chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: have soreness in her arms; she was dehydrated; legs have a rash,left one is slightly worse; more swollen than the right leg; left leg is also more red; warm than the right leg; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (have soreness in her arms), DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg) and ERYTHEMA (left leg is also more red) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and ESTRADIOL (ESTRACE) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-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 MYALGIA (have soreness in her arms), DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and FEELING HOT (warm than the right leg). The patient was treated with NYSTATIN at a dose of 1 dosage form; GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at a dose of 1 dosage form; COCONUT OIL at a dose of 1 dosage form; EUCALYPTUS OIL at a dose of 1 dosage form and CANNABIDIOL (CBD OIL) at a dose of 1 dosage form. At the time of the report, MYALGIA (have soreness in her arms), DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and FEELING HOT (warm than the right leg) outcome was unknown. Not Provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Hot; Injection Site is Inflamed; Itching; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), VACCINATION SITE INFLAMMATION (Injection Site is Inflamed), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE INFLAMMATION (Injection Site is Inflamed), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE WARMTH (Hot), VACCINATION SITE INFLAMMATION (Injection Site is Inflamed), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information included ice pack that helped her.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Erythema, Feeling hot, Myalgia, Peripheral swelling
Clinical narrative: she was dehydrated; have soreness in her arms; legs have a rash,left one is slightly worse; more swollen than the right leg; left leg is also more red; warm than the right leg; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and FEELING HOT (warm than the right leg) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and FEELING HOT (warm than the right leg). On an unknown date, the patient experienced DEHYDRATION (she was dehydrated) and MYALGIA (have soreness in her arms). The patient was treated with NYSTATIN ongoing since an unknown date for Rash, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) ongoing since an unknown date for Rash, at an unspecified dose and frequency. At the time of the report, DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and MYALGIA (have soreness in her arms) was resolving and FEELING HOT (warm than the right leg) had resolved.            Treatment medication: Coconut oil, Eucalyptus oil, CBD oil, and lotion were used for the treatment of rash.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: she was dehydrated; have soreness in her arms; legs have a rash,left one is slightly worse; more swollen than the right leg; left leg is also more red; warm than the right leg; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and FEELING HOT (warm than the right leg) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and FEELING HOT (warm than the right leg). On an unknown date, the patient experienced DEHYDRATION (she was dehydrated) and MYALGIA (have soreness in her arms). The patient was treated with NYSTATIN ongoing since an unknown date for Rash, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) ongoing since an unknown date for Rash, at an unspecified dose and frequency. At the time of the report, DEHYDRATION (she was dehydrated), RASH (legs have a rash,left one is slightly worse), PERIPHERAL SWELLING (more swollen than the right leg), ERYTHEMA (left leg is also more red) and MYALGIA (have soreness in her arms) was resolving and FEELING HOT (warm than the right leg) had resolved.            Treatment medication: Coconut oil, Eucalyptus oil, CBD oil, and lotion were used for the treatment of rash.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Onychoclasis, Rash, Rash pruritic
Clinical narrative: small spot on their hands that peeling,both hands are; rash starting to itch; fingernails are beginning to crack; rash all over,backside of both arms,rash on their back,backside of both thighs; backside of both thighs along with the rash thighs are red; backside of both thighs along with the rash thighs are sore; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (small spot on their hands that peeling,both hands are), RASH PRURITIC (rash starting to itch), ONYCHOCLASIS (fingernails are beginning to crack), RASH (rash all over,backside of both arms,rash on their back,backside of both thighs) and ERYTHEMA (backside of both thighs along with the rash thighs are red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN EXFOLIATION (small spot on their hands that peeling,both hands are), RASH PRURITIC (rash starting to itch), ONYCHOCLASIS (fingernails are beginning to crack), RASH (rash all over,backside of both arms,rash on their back,backside of both thighs), ERYTHEMA (backside of both thighs along with the rash thighs are red) and MYALGIA (backside of both thighs along with the rash thighs are sore). At the time of the report, SKIN EXFOLIATION (small spot on their hands that peeling,both hands are), RASH PRURITIC (rash starting to itch), ONYCHOCLASIS (fingernails are beginning to crack), RASH (rash all over,backside of both arms,rash on their back,backside of both thighs), ERYTHEMA (backside of both thighs along with the rash thighs are red) and MYALGIA (backside of both thighs along with the rash thighs are sore) outcome was unknown.            No Concomitants included. No Treatment was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: small spot on their hands that peeling,both hands are; rash starting to itch; fingernails are beginning to crack; rash all over,backside of both arms,rash on their back,backside of both thighs; backside of both thighs along with the rash thighs are red; backside of both thighs along with the rash thighs are sore; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (small spot on their hands that peeling,both hands are), RASH PRURITIC (rash starting to itch), ONYCHOCLASIS (fingernails are beginning to crack), RASH (rash all over,backside of both arms,rash on their back,backside of both thighs) and ERYTHEMA (backside of both thighs along with the rash thighs are red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN EXFOLIATION (small spot on their hands that peeling,both hands are), RASH PRURITIC (rash starting to itch), ONYCHOCLASIS (fingernails are beginning to crack), RASH (rash all over,backside of both arms,rash on their back,backside of both thighs), ERYTHEMA (backside of both thighs along with the rash thighs are red) and MYALGIA (backside of both thighs along with the rash thighs are sore). At the time of the report, SKIN EXFOLIATION (small spot on their hands that peeling,both hands are), RASH PRURITIC (rash starting to itch), ONYCHOCLASIS (fingernails are beginning to crack), RASH (rash all over,backside of both arms,rash on their back,backside of both thighs), ERYTHEMA (backside of both thighs along with the rash thighs are red) and MYALGIA (backside of both thighs along with the rash thighs are sore) outcome was unknown.            No Concomitants included. No Treatment was reported by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Cough, Dyspnoea
Clinical narrative: body aches; can't breath; upset stomach; cough; chills; fever ranging from 100.3 to 101.7; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (can't breath), ABDOMINAL DISCOMFORT (upset stomach), COUGH (cough), CHILLS (chills) and PYREXIA (fever ranging from 100.3 to 101.7) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and METFORMIN for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DYSPNOEA (can't breath), ABDOMINAL DISCOMFORT (upset stomach), COUGH (cough), CHILLS (chills) and PYREXIA (fever ranging from 100.3 to 101.7). On an unknown date, the patient experienced MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (fever ranging from 100.3 to 101.7) had resolved. At the time of the report, DYSPNOEA (can't breath), ABDOMINAL DISCOMFORT (upset stomach), COUGH (cough), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 100.3 to 101.7 (High) 100.3 to 101.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-JUN-2021 contains no new information.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: body aches; can't breath; upset stomach; cough; chills; fever ranging from 100.3 to 101.7; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (can't breath), ABDOMINAL DISCOMFORT (upset stomach), COUGH (cough), CHILLS (chills) and PYREXIA (fever ranging from 100.3 to 101.7) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and METFORMIN for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DYSPNOEA (can't breath), ABDOMINAL DISCOMFORT (upset stomach), COUGH (cough), CHILLS (chills) and PYREXIA (fever ranging from 100.3 to 101.7). On an unknown date, the patient experienced MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (fever ranging from 100.3 to 101.7) had resolved. At the time of the report, DYSPNOEA (can't breath), ABDOMINAL DISCOMFORT (upset stomach), COUGH (cough), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 100.3 to 101.7 (High) 100.3 to 101.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-JUN-2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: fever of 38.6; chills; puking; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 38.6), CHILLS (chills) and VOMITING (puking) 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 PYREXIA (fever of 38.6), CHILLS (chills) and VOMITING (puking). At the time of the report, PYREXIA (fever of 38.6), CHILLS (chills) and VOMITING (puking) outcome was unknown.            No treatment medication information was provided. No Concomitant medication information was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Dehydration, Dizziness, Food poisoning
Clinical narrative: felt dehydrated; a small case of food poisoning; dizziness; chills; tinnitus got really loud for 2 hours and then it went back down to normal.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus got really loud for 2 hours and then it went back down to normal.), DEHYDRATION (felt dehydrated), FOOD POISONING (a small case of food poisoning), DIZZINESS (dizziness) and CHILLS (chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced TINNITUS (tinnitus got really loud for 2 hours and then it went back down to normal.). On 12-Apr-2021, the patient experienced DEHYDRATION (felt dehydrated), FOOD POISONING (a small case of food poisoning), DIZZINESS (dizziness) and CHILLS (chills). At the time of the report, TINNITUS (tinnitus got really loud for 2 hours and then it went back down to normal.), DEHYDRATION (felt dehydrated), FOOD POISONING (a small case of food poisoning), DIZZINESS (dizziness) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal. On an unknown date, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medication has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Updated patient demographics, lab data and added vaccine facility details.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: felt dehydrated; a small case of food poisoning; dizziness; chills; tinnitus got really loud for 2 hours and then it went back down to normal.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus got really loud for 2 hours and then it went back down to normal.), DEHYDRATION (felt dehydrated), FOOD POISONING (a small case of food poisoning), DIZZINESS (dizziness) and CHILLS (chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced TINNITUS (tinnitus got really loud for 2 hours and then it went back down to normal.). On 12-Apr-2021, the patient experienced DEHYDRATION (felt dehydrated), FOOD POISONING (a small case of food poisoning), DIZZINESS (dizziness) and CHILLS (chills). At the time of the report, TINNITUS (tinnitus got really loud for 2 hours and then it went back down to normal.), DEHYDRATION (felt dehydrated), FOOD POISONING (a small case of food poisoning), DIZZINESS (dizziness) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal. On an unknown date, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medication has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Updated patient demographics, lab data and added vaccine facility details.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Chills; fever like 99.8; fatigue; body aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (fever like 99.8), FATIGUE (fatigue) and MYALGIA (body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 16-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (fever like 99.8), FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, CHILLS (Chills), PYREXIA (fever like 99.8), FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were not provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Electrocardiogram, Feeling abnormal, Thyroid function test, Vaccination site pain
Clinical narrative: Experienced some pretty weird stuff; had pain as the second dose really hurt while being administered; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Experienced some pretty weird stuff) and VACCINATION SITE PAIN (had pain as the second dose really hurt while being administered) in a 23-year-old female patient 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 FEELING ABNORMAL (Experienced some pretty weird stuff) and VACCINATION SITE PAIN (had pain as the second dose really hurt while being administered). At the time of the report, FEELING ABNORMAL (Experienced some pretty weird stuff) and VACCINATION SITE PAIN (had pain as the second dose really hurt while being administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test normal: normal normal. On an unknown date, Electrocardiogram: normal normal. On an unknown date, Thyroid function test: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon internal review on 04-Aug-2021, the age was corrected to 23 years.    This case was linked to MOD-2021-211825 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: lips felt like they were sunburned; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (lips felt like they were sunburned) 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 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RASH ERYTHEMATOUS (lips felt like they were sunburned). At the time of the report, RASH ERYTHEMATOUS (lips felt like they were sunburned) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication reported. treatment medication steroid cream   This case was linked to MOD-2021-211739 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Vaccination site erythema, Vaccination site pain
Clinical narrative: hasn't been feeling good; Its also itchy; Chills; tired; it looks like it's been stung by a bee or a wasp and it's like a rash; Injection site has red circles; hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (hasn't been feeling good), VACCINATION SITE PRURITUS (Its also itchy), CHILLS (Chills), FATIGUE (tired) and VACCINATION SITE RASH (it looks like it's been stung by a bee or a wasp and it's like a rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A2113 and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL], IPRATROPIUM, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (hasn't been feeling good), VACCINATION SITE PRURITUS (Its also itchy), CHILLS (Chills), FATIGUE (tired), VACCINATION SITE RASH (it looks like it's been stung by a bee or a wasp and it's like a rash), VACCINATION SITE ERYTHEMA (Injection site has red circles) and VACCINATION SITE PAIN (hurts). At the time of the report, FEELING ABNORMAL (hasn't been feeling good), VACCINATION SITE PRURITUS (Its also itchy), CHILLS (Chills), FATIGUE (tired), VACCINATION SITE RASH (it looks like it's been stung by a bee or a wasp and it's like a rash), VACCINATION SITE ERYTHEMA (Injection site has red circles) and VACCINATION SITE PAIN (hurts) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medications also included Oxygen. No treatment was given.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: hasn't been feeling good; Its also itchy; Chills; tired; it looks like it's been stung by a bee or a wasp and it's like a rash; Injection site has red circles; hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (hasn't been feeling good), VACCINATION SITE PRURITUS (Its also itchy), CHILLS (Chills), FATIGUE (tired) and VACCINATION SITE RASH (it looks like it's been stung by a bee or a wasp and it's like a rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A2113 and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL], IPRATROPIUM, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (hasn't been feeling good), VACCINATION SITE PRURITUS (Its also itchy), CHILLS (Chills), FATIGUE (tired), VACCINATION SITE RASH (it looks like it's been stung by a bee or a wasp and it's like a rash), VACCINATION SITE ERYTHEMA (Injection site has red circles) and VACCINATION SITE PAIN (hurts). At the time of the report, FEELING ABNORMAL (hasn't been feeling good), VACCINATION SITE PRURITUS (Its also itchy), CHILLS (Chills), FATIGUE (tired), VACCINATION SITE RASH (it looks like it's been stung by a bee or a wasp and it's like a rash), VACCINATION SITE ERYTHEMA (Injection site has red circles) and VACCINATION SITE PAIN (hurts) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medications also included Oxygen. No treatment was given.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: pain in arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm) and FATIGUE (fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in arm) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain in arm) and FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Angular cheilitis, Chapped lips, Hypoaesthesia oral, Lip erythema
Clinical narrative: Never reacted to a vaccine like this before.; lip sore/pain is horrible; Numbness; lips swollen; throbbing; burning lips; cracks on the sides of the mouth; so red it looks like it has blisters; especially on the bottom lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (lip sore/pain is horrible), HYPOAESTHESIA ORAL (Numbness), LIP SWELLING (lips swollen), PAIN (throbbing) and ORAL DISCOMFORT (burning lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced LIP PAIN (lip sore/pain is horrible), HYPOAESTHESIA ORAL (Numbness), LIP SWELLING (lips swollen), PAIN (throbbing), ORAL DISCOMFORT (burning lips), CHAPPED LIPS (cracks on the sides of the mouth), ANGULAR CHEILITIS (so red it looks like it has blisters) and LIP ERYTHEMA (especially on the bottom lip). On 16-Apr-2021, the patient experienced ALLERGY TO VACCINE (Never reacted to a vaccine like this before.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, LIP PAIN (lip sore/pain is horrible), HYPOAESTHESIA ORAL (Numbness), LIP SWELLING (lips swollen), PAIN (throbbing), ORAL DISCOMFORT (burning lips), CHAPPED LIPS (cracks on the sides of the mouth), ANGULAR CHEILITIS (so red it looks like it has blisters), LIP ERYTHEMA (especially on the bottom lip) and ALLERGY TO VACCINE (Never reacted to a vaccine like this before.) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Patient stated that she had this same reactions on NOV-2020 when she had COVID-19. She was refused to be treated by urgent care as the reactions were around the mouth area.   This case was linked to MOD-2021-211729 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling, Oral discomfort, Pain
Clinical narrative: Never reacted to a vaccine like this before.; lip sore/pain is horrible; Numbness; lips swollen; throbbing; burning lips; cracks on the sides of the mouth; so red it looks like it has blisters; especially on the bottom lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (lip sore/pain is horrible), HYPOAESTHESIA ORAL (Numbness), LIP SWELLING (lips swollen), PAIN (throbbing) and ORAL DISCOMFORT (burning lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced LIP PAIN (lip sore/pain is horrible), HYPOAESTHESIA ORAL (Numbness), LIP SWELLING (lips swollen), PAIN (throbbing), ORAL DISCOMFORT (burning lips), CHAPPED LIPS (cracks on the sides of the mouth), ANGULAR CHEILITIS (so red it looks like it has blisters) and LIP ERYTHEMA (especially on the bottom lip). On 16-Apr-2021, the patient experienced ALLERGY TO VACCINE (Never reacted to a vaccine like this before.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, LIP PAIN (lip sore/pain is horrible), HYPOAESTHESIA ORAL (Numbness), LIP SWELLING (lips swollen), PAIN (throbbing), ORAL DISCOMFORT (burning lips), CHAPPED LIPS (cracks on the sides of the mouth), ANGULAR CHEILITIS (so red it looks like it has blisters), LIP ERYTHEMA (especially on the bottom lip) and ALLERGY TO VACCINE (Never reacted to a vaccine like this before.) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Patient stated that she had this same reactions on NOV-2020 when she had COVID-19. She was refused to be treated by urgent care as the reactions were around the mouth area.   This case was linked to MOD-2021-211729 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling jittery, Irritability, Nervousness
Clinical narrative: anxiety was increased within 24 hours of the vaccine dose and it was getting worse; irritability; nervous; jittery; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (anxiety was increased within 24 hours of the vaccine dose and it was getting worse), IRRITABILITY (irritability), NERVOUSNESS (nervous) and FEELING JITTERY (jittery) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety depression, DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Irritable bowel syndrome.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced ANXIETY (anxiety was increased within 24 hours of the vaccine dose and it was getting worse), IRRITABILITY (irritability), NERVOUSNESS (nervous) and FEELING JITTERY (jittery). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg twice a day. At the time of the report, ANXIETY (anxiety was increased within 24 hours of the vaccine dose and it was getting worse), IRRITABILITY (irritability), NERVOUSNESS (nervous) and FEELING JITTERY (jittery) 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.   Patient had anxiety  increased within 24 hours of the first dose of the Moderna COVID-19 vaccine and it was getting worst up to 07-Jun-2021 along with other side effects.  Normally, patient has been well-maintained with daily medication.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Due to the IRD  of Follow up being a prior date, it was captured as 08-JUN-2021 due to Argus limitation.             Follow-up received on 08-JUN-2021 contains NNI.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL], IPRATROPIUM, OXYGEN, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-211730 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Dyspnoea, Oxygen saturation
Clinical narrative: shortness of breath; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), PYREXIA (fever) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), PYREXIA (fever) and CHILLS (chills). At the time of the report, DYSPNOEA (shortness of breath), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood pressure measurement: 90/50 (Inconclusive) inconclusive. On 03-Apr-2021, Body temperature: 104 (High) high. On 03-Apr-2021, Oxygen saturation: 85 percent (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. No treatment was reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: shortness of breath; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), PYREXIA (fever) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), PYREXIA (fever) and CHILLS (chills). At the time of the report, DYSPNOEA (shortness of breath), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood pressure measurement: 90/50 (Inconclusive) inconclusive. On 03-Apr-2021, Body temperature: 104 (High) high. On 03-Apr-2021, Oxygen saturation: 85 percent (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. No treatment was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: After the 2nd dose she had sore arm and mild aches; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (After the 2nd dose she had sore arm and mild aches) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 25-Jan-2021, the patient experienced FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced MYALGIA (After the 2nd dose she had sore arm and mild aches). At the time of the report, MYALGIA (After the 2nd dose she had sore arm and mild aches) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No treatment medication was reported .       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Insomnia
Clinical narrative: couldn't go work scared/not feeling like himself; Feeling very dizzy; didn't sleep well last night after receiving second dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (didn't sleep well last night after receiving second dose of Moderna vaccine), FEELING ABNORMAL (couldn't go work scared/not feeling like himself) and DIZZINESS (Feeling very dizzy) 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 06-Jun-2021, the patient experienced INSOMNIA (didn't sleep well last night after receiving second dose of Moderna vaccine). On 07-Jun-2021, the patient experienced FEELING ABNORMAL (couldn't go work scared/not feeling like himself) and DIZZINESS (Feeling very dizzy). At the time of the report, INSOMNIA (didn't sleep well last night after receiving second dose of Moderna vaccine), FEELING ABNORMAL (couldn't go work scared/not feeling like himself) and DIZZINESS (Feeling very dizzy) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Pain
Clinical narrative: DIZZINESS; pain all over; she feels like she is being hit by a baseball bat all over.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (DIZZINESS), PAIN (pain all over) and MYALGIA (she feels like she is being hit by a baseball bat all over.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included Sciatica. Concomitant products included GABAPENTIN, ATORVASTATIN, LANSOPRAZOLE, SERTRALINE, HYDROCHLOROTHIAZIDE, AMLODIPINE and CELECOXIB for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (DIZZINESS), PAIN (pain all over) and MYALGIA (she feels like she is being hit by a baseball bat all over.). At the time of the report, DIZZINESS (DIZZINESS), PAIN (pain all over) and MYALGIA (she feels like she is being hit by a baseball bat all over.) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal discomfort, Rash
Clinical narrative: 4 inch rash; swollen lymph nodes in her arm pit; shoulder is hot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (shoulder is hot), RASH (4 inch rash) and LYMPHADENOPATHY (swollen lymph nodes in her arm pit) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (shoulder is hot) and LYMPHADENOPATHY (swollen lymph nodes in her arm pit). On 16-Apr-2021, the patient experienced RASH (4 inch rash). At the time of the report, MUSCULOSKELETAL DISCOMFORT (shoulder is hot), RASH (4 inch rash) and LYMPHADENOPATHY (swollen lymph nodes in her arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR document was attached.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site was red; vaccination site puffy; Vaccination site warm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site was red), VACCINATION SITE SWELLING (vaccination site puffy) and VACCINATION SITE WARMTH (Vaccination site warm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site was red), VACCINATION SITE SWELLING (vaccination site puffy) and VACCINATION SITE WARMTH (Vaccination site warm). At the time of the report, VACCINATION SITE ERYTHEMA (injection site was red), VACCINATION SITE SWELLING (vaccination site puffy) and VACCINATION SITE WARMTH (Vaccination site warm) outcome was unknown. Not Provided          No concomitant medication provided.  No treatment medication provided.