treatment for covid-19. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: So much pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (So much pain) 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 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (So much pain). At the time of the report, MYALGIA (So much pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Vaccination site erythema
Clinical narrative: Redness on her arm seems rather large about 5 inches around in circumference/ The entire area was red; arm was swollen like the size of a golf ball; It was sore; left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurt), PERIPHERAL SWELLING (arm was swollen like the size of a golf ball), MYALGIA (It was sore) and VACCINATION SITE ERYTHEMA (Redness on her arm seems rather large about 5 inches around in circumference/ The entire area was red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (left arm hurt) and MYALGIA (It was sore). On 23-Oct-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen like the size of a golf ball). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness on her arm seems rather large about 5 inches around in circumference/ The entire area was red). At the time of the report, PAIN IN EXTREMITY (left arm hurt), PERIPHERAL SWELLING (arm was swollen like the size of a golf ball) and MYALGIA (It was sore) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness on her arm seems rather large about 5 inches around in circumference/ The entire area was red) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Reporter information added. Patient information updated. Product information updated. Events were added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened). received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened). 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 EXPIRED PRODUCT ADMINISTERED (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).) and PRODUCT STORAGE ERROR (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).) 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 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).) and PRODUCT STORAGE ERROR (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).) and PRODUCT STORAGE ERROR (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Pain in extremity
Clinical narrative: arm pain; severe collar bone pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and BONE PAIN (severe collar bone pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced BONE PAIN (severe collar bone pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown and BONE PAIN (severe collar bone pain) had not resolved.        Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   No concomitant medications were reported. No treatment medications were reported
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Headache, Pain in extremity
Clinical narrative: A sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    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 and INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (A sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (A sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Anxiety. Concomitant products included SERTRALINE for Anxiety, LEVOTHYROXINE for Hypothyroidism.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details not provided 19 doses of Moderna lot number 009C21A, Expiry Date 10-15-2021 were administered to 19 patients on 10-18-2021. 16 patients received 0.25 ml booster dose and 3 patients received 0.5 ml full dose.    This case was linked to MOD-2021-355973 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Nausea, Pruritus, Swelling
Clinical narrative: Swelling; Redness; Itchiness; A little bit of nausea; Pain in the muscels; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (Itchiness), NAUSEA (A little bit of nausea) and MYALGIA (Pain in the muscels) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.  On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (Itchiness), NAUSEA (A little bit of nausea) and MYALGIA (Pain in the muscels). At the time of the report, SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (Itchiness), NAUSEA (A little bit of nausea) and MYALGIA (Pain in the muscels) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in an 84-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 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021 at 12:23 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 18-Oct-2021 at 12:23 PM, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided 19 doses of Moderna lot number 009C21A, Expiry Date 10-15-2021 were administered to 19 patients on 10-18-2021.  16 patients received 0.25 ml booster dose and 3 patients received 0.5 ml full dose.   This case was linked to MOD-2021-355973 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 19 doses of Moderna lot # 009C21A, Exp. Date 10-15-2021 were administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (19 doses of Moderna lot # 009C21A, Exp. Date 10-15-2021 were administered) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (19 doses of Moderna lot # 009C21A, Exp. Date 10-15-2021 were administered). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (19 doses of Moderna lot # 009C21A, Exp. Date 10-15-2021 were administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Onset time of event provided as 02:03 PM  No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  The Moderna vial (10 dose, 0.5ml) was removed from the freezer to the refrigerator on 10-11-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color.  No variation in color from all the other previously used vials.16 patients received 0.25 ml booster dose.3 patients received 0.5 ml full dose.All patients tolerated vaccine administration well, without any complications in the office after observed for 15 minutes per protocol. As of 10-18-2021, no adverse reactions have been reported to office staff or medical staff.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Incorrect dose administered, Myalgia, Nasopharyngitis
Clinical narrative: cold; very sick; body aches; chills; possible administered a 3rd full dose; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), ILLNESS (very sick), MYALGIA (body aches), CHILLS (chills) and INCORRECT DOSE ADMINISTERED (possible administered a 3rd full dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 030A21A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (possible administered a 3rd full dose). On an unknown date, the patient experienced NASOPHARYNGITIS (cold), ILLNESS (very sick), MYALGIA (body aches) and CHILLS (chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 23-Oct-2021, INCORRECT DOSE ADMINISTERED (possible administered a 3rd full dose) had resolved. At the time of the report, NASOPHARYNGITIS (cold), ILLNESS (very sick), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.      Reporter stated that she was taken Heartburn pill before vaccination Concomitant medications was not specified   This case was linked to MOD-2021-361787 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Illness, Pyrexia, Vaccination complication
Clinical narrative: Very sick; Wasn't felling good at all; Fever of a 101.1°F,temperature of  102.1°F; sore on her right arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Wasn't felling good at all), ILLNESS (Very sick), VACCINATION SITE PAIN (sore on her right arm), FATIGUE (Felt tired) and PYREXIA (Fever of a 101.1°F,temperature of  102.1°F) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032m20a and 039k20a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced VACCINATION SITE PAIN (sore on her right arm) and FATIGUE (Felt tired). On 23-Oct-2021, the patient experienced VACCINATION COMPLICATION (Wasn't felling good at all) and PYREXIA (Fever of a 101.1°F,temperature of  102.1°F). On 24-Oct-2021, the patient experienced ILLNESS (Very sick). The patient was treated with PARACETAMOL (TYLENOL) on 23-Oct-2021 for Fever, Vaccination site pain and Fatigue, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Wasn't felling good at all), ILLNESS (Very sick), VACCINATION SITE PAIN (sore on her right arm), FATIGUE (Felt tired) and PYREXIA (Fever of a 101.1°F,temperature of  102.1°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 101.1 (High) had a fever of a 101.1°F. On 24-Oct-2021, Body temperature: 102.1 (High) temperature of 102.1°F.         Concomitant medications include water pill and blood pressure medicine.   Treatment also include cold compresses for fever of a 101.1°F.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Very sick; Wasn't felling good at all; Fever of a 101.1°F,temperature of  102.1°F; sore on her right arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Wasn't felling good at all), ILLNESS (Very sick), VACCINATION SITE PAIN (sore on her right arm), FATIGUE (Felt tired) and PYREXIA (Fever of a 101.1°F,temperature of  102.1°F) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032m20a and 039k20a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced VACCINATION SITE PAIN (sore on her right arm) and FATIGUE (Felt tired). On 23-Oct-2021, the patient experienced VACCINATION COMPLICATION (Wasn't felling good at all) and PYREXIA (Fever of a 101.1°F,temperature of  102.1°F). On 24-Oct-2021, the patient experienced ILLNESS (Very sick). The patient was treated with PARACETAMOL (TYLENOL) on 23-Oct-2021 for Fever, Vaccination site pain and Fatigue, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Wasn't felling good at all), ILLNESS (Very sick), VACCINATION SITE PAIN (sore on her right arm), FATIGUE (Felt tired) and PYREXIA (Fever of a 101.1°F,temperature of  102.1°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 101.1 (High) had a fever of a 101.1°F. On 24-Oct-2021, Body temperature: 102.1 (High) temperature of 102.1°F.         Concomitant medications include water pill and blood pressure medicine.   Treatment also include cold compresses for fever of a 101.1°F.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue disorder
Clinical narrative: about a quarter inch swollen/ my tongue is swollen; tongue feels thicker; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (about a quarter inch swollen/ my tongue is swollen) and TONGUE DISORDER (tongue feels thicker) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic bronchitis. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Chronic bronchitis.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced SWOLLEN TONGUE (about a quarter inch swollen/ my tongue is swollen) and TONGUE DISORDER (tongue feels thicker). At the time of the report, SWOLLEN TONGUE (about a quarter inch swollen/ my tongue is swollen) and TONGUE DISORDER (tongue feels thicker) outcome was unknown.            It was reported that the patient had completed the series of Moderna COVID-19 Vaccination in Feb-2021 and did not experienced this symptoms.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site vesicles
Clinical narrative: 2 air bubbles on my skin (left arm),on the injection site; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (2 air bubbles on my skin (left arm),on the injection site), HEADACHE (Headache) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced VACCINATION SITE VESICLES (2 air bubbles on my skin (left arm),on the injection site), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, VACCINATION SITE VESICLES (2 air bubbles on my skin (left arm),on the injection site), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Hot flush
Clinical narrative: Feeling wind hurt; A lot of hot flashes; Extremely fatigued; Extreme chills; 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 FEELING ABNORMAL (Feeling wind hurt), HOT FLUSH (A lot of hot flashes), FATIGUE (Extremely fatigued) and CHILLS (Extreme chills) 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 14-Oct-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. In October 2021, the patient experienced FEELING ABNORMAL (Feeling wind hurt), HOT FLUSH (A lot of hot flashes), FATIGUE (Extremely fatigued) and CHILLS (Extreme chills). In October 2021, FEELING ABNORMAL (Feeling wind hurt), HOT FLUSH (A lot of hot flashes), FATIGUE (Extremely fatigued) and CHILLS (Extreme chills) had resolved.            No concomitant medication was reported. The treatment information was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM and COLECALCIFEROL (VIT D3) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 17-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Blood pressure medications have been used by patient. No Treatment medications are provided.   This case was linked to MOD-2021-361515 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: vial punctured more than 20 times administrated to 2 patients; 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial punctured more than 20 times administrated to 2 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial punctured more than 20 times administrated to 2 patients). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial punctured more than 20 times administrated to 2 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-362912 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose of the Moderna COVID-19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Oct-2021 and was forwarded to Moderna on 25-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant  and treatment medication were reported. The pharmacist reported that he had administered the expired vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Some side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some side effects) 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 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced VACCINATION COMPLICATION (Some side effects). At the time of the report, VACCINATION COMPLICATION (Some side effects) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This spontaneous case was reported by a physician and describes the occurrence of PERICARDITIS (Pericarditis) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) 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.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.  Patient does not have any cardiac related historical events.  Company comment: This spontaneous report concerns a 30 year old patient with no relevant medical history who experienced a serious expected event of pericarditis. The event occurred unknown duration after receiving a dose of mRNA-1273. There is no information on the vaccine doses and hence re-challenge was unknown. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-363499 (Patient Link).; Sender's Comments: This spontaneous report concerns a 30 year old patient with no relevant medical history who experienced a serious expected event of pericarditis. The event occurred unknown duration after receiving a dose of mRNA-1273. There is no information on the vaccine doses and hence re-challenge was unknown. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad) 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 FEELING ABNORMAL (Feeling bad). At the time of the report, FEELING ABNORMAL (Feeling bad) outcome was unknown. Not Provided          No concomitant and treatment medications information was reported. The patient feeling bad post second dose.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Constipation, Headache, Myalgia
Clinical narrative: Fever, chills, muscle pain, Headache, stomach pain, constipation, arm pain
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, muscle pain, Headache, stomach pain, constipation, arm pain
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Hyperhidrosis, Lip disorder, Loss of control of legs, Pain in extremity
Clinical narrative: pts received j&j sunday  24th at pharmacy slight loss of control lips ,slight control in legs,felt wobbily, heavey prespiration ,blurry vision  traveling pain in the back of his legs , pain lower back
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: pts received j&j sunday  24th at pharmacy slight loss of control lips ,slight control in legs,felt wobbily, heavey prespiration ,blurry vision  traveling pain in the back of his legs , pain lower back
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Hyperhidrosis, Lip disorder, Pain in extremity, Physical examination
Clinical narrative: LISPING OR SLIGHT LOSS OF CONTROL OF lips ,sunday evening the 24th into monday afternoon 25th on and off slight loss of control of lips ,sunday evening the 24th into monday evening the 25th heavy perspiration almost all day every day from monday the 25th burred vision from time to time ,sunday evening the 24th to monday morning the 25th traveling pain in the back of my legs,monday night the 25th and tuesday night the 26th pain in the lower back tuesday night 26th. pts description
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: LISPING OR SLIGHT LOSS OF CONTROL OF lips ,sunday evening the 24th into monday afternoon 25th on and off slight loss of control of lips ,sunday evening the 24th into monday evening the 25th heavy perspiration almost all day every day from monday the 25th burred vision from time to time ,sunday evening the 24th to monday morning the 25th traveling pain in the back of my legs,monday night the 25th and tuesday night the 26th pain in the lower back tuesday night 26th. pts description
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Injection site mass, Lymphadenopathy
Clinical narrative: Friday night, sore red swollen arm. Lump under injection site.Sat: swollen lymph nodes, fatigue,  fever chills nausea.Sunday: fever fatigue chills vomiting.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Friday night, sore red swollen arm. Lump under injection site.Sat: swollen lymph nodes, fatigue,  fever chills nausea.Sunday: fever fatigue chills vomiting.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node inflammation above left clavicle (painful). Pain & swelling at injection site.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Injection site rash, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Inflamed red rash below injection site. Warm and slightly itchy.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dizziness, Dyspnoea, Eye pruritus
Clinical narrative: 15 minutes; dizziness,nausee urgent onset of soft stool,  ,itchy ears ,,blurry vision, 30 min; swollen throat , itchy eye's, itchy shin, upper body hives..45 min to 1 hour ; right side numbness and tingling ,, left side bone joint pain ,sore throat,, about 2 hours after  shortness of breath, chest tightening,,,,, rapid heart rate,,,..2.5 weeks after still severe left arm. nerve pain, limited range of motion, pain mostly worse while body at rest,,vision changes.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Faeces soft, Heart rate increased, Hypoaesthesia, Joint range of motion decreased, Nausea
Clinical narrative: 15 minutes; dizziness,nausee urgent onset of soft stool,  ,itchy ears ,,blurry vision, 30 min; swollen throat , itchy eye's, itchy shin, upper body hives..45 min to 1 hour ; right side numbness and tingling ,, left side bone joint pain ,sore throat,, about 2 hours after  shortness of breath, chest tightening,,,,, rapid heart rate,,,..2.5 weeks after still severe left arm. nerve pain, limited range of motion, pain mostly worse while body at rest,,vision changes.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Oropharyngeal pain, Pain in extremity, Paraesthesia, Pharyngeal swelling
Clinical narrative: 15 minutes; dizziness,nausee urgent onset of soft stool,  ,itchy ears ,,blurry vision, 30 min; swollen throat , itchy eye's, itchy shin, upper body hives..45 min to 1 hour ; right side numbness and tingling ,, left side bone joint pain ,sore throat,, about 2 hours after  shortness of breath, chest tightening,,,,, rapid heart rate,,,..2.5 weeks after still severe left arm. nerve pain, limited range of motion, pain mostly worse while body at rest,,vision changes.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vision blurred, Visual impairment
Clinical narrative: 15 minutes; dizziness,nausee urgent onset of soft stool,  ,itchy ears ,,blurry vision, 30 min; swollen throat , itchy eye's, itchy shin, upper body hives..45 min to 1 hour ; right side numbness and tingling ,, left side bone joint pain ,sore throat,, about 2 hours after  shortness of breath, chest tightening,,,,, rapid heart rate,,,..2.5 weeks after still severe left arm. nerve pain, limited range of motion, pain mostly worse while body at rest,,vision changes.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Red arm below injection site; arm thick below injection site; Warm arm below injection site; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities, induration and skin warm. On an unknown date, the outcome of the erythema of extremities, induration and skin warm were unknown.   It was unknown if the reporter considered the erythema of extremities, induration and skin warm to be related to Shingrix.  Additional details were provided as follows: The case was reported for the pharmacist's father. The age at vaccination was not reported. After receiving Shingrix, the patient's arm was red, thick and warm below the injection site. The reporter consented to follow up. This case had been linked with case US2021221657, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021221657:Same reporter