chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Slow response to stimuli
Clinical narrative: Slow response; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SLOW RESPONSE TO STIMULI (Slow response) and NAUSEA (nauseous) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 14-Feb-2021, the patient experienced SLOW RESPONSE TO STIMULI (Slow response) and NAUSEA (nauseous). At the time of the report, SLOW RESPONSE TO STIMULI (Slow response) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: F/U  received on 05 May 2021 contains no new information.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on lower extremity rash (waste to ankle); This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (Rash on lower extremity rash (waste to ankle)) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease and Rheumatoid arthritis.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RASH (Rash on lower extremity rash (waste to ankle)). On 12-Feb-2021, RASH (Rash on lower extremity rash (waste to ankle)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Cream lotion.  Stopped Methotrexate at providers request before vaccine.; 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pain
Clinical narrative: Injection site started itching; it feels like a knot under the skin; Injection site is swollen; Injection site is red; Injection site is hard to the touch; Injection site was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was a little sore), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE MASS (it feels like a knot under the skin), INJECTION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0416Z0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Highly allergic to insects, bee stings and some drugs.).    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site was a little sore). On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE MASS (it feels like a knot under the skin), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE INDURATION (Injection site is hard to the touch). At the time of the report, VACCINATION SITE PAIN (Injection site was a little sore), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE MASS (it feels like a knot under the skin), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE INDURATION (Injection site is hard to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information include Benadryl.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Injection site started itching; it feels like a knot under the skin; Injection site is swollen; Injection site is red; Injection site is hard to the touch; Injection site was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was a little sore), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE MASS (it feels like a knot under the skin), INJECTION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0416Z0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Highly allergic to insects, bee stings and some drugs.).    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site was a little sore). On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE MASS (it feels like a knot under the skin), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE INDURATION (Injection site is hard to the touch). At the time of the report, VACCINATION SITE PAIN (Injection site was a little sore), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE MASS (it feels like a knot under the skin), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE INDURATION (Injection site is hard to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information include Benadryl.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site mass
Clinical narrative: Big red welt at injection site; arm soreness; Hard (welt at injection site); red (welt at injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big red welt at injection site), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE INDURATION (Hard (welt at injection site)) and VACCINATION SITE ERYTHEMA (red (welt at injection site)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 an unknown date, the patient experienced VACCINATION SITE MASS (Big red welt at injection site), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE INDURATION (Hard (welt at injection site)) and VACCINATION SITE ERYTHEMA (red (welt at injection site)). At the time of the report, VACCINATION SITE MASS (Big red welt at injection site), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE INDURATION (Hard (welt at injection site)) and VACCINATION SITE ERYTHEMA (red (welt at injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided. Treatment information not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: half dollar sized, warm to touch swelling at the injection site; half dollar sized, warm to touch swelling at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (half dollar sized, warm to touch swelling at the injection site) and VACCINATION SITE SWELLING (half dollar sized, warm to touch swelling at the injection site) in a 63-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 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE WARMTH (half dollar sized, warm to touch swelling at the injection site) and VACCINATION SITE SWELLING (half dollar sized, warm to touch swelling at the injection site). At the time of the report, VACCINATION SITE WARMTH (half dollar sized, warm to touch swelling at the injection site) and VACCINATION SITE SWELLING (half dollar sized, warm to touch swelling at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was provided.  No concomitant product was provided by the reporter. Action taken with mRNA-123 is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site swelling is consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate irregular, Injection site induration, Injection site pain
Clinical narrative: hardness near injection site; sweling at injection site; itchy sensation at injection site; injection site rash; fatigue; soreness near injection site; light headedness; irregular heartbeat; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (light headedness), HEART RATE IRREGULAR (irregular heartbeat), INJECTION SITE INDURATION (hardness near injection site), INJECTION SITE PRURITUS (itchy sensation at injection site) and INJECTION SITE RASH (injection site rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DIZZINESS (light headedness) and HEART RATE IRREGULAR (irregular heartbeat). On 22-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy sensation at injection site), INJECTION SITE RASH (injection site rash), FATIGUE (fatigue) and INJECTION SITE PAIN (soreness near injection site). On 26-Jan-2021, the patient experienced INJECTION SITE INDURATION (hardness near injection site) and INJECTION SITE SWELLING (sweling at injection site). At the time of the report, DIZZINESS (light headedness), HEART RATE IRREGULAR (irregular heartbeat), INJECTION SITE INDURATION (hardness near injection site), INJECTION SITE PRURITUS (itchy sensation at injection site), INJECTION SITE RASH (injection site rash), FATIGUE (fatigue), INJECTION SITE PAIN (soreness near injection site) and INJECTION SITE SWELLING (sweling at injection site) 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.   No relevant concomitant medications were reported.      Treatment details include Aleve.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The events of fatigue, injection site-  pain, pruritus-induration, swelling rash, are consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: hardness near injection site; sweling at injection site; itchy sensation at injection site; injection site rash; fatigue; soreness near injection site; light headedness; irregular heartbeat; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (light headedness), HEART RATE IRREGULAR (irregular heartbeat), INJECTION SITE INDURATION (hardness near injection site), INJECTION SITE PRURITUS (itchy sensation at injection site) and INJECTION SITE RASH (injection site rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DIZZINESS (light headedness) and HEART RATE IRREGULAR (irregular heartbeat). On 22-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy sensation at injection site), INJECTION SITE RASH (injection site rash), FATIGUE (fatigue) and INJECTION SITE PAIN (soreness near injection site). On 26-Jan-2021, the patient experienced INJECTION SITE INDURATION (hardness near injection site) and INJECTION SITE SWELLING (sweling at injection site). At the time of the report, DIZZINESS (light headedness), HEART RATE IRREGULAR (irregular heartbeat), INJECTION SITE INDURATION (hardness near injection site), INJECTION SITE PRURITUS (itchy sensation at injection site), INJECTION SITE RASH (injection site rash), FATIGUE (fatigue), INJECTION SITE PAIN (soreness near injection site) and INJECTION SITE SWELLING (sweling at injection site) 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.   No relevant concomitant medications were reported.      Treatment details include Aleve.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The events of fatigue, injection site-  pain, pruritus-induration, swelling rash, are consistent with the product safety profile
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Flatulence, Nausea
Clinical narrative: feeling nauseous; feel tired and weak; feel gassy; have no appetite; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (feeling nauseous), FATIGUE (feel tired and weak), FLATULENCE (feel gassy) and DECREASED APPETITE (have no appetite) in a not specif 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) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (feeling nauseous), FATIGUE (feel tired and weak), FLATULENCE (feel gassy) and DECREASED APPETITE (have no appetite). At the time of the report, NAUSEA (feeling nauseous), FATIGUE (feel tired and weak), FLATULENCE (feel gassy) and DECREASED APPETITE (have no appetite) 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 mentioned.   No treatment information is provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea and fatigue are consistent with the product safety profile
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Paraesthesia, Vaccination site erythema, Vaccination site induration
Clinical narrative: pins and needles through the body; bump on arm; hard to the touch; swollen; red; chills; muscles in body aches and feel funny, feels like pins and needles through the body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles through the body), VACCINATION SITE MASS (bump on arm), VACCINATION SITE INDURATION (hard to the touch), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) in an 82-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.     The patient's past medical history included No adverse event (No medical history reported.).    On 30-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 PARAESTHESIA (pins and needles through the body), VACCINATION SITE MASS (bump on arm), VACCINATION SITE INDURATION (hard to the touch), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red), CHILLS (chills) and MYALGIA (muscles in body aches and feel funny, feels like pins and needles through the body). At the time of the report, PARAESTHESIA (pins and needles through the body), VACCINATION SITE MASS (bump on arm), VACCINATION SITE INDURATION (hard to the touch), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red), CHILLS (chills) and MYALGIA (muscles in body aches and feel funny, feels like pins and needles through the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product and treatment information were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Myalgia, chills, vaccination site induration, vaccination site swelling and vaccination site erythema are consistent with the product safety profile
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: pins and needles through the body; bump on arm; hard to the touch; swollen; red; chills; muscles in body aches and feel funny, feels like pins and needles through the body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles through the body), VACCINATION SITE MASS (bump on arm), VACCINATION SITE INDURATION (hard to the touch), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) in an 82-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.     The patient's past medical history included No adverse event (No medical history reported.).    On 30-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 PARAESTHESIA (pins and needles through the body), VACCINATION SITE MASS (bump on arm), VACCINATION SITE INDURATION (hard to the touch), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red), CHILLS (chills) and MYALGIA (muscles in body aches and feel funny, feels like pins and needles through the body). At the time of the report, PARAESTHESIA (pins and needles through the body), VACCINATION SITE MASS (bump on arm), VACCINATION SITE INDURATION (hard to the touch), VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red), CHILLS (chills) and MYALGIA (muscles in body aches and feel funny, feels like pins and needles through the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product and treatment information were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Myalgia, chills, vaccination site induration, vaccination site swelling and vaccination site erythema are consistent with the product safety profile
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Made Sjogren's Syndrome better/autoimmune disease gone after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Made Sjogren's Syndrome better/autoimmune disease gone after the vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain and Fever. Concurrent medical conditions included Sjogren's syndrome and Osteoarthritis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Made Sjogren's Syndrome better/autoimmune disease gone after the vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Made Sjogren's Syndrome better/autoimmune disease gone after the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.   Patient was a retired teacher who has Sjogren's syndrome where her white blood cells attack her. Patient was enflamed everywhere all the time. The vaccine has made her Sjogren's syndrome better and was reporting a positive side effect. Patient can move without pain. Patient has osteoarthritis from her syndrome and it's usually debilitating, but now she can move without pain. Patient had Sjogren's syndrome and that syndrome was lupus kind autoimmune disease. Patient used to have pain and fever, now she has no pain no fever.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up received on 23-04-2021 added second dose and reporter details. On 13-Jul-2021: Follow-up received on 13-07--2021 contains no new information.; 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. The patient's Sjogren's syndrome and osteoarthritis have improved with positive side effects, she can move without pain.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Whole body hurting; Drenched in sweat; Fever; Nausea; Headache; Chills; Did not feel good,tired,Fatigue; Light headedness; Arm stiffness; Drowsy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), HEADACHE (Headache), MUSCULOSKELETAL STIFFNESS (Arm stiffness), SOMNOLENCE (Drowsy) and FATIGUE (Did not feel good,tired,Fatigue) in a 33-year-old male 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.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced DIZZINESS (Light headedness), HEADACHE (Headache), MUSCULOSKELETAL STIFFNESS (Arm stiffness), SOMNOLENCE (Drowsy), FATIGUE (Did not feel good,tired,Fatigue) and CHILLS (Chills). On 16-Feb-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea), PAIN (Whole body hurting) and HYPERHIDROSIS (Drenched in sweat). At the time of the report, DIZZINESS (Light headedness), HEADACHE (Headache), MUSCULOSKELETAL STIFFNESS (Arm stiffness), SOMNOLENCE (Drowsy), FATIGUE (Did not feel good,tired,Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), PAIN (Whole body hurting) and HYPERHIDROSIS (Drenched in sweat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment for the events included Ibuprofen and Emergen C on daily basis. Concomitant product was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, fatigue, fever, chills, are consistent with the product safety profile
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: Whole body hurting; Drenched in sweat; Fever; Nausea; Headache; Chills; Did not feel good,tired,Fatigue; Light headedness; Arm stiffness; Drowsy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), HEADACHE (Headache), MUSCULOSKELETAL STIFFNESS (Arm stiffness), SOMNOLENCE (Drowsy) and FATIGUE (Did not feel good,tired,Fatigue) in a 33-year-old male 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.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced DIZZINESS (Light headedness), HEADACHE (Headache), MUSCULOSKELETAL STIFFNESS (Arm stiffness), SOMNOLENCE (Drowsy), FATIGUE (Did not feel good,tired,Fatigue) and CHILLS (Chills). On 16-Feb-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea), PAIN (Whole body hurting) and HYPERHIDROSIS (Drenched in sweat). At the time of the report, DIZZINESS (Light headedness), HEADACHE (Headache), MUSCULOSKELETAL STIFFNESS (Arm stiffness), SOMNOLENCE (Drowsy), FATIGUE (Did not feel good,tired,Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), PAIN (Whole body hurting) and HYPERHIDROSIS (Drenched in sweat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment for the events included Ibuprofen and Emergen C on daily basis. Concomitant product was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, fatigue, fever, chills, are consistent with the product safety profile
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: a little dizzy; felt very weak; felt really tired; nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (a little dizzy), ASTHENIA (felt very weak), FATIGUE (felt really tired) and NAUSEA (nauseous) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Feb-2021, the patient experienced DIZZINESS (a little dizzy), ASTHENIA (felt very weak), FATIGUE (felt really tired) and NAUSEA (nauseous). At the time of the report, DIZZINESS (a little dizzy), ASTHENIA (felt very weak), FATIGUE (felt really tired) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was provided as patient was given antivertigo medication medicine.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue and nausea are consistent with the product safety profile
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on both arms and knees/Skin rash post-vaccination; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash on both arms and knees/Skin rash post-vaccination) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 RASH (Rash on both arms and knees/Skin rash post-vaccination). At the time of the report, RASH (Rash on both arms and knees/Skin rash post-vaccination) 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.   This case was linked to MOD-2021-027273, MOD-2021-027363, MOD-2021-020109, MOD-2021-028798, MOD-2021-027379, MOD-2021-027398 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: injection site is warm; hard bump; sore; pink; pinkness has spread; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (hard bump), VACCINATION SITE PAIN (sore), VACCINATION SITE ERYTHEMA (pink) and VACCINATION SITE ERYTHEMA (pinkness has spread) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (hard bump), VACCINATION SITE PAIN (sore), VACCINATION SITE ERYTHEMA (pink) and VACCINATION SITE ERYTHEMA (pinkness has spread). At the time of the report, VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (hard bump), VACCINATION SITE PAIN (sore), VACCINATION SITE ERYTHEMA (pink) and VACCINATION SITE ERYTHEMA (pinkness has spread) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information and concomitant product is not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Vaccination site induration, vaccination site pain and vaccination site erythema  are consistent with the product safety profile
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: generalized itching; Sore Left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left arm) and PRURITUS (generalized itching) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (cholesterol pills).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Left arm). On an unknown date, the patient experienced PRURITUS (generalized itching). At the time of the report, PAIN IN EXTREMITY (Sore Left arm) and PRURITUS (generalized itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were reported and it contains water pill, blood pressure pill and pills for acid reflect .  Treatment medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm around injection site; swollen around injection site; red around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm around injection site), VACCINATION SITE SWELLING (swollen around injection site) and VACCINATION SITE ERYTHEMA (red around injection site) in a 78-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 (No reported medical history.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (warm around injection site), VACCINATION SITE SWELLING (swollen around injection site) and VACCINATION SITE ERYTHEMA (red around injection site). In February 2021, VACCINATION SITE WARMTH (warm around injection site), VACCINATION SITE SWELLING (swollen around injection site) and VACCINATION SITE ERYTHEMA (red around injection site) 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 medication include antibiotics.Concomitant medications are not reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product safety profile. Vaccination site swelling and vaccination site erythema  are consistent with the product safety profile
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Decreased appetite, Headache, Illness
Clinical narrative: cant get out of bed; fever blisters in ear, nose, lip; loss of appetite; has to stay in bed most of the day/Feels so sick; chills; sore lymph nodes; headache; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (cant get out of bed), BLISTER (fever blisters in ear, nose, lip), DECREASED APPETITE (loss of appetite), ILLNESS (has to stay in bed most of the day/Feels so sick) and CHILLS (chills) in a 69-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 Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (nauseas). On 14-Feb-2021, the patient experienced MALAISE (cant get out of bed), BLISTER (fever blisters in ear, nose, lip), DECREASED APPETITE (loss of appetite), ILLNESS (has to stay in bed most of the day/Feels so sick), CHILLS (chills), LYMPHADENOPATHY (sore lymph nodes) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 06-Feb-2021, NAUSEA (nauseas) had resolved. At the time of the report, MALAISE (cant get out of bed), BLISTER (fever blisters in ear, nose, lip), DECREASED APPETITE (loss of appetite), ILLNESS (has to stay in bed most of the day/Feels so sick), CHILLS (chills), LYMPHADENOPATHY (sore lymph nodes) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up document received via TCR on 13-JUL-2021 contains no information: ; 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Nausea
Clinical narrative: cant get out of bed; fever blisters in ear, nose, lip; loss of appetite; has to stay in bed most of the day/Feels so sick; chills; sore lymph nodes; headache; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (cant get out of bed), BLISTER (fever blisters in ear, nose, lip), DECREASED APPETITE (loss of appetite), ILLNESS (has to stay in bed most of the day/Feels so sick) and CHILLS (chills) in a 69-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 Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (nauseas). On 14-Feb-2021, the patient experienced MALAISE (cant get out of bed), BLISTER (fever blisters in ear, nose, lip), DECREASED APPETITE (loss of appetite), ILLNESS (has to stay in bed most of the day/Feels so sick), CHILLS (chills), LYMPHADENOPATHY (sore lymph nodes) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 06-Feb-2021, NAUSEA (nauseas) had resolved. At the time of the report, MALAISE (cant get out of bed), BLISTER (fever blisters in ear, nose, lip), DECREASED APPETITE (loss of appetite), ILLNESS (has to stay in bed most of the day/Feels so sick), CHILLS (chills), LYMPHADENOPATHY (sore lymph nodes) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up document received via TCR on 13-JUL-2021 contains no information: ; 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy, Ultrasound scan
Clinical narrative: exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 31-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 030ML0A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. The patient's last menstrual period was on 08-Oct-2020 and the estimated date of delivery was 16-Jul-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: (normal) Normal. In December 2021, Blood test: (Inconclusive) not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products was npt provided by the reporter.  Action taken with mRNA-1273 is not applicable.; Sender's Comments: This case concerns a 31-Year-old female, Para1 gravida 2, who received mRNA-1273 while pregnant (vaccine exposure during pregnancy) The patient's last menstrual period was 08-Oct-2020 a, estimated date of conception was 15-Oct-2020 and estimated due date is 16-Jul-2021. the event of vaccine exposure during pregnancy is assessed as not applicable
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: pain in the right leg; muscle pain in the lower back region; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the right leg) and MYALGIA (muscle pain in the lower back region) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the right leg) and MYALGIA (muscle pain in the lower back region). At the time of the report, PAIN IN EXTREMITY (pain in the right leg) and MYALGIA (muscle pain in the lower back region) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Myalgia with severe muscle pain in neck, shoulder, arm and back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (Myalgia with severe muscle pain in neck, shoulder, arm and back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (chloroquine). Concomitant products included METOPROLOL, ROSUVASTATIN, CALCIUM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) and GABAPENTIN.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (Myalgia with severe muscle pain in neck, shoulder, arm and back). At the time of the report, MYALGIA (Myalgia with severe muscle pain in neck, shoulder, arm and back) outcome was unknown.            Treatment received for the event, was not provided.   Action taken with mRNA-1273 in response to the event was not applicable; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  Myalgia is consistent with the product safety profile
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Slightly itchy; Arm was enlarged the next day; headache; nausea; Arm got red; Arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE PRURITUS (Slightly itchy), VACCINATION SITE ERYTHEMA (Arm got red), VACCINATION SITE SWELLING (Arm was enlarged the next day) and HEADACHE (headache) in a 79-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 Drug allergy (Allergic to statins), Hyperlipidemia and Drug allergy (Allergic to sulfa drugs). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), EZETIMIBE, AZITHROMYCIN (AZO) and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm) and VACCINATION SITE ERYTHEMA (Arm got red). On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Slightly itchy), VACCINATION SITE SWELLING (Arm was enlarged the next day), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE PRURITUS (Slightly itchy), VACCINATION SITE ERYTHEMA (Arm got red), VACCINATION SITE SWELLING (Arm was enlarged the next day), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.