chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Fatigue; Muscle pain; Joint pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Fatigue; Muscle pain; Joint pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin reaction
Clinical narrative: Rash on chest and neck; Delayed reaction; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on chest and neck) and SKIN REACTION (Delayed reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on chest and neck) and SKIN REACTION (Delayed reaction). At the time of the report, RASH (Rash on chest and neck) and SKIN REACTION (Delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: itchiness; Negative rapid test and antigen test; rash started on feet and legs then moved to torso and the rest of body except the face; fever 101.5 F; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), SARS-COV-2 TEST NEGATIVE (Negative rapid test and antigen test), RASH (rash started on feet and legs then moved to torso and the rest of body except the face), PYREXIA (fever 101.5 F) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PRURITUS (itchiness), SARS-COV-2 TEST NEGATIVE (Negative rapid test and antigen test), RASH (rash started on feet and legs then moved to torso and the rest of body except the face), PYREXIA (fever 101.5 F) and NAUSEA (nausea). At the time of the report, PRURITUS (itchiness), SARS-COV-2 TEST NEGATIVE (Negative rapid test and antigen test), RASH (rash started on feet and legs then moved to torso and the rest of body except the face), PYREXIA (fever 101.5 F) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included Benadryl, PREDNISONE .   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Vaccination site pain
Clinical narrative: Fibromyalgia; Arm Pain - Near Injection Site/ Soreness - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FIBROMYALGIA (Fibromyalgia) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site/ Soreness - Near Injection Site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included ALPRAZOLAM, OXYCODONE HYDROCHLORIDE (OXYCONTIN), OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), GABAPENTIN, MIRTAZAPINE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN LOW) and METOPROLOL for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm Pain - Near Injection Site/ Soreness - Near Injection Site). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia). At the time of the report, FIBROMYALGIA (Fibromyalgia) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site/ Soreness - Near 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 treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23APR2021, patient stated that she is in hospital and rehab after 1st dose and updated the 2nd dose details and states she fell a lot of additional pain.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: spike in her blood sugar glucose for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (spike in her blood sugar glucose for 3 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Diabetes.   On 11-Feb-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 11-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (spike in her blood sugar glucose for 3 days). At the time of the report, BLOOD GLUCOSE INCREASED (spike in her blood sugar glucose for 3 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood glucose increased: (High) Spike in her blood sugar glucose.         No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Erythema, Induration
Clinical narrative: Induration circular area redness; Induration circular area redness; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Induration circular area redness) and INDURATION (Induration circular area redness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]), KETOROLAC TROMETHAMINE (TORADOL), MORPHINE and IBUPROFEN for an unknown indication.   On 29-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 29-Dec-2020, the patient experienced ERYTHEMA (Induration circular area redness) and INDURATION (Induration circular area redness). On 01-Jan-2021, ERYTHEMA (Induration circular area redness) and INDURATION (Induration circular area redness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-024639 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: fever; sneezing runny nose; sneezing runny nose; headache; diarrhea; vomit; fatigue body ache; fatigue body ache; rash on stomach (upper leg, calf, private area); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (sneezing runny nose), SNEEZING (sneezing runny nose), DIARRHOEA (diarrhea), PYREXIA (fever) and RASH (rash on stomach (upper leg, calf, private area)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2000 and Knee surgery NOS. Concurrent medical conditions included Hypertension, Obesity and Arthritis. Concomitant products included MELOXICAM (MOBIC) and ACETAMINOPHEN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced RASH (rash on stomach (upper leg, calf, private area)). On 01-Feb-2021, the patient experienced FATIGUE (fatigue body ache) and MYALGIA (fatigue body ache). On 05-Feb-2021, the patient experienced VOMITING (vomit). On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 07-Feb-2021, the patient experienced HEADACHE (headache). On 08-Feb-2021, the patient experienced RHINORRHOEA (sneezing runny nose) and SNEEZING (sneezing runny nose). On 10-Feb-2021, the patient experienced PYREXIA (fever). On 31-Jan-2021, RASH (rash on stomach (upper leg, calf, private area)) had resolved. On 07-Feb-2021, DIARRHOEA (diarrhea) had resolved. On 09-Feb-2021, RHINORRHOEA (sneezing runny nose) and SNEEZING (sneezing runny nose) had resolved. At the time of the report, PYREXIA (fever), FATIGUE (fatigue body ache), MYALGIA (fatigue body ache), VOMITING (vomit) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consulted Jan 27 and 28 Jan: Medicine prescribed by physician follow adverse events include Zyrtec daily four days and Benadryl daily four days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinorrhoea, Sneezing, Vomiting
Clinical narrative: fever; sneezing runny nose; sneezing runny nose; headache; diarrhea; vomit; fatigue body ache; fatigue body ache; rash on stomach (upper leg, calf, private area); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (sneezing runny nose), SNEEZING (sneezing runny nose), DIARRHOEA (diarrhea), PYREXIA (fever) and RASH (rash on stomach (upper leg, calf, private area)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2000 and Knee surgery NOS. Concurrent medical conditions included Hypertension, Obesity and Arthritis. Concomitant products included MELOXICAM (MOBIC) and ACETAMINOPHEN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced RASH (rash on stomach (upper leg, calf, private area)). On 01-Feb-2021, the patient experienced FATIGUE (fatigue body ache) and MYALGIA (fatigue body ache). On 05-Feb-2021, the patient experienced VOMITING (vomit). On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 07-Feb-2021, the patient experienced HEADACHE (headache). On 08-Feb-2021, the patient experienced RHINORRHOEA (sneezing runny nose) and SNEEZING (sneezing runny nose). On 10-Feb-2021, the patient experienced PYREXIA (fever). On 31-Jan-2021, RASH (rash on stomach (upper leg, calf, private area)) had resolved. On 07-Feb-2021, DIARRHOEA (diarrhea) had resolved. On 09-Feb-2021, RHINORRHOEA (sneezing runny nose) and SNEEZING (sneezing runny nose) had resolved. At the time of the report, PYREXIA (fever), FATIGUE (fatigue body ache), MYALGIA (fatigue body ache), VOMITING (vomit) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consulted Jan 27 and 28 Jan: Medicine prescribed by physician follow adverse events include Zyrtec daily four days and Benadryl daily four days.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Neck pain, Pain in extremity
Clinical narrative: The patient has severe pain on the back of the arm under her breast to her neck; The patient has severe pain on the back of the arm under her breast to her neck; The patient has severe pain on the back of the arm under her breast to her neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (The patient has severe pain on the back of the arm under her breast to her neck), NECK PAIN (The patient has severe pain on the back of the arm under her breast to her neck) and BREAST PAIN (The patient has severe pain on the back of the arm under her breast to her neck) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZOA) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (The patient has severe pain on the back of the arm under her breast to her neck), NECK PAIN (The patient has severe pain on the back of the arm under her breast to her neck) and BREAST PAIN (The patient has severe pain on the back of the arm under her breast to her neck). The patient was treated with KETOROLAC for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (The patient has severe pain on the back of the arm under her breast to her neck), NECK PAIN (The patient has severe pain on the back of the arm under her breast to her neck) and BREAST PAIN (The patient has severe pain on the back of the arm under her breast to her neck) 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 concomitant medications reported by investigator.  Patient used ketorolac 1 tablet by mouth every 6 hours as needed for pain for 5 days.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Having some difficulties with her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Having some difficulties with her arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (Having some difficulties with her arm at the injection site). At the time of the report, VACCINATION SITE DISCOMFORT (Having some difficulties with her arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Therapeutic response unexpected
Clinical narrative: essential tremor gone; Sore Arm; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone), PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Essential tremor (Suffering from Essential tremors for about 5 years) since an unknown date. Concomitant products included LOSARTAN, DIGOXIN, BUMETANIDE and WARFARIN for an unknown indication.    On 06-Feb-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 PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache). On 08-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone), PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not 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 THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone), PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Essential tremor (Suffering from Essential tremors for about 5 years) since an unknown date. Concomitant products included LOSARTAN, DIGOXIN, BUMETANIDE and WARFARIN for an unknown indication.    On 06-Feb-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 PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache). On 08-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone), PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination complication, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching on right arm; Pain at injection site; Vaccination site urticaria; Swelling at injection site; Exhausted; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 72-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.     The patient's past medical history included Breast cancer, Brain tumor, Immunocompromised and Surgery (on left hand).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE URTICARIA (Vaccination site urticaria). On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching on right arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE URTICARIA (Vaccination site urticaria) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  ; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Itching on right arm; Pain at injection site; Vaccination site urticaria; Swelling at injection site; Exhausted; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 72-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.     The patient's past medical history included Breast cancer, Brain tumor, Immunocompromised and Surgery (on left hand).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE URTICARIA (Vaccination site urticaria). On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching on right arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE URTICARIA (Vaccination site urticaria) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  ; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lymphadenopathy
Clinical narrative: Breathing problem but not bad enough to stop her from going on with her day // 1st dose; Lump on the lymph node on her neck // 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing problem but not bad enough to stop her from going on with her day // 1st dose) and LYMPHADENOPATHY (Lump on the lymph node on her neck // 1st dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DYSPNOEA (Breathing problem but not bad enough to stop her from going on with her day // 1st dose) and LYMPHADENOPATHY (Lump on the lymph node on her neck // 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Breathing problem but not bad enough to stop her from going on with her day // 1st dose) and LYMPHADENOPATHY (Lump on the lymph node on her neck // 1st dose) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-027216 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: NNI pertaining to case. Updated patient's contact information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rash, Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: Runny Nose; Sneezing; Scratchy Throat; Cough; Hardness - Near Injection Site; Rash - Inside of Right Forearm; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Soreness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), THROAT IRRITATION (Scratchy Throat), COUGH (Cough) and VACCINATION SITE INDURATION (Hardness - Near Injection Site) in a 75-year-old female patient who received mRNA-1273 (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), THROAT IRRITATION (Scratchy Throat), COUGH (Cough), VACCINATION SITE INDURATION (Hardness - Near Injection Site), RASH (Rash - Inside of Right Forearm), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE (CORTIZONE-10 [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), THROAT IRRITATION (Scratchy Throat), COUGH (Cough), VACCINATION SITE INDURATION (Hardness - Near Injection Site), RASH (Rash - Inside of Right Forearm), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) had not resolved. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Runny Nose; Sneezing; Scratchy Throat; Cough; Hardness - Near Injection Site; Rash - Inside of Right Forearm; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Soreness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), THROAT IRRITATION (Scratchy Throat), COUGH (Cough) and VACCINATION SITE INDURATION (Hardness - Near Injection Site) in a 75-year-old female patient who received mRNA-1273 (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), THROAT IRRITATION (Scratchy Throat), COUGH (Cough), VACCINATION SITE INDURATION (Hardness - Near Injection Site), RASH (Rash - Inside of Right Forearm), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE (CORTIZONE-10 [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), THROAT IRRITATION (Scratchy Throat), COUGH (Cough), VACCINATION SITE INDURATION (Hardness - Near Injection Site), RASH (Rash - Inside of Right Forearm), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) had not resolved. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: dizziness; fever; chills; nausea; vomiting; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: dizziness; fever; chills; nausea; vomiting; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Low fever; Big hard lump and rash at injection site; Big hard lump and rash at injection site; Itcy at inejction site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big hard lump and rash at injection site), VACCINATION SITE RASH (Big hard lump and rash at injection site), VACCINATION SITE PRURITUS (Itcy at inejction site) and PYREXIA (Low fever) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE MASS (Big hard lump and rash at injection site), VACCINATION SITE RASH (Big hard lump and rash at injection site) and VACCINATION SITE PRURITUS (Itcy at inejction site). On 31-Jan-2021, the patient experienced PYREXIA (Low fever). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Big hard lump and rash at injection site), VACCINATION SITE RASH (Big hard lump and rash at injection site), VACCINATION SITE PRURITUS (Itcy at inejction site) and PYREXIA (Low fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: dry heaves; fever; headache; joints and muscle aches; joints and muscle aches; chills; vomiting; slight diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches) and ARTHRALGIA (joints and muscle aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches), ARTHRALGIA (joints and muscle aches), CHILLS (chills), VOMITING (vomiting) and DIARRHOEA (slight diarrhea). On 06-Feb-2021, RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches), ARTHRALGIA (joints and muscle aches), CHILLS (chills), VOMITING (vomiting) and DIARRHOEA (slight diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Retching, Vomiting
Clinical narrative: dry heaves; fever; headache; joints and muscle aches; joints and muscle aches; chills; vomiting; slight diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches) and ARTHRALGIA (joints and muscle aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches), ARTHRALGIA (joints and muscle aches), CHILLS (chills), VOMITING (vomiting) and DIARRHOEA (slight diarrhea). On 06-Feb-2021, RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches), ARTHRALGIA (joints and muscle aches), CHILLS (chills), VOMITING (vomiting) and DIARRHOEA (slight diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Swelling
Clinical narrative: Swelling; Itchiness; Arm was warm to touch; soreness; Redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness), ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (Itchiness) and FEELING HOT (Arm was warm to touch) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 28-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 PAIN (soreness) and ERYTHEMA (Redness). On 06-Feb-2021, the patient experienced SWELLING (Swelling), PRURITUS (Itchiness) and FEELING HOT (Arm was warm to touch). The patient was treated with CORTISONE at an unspecified dose and frequency. On 29-Jan-2021, PAIN (soreness) and ERYTHEMA (Redness) had resolved. At the time of the report, SWELLING (Swelling), PRURITUS (Itchiness) and FEELING HOT (Arm was warm to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Site of injection swelling; Pain on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Site of injection swelling) and VACCINATION SITE PAIN (Pain on the site of injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Site of injection swelling) and VACCINATION SITE PAIN (Pain on the site of injection). At the time of the report, VACCINATION SITE SWELLING (Site of injection swelling) and VACCINATION SITE PAIN (Pain on the site of injection) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives; Itchy; Redness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PRURITUS (Itchy) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L2019) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported).    On 29-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 URTICARIA (Hives), PRURITUS (Itchy) and ERYTHEMA (Redness). The patient was treated with HYDROCORTISONE (topical) for Itchy, at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives), PRURITUS (Itchy) and ERYTHEMA (Redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Follow-up received on 12-FEB-2021.Patient demographics, Vaccine information which includes date of first dose, batch number, Route of administration were added.Treatment information and new events which includes Itchiness, Redness were added.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Diarrhoea, Lethargy
Clinical narrative: Diarrhea; Stomach hurt; Neck hurt; Shoulders hurt; Nausea; Very weak; Lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Very weak), LETHARGY (Lethargic), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt) and NECK PAIN (Neck hurt) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ASTHENIA (Very weak) and LETHARGY (Lethargic). On 09-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), NECK PAIN (Neck hurt), ARTHRALGIA (Shoulders hurt) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Very weak), LETHARGY (Lethargic), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), NECK PAIN (Neck hurt), ARTHRALGIA (Shoulders hurt) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Neck pain
Clinical narrative: Diarrhea; Stomach hurt; Neck hurt; Shoulders hurt; Nausea; Very weak; Lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Very weak), LETHARGY (Lethargic), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt) and NECK PAIN (Neck hurt) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ASTHENIA (Very weak) and LETHARGY (Lethargic). On 09-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), NECK PAIN (Neck hurt), ARTHRALGIA (Shoulders hurt) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Very weak), LETHARGY (Lethargic), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), NECK PAIN (Neck hurt), ARTHRALGIA (Shoulders hurt) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Vaccination site lymphadenopathy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Vaccination site lymphadenopathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Vaccination site lymphadenopathy). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Vaccination site lymphadenopathy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter. 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Nausea
Clinical narrative: nauseous; discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and DISCOMFORT (discomfort) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-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 NAUSEA (nauseous) and DISCOMFORT (discomfort). The patient was treated with FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, NAUSEA (nauseous) and DISCOMFORT (discomfort) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator