chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: sore arm; SWEATY; weak; Fatigue; thirsty; Left shoulder is weak; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue) and THIRST (thirsty) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-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) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue), THIRST (thirsty) and MUSCULAR WEAKNESS (Left shoulder is weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue), THIRST (thirsty) and MUSCULAR WEAKNESS (Left shoulder is weak) outcome was unknown. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-026636 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue) and THIRST (thirsty) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-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) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue), THIRST (thirsty) and MUSCULAR WEAKNESS (Left shoulder is weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue), THIRST (thirsty) and MUSCULAR WEAKNESS (Left shoulder is weak) outcome was unknown. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: She was having some symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (She was having some symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (She was having some symptoms). At the time of the report, ADVERSE EVENT (She was having some symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (She was having some symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (She was having some symptoms). At the time of the report, ADVERSE EVENT (She was having some symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter.   No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash
Clinical narrative: Feels like have fever in it; Itch; 4 in x 4 in Red; Rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy and Drug allergy (Amoxicillin allergy.).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash). The patient was treated with HYDROCORTISONE at a dose of Cream. At the time of the report, FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy and Drug allergy (Amoxicillin allergy.).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash). The patient was treated with HYDROCORTISONE at a dose of Cream. At the time of the report, FEELING HOT (Feels like have fever in it), PRURITUS (Itch), ERYTHEMA (4 in x 4 in Red) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Aches in my body; Joint pain; Tiredness; A low-grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021 at 7:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021 at 7:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches in my body), ARTHRALGIA (Joint pain), FATIGUE (Tiredness), PYREXIA (A low-grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site erythema
Clinical narrative: site of injection started itching and developed red mark (5 inches long); site of injection started itching and developed red mark (5 inches long); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (site of injection started itching and developed red mark (5 inches long)) and VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark (5 inches long)) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE PRURITUS (site of injection started itching and developed red mark (5 inches long)). 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark (5 inches long)). At the time of the report, INJECTION SITE PRURITUS (site of injection started itching and developed red mark (5 inches long)) and VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark (5 inches long)) had not resolved.            Treatment medicines include Cortozone-10 cream
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Myalgia, Peripheral swelling
Clinical narrative: Swollen arm; Fever; Chills; Swollen lymph nodes (neck and back of head); Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills), LYMPHADENOPATHY (Swollen lymph nodes (neck and back of head)) and MYALGIA (Body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills), LYMPHADENOPATHY (Swollen lymph nodes (neck and back of head)) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes (neck and back of head)) had resolved. On 28-Jan-2021, MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 100.5 (Inconclusive) 100.5.         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Swollen arm; Fever; Chills; Swollen lymph nodes (neck and back of head); Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills), LYMPHADENOPATHY (Swollen lymph nodes (neck and back of head)) and MYALGIA (Body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills), LYMPHADENOPATHY (Swollen lymph nodes (neck and back of head)) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes (neck and back of head)) had resolved. On 28-Jan-2021, MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 100.5 (Inconclusive) 100.5.         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Received the two doses of the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the two doses of the vaccine while pregnant) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 043L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 9:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Sep-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received the two doses of the vaccine while pregnant). On 25-Feb-2021, EXPOSURE DURING PREGNANCY (Received the two doses of the vaccine while pregnant) had resolved. Not Provided; Reporter's Comments: This case concerns a 33 year-old, female patient, who is pregnant and experienced an event of exposure during pregnancy after receiving her first and then the second dose of mRNA-1273 vaccine on the 11th week of pregnancy. No adverse events were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in her shoulder) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    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 ARTHRALGIA (Pain in her shoulder). At the time of the report, ARTHRALGIA (Pain in her shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in her shoulder) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    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 ARTHRALGIA (Pain in her shoulder). At the time of the report, ARTHRALGIA (Pain in her shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension
Clinical narrative: bloating discomfort that comes and goes in her stomach and even in her back; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (bloating discomfort that comes and goes in her stomach and even in her back) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ABDOMINAL DISTENSION (bloating discomfort that comes and goes in her stomach and even in her back). At the time of the report, ABDOMINAL DISTENSION (bloating discomfort that comes and goes in her stomach and even in her back) outcome was unknown.            Treatment medicine include antacid.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever 101; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever 101) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive in October 2020 and Fever (Fever ran for 16 days) in October 2020. Concomitant products included APIXABAN (ELIQUIS), BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), ROSUVASTATIN CALCIUM (CRESTOR) and CALCIUM CARBONATE (OSCAL [CALCIUM CARBONATE]) 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 25-Feb-2021, the patient experienced CHILLS (Chills). On 26-Feb-2021, the patient experienced PYREXIA (fever 101). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) and PYREXIA (fever 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever 101) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive in October 2020 and Fever (Fever ran for 16 days) in October 2020. Concomitant products included APIXABAN (ELIQUIS), BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), ROSUVASTATIN CALCIUM (CRESTOR) and CALCIUM CARBONATE (OSCAL [CALCIUM CARBONATE]) 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 25-Feb-2021, the patient experienced CHILLS (Chills). On 26-Feb-2021, the patient experienced PYREXIA (fever 101). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) and PYREXIA (fever 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Migraine, Pain in extremity
Clinical narrative: whole day migraine; right arm was in pain; dizzy; weak and overly tired; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (whole day migraine), PAIN IN EXTREMITY (right arm was in pain), DIZZINESS (dizzy) and FATIGUE (weak and overly tired) 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 31-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 MIGRAINE (whole day migraine), PAIN IN EXTREMITY (right arm was in pain), DIZZINESS (dizzy) and FATIGUE (weak and overly tired). At the time of the report, MIGRAINE (whole day migraine), PAIN IN EXTREMITY (right arm was in pain), DIZZINESS (dizzy) and FATIGUE (weak and overly tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter Treatment medication: Pain killers for the pain on her arm  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: itchy, red hot rash 2-3 inches in diameter at the injection site; A spontaneous report was received from a consumer concerning who received Modern's COVID-19 vaccine (mRNA-1273) patient who developed itchy, red hot rash 2-3 inches in diameter at the injection site.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) ON 03-FEB-2021, approximately eight day prior to the onset of the events for intramuscularly in the right arm prophylaxis of COVID-19 infection.   Treatment information was Benadryl.   The second dose of mRNA-1273 was not given yet in response to the events. therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events itchy, red hot rash 2-3 inches in diameter at the injection site were recovered/resolved.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Vaccination site pain, Vaccination site swelling
Clinical narrative: Want the temperature to go down; Sore arm/arm pain; Swelling/arm swelled; Pain in shoulder; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Want the temperature to go down), VACCINATION SITE PAIN (Sore arm/arm pain), VACCINATION SITE SWELLING (Swelling/arm swelled) and ARTHRALGIA (Pain in shoulder) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FEELING HOT (Want the temperature to go down), VACCINATION SITE PAIN (Sore arm/arm pain), VACCINATION SITE SWELLING (Swelling/arm swelled) and ARTHRALGIA (Pain in shoulder). The patient was treated with ETHANOL (LINIMENT AQUOS SR) for Adverse event, at an unspecified dose and frequency and ISOPROPANOL (RUBBING ALCOHOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING HOT (Want the temperature to go down), VACCINATION SITE PAIN (Sore arm/arm pain), VACCINATION SITE SWELLING (Swelling/arm swelled) and ARTHRALGIA (Pain in shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Patient states she doesn't need anymore follow up.; 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hangover, Headache, Insomnia
Clinical narrative: Head feels like a bad hangover; Very bad headache; Headache not allowing him to sleep; This spontaneous case was reported by a consumer and describes the occurrence of HANGOVER (Head feels like a bad hangover), INSOMNIA (Headache not allowing him to sleep) and HEADACHE (Very bad headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain. Concomitant products included OXYCODONE for Back pain.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INSOMNIA (Headache not allowing him to sleep). On 20-Feb-2021, the patient experienced HANGOVER (Head feels like a bad hangover) and HEADACHE (Very bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Hangover, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Headache, at an unspecified dose and frequency. At the time of the report, HANGOVER (Head feels like a bad hangover), INSOMNIA (Headache not allowing him to sleep) and HEADACHE (Very bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. The reporter mentioned that the pain comes back as Tylenol wears off.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Slight nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Slight nose bleed) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination.     The patient's past medical history included Cautery to nose. Concurrent medical conditions included Hypertension.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced EPISTAXIS (Slight nose bleed). At the time of the report, EPISTAXIS (Slight nose bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Product included as blood pressure medication. No Treatment Medication was provided.     Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Reporter's address is updated.current condition hypertension was added.Concomitant products included as blood pressure medication.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Confusional state, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: High Heart Rate; High BP; Dizziness; Confusion; Diarrhea; Shortness of breath; Lost 15 pounds; Loud in the ears; Headache; Fatigue; vomiting; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion) and DIARRHOEA (Diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), ABNORMAL LOSS OF WEIGHT (Lost 15 pounds), TINNITUS (Loud in the ears), HEADACHE (Headache), FATIGUE (Fatigue), VOMITING (vomiting) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), ABNORMAL LOSS OF WEIGHT (Lost 15 pounds), TINNITUS (Loud in the ears), HEADACHE (Headache), FATIGUE (Fatigue), VOMITING (vomiting) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication: Antacids, Mortrin and Tylenol.  No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Hypertension, Nausea
Clinical narrative: High Heart Rate; High BP; Dizziness; Confusion; Diarrhea; Shortness of breath; Lost 15 pounds; Loud in the ears; Headache; Fatigue; vomiting; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion) and DIARRHOEA (Diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), ABNORMAL LOSS OF WEIGHT (Lost 15 pounds), TINNITUS (Loud in the ears), HEADACHE (Headache), FATIGUE (Fatigue), VOMITING (vomiting) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), ABNORMAL LOSS OF WEIGHT (Lost 15 pounds), TINNITUS (Loud in the ears), HEADACHE (Headache), FATIGUE (Fatigue), VOMITING (vomiting) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication: Antacids, Mortrin and Tylenol.  No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vomiting
Clinical narrative: High Heart Rate; High BP; Dizziness; Confusion; Diarrhea; Shortness of breath; Lost 15 pounds; Loud in the ears; Headache; Fatigue; vomiting; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion) and DIARRHOEA (Diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), ABNORMAL LOSS OF WEIGHT (Lost 15 pounds), TINNITUS (Loud in the ears), HEADACHE (Headache), FATIGUE (Fatigue), VOMITING (vomiting) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (High Heart Rate), HYPERTENSION (High BP), DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), ABNORMAL LOSS OF WEIGHT (Lost 15 pounds), TINNITUS (Loud in the ears), HEADACHE (Headache), FATIGUE (Fatigue), VOMITING (vomiting) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication: Antacids, Mortrin and Tylenol.  No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: both of my legs went numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (both of my legs went numb) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to aspirin). Concomitant products included PRAMIPEXOLE from 10-Jan-2008 to an unknown date for Restless leg syndrome.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 25-Feb-2021, the patient experienced HYPOAESTHESIA (both of my legs went numb). On 25-Feb-2021, HYPOAESTHESIA (both of my legs went numb) had resolved.            No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up information received on 05 May 2021, No new significant information On 06-May-2021: Follow up information received on 06 May 2021, contains No New Information. On 16-Jul-2021: Follow up information received on 16 Jul 2021, Patient demographics updated and first dose information, concomitant  were added, outcome was updated.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Peripheral swelling, Rash
Clinical narrative: mild rash; stiff joints; lump on his arm; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (stiff joints), PERIPHERAL SWELLING (lump on his arm) and RASH (mild rash) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Thrombosis.    The patient's past medical history included COVID-19. Concurrent medical conditions included Allergy to antibiotic, Ragweed allergy, Drug allergy (Novocaine), Diabetes since 2006, Venous ulcer NOS since 2018 and Hypertension since 1998. Concomitant products included INSULIN for Blood glucose abnormal, ATENOLOL for Blood pressure management, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VIT D [COLECALCIFEROL]), HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE), ACETYLSALICYLIC ACID (BABY ASPIRIN) and CYANOCOBALAMIN (VIT B12) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) (unknown route) 83 mg. On 02-Feb-2021, the patient experienced JOINT STIFFNESS (stiff joints) and PERIPHERAL SWELLING (lump on his arm). On 07-Feb-2021, the patient experienced RASH (mild rash). The patient was treated with BETAMETHASONE at an unspecified dose and frequency. At the time of the report, JOINT STIFFNESS (stiff joints), PERIPHERAL SWELLING (lump on his arm) and RASH (mild rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received second dose on 02-MAR-2021.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Added relevant history, updated concomitant medications, updated second dose details.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Lip swelling
Clinical narrative: sweating; lips are starting to swell; hot; rash; chills; headache; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), LIP SWELLING (lips are starting to swell), FEELING HOT (hot), PAIN IN EXTREMITY (arm hurt) and RASH (rash) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 08-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), LIP SWELLING (lips are starting to swell), FEELING HOT (hot), RASH (rash), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Headache, Lip swelling and Pain in arm, at an unspecified dose and frequency. On 08-Feb-2021, HYPERHIDROSIS (sweating) and CHILLS (chills) had resolved. At the time of the report, LIP SWELLING (lips are starting to swell), FEELING HOT (hot), PAIN IN EXTREMITY (arm hurt), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: sweating; lips are starting to swell; hot; rash; chills; headache; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), LIP SWELLING (lips are starting to swell), FEELING HOT (hot), PAIN IN EXTREMITY (arm hurt) and RASH (rash) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 08-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), LIP SWELLING (lips are starting to swell), FEELING HOT (hot), RASH (rash), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Headache, Lip swelling and Pain in arm, at an unspecified dose and frequency. On 08-Feb-2021, HYPERHIDROSIS (sweating) and CHILLS (chills) had resolved. At the time of the report, LIP SWELLING (lips are starting to swell), FEELING HOT (hot), PAIN IN EXTREMITY (arm hurt), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Nauseous; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), HEADACHE (Headache) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced NAUSEA (Nauseous), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, NAUSEA (Nauseous), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rashes; Skin was itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes) and PRURITUS (Skin was itchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced RASH (Rashes) and PRURITUS (Skin was itchy). At the time of the report, RASH (Rashes) and PRURITUS (Skin was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Movement disorder, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: couldn't move, felt paralyzed; malaise; sore arm; Fever; body aches everywhere; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MOVEMENT DISORDER (couldn't move, felt paralyzed), MALAISE (malaise), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and MYALGIA (body aches everywhere) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (couldn't move, felt paralyzed), MALAISE (malaise), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and MYALGIA (body aches everywhere). At the time of the report, MOVEMENT DISORDER (couldn't move, felt paralyzed), MALAISE (malaise), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and MYALGIA (body aches everywhere) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia, Nausea, Pyrexia
Clinical narrative: high temperature; Nausea; chills; dizziness; achiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high temperature), NAUSEA (Nausea), CHILLS (chills), DIZZINESS (dizziness) and MYALGIA (achiness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (high temperature), NAUSEA (Nausea), CHILLS (chills), DIZZINESS (dizziness) and MYALGIA (achiness). At the time of the report, PYREXIA (high temperature), NAUSEA (Nausea), CHILLS (chills), DIZZINESS (dizziness) and MYALGIA (achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: terrible rashes all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (terrible rashes all over her body) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced RASH (terrible rashes all over her body). The patient was treated with ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH (terrible rashes all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Vaccination site warmth; vaccination site discoloration; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE DISCOLOURATION (vaccination site discoloration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE DISCOLOURATION (vaccination site discoloration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE DISCOLOURATION (vaccination site discoloration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.            Concomitant information use was not reported.  Treatment information was not provided.