chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Headache, Influenza, Muscular weakness
Clinical narrative: Felt like a funny flu; Both arms felt sore; Whole upper body felt weak; Loss of appetite; Funny feeling in her stomach; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt like a funny flu), PAIN IN EXTREMITY (Both arms felt sore), MUSCULAR WEAKNESS (Whole upper body felt weak), DECREASED APPETITE (Loss of appetite) and ABDOMINAL DISCOMFORT (Funny feeling in her stomach) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa) and Penicillin allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced INFLUENZA (Felt like a funny flu), PAIN IN EXTREMITY (Both arms felt sore), MUSCULAR WEAKNESS (Whole upper body felt weak), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Funny feeling in her stomach) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA (Felt like a funny flu), PAIN IN EXTREMITY (Both arms felt sore), MUSCULAR WEAKNESS (Whole upper body felt weak), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Funny feeling in her stomach) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up included no new information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Felt like a funny flu; Both arms felt sore; Whole upper body felt weak; Loss of appetite; Funny feeling in her stomach; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt like a funny flu), PAIN IN EXTREMITY (Both arms felt sore), MUSCULAR WEAKNESS (Whole upper body felt weak), DECREASED APPETITE (Loss of appetite) and ABDOMINAL DISCOMFORT (Funny feeling in her stomach) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa) and Penicillin allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced INFLUENZA (Felt like a funny flu), PAIN IN EXTREMITY (Both arms felt sore), MUSCULAR WEAKNESS (Whole upper body felt weak), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Funny feeling in her stomach) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA (Felt like a funny flu), PAIN IN EXTREMITY (Both arms felt sore), MUSCULAR WEAKNESS (Whole upper body felt weak), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Funny feeling in her stomach) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up included no new information.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vaccination site pain
Clinical narrative: Pain at injection site; Body ache; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Body ache), HEADACHE (Headache) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Body ache), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Body ache), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: site of injection developed red mark; pain on site of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (site of injection developed red mark) and VACCINATION SITE PAIN (pain on site of injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 VACCINATION SITE ERYTHEMA (site of injection developed red mark) and VACCINATION SITE PAIN (pain on site of injection). At the time of the report, VACCINATION SITE ERYTHEMA (site of injection developed red mark) and VACCINATION SITE PAIN (pain on site of injection) outcome was unknown. Not Provided      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: Fall, Joint injury
Clinical narrative: fell and hurt knee; fell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT INJURY (fell and hurt knee) and FALL (fell) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced JOINT INJURY (fell and hurt knee) and FALL (fell). At the time of the report, JOINT INJURY (fell and hurt knee) and FALL (fell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. the patient was suggested to take Tylenol on 23-feb-2021.    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: NNI
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Hardly keep her eyes open, drowsey; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Hardly keep her eyes open, drowsey) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SOMNOLENCE (Hardly keep her eyes open, drowsey). On 28-Feb-2021, SOMNOLENCE (Hardly keep her eyes open, drowsey) 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 use was not reported.   Treatment information was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Fatigue, Insomnia, Malaise
Clinical narrative: pain from the head to the breast to the legs/The pain went to the glands/sore; Feel aweful; she couldn't sleep; Very bad chills; a fever; felt very tired; Her arm is still very swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain from the head to the breast to the legs/The pain went to the glands/sore), MALAISE (Feel aweful), INSOMNIA (she couldn't sleep), CHILLS (Very bad chills) and PYREXIA (a fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lumpectomy (years ago). Concurrent medical conditions included Blood pressure, Dyslipidemia, Thyroid disorder and Vertigo (had vertigo prior to vaccination). Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (pain from the head to the breast to the legs/The pain went to the glands/sore), MALAISE (Feel aweful), INSOMNIA (she couldn't sleep), CHILLS (Very bad chills), PYREXIA (a fever), FATIGUE (felt very tired) and VACCINATION SITE SWELLING (Her arm is still very swollen). At the time of the report, PAIN (pain from the head to the breast to the legs/The pain went to the glands/sore), MALAISE (Feel aweful), INSOMNIA (she couldn't sleep), CHILLS (Very bad chills), PYREXIA (a fever), FATIGUE (felt very tired) and VACCINATION SITE SWELLING (Her arm is still very swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 168 (High) Blood pressure elevated 165 which is normally 138.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Patient was also reported to take medications for blood pressure and cholesterol along with levothyroxine as concomitant medications. No treatment medications were reported.   This case was linked to MOD21-040820 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up was received on 29-APR-2021. Vertigo in patient's medical history was updated to current condition. Action taken was updated to withdrawn.; Sender's Comments:  MOD21-040820:same reporter
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site swelling
Clinical narrative: pain from the head to the breast to the legs/The pain went to the glands/sore; Feel aweful; she couldn't sleep; Very bad chills; a fever; felt very tired; Her arm is still very swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain from the head to the breast to the legs/The pain went to the glands/sore), MALAISE (Feel aweful), INSOMNIA (she couldn't sleep), CHILLS (Very bad chills) and PYREXIA (a fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lumpectomy (years ago). Concurrent medical conditions included Blood pressure, Dyslipidemia, Thyroid disorder and Vertigo (had vertigo prior to vaccination). Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (pain from the head to the breast to the legs/The pain went to the glands/sore), MALAISE (Feel aweful), INSOMNIA (she couldn't sleep), CHILLS (Very bad chills), PYREXIA (a fever), FATIGUE (felt very tired) and VACCINATION SITE SWELLING (Her arm is still very swollen). At the time of the report, PAIN (pain from the head to the breast to the legs/The pain went to the glands/sore), MALAISE (Feel aweful), INSOMNIA (she couldn't sleep), CHILLS (Very bad chills), PYREXIA (a fever), FATIGUE (felt very tired) and VACCINATION SITE SWELLING (Her arm is still very swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 168 (High) Blood pressure elevated 165 which is normally 138.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Patient was also reported to take medications for blood pressure and cholesterol along with levothyroxine as concomitant medications. No treatment medications were reported.   This case was linked to MOD21-040820 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up was received on 29-APR-2021. Vertigo in patient's medical history was updated to current condition. Action taken was updated to withdrawn.; Sender's Comments:  MOD21-040820:same reporter
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Red blotches; rash; itching head, back, torso,a rm and thighs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching head, back, torso,a rm and thighs), RASH MACULAR (Red blotches) and RASH (rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included RISEDRONATE SODIUM for Osteoporosis.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (itching head, back, torso,a rm and thighs). On an unknown date, the patient experienced RASH MACULAR (Red blotches) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching head, back, torso,a rm and thighs), RASH MACULAR (Red blotches) and RASH (rash) 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 products included vitamins and calcium.
Sex: M
Vaccine: COVID19
Symptoms: Yellow skin
Clinical narrative: Skin yellowing or being pale; This spontaneous case was reported by a consumer and describes the occurrence of YELLOW SKIN (Skin yellowing or being pale) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced YELLOW SKIN (Skin yellowing or being pale). At the time of the report, YELLOW SKIN (Skin yellowing or being pale) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: arm where the vaccine was administered wa warm; area felt hard; the area was red oval-shaped; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm where the vaccine was administered wa warm), VACCINATION SITE INDURATION (area felt hard) and VACCINATION SITE ERYTHEMA (the area was red oval-shaped) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm where the vaccine was administered wa warm), VACCINATION SITE INDURATION (area felt hard) and VACCINATION SITE ERYTHEMA (the area was red oval-shaped). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm where the vaccine was administered wa warm), VACCINATION SITE INDURATION (area felt hard) and VACCINATION SITE ERYTHEMA (the area was red oval-shaped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Pink injection site; COVID arm 8 days after first shot; Soreness at the injection site; Swollen injection site; A spontaneous report was received from a consumer concerning a 71 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  covid arm 8 days after first shot, pink injection site with a pink line running out of it and going down to the arm pit, soreness at the injection site, swollen injection site.  The patient's medical history was not provided. Concomitant medications reported were Rapaflo, Lovastatin, Gabapentin  drug used for unknown indication.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:  Batch number not provided) for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch:  Batch number not provided) in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, COVID arm 8 days after first shot. Pink injection site with a pink line running out of it and going down to the arm pit. On 10 Feb 2021, the patient experienced the  soreness at the injection site and  swollen injection site.  No treatment information was provided.    No relevant laboratory details were included  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, covid arm was unknown.The outcome of event, pink injection site with a pink line running out of it and going down to the arm pit was unknown.The outcome of events, soreness at the injection site and swollen injection site was unknown.; Reporter'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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: arm pain; fatigue more than normal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain) and FATIGUE (fatigue more than normal) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm pain) and FATIGUE (fatigue more than normal). At the time of the report, VACCINATION SITE PAIN (arm pain) and FATIGUE (fatigue more than normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations for about 2-3; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations for about 2-3) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included ATORVASTATIN, EZETIMIBE (ZETIA), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and MAGNESIUM CITRATE (MAGNESIUM DIASPORAL 300) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PALPITATIONS (Heart palpitations for about 2-3). At the time of the report, PALPITATIONS (Heart palpitations for about 2-3) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Excruciating pain in left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Excruciating pain in left shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Excruciating pain in left shoulder). At the time of the report, ARTHRALGIA (Excruciating pain in left shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Chills, Fatigue, Muscular weakness, Pain in extremity
Clinical narrative: Rash down from the elbow to the fingers; slept all day; Fatigue; Fever; Severe chills; Allergic reaction; Severe pain in th e arm down to the elbow; Couldn't raise the arm; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Severe pain in th e arm down to the elbow), MUSCULAR WEAKNESS (Couldn't raise the arm), SOMNOLENCE (slept all day) and RASH (Rash down from the elbow to the fingers) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) 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 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Severe pain in th e arm down to the elbow), MUSCULAR WEAKNESS (Couldn't raise the arm), PYREXIA (Fever) and CHILLS (Severe chills). On 24-Feb-2021, the patient experienced SOMNOLENCE (slept all day) and FATIGUE (Fatigue). On an unknown date, the patient experienced RASH (Rash down from the elbow to the fingers). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Severe pain in th e arm down to the elbow), MUSCULAR WEAKNESS (Couldn't raise the arm), SOMNOLENCE (slept all day), RASH (Rash down from the elbow to the fingers), PYREXIA (Fever), CHILLS (Severe chills) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications provided.  Follow-up received on 09-Jul-2021 included no new information.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received on 09-JUL-2021 contains non-significant information.Updated Reporter's information-Corrected Reporter's Name, Address, E-Mail.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Somnolence
Clinical narrative: Rash down from the elbow to the fingers; slept all day; Fatigue; Fever; Severe chills; Allergic reaction; Severe pain in th e arm down to the elbow; Couldn't raise the arm; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Severe pain in th e arm down to the elbow), MUSCULAR WEAKNESS (Couldn't raise the arm), SOMNOLENCE (slept all day) and RASH (Rash down from the elbow to the fingers) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) 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 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Severe pain in th e arm down to the elbow), MUSCULAR WEAKNESS (Couldn't raise the arm), PYREXIA (Fever) and CHILLS (Severe chills). On 24-Feb-2021, the patient experienced SOMNOLENCE (slept all day) and FATIGUE (Fatigue). On an unknown date, the patient experienced RASH (Rash down from the elbow to the fingers). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Severe pain in th e arm down to the elbow), MUSCULAR WEAKNESS (Couldn't raise the arm), SOMNOLENCE (slept all day), RASH (Rash down from the elbow to the fingers), PYREXIA (Fever), CHILLS (Severe chills) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications provided.  Follow-up received on 09-Jul-2021 included no new information.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received on 09-JUL-2021 contains non-significant information.Updated Reporter's information-Corrected Reporter's Name, Address, E-Mail.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Palpitations
Clinical narrative: rapid heartbeats; blood pressure droped; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heartbeats) and HYPOTENSION (blood pressure droped) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 PALPITATIONS (rapid heartbeats) and HYPOTENSION (blood pressure droped). At the time of the report, PALPITATIONS (rapid heartbeats) and HYPOTENSION (blood pressure droped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment drugs included aloquit and tropomin
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling in upper shoulder; Very sore arm; Redness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in upper shoulder), PAIN (Very sore arm) and ERYTHEMA (Redness) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SWELLING (Swelling in upper shoulder), PAIN (Very sore arm) and ERYTHEMA (Redness). At the time of the report, SWELLING (Swelling in upper shoulder), PAIN (Very sore arm) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment information was provided. Patient had the shingles vaccine a month ago.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema
Clinical narrative: Dry like it burned; Red over left eyebrow/Red over right eyebrow/Red on right side of nose; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red over left eyebrow/Red over right eyebrow/Red on right side of nose) and DRY SKIN (Dry like it burned) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20a) for COVID-19 vaccination.     Concomitant products included GABAPENTIN (NEUROTIN [GABAPENTIN]) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced ERYTHEMA (Red over left eyebrow/Red over right eyebrow/Red on right side of nose). On 16-Feb-2021, the patient experienced DRY SKIN (Dry like it burned). At the time of the report, ERYTHEMA (Red over left eyebrow/Red over right eyebrow/Red on right side of nose) and DRY SKIN (Dry like it burned) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included cholesterol medications. Treatment information was not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: she developed an incredible itchy (injection site, L arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (she developed an incredible itchy (injection site, L arm)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (she developed an incredible itchy (injection site, L arm)). At the time of the report, VACCINATION SITE PRURITUS (she developed an incredible itchy (injection site, L arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant : Type 2 diabetes  Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: Bad diarrhea; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Bad diarrhea), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced NAUSEA (Nausea). On 26-Feb-2021, the patient experienced DIARRHOEA (Bad diarrhea), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Bad diarrhea), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient on BP medication and Aspirin
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red hot very itchy spot; Red hot very itchy spot; Woke up to a large swelling on same left arm about area 3X2 inches, red hot very itchy spot; Red hot very itchy spot; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Red hot very itchy spot), VACCINATION SITE PRURITUS (Red hot very itchy spot), VACCINATION SITE SWELLING (Woke up to a large swelling on same left arm about area 3X2 inches, red hot very itchy spot) and VACCINATION SITE ERYTHEMA (Red hot very itchy spot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (usually from skin product like makeup products or sunscreen). Concomitant products included VITAMINS NOS and BIMATOPROST (LUMIGAN) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Red hot very itchy spot), VACCINATION SITE PRURITUS (Red hot very itchy spot), VACCINATION SITE SWELLING (Woke up to a large swelling on same left arm about area 3X2 inches, red hot very itchy spot) and VACCINATION SITE ERYTHEMA (Red hot very itchy spot). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Antibiotic therapy, at an unspecified dose and frequency and TRIAMCINOLONE for Rash, at an unspecified dose and frequency. On 11-Feb-2021, VACCINATION SITE WARMTH (Red hot very itchy spot) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Red hot very itchy spot) and VACCINATION SITE SWELLING (Woke up to a large swelling on same left arm about area 3X2 inches, red hot very itchy spot) had not resolved and VACCINATION SITE ERYTHEMA (Red hot very itchy spot) 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 60-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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The patient's medical history was not provided. Concomitant medications were not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Symptom recurrence, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: received a shingles vaccine one week before getting the Moderna vaccine; arm was red, swollen, and hot to the touch; Two weeks later, her side effects returned; red splotchy area on her arm; arm was red, swollen, and hot to the touch; pain in arm / pain in extremity; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a shingles vaccine one week before getting the Moderna vaccine), VACCINATION SITE WARMTH (arm was red, swollen, and hot to the touch), SYMPTOM RECURRENCE (Two weeks later, her side effects returned), VACCINATION SITE PAIN (pain in arm / pain in extremity) and VACCINATION SITE ERYTHEMA (red splotchy area on her arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.). Previously administered products included for an unreported indication: Vaccine for shingles (Vaccine for shingles) on 10-Feb-2021.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in arm / pain in extremity). On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a shingles vaccine one week before getting the Moderna vaccine), VACCINATION SITE WARMTH (arm was red, swollen, and hot to the touch), SYMPTOM RECURRENCE (Two weeks later, her side effects returned), VACCINATION SITE ERYTHEMA (red splotchy area on her arm) and VACCINATION SITE SWELLING (arm was red, swollen, and hot to the touch). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a shingles vaccine one week before getting the Moderna vaccine), VACCINATION SITE WARMTH (arm was red, swollen, and hot to the touch), SYMPTOM RECURRENCE (Two weeks later, her side effects returned), VACCINATION SITE PAIN (pain in arm / pain in extremity), VACCINATION SITE ERYTHEMA (red splotchy area on her arm) and VACCINATION SITE SWELLING (arm was red, swollen, and hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.  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.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: received a shingles vaccine one week before getting the Moderna vaccine; arm was red, swollen, and hot to the touch; Two weeks later, her side effects returned; red splotchy area on her arm; arm was red, swollen, and hot to the touch; pain in arm / pain in extremity; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a shingles vaccine one week before getting the Moderna vaccine), VACCINATION SITE WARMTH (arm was red, swollen, and hot to the touch), SYMPTOM RECURRENCE (Two weeks later, her side effects returned), VACCINATION SITE PAIN (pain in arm / pain in extremity) and VACCINATION SITE ERYTHEMA (red splotchy area on her arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.). Previously administered products included for an unreported indication: Vaccine for shingles (Vaccine for shingles) on 10-Feb-2021.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in arm / pain in extremity). On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a shingles vaccine one week before getting the Moderna vaccine), VACCINATION SITE WARMTH (arm was red, swollen, and hot to the touch), SYMPTOM RECURRENCE (Two weeks later, her side effects returned), VACCINATION SITE ERYTHEMA (red splotchy area on her arm) and VACCINATION SITE SWELLING (arm was red, swollen, and hot to the touch). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a shingles vaccine one week before getting the Moderna vaccine), VACCINATION SITE WARMTH (arm was red, swollen, and hot to the touch), SYMPTOM RECURRENCE (Two weeks later, her side effects returned), VACCINATION SITE PAIN (pain in arm / pain in extremity), VACCINATION SITE ERYTHEMA (red splotchy area on her arm) and VACCINATION SITE SWELLING (arm was red, swollen, and hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.  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.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck mass
Clinical narrative: lump on neck and clavicle; Swollen lymph nodes on left side, neck and clavicle; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (lump on neck and clavicle) and LYMPHADENOPATHY (Swollen lymph nodes on left side, neck and clavicle) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney stones since 2019. Concomitant products included VITAMIN D3, BIOTIN from 01-Jan-2021 to an unknown date and MULTIVITAMIN [VITAMINS NOS] from 15-Feb-2021 to an unknown date for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on left side, neck and clavicle). On an unknown date, the patient experienced NECK MASS (lump on neck and clavicle). At the time of the report, NECK MASS (lump on neck and clavicle) and LYMPHADENOPATHY (Swollen lymph nodes on left side, neck and clavicle) 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.   Ultrasound  was performed left side of neck . Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Updated patient demographics, medical history, vaccine facility.Updated event neck mass. concomitant medications updated
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue
Clinical narrative: Discomfort from under left arm towards her left breast; Slight fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Discomfort from under left arm towards her left breast) and FATIGUE (Slight fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer. No concomitant medication reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (Slight fatigue). On 15-Feb-2021, the patient experienced AXILLARY PAIN (Discomfort from under left arm towards her left breast). At the time of the report, AXILLARY PAIN (Discomfort from under left arm towards her left breast) and FATIGUE (Slight fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Right arm is red below the injection site about the size of 2 quarters; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Right arm is red below the injection site about the size of 2 quarters) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Right arm is red below the injection site about the size of 2 quarters). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site erythema, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Right arm is red below the injection site about the size of 2 quarters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Haemoptysis, Pain
Clinical narrative: Body aches; Chest hurts when they cough; Coughing up a bloody phelgm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHEST PAIN (Chest hurts when they cough) and HAEMOPTYSIS (Coughing up a bloody phelgm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (Body aches), CHEST PAIN (Chest hurts when they cough) and HAEMOPTYSIS (Coughing up a bloody phelgm). At the time of the report, PAIN (Body aches), CHEST PAIN (Chest hurts when they cough) and HAEMOPTYSIS (Coughing up a bloody phelgm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.