chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Hyperhidrosis, Pain in extremity, Rash
Clinical narrative: Rash on thigh, elbow, back, stomach; Dizziness,Feeling Lightheaded; Sweating; Mild Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild Soreness in arm), DIZZINESS (Dizziness,Feeling Lightheaded), HYPERHIDROSIS (Sweating) and RASH (Rash on thigh, elbow, back, stomach) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diverticulitis (2 weeks prior to shot.), Ehlers-Danlos syndrome, Drug allergy (Allergy to Meperidine), Drug allergy (Allergy to Morphine), Latex allergy, Drug allergy (Allergy to qeutamycine) and Drug allergy (Allergy to Terbinifine).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Mild Soreness in arm). On 16-Jan-2021, the patient experienced DIZZINESS (Dizziness,Feeling Lightheaded) and HYPERHIDROSIS (Sweating). On 23-Jan-2021, the patient experienced RASH (Rash on thigh, elbow, back, stomach). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency; ACRIVASTINE (BENADRYL ALLERGY RELIEF) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE at a dose of 0.1 percent. On 13-Jan-2021, PAIN IN EXTREMITY (Mild Soreness in arm) had resolved. On 19-Jan-2021, DIZZINESS (Dizziness,Feeling Lightheaded) and HYPERHIDROSIS (Sweating) had resolved. At the time of the report, RASH (Rash on thigh, elbow, back, stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient temperature was running low& got resolved on 19/Jan/2021.  Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18-JUN-2021 and contains no new significant information On 28-Jun-2021: Patient heights and weight updated. Allergies and medical history updated.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site paraesthesia
Clinical narrative: a tingle on her left arm and now she is feeling the same on her right arm as well; little of numbness on her hands and both of her arms; Vaccination site Paresthesia; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (a tingle on her left arm and now she is feeling the same on her right arm as well), HYPOAESTHESIA (little of numbness on her hands and both of her arms) and VACCINATION SITE PARAESTHESIA (Vaccination site Paresthesia) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043l20a) for COVID-19 vaccination.     No Medical History information was reported.    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 PARAESTHESIA (a tingle on her left arm and now she is feeling the same on her right arm as well), HYPOAESTHESIA (little of numbness on her hands and both of her arms) and VACCINATION SITE PARAESTHESIA (Vaccination site Paresthesia). At the time of the report, PARAESTHESIA (a tingle on her left arm and now she is feeling the same on her right arm as well), HYPOAESTHESIA (little of numbness on her hands and both of her arms) and VACCINATION SITE PARAESTHESIA (Vaccination site Paresthesia) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information were 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: arm pain; slight headache; a little bit of the chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), HEADACHE (slight headache) and CHILLS (a little bit of the chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.    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 PAIN IN EXTREMITY (arm pain), HEADACHE (slight headache) and CHILLS (a little bit of the chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), HEADACHE (slight headache) and CHILLS (a little bit of the chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was reported   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Red rash at the injection site; A spontaneous report  was received from a Consumer concerning of an unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red rash at the injection site.  The patient's medical history and current condition were not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced Red rash at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event red rash at the injection site was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Malaise, Nausea, Pyrexia
Clinical narrative: sick all week; does not feel good/ lying around; nauseous; fever; arm is still red, it's a huge red spot under the injection site, very tender; arm is still red, it's a huge red spot under the injection site, very tender; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick all week), MALAISE (does not feel good/ lying around), NAUSEA (nauseous), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (arm is still red, it's a huge red spot under the injection site, very tender) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 05-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 ILLNESS (sick all week), MALAISE (does not feel good/ lying around), NAUSEA (nauseous), PYREXIA (fever), VACCINATION SITE ERYTHEMA (arm is still red, it's a huge red spot under the injection site, very tender), VACCINATION SITE PAIN (arm is still red, it's a huge red spot under the injection site, very tender) and CHILLS (chills). At the time of the report, ILLNESS (sick all week), MALAISE (does not feel good/ lying around), NAUSEA (nauseous), PYREXIA (fever), VACCINATION SITE ERYTHEMA (arm is still red, it's a huge red spot under the injection site, very tender), VACCINATION SITE PAIN (arm is still red, it's a huge red spot under the injection site, very tender) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: sick all week; does not feel good/ lying around; nauseous; fever; arm is still red, it's a huge red spot under the injection site, very tender; arm is still red, it's a huge red spot under the injection site, very tender; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick all week), MALAISE (does not feel good/ lying around), NAUSEA (nauseous), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (arm is still red, it's a huge red spot under the injection site, very tender) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 05-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 ILLNESS (sick all week), MALAISE (does not feel good/ lying around), NAUSEA (nauseous), PYREXIA (fever), VACCINATION SITE ERYTHEMA (arm is still red, it's a huge red spot under the injection site, very tender), VACCINATION SITE PAIN (arm is still red, it's a huge red spot under the injection site, very tender) and CHILLS (chills). At the time of the report, ILLNESS (sick all week), MALAISE (does not feel good/ lying around), NAUSEA (nauseous), PYREXIA (fever), VACCINATION SITE ERYTHEMA (arm is still red, it's a huge red spot under the injection site, very tender), VACCINATION SITE PAIN (arm is still red, it's a huge red spot under the injection site, very tender) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Itchy Sensation - Near Injection Site; Rash - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). At the time of the report, PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - 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.   Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. The reported events are consistent with the known safety profile of the vaccine; Sender's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. The reported events are consistent with the known safety profile of the vaccine
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Insomnia, Nausea
Clinical narrative: Sleeplessness; Stomach ache; Slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness), ABDOMINAL PAIN UPPER (Stomach ache) and NAUSEA (Slight nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20M) 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 29-Jan-2021, the patient experienced INSOMNIA (Sleeplessness), ABDOMINAL PAIN UPPER (Stomach ache) and NAUSEA (Slight nausea). At the time of the report, INSOMNIA (Sleeplessness), ABDOMINAL PAIN UPPER (Stomach ache) and NAUSEA (Slight nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: my whole body was stabbed with thousand needles; sore arm; chills; major body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (my whole body was stabbed with thousand needles), VACCINATION SITE PAIN (sore arm), CHILLS (chills), MYALGIA (major body aches) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (my whole body was stabbed with thousand needles), VACCINATION SITE PAIN (sore arm), CHILLS (chills), MYALGIA (major body aches) and PYREXIA (fever). At the time of the report, PAIN (my whole body was stabbed with thousand needles), VACCINATION SITE PAIN (sore arm), CHILLS (chills), MYALGIA (major body aches) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1f (Inconclusive) 100.1F.         Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my whole body was stabbed with thousand needles; sore arm; chills; major body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (my whole body was stabbed with thousand needles), VACCINATION SITE PAIN (sore arm), CHILLS (chills), MYALGIA (major body aches) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (my whole body was stabbed with thousand needles), VACCINATION SITE PAIN (sore arm), CHILLS (chills), MYALGIA (major body aches) and PYREXIA (fever). At the time of the report, PAIN (my whole body was stabbed with thousand needles), VACCINATION SITE PAIN (sore arm), CHILLS (chills), MYALGIA (major body aches) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1f (Inconclusive) 100.1F.         Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Positive) 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 COVID-19 (COVID-19 Positive). At the time of the report, COVID-19 (COVID-19 Positive) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No medical history was provided by the reporter.  On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Hypersensitivity, Illness
Clinical narrative: extreme weakness; Felt very sick; Diarrhea; Muscle weakness; Decreased appetite; rash on her arm at the injection site; Swelling at the injection site probably about the size of my fist; Very, very itchy, swelling at injection site; Thinks its some sort of allergic reaction; Injection site red; Pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Thinks its some sort of allergic reaction), PAIN IN EXTREMITY (Arm, of course, was extremely sore and lasted about a week), VACCINATION SITE ERYTHEMA (Injection site red), ASTHENIA (extreme weakness) and ILLNESS (Felt very sick) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HYPERSENSITIVITY (Thinks its some sort of allergic reaction), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE SWELLING (Swelling at the injection site probably about the size of my fist) and VACCINATION SITE PRURITUS (Very, very itchy, swelling at injection site). 26-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on her arm at the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm, of course, was extremely sore and lasted about a week), ASTHENIA (extreme weakness), ILLNESS (Felt very sick), DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Muscle weakness) and DECREASED APPETITE (Decreased appetite). At the time of the report, HYPERSENSITIVITY (Thinks its some sort of allergic reaction), PAIN IN EXTREMITY (Arm, of course, was extremely sore and lasted about a week), VACCINATION SITE ERYTHEMA (Injection site red), ASTHENIA (extreme weakness), ILLNESS (Felt very sick), DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Muscle weakness), DECREASED APPETITE (Decreased appetite), VACCINATION SITE RASH (rash on her arm at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site probably about the size of my fist) and VACCINATION SITE PRURITUS (Very, very itchy, swelling at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant products were reported. No Treatment were reported. Patient had Trouble staying awake, severe generalized pain. The second planned dose was scheduled on 16FEB2021. Unknown if the patient received.   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Patient demographics was updated. Treatment with mRNA-1273 was updated. Additional events of hypersensitivity, pain in extremity and injection site pruritus were reported. The patient's doctor told her to monitor it and come in if it got worse. On 24-Jun-2021: Events outcome was updated. The reporter declined further follow-up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: extreme weakness; Felt very sick; Diarrhea; Muscle weakness; Decreased appetite; rash on her arm at the injection site; Swelling at the injection site probably about the size of my fist; Very, very itchy, swelling at injection site; Thinks its some sort of allergic reaction; Injection site red; Pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Thinks its some sort of allergic reaction), PAIN IN EXTREMITY (Arm, of course, was extremely sore and lasted about a week), VACCINATION SITE ERYTHEMA (Injection site red), ASTHENIA (extreme weakness) and ILLNESS (Felt very sick) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HYPERSENSITIVITY (Thinks its some sort of allergic reaction), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE SWELLING (Swelling at the injection site probably about the size of my fist) and VACCINATION SITE PRURITUS (Very, very itchy, swelling at injection site). 26-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on her arm at the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm, of course, was extremely sore and lasted about a week), ASTHENIA (extreme weakness), ILLNESS (Felt very sick), DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Muscle weakness) and DECREASED APPETITE (Decreased appetite). At the time of the report, HYPERSENSITIVITY (Thinks its some sort of allergic reaction), PAIN IN EXTREMITY (Arm, of course, was extremely sore and lasted about a week), VACCINATION SITE ERYTHEMA (Injection site red), ASTHENIA (extreme weakness), ILLNESS (Felt very sick), DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Muscle weakness), DECREASED APPETITE (Decreased appetite), VACCINATION SITE RASH (rash on her arm at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site probably about the size of my fist) and VACCINATION SITE PRURITUS (Very, very itchy, swelling at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant products were reported. No Treatment were reported. Patient had Trouble staying awake, severe generalized pain. The second planned dose was scheduled on 16FEB2021. Unknown if the patient received.   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Patient demographics was updated. Treatment with mRNA-1273 was updated. Additional events of hypersensitivity, pain in extremity and injection site pruritus were reported. The patient's doctor told her to monitor it and come in if it got worse. On 24-Jun-2021: Events outcome was updated. The reporter declined further follow-up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive Test for COVID-19; Right arm hurting; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive Test for COVID-19) and PAIN IN EXTREMITY (Right arm hurting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 112 21 Not Sure) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive Test for COVID-19) and PAIN IN EXTREMITY (Right arm hurting). On 08-Feb-2021, SARS-COV-2 TEST POSITIVE (Positive Test for COVID-19) and PAIN IN EXTREMITY (Right arm hurting) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sever body aches), MYALGIA (muscle pain), FATIGUE (Fatigue) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (sever body aches), MYALGIA (muscle pain), FATIGUE (Fatigue) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (sever body aches), MYALGIA (muscle pain), FATIGUE (Fatigue) and PYREXIA (fever) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Vitamin B and D used as a Concomitant medication.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; A spontaneous report was received from a consumer concerning herself, a 74-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm at injection site.   The patient's medical history was not provided. No concomitant medications were reported.   On 20 Jan 2021 8:00 am prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the patient experienced sore arm at injection site.  Lab details were not provided.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, sore arm at injection site was reported unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: feverish; soreness (arm); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish) and INJECTION SITE PAIN (soreness (arm)) 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 (No reported medical history).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (feverish) and INJECTION SITE PAIN (soreness (arm)). At the time of the report, PYREXIA (feverish) and INJECTION SITE PAIN (soreness (arm)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT MEDICATION AND TREATMENT PROVIDED; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Bump at injection site; Little itchy at injection site; Swelling at injection site; Pink-red at injection site; Slight soreness in arm; A spontaneous report was received from a consumer concerning an 83-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bump at injection site (vaccination site mass), swelling at injection site (vaccination site swelling), pink-red at injection site (vaccination site erythema), little itchy at injection site (vaccination site pruritus) and slight soreness in arm (vaccination site pain).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included pravastatin and esomeprazole magnesium.  On 26 Jan 2021, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Batch Number: G29L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, after the vaccination, patient's left arm was little sore. On 03 Feb 2021, 8 days later, patient experienced bump at injection site, swelling at injection site, pink red at injection site and little itchy at injection site. Treatment information cortisone and paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, bump at injection site, swelling at injection site, pink red at injection site, little itchy at injection site and slight soreness in arm, was recovering at the time of this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: really bad itchy; hurt inside; like a bump; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (really bad itchy), INJECTION SITE PAIN (hurt inside) and INJECTION SITE SWELLING (like a bump) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DEXLANSOPRAZOLE (DEXILANT SOLUTAB) and ROPINIROLE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PRURITUS (really bad itchy), INJECTION SITE PAIN (hurt inside) and INJECTION SITE SWELLING (like a bump). At the time of the report, INJECTION SITE PRURITUS (really bad itchy), INJECTION SITE PAIN (hurt inside) and INJECTION SITE SWELLING (like a bump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl for Itching
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Insomnia
Clinical narrative: Insomnia; warm inside; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) and FEELING HOT (warm inside) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INSOMNIA (Insomnia) and FEELING HOT (warm inside). At the time of the report, INSOMNIA (Insomnia) and FEELING HOT (warm inside) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Patient feels like got run over with a truck and back over again; Patient has a fever of 102.8 F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient feels like got run over with a truck and back over again) and PYREXIA (Patient has a fever of 102.8 F) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient previously had COVID) and Pneumonia (Patient previously had COVID and was hospitalized with pneumonia).    On 28-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 MALAISE (Patient feels like got run over with a truck and back over again) and PYREXIA (Patient has a fever of 102.8 F). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event following immunisation, at a dose of 2 dosage form. At the time of the report, MALAISE (Patient feels like got run over with a truck and back over again) and PYREXIA (Patient has a fever of 102.8 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102.8 f (High) fever of 102.8 F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: extremely dizzy; horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy) and HEADACHE (horrible headache) 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 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (extremely dizzy) and HEADACHE (horrible headache). At the time of the report, DIZZINESS (extremely dizzy) and HEADACHE (horrible headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.  Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Reported there were about 4 to 6 hives, mostly small and 1 larger, on her upper chest area; Itchy and started about an hour ago, but they are subsiding; Rash is less red; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Reported there were about 4 to 6 hives, mostly small and 1 larger, on her upper chest area), PRURITUS (Itchy and started about an hour ago, but they are subsiding) and RASH ERYTHEMATOUS (Rash is less red) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 29-Jan-2021, the patient experienced URTICARIA (Reported there were about 4 to 6 hives, mostly small and 1 larger, on her upper chest area), PRURITUS (Itchy and started about an hour ago, but they are subsiding) and RASH ERYTHEMATOUS (Rash is less red). At the time of the report, URTICARIA (Reported there were about 4 to 6 hives, mostly small and 1 larger, on her upper chest area) and RASH ERYTHEMATOUS (Rash is less red) outcome was unknown and PRURITUS (Itchy and started about an hour ago, but they are subsiding) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  She was going to take diphenhydramine (BENADRYL) as treatment medication.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Left arm puffed up about an inch from the injection site; Feverish underneath the injection site; Redness underneath the injection site; Swollen hurting for about 5-6 days underneath the injection site; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), VACCINATION SITE SWELLING (Left arm puffed up about an inch from the injection site), PYREXIA (Feverish underneath the injection site), VACCINATION SITE ERYTHEMA (Redness underneath the injection site) and VACCINATION SITE PAIN (Swollen hurting for about 5-6 days underneath the injection site) in an 88-year-old female 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) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Left arm puffed up about an inch from the injection site), PYREXIA (Feverish underneath the injection site), VACCINATION SITE ERYTHEMA (Redness underneath the injection site) and VACCINATION SITE PAIN (Swollen hurting for about 5-6 days underneath the injection site). At the time of the report, RASH ERYTHEMATOUS (Red rash), VACCINATION SITE SWELLING (Left arm puffed up about an inch from the injection site), PYREXIA (Feverish underneath the injection site), VACCINATION SITE ERYTHEMA (Redness underneath the injection site) and VACCINATION SITE PAIN (Swollen hurting for about 5-6 days underneath the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Type IV hypersensitivity reaction
Clinical narrative: rash on the arm of injection; delayed hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash on the arm of injection) and TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE RASH (rash on the arm of injection) and TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity reaction). At the time of the report, INJECTION SITE RASH (rash on the arm of injection) and TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive Saliva test for COVID-19 post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Saliva test for COVID-19 post vaccination) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 COVID-19 (Positive Saliva test for COVID-19 post vaccination). At the time of the report, COVID-19 (Positive Saliva test for COVID-19 post vaccination) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: (Negative) Negative. On 28-Jan-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up received on 01-JUN-2021 and it contains No new information
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over the body; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash all over the body) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced RASH (Rash all over the body). At the time of the report, RASH (Rash all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient used unspecified allergic medication as treatment for symptoms.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: A rash at the injection site that was puffy, very itchy and red; A rash at the injection site that was puffy, very itchy and red; A rash at the injection site that was puffy, very itchy and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (A rash at the injection site that was puffy, very itchy and red), VACCINATION SITE RASH (A rash at the injection site that was puffy, very itchy and red) and VACCINATION SITE ERYTHEMA (A rash at the injection site that was puffy, very itchy and red) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L22A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included HYDROCHLOROTHIAZIDE, APIXABAN (ELIQUIS), DONEPEZIL, ESCITALOPRAM, MEMANTINE, SOLIFENACIN and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (A rash at the injection site that was puffy, very itchy and red), VACCINATION SITE RASH (A rash at the injection site that was puffy, very itchy and red) and VACCINATION SITE ERYTHEMA (A rash at the injection site that was puffy, very itchy and red). At the time of the report, VACCINATION SITE PRURITUS (A rash at the injection site that was puffy, very itchy and red), VACCINATION SITE RASH (A rash at the injection site that was puffy, very itchy and red) and VACCINATION SITE ERYTHEMA (A rash at the injection site that was puffy, very itchy and red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Vaccination site mass, Vaccination site pruritus
Clinical narrative: lump on arm; itches at injection site; hardness at injection site; redness the size of a fifty cent piece at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (lump on arm), VACCINATION SITE PRURITUS (itches at injection site), INJECTION SITE INDURATION (hardness at injection site) and INJECTION SITE ERYTHEMA (redness the size of a fifty cent piece at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (lump on arm), VACCINATION SITE PRURITUS (itches at injection site), INJECTION SITE INDURATION (hardness at injection site) and INJECTION SITE ERYTHEMA (redness the size of a fifty cent piece at injection site). At the time of the report, VACCINATION SITE MASS (lump on arm), VACCINATION SITE PRURITUS (itches at injection site), INJECTION SITE INDURATION (hardness at injection site) and INJECTION SITE ERYTHEMA (redness the size of a fifty cent piece at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information included address and email.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Vaccination site rash
Clinical narrative: a skin rash on my injection site one week after receiving the vaccine; Pain at the injection site; Raised, reddened, itchy area at injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PRURITUS (Raised, reddened, itchy area at injection site), VACCINATION SITE RASH (a skin rash on my injection site one week after receiving the vaccine) and INJECTION SITE PAIN (Pain at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Raised, reddened, itchy area at injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (a skin rash on my injection site one week after receiving the vaccine) and INJECTION SITE PAIN (Pain at the injection site). On 01-Feb-2021, INJECTION SITE PRURITUS (Raised, reddened, itchy area at injection site) had resolved. At the time of the report, VACCINATION SITE RASH (a skin rash on my injection site one week after receiving the vaccine) and INJECTION SITE PAIN (Pain at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included Air Shield Immunity Support Gummies 3 jan 2021. Treatment medication included hydrocortisone cream, Sarna lotion/ Camphor 0.5 %, Menthol 0.5% .   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient demographic details, second dose information, event start and stop date, outcome of event, concomitant medication were updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.