chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Gait disturbance, Insomnia, Pyrexia
Clinical narrative: very weak; hardly walk; can't sleep; couldn't stand up; is quite sick; started throwing up; chills; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up) and PYREXIA (is quite sick) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up), PYREXIA (is quite sick), VOMITING (started throwing up) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up), PYREXIA (is quite sick), VOMITING (started throwing up) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: very weak; hardly walk; can't sleep; couldn't stand up; is quite sick; started throwing up; chills; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up) and PYREXIA (is quite sick) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up), PYREXIA (is quite sick), VOMITING (started throwing up) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up), PYREXIA (is quite sick), VOMITING (started throwing up) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102 degrees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.   No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever of 102 degrees). At the time of the report, PYREXIA (Fever of 102 degrees) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 102 (Inconclusive) fever of 102 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Soreness; Headache; 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 (Soreness) and HEADACHE (Headache) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness) and HEADACHE (Headache). At the time of the report, PAIN (Soreness) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; Body aches; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment or concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018119) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018119)
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: muscle twitches over whole body; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TWITCHING (muscle twitches over whole body) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 28-Jan-2021, the patient experienced MUSCLE TWITCHING (muscle twitches over whole body) and PYREXIA (Fever). At the time of the report, MUSCLE TWITCHING (muscle twitches over whole body) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Relevant concomitant medication was not reported.   This case was linked to MODERNATX, INC.-MOD-2021-022474, MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018071) MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018071)
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) 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 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were reported.  Treatment details included were not reported.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site erythema
Clinical narrative: Spot that was running down from the injection site towards my elbow; Redness in the arm at the site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Spot that was running down from the injection site towards my elbow) and VACCINATION SITE ERYTHEMA (Redness in the arm at the site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ATORVASTATIN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced RASH MACULAR (Spot that was running down from the injection site towards my elbow) and VACCINATION SITE ERYTHEMA (Redness in the arm at the site). At the time of the report, RASH MACULAR (Spot that was running down from the injection site towards my elbow) was resolving and VACCINATION SITE ERYTHEMA (Redness in the arm at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The caller confirmed that she got the Moderna vaccine on 14-Jan-2021. she stated that she had no initial side effects. On 29-Jan-2021, I noticed a spot that was running down from the injection site towards my elbow. On the 30th the shape of the spot changed into a rectangle 2 by 4 inches. The patient indicated that the spot is lighter in color today and will continue to monitor it. The patient received the Moderna vaccine in the upper left arm on 14-Jan-2021, just before 4:00 PM. The vaccine was given to prevent COVID-19. The lot number an expiration date were unavailable at this time.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Report received: Initiative recieved; Reporter'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. Further information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pruritus, Rash macular
Clinical narrative: started to get little red marks had all red blotches in chest and arm; terrible headache; it was as red as an apple; itched in chest and arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (started to get little red marks had all red blutches in chest and arm), PRURITUS (itched in chest and arm), HEADACHE (terrible headache) and ERYTHEMA (it was as red as an apple) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and Amadelz for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Jan-2021, the patient experienced PRURITUS (itched in chest and arm). On an unknown date, the patient experienced RASH MACULAR (started to get little red marks had all red blutches in chest and arm), HEADACHE (terrible headache) and ERYTHEMA (it was as red as an apple). At the time of the report, RASH MACULAR (started to get little red marks had all red blutches in chest and arm), PRURITUS (itched in chest and arm) and ERYTHEMA (it was as red as an apple) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Took Benadryl and Triamcinolone acetonide cream. Hydroxycine prescription so that they could sleep better (took it one night). Dermathologist was going to prescribe Prednisone for skin rash but did not try it in the end. Family doctor told them to take Claritin and Zyrteck if it continues. One doctor told them to go to the ER and got an IV steroids if it came back.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: a case of throwing up; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (a case of throwing up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical conditions reported).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (a case of throwing up). At the time of the report, VOMITING (a case of throwing up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. 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.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Loss of taste; FEVER; HEADACHE; soreness in my arm (inj site); This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), PYREXIA (FEVER), HEADACHE (HEADACHE) and INJECTION SITE PAIN (soreness in my arm (inj site)) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (FEVER), HEADACHE (HEADACHE) and INJECTION SITE PAIN (soreness in my arm (inj site)). On 03-Feb-2021, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste), PYREXIA (FEVER), HEADACHE (HEADACHE) and INJECTION SITE PAIN (soreness in my arm (inj site)) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24 Jun 2021contains non-significant information. Patient demographics updated.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity, Paraesthesia oral
Clinical narrative: sore arm; did not feel good; fatigue; Heavy and weird tongue feeling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Heavy and weird tongue feeling), PAIN IN EXTREMITY (sore arm), MALAISE (did not feel good) and FATIGUE (fatigue) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (Heavy and weird tongue feeling), PAIN IN EXTREMITY (sore arm), MALAISE (did not feel good) and FATIGUE (fatigue). At the time of the report, PARAESTHESIA ORAL (Heavy and weird tongue feeling), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown and MALAISE (did not feel good) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Oral discomfort, Pain in extremity, Paraesthesia oral
Clinical narrative: Arm was sore; Upper lip started tingling a little bit; Lips felt tight but they didn't look swollen; Tongue tingled just a tiny bit; Slight metallic taste; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), PARAESTHESIA ORAL (Upper lip started tingling a little bit), ORAL DISCOMFORT (Lips felt tight but they didn't look swollen), PARAESTHESIA ORAL (Tongue tingled just a tiny bit) and DYSGEUSIA (Slight metallic taste) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Blood pressure under control) since 2007, Prediabetes (Under control no medicines) since 2015, Drug allergy (Cefzil), Drug allergy (Cipro) and Drug allergy (Sulfa). Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure high, VITAMIN D NOS for Bone disorder, ESCITALOPRAM OXALATE (LEXAPRO) for Stress, KRILL OIL for an unknown indication.    On 22-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PARAESTHESIA ORAL (Upper lip started tingling a little bit), ORAL DISCOMFORT (Lips felt tight but they didn't look swollen), PARAESTHESIA ORAL (Tongue tingled just a tiny bit), DYSGEUSIA (Slight metallic taste) and HEADACHE (headache). On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). The patient was treated with PARACETAMOL (TYLENOL) from 22-Jan-2021 to 23-Jan-2021 for Headache and Pain in arm, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 22-Jan-2021, PARAESTHESIA ORAL (Upper lip started tingling a little bit), ORAL DISCOMFORT (Lips felt tight but they didn't look swollen) and PARAESTHESIA ORAL (Tongue tingled just a tiny bit) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), DYSGEUSIA (Slight metallic taste) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced similar tingling feeling when she took Cipro several years ago.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received and contains patient demographic data, medical history, concomitant medication and Second dose vaccine details updated.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Swelling face
Clinical narrative: had an allergic reaction; face was swollen; face was red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (had an allergic reaction), SWELLING FACE (face was swollen) and ERYTHEMA (face was red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN, LOSARTAN, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MULTIVITAMINS & MINERALS PLUS LUTEIN and ZOLPIDEM for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced SWELLING FACE (face was swollen) and ERYTHEMA (face was red). On 02-Feb-2021, the patient experienced HYPERSENSITIVITY (had an allergic reaction). On 02-Jan-2021, SWELLING FACE (face was swollen) and ERYTHEMA (face was red) had resolved. On 02-Feb-2021, HYPERSENSITIVITY (had an allergic reaction) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching at the inoculation area; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching at the inoculation area) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the inoculation area). At the time of the report, VACCINATION SITE PRURITUS (itching at the inoculation area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive tested positive for COVID-19.         Treatment included monoclonal antibody infusion.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Pyrexia
Clinical narrative: fever 101; chills; hot flashes; extreme fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 101), CHILLS (chills), HOT FLUSH (hot flashes) and FATIGUE (extreme fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (fever 101), CHILLS (chills), HOT FLUSH (hot flashes) and FATIGUE (extreme fatigue). At the time of the report, PYREXIA (fever 101), CHILLS (chills), HOT FLUSH (hot flashes) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tylenol.  patient taken concomitant medications called prevalent for GERD and a anti-histamine for unknown indication.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: vomiting; rash all over my arm; very fast heart beat; Headache; dizzy; Joint pain; Nausea; Fever; difficulty breathing; very tired; left arm started to hurt; arm swelled; hard; High blood pressure highest 108; chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medically reported history provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL SUCCINATE (TOPROL XL), SPIRONOLACTONE and CLONIDINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard), CHILLS (chills), MYALGIA (Muscle pain), PYREXIA (Fever), DYSPNOEA (difficulty breathing) and HYPERTENSION (High blood pressure highest 108). On 21-Jan-2021, the patient experienced HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and DIZZINESS (dizzy). On an unknown date, the patient experienced VOMITING (vomiting), VACCINATION SITE RASH (rash all over my arm) and HEART RATE INCREASED (very fast heart beat). At the time of the report, FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard), HEADACHE (Headache), CHILLS (chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Fever), DYSPNOEA (difficulty breathing), DIZZINESS (dizzy), HYPERTENSION (High blood pressure highest 108), VOMITING (vomiting), VACCINATION SITE RASH (rash all over my arm) and HEART RATE INCREASED (very fast heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications include NONE..   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: An additional document received 15 Apr 2021 included only reporter details updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Myalgia, Nausea
Clinical narrative: vomiting; rash all over my arm; very fast heart beat; Headache; dizzy; Joint pain; Nausea; Fever; difficulty breathing; very tired; left arm started to hurt; arm swelled; hard; High blood pressure highest 108; chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medically reported history provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL SUCCINATE (TOPROL XL), SPIRONOLACTONE and CLONIDINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard), CHILLS (chills), MYALGIA (Muscle pain), PYREXIA (Fever), DYSPNOEA (difficulty breathing) and HYPERTENSION (High blood pressure highest 108). On 21-Jan-2021, the patient experienced HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and DIZZINESS (dizzy). On an unknown date, the patient experienced VOMITING (vomiting), VACCINATION SITE RASH (rash all over my arm) and HEART RATE INCREASED (very fast heart beat). At the time of the report, FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard), HEADACHE (Headache), CHILLS (chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Fever), DYSPNOEA (difficulty breathing), DIZZINESS (dizzy), HYPERTENSION (High blood pressure highest 108), VOMITING (vomiting), VACCINATION SITE RASH (rash all over my arm) and HEART RATE INCREASED (very fast heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications include NONE..   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: An additional document received 15 Apr 2021 included only reporter details updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site induration, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: vomiting; rash all over my arm; very fast heart beat; Headache; dizzy; Joint pain; Nausea; Fever; difficulty breathing; very tired; left arm started to hurt; arm swelled; hard; High blood pressure highest 108; chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medically reported history provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL SUCCINATE (TOPROL XL), SPIRONOLACTONE and CLONIDINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard), CHILLS (chills), MYALGIA (Muscle pain), PYREXIA (Fever), DYSPNOEA (difficulty breathing) and HYPERTENSION (High blood pressure highest 108). On 21-Jan-2021, the patient experienced HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and DIZZINESS (dizzy). On an unknown date, the patient experienced VOMITING (vomiting), VACCINATION SITE RASH (rash all over my arm) and HEART RATE INCREASED (very fast heart beat). At the time of the report, FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard), HEADACHE (Headache), CHILLS (chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Fever), DYSPNOEA (difficulty breathing), DIZZINESS (dizzy), HYPERTENSION (High blood pressure highest 108), VOMITING (vomiting), VACCINATION SITE RASH (rash all over my arm) and HEART RATE INCREASED (very fast heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications include NONE..   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: An additional document received 15 Apr 2021 included only reporter details updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; rash all over my arm; very fast heart beat; Headache; dizzy; Joint pain; Nausea; Fever; difficulty breathing; very tired; left arm started to hurt; arm swelled; hard; High blood pressure highest 108; chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medically reported history provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL SUCCINATE (TOPROL XL), SPIRONOLACTONE and CLONIDINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard), CHILLS (chills), MYALGIA (Muscle pain), PYREXIA (Fever), DYSPNOEA (difficulty breathing) and HYPERTENSION (High blood pressure highest 108). On 21-Jan-2021, the patient experienced HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and DIZZINESS (dizzy). On an unknown date, the patient experienced VOMITING (vomiting), VACCINATION SITE RASH (rash all over my arm) and HEART RATE INCREASED (very fast heart beat). At the time of the report, FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard), HEADACHE (Headache), CHILLS (chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Fever), DYSPNOEA (difficulty breathing), DIZZINESS (dizzy), HYPERTENSION (High blood pressure highest 108), VOMITING (vomiting), VACCINATION SITE RASH (rash all over my arm) and HEART RATE INCREASED (very fast heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications include NONE..   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: An additional document received 15 Apr 2021 included only reporter details updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: rash at the injection site; soreness at the injection arm; swollenness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at the injection arm), INJECTION SITE SWELLING (swollenness at the injection site) and INJECTION SITE RASH (rash at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 6381C20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol, Kidney absent and Hyperthyroidism. Concomitant products included SERTRALINE for Anxious depression, EVOLOCUMAB (REPATHA) for High cholesterol, AMLODIPINE and RAMIPRIL for Kidney disorder, LEVOTHYROXINE for Thyroid disorder.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-2021, the patient experienced INJECTION SITE PAIN (soreness at the injection arm) and INJECTION SITE SWELLING (swollenness at the injection site). On 12-Feb-2021, the patient experienced INJECTION SITE RASH (rash at the injection site). At the time of the report, INJECTION SITE PAIN (soreness at the injection arm) and INJECTION SITE SWELLING (swollenness at the injection site) had resolved and INJECTION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: ADR form
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Rash macular, Rash pruritic
Clinical narrative: itchy rash on her upper body; blotchy rash; trouble catching her breathe while moving; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued), RASH PRURITIC (itchy rash on her upper body), RASH MACULAR (blotchy rash) and DYSPNEA (trouble catching her breathe while moving) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M28) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ISOSORBIDE, AMLODIPINE, ALPRAZOLAM (XANAX), ATORVASTATIN, CARVEDILOL, CLOPIDOGREL BISULFATE (PLAVIX), LISINOPRIL and GLYCERYL TRINITRATE (NITROGLYCERIN TE) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced FATIGUE (fatigued). On 09-Feb-2021, the patient experienced RASH PRURITIC (itchy rash on her upper body), RASH MACULAR (blotchy rash) and DYSPNEA (trouble catching her breathe while moving). On 10-Feb-2021, RASH PRURITIC (itchy rash on her upper body) had resolved. On 12-Feb-2021, FATIGUE (fatigued) and DYSPNEA (trouble catching her breathe while moving) had resolved. On 13-Feb-2021, RASH MACULAR (blotchy rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Fatigue, Headache, Hypertension
Clinical narrative: SHAKINESS; PAIN IN HER CHEST; DIARRHEA; FEVER; HEADACHE; HIGH BLOOD PRESSURE; LYMPH NODES WERE INFLAMED; HEAVINESS IN ARM LFT INJECTION SITE; CANT MOVE LEFT ARM; SWELLING AT INJECTION SITE; EXTREME FATIGUE; PAIN ATA INJECTION SITE; A spontaneous report was received from a Healthcare Professional concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site, heaviness in arm left inject site, can't move left arm, worsened heaviness in left arm, worsened pain at injection site, swelling at the injection site, extreme fatigue, high blood pressure, fever, diarrhea, shakiness, lymph nodes were inflamed, pain in her chest, pain in the back of her neck, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events pain at injection site. heaviness in arm left inject site, can't move left arm. On 16 Jan 2021, the patient experienced the events worsened heaviness in left arm. worsened pain at injection site, swelling at the injection site. On 17 Jan 2021, the patient experienced the events extreme fatigue . On 20 Jan 2021, the patient experienced the events high blood pressure. fever, diarrhea, shakiness. On 21 Jan 2021, the patient experienced the events lymph nodes were inflamed . On 22 Jan 2021, the patient experienced the events pain in her chest. pain in the back of her neck, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, pain at injection site, heaviness in arm left inject site, can't move left arm, worsened heaviness in left arm, worsened pain at injection site, swelling at the injection site, extreme fatigue, high blood pressure, fever, diarrhea, shakiness, lymph nodes were inflamed, pain in her chest, pain in the back of her neck, headache was not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Limb discomfort, Lymphadenitis, Pyrexia
Clinical narrative: SHAKINESS; PAIN IN HER CHEST; DIARRHEA; FEVER; HEADACHE; HIGH BLOOD PRESSURE; LYMPH NODES WERE INFLAMED; HEAVINESS IN ARM LFT INJECTION SITE; CANT MOVE LEFT ARM; SWELLING AT INJECTION SITE; EXTREME FATIGUE; PAIN ATA INJECTION SITE; A spontaneous report was received from a Healthcare Professional concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site, heaviness in arm left inject site, can't move left arm, worsened heaviness in left arm, worsened pain at injection site, swelling at the injection site, extreme fatigue, high blood pressure, fever, diarrhea, shakiness, lymph nodes were inflamed, pain in her chest, pain in the back of her neck, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events pain at injection site. heaviness in arm left inject site, can't move left arm. On 16 Jan 2021, the patient experienced the events worsened heaviness in left arm. worsened pain at injection site, swelling at the injection site. On 17 Jan 2021, the patient experienced the events extreme fatigue . On 20 Jan 2021, the patient experienced the events high blood pressure. fever, diarrhea, shakiness. On 21 Jan 2021, the patient experienced the events lymph nodes were inflamed . On 22 Jan 2021, the patient experienced the events pain in her chest. pain in the back of her neck, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, pain at injection site, heaviness in arm left inject site, can't move left arm, worsened heaviness in left arm, worsened pain at injection site, swelling at the injection site, extreme fatigue, high blood pressure, fever, diarrhea, shakiness, lymph nodes were inflamed, pain in her chest, pain in the back of her neck, headache was not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHAKINESS; PAIN IN HER CHEST; DIARRHEA; FEVER; HEADACHE; HIGH BLOOD PRESSURE; LYMPH NODES WERE INFLAMED; HEAVINESS IN ARM LFT INJECTION SITE; CANT MOVE LEFT ARM; SWELLING AT INJECTION SITE; EXTREME FATIGUE; PAIN ATA INJECTION SITE; A spontaneous report was received from a Healthcare Professional concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site, heaviness in arm left inject site, can't move left arm, worsened heaviness in left arm, worsened pain at injection site, swelling at the injection site, extreme fatigue, high blood pressure, fever, diarrhea, shakiness, lymph nodes were inflamed, pain in her chest, pain in the back of her neck, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events pain at injection site. heaviness in arm left inject site, can't move left arm. On 16 Jan 2021, the patient experienced the events worsened heaviness in left arm. worsened pain at injection site, swelling at the injection site. On 17 Jan 2021, the patient experienced the events extreme fatigue . On 20 Jan 2021, the patient experienced the events high blood pressure. fever, diarrhea, shakiness. On 21 Jan 2021, the patient experienced the events lymph nodes were inflamed . On 22 Jan 2021, the patient experienced the events pain in her chest. pain in the back of her neck, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, pain at injection site, heaviness in arm left inject site, can't move left arm, worsened heaviness in left arm, worsened pain at injection site, swelling at the injection site, extreme fatigue, high blood pressure, fever, diarrhea, shakiness, lymph nodes were inflamed, pain in her chest, pain in the back of her neck, headache was not reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Loss/Changed- Taste; Loss/Changed- Smell; Redness at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Loss/Changed- Taste), PAROSMIA (Loss/Changed- Smell), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L0A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 27-Jan-2021, the patient experienced TASTE DISORDER (Loss/Changed- Taste) and PAROSMIA (Loss/Changed- Smell). At the time of the report, TASTE DISORDER (Loss/Changed- Taste) and PAROSMIA (Loss/Changed- Smell) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided