chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Heart rate, Heart rate increased, Insomnia, Vaccination site bruising
Clinical narrative: Feels scared; Itching at the injection site; Fast heart beat; Black and blue from the injection; Bled a little during administration of the vaccine; It was slightly pink ath injection site; Lump in her arm at injection site; Hasn't slept well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), HEART RATE INCREASED (Fast heart beat), VACCINATION SITE BRUISING (Black and blue from the injection), VACCINATION SITE HAEMORRHAGE (Bled a little during administration of the vaccine) and VACCINATION SITE SWELLING (Lump in her arm at injection site) in a 40-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.     Concomitant products included LISINOPRIL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Black and blue from the injection), VACCINATION SITE HAEMORRHAGE (Bled a little during administration of the vaccine), VACCINATION SITE SWELLING (Lump in her arm at injection site) and VACCINATION SITE DISCOLOURATION (It was slightly pink ath injection site). In January 2021, the patient experienced INSOMNIA (Hasn't slept well). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site) and HEART RATE INCREASED (Fast heart beat). On an unknown date, the patient experienced FEAR (Feels scared). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) (topical) in January 2021 for Vaccination site pruritus, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), HEART RATE INCREASED (Fast heart beat), VACCINATION SITE BRUISING (Black and blue from the injection), VACCINATION SITE HAEMORRHAGE (Bled a little during administration of the vaccine), VACCINATION SITE SWELLING (Lump in her arm at injection site), VACCINATION SITE DISCOLOURATION (It was slightly pink ath injection site), INSOMNIA (Hasn't slept well) and FEAR (Feels scared) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Heart rate: fast (High) fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20-Jan-2021, it was day 8 and lump size was a little bigger than a silver dollar.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site haemorrhage, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Feels scared; Itching at the injection site; Fast heart beat; Black and blue from the injection; Bled a little during administration of the vaccine; It was slightly pink ath injection site; Lump in her arm at injection site; Hasn't slept well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), HEART RATE INCREASED (Fast heart beat), VACCINATION SITE BRUISING (Black and blue from the injection), VACCINATION SITE HAEMORRHAGE (Bled a little during administration of the vaccine) and VACCINATION SITE SWELLING (Lump in her arm at injection site) in a 40-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.     Concomitant products included LISINOPRIL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Black and blue from the injection), VACCINATION SITE HAEMORRHAGE (Bled a little during administration of the vaccine), VACCINATION SITE SWELLING (Lump in her arm at injection site) and VACCINATION SITE DISCOLOURATION (It was slightly pink ath injection site). In January 2021, the patient experienced INSOMNIA (Hasn't slept well). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site) and HEART RATE INCREASED (Fast heart beat). On an unknown date, the patient experienced FEAR (Feels scared). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) (topical) in January 2021 for Vaccination site pruritus, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), HEART RATE INCREASED (Fast heart beat), VACCINATION SITE BRUISING (Black and blue from the injection), VACCINATION SITE HAEMORRHAGE (Bled a little during administration of the vaccine), VACCINATION SITE SWELLING (Lump in her arm at injection site), VACCINATION SITE DISCOLOURATION (It was slightly pink ath injection site), INSOMNIA (Hasn't slept well) and FEAR (Feels scared) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Heart rate: fast (High) fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20-Jan-2021, it was day 8 and lump size was a little bigger than a silver dollar.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: macular pruritic rash around the site of injection; macular pruritic rash around the site of injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (macular pruritic rash around the site of injection) and VACCINATION SITE PRURITUS (macular pruritic rash around the site of injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (macular pruritic rash around the site of injection) and VACCINATION SITE PRURITUS (macular pruritic rash around the site of injection). At the time of the report, VACCINATION SITE RASH (macular pruritic rash around the site of injection) and VACCINATION SITE PRURITUS (macular pruritic rash around the site of injection) 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.   Concomitant medication was not reported. Treatment medication was not reported. It was reported that the events were allergic reactions to Moderna.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: irritating generalized itchiness which comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (irritating generalized itchiness which comes and goes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PRURITUS (irritating generalized itchiness which comes and goes). In January 2021, PRURITUS (irritating generalized itchiness which comes and goes) 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.   Concomitant medication was not reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Arthralgia, Fatigue, Headache, Insomnia
Clinical narrative: couldn't sleep because felt pain in her arm (left); pain in her arm (left); a reaction; extreme fatigue; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep because felt pain in her arm (left)), PAIN IN EXTREMITY (pain in her arm (left)), FATIGUE (extreme fatigue), ARTHRALGIA (joint pain) and HEADACHE (headache) in an 82-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.     Concurrent medical conditions included Polymyalgia rheumatica. Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INSOMNIA (couldn't sleep because felt pain in her arm (left)), PAIN IN EXTREMITY (pain in her arm (left)), FATIGUE (extreme fatigue), ARTHRALGIA (joint pain), HEADACHE (headache) and ADVERSE REACTION (a reaction). On 18-Jan-2021, INSOMNIA (couldn't sleep because felt pain in her arm (left)), PAIN IN EXTREMITY (pain in her arm (left)), FATIGUE (extreme fatigue), ARTHRALGIA (joint pain), HEADACHE (headache) and ADVERSE REACTION (a reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication included unspecified supplements. The patient had severe symptoms about two days. After 2 days the symptoms ended. The patient reported that she did not have any breathing problems and never thought her life was at risk.; 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: couldn't sleep because felt pain in her arm (left); pain in her arm (left); a reaction; extreme fatigue; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep because felt pain in her arm (left)), PAIN IN EXTREMITY (pain in her arm (left)), FATIGUE (extreme fatigue), ARTHRALGIA (joint pain) and HEADACHE (headache) in an 82-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.     Concurrent medical conditions included Polymyalgia rheumatica. Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INSOMNIA (couldn't sleep because felt pain in her arm (left)), PAIN IN EXTREMITY (pain in her arm (left)), FATIGUE (extreme fatigue), ARTHRALGIA (joint pain), HEADACHE (headache) and ADVERSE REACTION (a reaction). On 18-Jan-2021, INSOMNIA (couldn't sleep because felt pain in her arm (left)), PAIN IN EXTREMITY (pain in her arm (left)), FATIGUE (extreme fatigue), ARTHRALGIA (joint pain), HEADACHE (headache) and ADVERSE REACTION (a reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication included unspecified supplements. The patient had severe symptoms about two days. After 2 days the symptoms ended. The patient reported that she did not have any breathing problems and never thought her life was at risk.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: injection site was a red, warm, itchy, and a little bit elevated; red area was almost a perfect circle and a couple of inches in diameter; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (injection site was a red, warm, itchy, and a little bit elevated) and INJECTION SITE SWELLING (red area was almost a perfect circle and a couple of inches in diameter) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site was a red, warm, itchy, and a little bit elevated) and INJECTION SITE SWELLING (red area was almost a perfect circle and a couple of inches in diameter). At the time of the report, INJECTION SITE ERYTHEMA (injection site was a red, warm, itchy, and a little bit elevated) and INJECTION SITE SWELLING (red area was almost a perfect circle and a couple of inches in diameter) 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 considered INJECTION SITE ERYTHEMA (injection site was a red, warm, itchy, and a little bit elevated) and INJECTION SITE SWELLING (red area was almost a perfect circle and a couple of inches in diameter) to be possibly related.    No relevant concomitant medications were reported.  She took Benadryl for 3-4 days along with cortisone cream.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: itching rash allover the body; Painful rash allover the body; Red rash allover the body; Pain in both legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both legs), RASH PRURITIC (itching rash allover the body), RASH (Painful rash allover the body) and RASH ERYTHEMATOUS (Red rash allover the body) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in both legs). On 19-Jan-2021, the patient experienced RASH PRURITIC (itching rash allover the body), RASH (Painful rash allover the body) and RASH ERYTHEMATOUS (Red rash allover the body). The patient was treated with SALICYLIC ACID (CREAM 91) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in both legs) outcome was unknown, RASH PRURITIC (itching rash allover the body) was resolving and RASH (Painful rash allover the body) and RASH ERYTHEMATOUS (Red rash allover the body) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medications have not been provided.  Treatment included topical cream.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Oropharyngeal pain
Clinical narrative: Sore Throat; Arm Pain - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) and INJECTION SITE PAIN (Arm Pain - Near Injection Site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and INJECTION SITE PAIN (Arm Pain - Near Injection Site). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) and INJECTION SITE PAIN (Arm Pain - Near Injection Site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medication were reported.  No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Headache, Hypertension
Clinical narrative: Burning headache on top of my head leaving and coming back; Nausea; Diarrhea; All noises irritating were irritating to me; High blood pressure; Very tired all day; Soreness and redness at injection site; Soreness and redness at injection site; Felt funny, shittery and something like an out of the body experience; Pain at injection site; week muscles on the back of the leg and arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at injection site), MUSCULAR WEAKNESS (week muscles on the back of the leg and arm), HEADACHE (Burning headache on top of my head leaving and coming back), FATIGUE (Very tired all day) and INJECTION SITE DISCOMFORT (Soreness and redness at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CT scan. Concurrent medical conditions included Psoriasis. Concomitant products included ESTRADIOL, ROSUVASTATIN, TELMISARTAN, CAPTOPRIL (METOPRIL) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication, CLONIDINE.  On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site), MUSCULAR WEAKNESS (week muscles on the back of the leg and arm), FATIGUE (Very tired all day), INJECTION SITE DISCOMFORT (Soreness and redness at injection site), INJECTION SITE ERYTHEMA (Soreness and redness at injection site) and FEELING ABNORMAL (Felt funny, shittery and something like an out of the body experience). On 09-Jan-2021, the patient experienced NAUSEA (Nausea), DIARRHOEA (Diarrhea), IRRITABILITY (All noises irritating were irritating to me) and HYPERTENSION (High blood pressure). On an unknown date, the patient experienced HEADACHE (Burning headache on top of my head leaving and coming back). On 08-Jan-2021, INJECTION SITE PAIN (Pain at injection site) and MUSCULAR WEAKNESS (week muscles on the back of the leg and arm) had resolved. On 09-Jan-2021, NAUSEA (Nausea), DIARRHOEA (Diarrhea) and IRRITABILITY (All noises irritating were irritating to me) had resolved. On 10-Jan-2021, HEADACHE (Burning headache on top of my head leaving and coming back), FATIGUE (Very tired all day), INJECTION SITE DISCOMFORT (Soreness and redness at injection site), INJECTION SITE ERYTHEMA (Soreness and redness at injection site) and FEELING ABNORMAL (Felt funny, shittery and something like an out of the body experience) had resolved. On 12-Jan-2021, HYPERTENSION (High blood pressure) 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 information provided includes Xanax, Tylenol and Zofran.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Irritability, Muscular weakness
Clinical narrative: Burning headache on top of my head leaving and coming back; Nausea; Diarrhea; All noises irritating were irritating to me; High blood pressure; Very tired all day; Soreness and redness at injection site; Soreness and redness at injection site; Felt funny, shittery and something like an out of the body experience; Pain at injection site; week muscles on the back of the leg and arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at injection site), MUSCULAR WEAKNESS (week muscles on the back of the leg and arm), HEADACHE (Burning headache on top of my head leaving and coming back), FATIGUE (Very tired all day) and INJECTION SITE DISCOMFORT (Soreness and redness at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CT scan. Concurrent medical conditions included Psoriasis. Concomitant products included ESTRADIOL, ROSUVASTATIN, TELMISARTAN, CAPTOPRIL (METOPRIL) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication, CLONIDINE.  On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site), MUSCULAR WEAKNESS (week muscles on the back of the leg and arm), FATIGUE (Very tired all day), INJECTION SITE DISCOMFORT (Soreness and redness at injection site), INJECTION SITE ERYTHEMA (Soreness and redness at injection site) and FEELING ABNORMAL (Felt funny, shittery and something like an out of the body experience). On 09-Jan-2021, the patient experienced NAUSEA (Nausea), DIARRHOEA (Diarrhea), IRRITABILITY (All noises irritating were irritating to me) and HYPERTENSION (High blood pressure). On an unknown date, the patient experienced HEADACHE (Burning headache on top of my head leaving and coming back). On 08-Jan-2021, INJECTION SITE PAIN (Pain at injection site) and MUSCULAR WEAKNESS (week muscles on the back of the leg and arm) had resolved. On 09-Jan-2021, NAUSEA (Nausea), DIARRHOEA (Diarrhea) and IRRITABILITY (All noises irritating were irritating to me) had resolved. On 10-Jan-2021, HEADACHE (Burning headache on top of my head leaving and coming back), FATIGUE (Very tired all day), INJECTION SITE DISCOMFORT (Soreness and redness at injection site), INJECTION SITE ERYTHEMA (Soreness and redness at injection site) and FEELING ABNORMAL (Felt funny, shittery and something like an out of the body experience) had resolved. On 12-Jan-2021, HYPERTENSION (High blood pressure) 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 information provided includes Xanax, Tylenol and Zofran.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Burning headache on top of my head leaving and coming back; Nausea; Diarrhea; All noises irritating were irritating to me; High blood pressure; Very tired all day; Soreness and redness at injection site; Soreness and redness at injection site; Felt funny, shittery and something like an out of the body experience; Pain at injection site; week muscles on the back of the leg and arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at injection site), MUSCULAR WEAKNESS (week muscles on the back of the leg and arm), HEADACHE (Burning headache on top of my head leaving and coming back), FATIGUE (Very tired all day) and INJECTION SITE DISCOMFORT (Soreness and redness at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CT scan. Concurrent medical conditions included Psoriasis. Concomitant products included ESTRADIOL, ROSUVASTATIN, TELMISARTAN, CAPTOPRIL (METOPRIL) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication, CLONIDINE.  On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site), MUSCULAR WEAKNESS (week muscles on the back of the leg and arm), FATIGUE (Very tired all day), INJECTION SITE DISCOMFORT (Soreness and redness at injection site), INJECTION SITE ERYTHEMA (Soreness and redness at injection site) and FEELING ABNORMAL (Felt funny, shittery and something like an out of the body experience). On 09-Jan-2021, the patient experienced NAUSEA (Nausea), DIARRHOEA (Diarrhea), IRRITABILITY (All noises irritating were irritating to me) and HYPERTENSION (High blood pressure). On an unknown date, the patient experienced HEADACHE (Burning headache on top of my head leaving and coming back). On 08-Jan-2021, INJECTION SITE PAIN (Pain at injection site) and MUSCULAR WEAKNESS (week muscles on the back of the leg and arm) had resolved. On 09-Jan-2021, NAUSEA (Nausea), DIARRHOEA (Diarrhea) and IRRITABILITY (All noises irritating were irritating to me) had resolved. On 10-Jan-2021, HEADACHE (Burning headache on top of my head leaving and coming back), FATIGUE (Very tired all day), INJECTION SITE DISCOMFORT (Soreness and redness at injection site), INJECTION SITE ERYTHEMA (Soreness and redness at injection site) and FEELING ABNORMAL (Felt funny, shittery and something like an out of the body experience) had resolved. On 12-Jan-2021, HYPERTENSION (High blood pressure) 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 information provided includes Xanax, Tylenol and Zofran.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Dehydration, Diarrhoea
Clinical narrative: diarrhea; sugar levels elevated; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), BLOOD GLUCOSE INCREASED (sugar levels elevated) and DEHYDRATION (dehydration) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (diarrhea), BLOOD GLUCOSE INCREASED (sugar levels elevated) and DEHYDRATION (dehydration). At the time of the report, DIARRHOEA (diarrhea), BLOOD GLUCOSE INCREASED (sugar levels elevated) and DEHYDRATION (dehydration) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood glucose (120-150 mg/dl): 185 mg/dl High, 196 mg/dl High, 221 mg/dl High and 211 mg/dl High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications were provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: injection site swelling; The injection site is red; itches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (The injection site is red) and INJECTION SITE PRURITUS (itches) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included FLUOROMETHOLONE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and ACETYLSALICYLIC ACID (ASPRIN).   On 12-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 INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (The injection site is red) and INJECTION SITE PRURITUS (itches). At the time of the report, INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (The injection site is red) and INJECTION SITE PRURITUS (itches) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Applied cortisone cream and sprayed Flonase as treatment.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Epistaxis
Clinical narrative: nosebleed; chills; upset stomach; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary embolism (hospitalized for 5 days and had blood clots in his lungs.) in November 2020.    On 12-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 ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment has not provided. The patient's concomitants has not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Illness, Pyrexia
Clinical narrative: fever; chills; fatigue ("we just wanted to go to bed"); no appetitie; felt really sick after the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jan-2021 and was forwarded to Moderna on 21-Jan-2021.    This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue ("we just wanted to go to bed")), DECREASED APPETITE (no appetitie) and ILLNESS (felt really sick after the vaccine) in a 78-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 medical history provided).    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 PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue ("we just wanted to go to bed")), DECREASED APPETITE (no appetitie) and ILLNESS (felt really sick after the vaccine). At the time of the report, PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue ("we just wanted to go to bed")), DECREASED APPETITE (no appetitie) and ILLNESS (felt really sick after the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were provided No treatment were provided
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: headaches; pain on his body; pain on the arm where he was injected; A spontaneous case was received from the consumer concerning male patient of 70 years who received Moderna's  COVID-19 vaccine and experienced  headaches/Headache, pain on his body/ Pain, pain on the arm where he was injected/ Injection site pain.  The patient's medical history was not provided. No relevant concomitant medications was reported.  On 18-Jan-2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 in arm for the prophylaxis of COVID-19 infection.  On 18-Jan-2021 the patient experienced headaches, pain on his body and pain on the arm where he was injected.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, injection headaches/Headache, pain on his body/ Pain, pain on the arm where he was injected/ Injection site pain, was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: soreness/Sore at the injection site; red spot the size of a quarter at the injection site; injection site swollen; injection site itching/itching a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness/Sore at the injection site), VACCINATION SITE ERYTHEMA (red spot the size of a quarter at the injection site), INJECTION SITE SWELLING (injection site swollen) and VACCINATION SITE PRURITUS (injection site itching/itching a little bit) in an 85-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 medical history provided). Concomitant products included OLMESARTAN, APIXABAN (ELIQUIS), HYDROCHLOROTHIAZIDE, ATORVASTATIN, METOPROLOL TARTRATE, HYDRALAZINE, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS 2), VITAMIN C [ASCORBIC ACID], BIOTIN, VITAMIN D3, CALCIUM and ELDERBERRY [SAMBUCUS NIGRA].    On 13-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 VACCINATION SITE PAIN (soreness/Sore at the injection site), VACCINATION SITE ERYTHEMA (red spot the size of a quarter at the injection site), INJECTION SITE SWELLING (injection site swollen) and VACCINATION SITE PRURITUS (injection site itching/itching a little bit). At the time of the report, VACCINATION SITE PAIN (soreness/Sore at the injection site), VACCINATION SITE ERYTHEMA (red spot the size of a quarter at the injection site), INJECTION SITE SWELLING (injection site swollen) and VACCINATION SITE PRURITUS (injection site itching/itching a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment were provided
Sex: F
Vaccine: COVID19
Symptoms: Eyelid margin crusting, Headache, Herpes zoster, Urticaria
Clinical narrative: her right eye was crusted shut; headache on the same side; shingles; rash on her forehead and scalp; This spontaneous case was reported by an other caregiver and describes the occurrence of EYELID MARGIN CRUSTING (her right eye was crusted shut), HEADACHE (headache on the same side), HERPES ZOSTER (shingles) and URTICARIA (rash on her forehead and scalp) in a 74-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 Aneurysm (aneurism in 2015). Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced EYELID MARGIN CRUSTING (her right eye was crusted shut), HEADACHE (headache on the same side), HERPES ZOSTER (shingles) and URTICARIA (rash on her forehead and scalp). At the time of the report, EYELID MARGIN CRUSTING (her right eye was crusted shut), HEADACHE (headache on the same side), HERPES ZOSTER (shingles) and URTICARIA (rash on her forehead and scalp) 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 Concomitant medication were provided No treatment were provided
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            No Concomitant medication were provided No treatment were provided
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (Pregnancy is current condition).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Sep-2021. On 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Malaise, Pain, Pyrexia
Clinical narrative: not feeling too well; fever; headache; body aches; shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (not feeling too well), PYREXIA (fever), HEADACHE (headache), PAIN (body aches) and DYSPNOEA (shortness of breath) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced MALAISE (not feeling too well), PYREXIA (fever), HEADACHE (headache), PAIN (body aches) and DYSPNOEA (shortness of breath). At the time of the report, MALAISE (not feeling too well), PYREXIA (fever), HEADACHE (headache), PAIN (body aches) and DYSPNOEA (shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Fatigue, Headache, Hyperhidrosis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness of arm), fatigue (fatigue/was tired), hyperhidrosis (sweating), chills (cold chills) and nausea in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. Concurrent medical conditions included diabetes. On Jan 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (soreness of arm), fatigue (fatigue/was tired), hyperhidrosis (sweating), chills (cold chills), nausea, confusional state (being confused) and headache. At the time of the report, pain in extremity (soreness of arm), fatigue (fatigue/was tired), hyperhidrosis (sweating), chills (cold chills), nausea, confusional state (being confused) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness of arm), fatigue (fatigue/was tired), hyperhidrosis (sweating), chills (cold chills) and nausea in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. Concurrent medical conditions included diabetes. On Jan 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (soreness of arm), fatigue (fatigue/was tired), hyperhidrosis (sweating), chills (cold chills), nausea, confusional state (being confused) and headache. At the time of the report, pain in extremity (soreness of arm), fatigue (fatigue/was tired), hyperhidrosis (sweating), chills (cold chills), nausea, confusional state (being confused) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site rash, Pain in extremity
Clinical narrative: sore arm; bruising at the injection site; rash in the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash in the area of the injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 INJECTION SITE RASH (rash in the area of the injection). At the time of the report, INJECTION SITE RASH (rash in the area of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Slight fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Slight fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Slight fever). At the time of the report, CHILLS (Chills) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment for the events unknown.  Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 21-Jun-2021. On 05-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 05-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Urticaria, Vaccination site erythema
Clinical narrative: Hives all over her leg; Rash all over her leg; Arm became very red around the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm became very red around the injection site), HEADACHE (Headache), URTICARIA (Hives all over her leg) and RASH (Rash all over her leg) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PITAVASTATIN CALCIUM (LIVALO) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm became very red around the injection site) and HEADACHE (Headache). On 21-Jan-2021, the patient experienced URTICARIA (Hives all over her leg) and RASH (Rash all over her leg). At the time of the report, VACCINATION SITE ERYTHEMA (Arm became very red around the injection site), HEADACHE (Headache), URTICARIA (Hives all over her leg) and RASH (Rash all over her leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.