chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell count, SARS-CoV-2 test, Splenomegaly
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), SPLENOMEGALY (spleen was enlarged), LYMPHADENOPATHY (lymph nodes are swollen) and PYREXIA (ran low grade fever, 103.5 was the highest, fever ranges from 101.8 to 103.5) 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 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and LYMPHADENOPATHY (lymph nodes are swollen). On 10-Aug-2021, the patient experienced PYREXIA (ran low grade fever, 103.5 was the highest, fever ranges from 101.8 to 103.5). On an unknown date, the patient experienced SPLENOMEGALY (spleen was enlarged). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), SPLENOMEGALY (spleen was enlarged), LYMPHADENOPATHY (lymph nodes are swollen) and PYREXIA (ran low grade fever, 103.5 was the highest, fever ranges from 101.8 to 103.5) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, Body temperature: 103.5 (High) Ranges from 101.8 to 103.5. On 10-Aug-2021, Liver function test: elevated (High) Elevated. On 10-Aug-2021, Mononucleosis heterophile test: positive (Positive) positive. On 10-Aug-2021, Red blood cell count: low (Low) Down a little bit. On 10-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Body temperature: 101.8 (High) 101.8. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Mono test was done which came back as positive and immune system was down. No Concomitant medication information was reported. The patient started to run a low grad e fever, mother said she also had the same low grade, fever got the fever and had the fever since, 10-Aug-2021.The fever ranges from 101.8 to 103.5. The patient took Tylenol for treatment. The patient had a stiff neck and her lymph nodes was swollen, that started around 09-AUG-2021 and was scheduled for the second on 31-AUG-2021. The red blood count was down a little bit. Three Covid tests within a week and all were negative. This case was linked to MOD-2021-293008. Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up received on 20-AUG-2021 include reporter details, patient Lab details, treatment medications updated.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Muscle spasms
Clinical narrative: Having flu like symptoms; Mild muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Having flu like symptoms) and MUSCLE SPASMS (Mild muscle spasms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Having flu like symptoms) and MUSCLE SPASMS (Mild muscle spasms). At the time of the report, INFLUENZA LIKE ILLNESS (Having flu like symptoms) and MUSCLE SPASMS (Mild muscle spasms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. It was reported that the patient got the vaccine on Tuesday and was still having side effects. No treatment information provided.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Accidentally gave a patient a dose of 1ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Accidentally gave a patient a dose of 1ml instead of 0.5 ml) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Accidentally gave a patient a dose of 1ml instead of 0.5 ml). At the time of the report, ACCIDENTAL OVERDOSE (Accidentally gave a patient a dose of 1ml instead of 0.5 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Product dose omission issue, SARS-CoV-2 antibody test, Tachycardia
Clinical narrative: Breathing problems/she still has breathing problems; She still has tachycardia; She didn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing problems/she still has breathing problems), TACHYCARDIA (She still has tachycardia) and PRODUCT DOSE OMISSION ISSUE (She didn't receive the 2nd dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (LUTERA) for an unknown indication.    On 30-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 DYSPNOEA (Breathing problems/she still has breathing problems), TACHYCARDIA (She still has tachycardia) and PRODUCT DOSE OMISSION ISSUE (She didn't receive the 2nd dose). At the time of the report, DYSPNOEA (Breathing problems/she still has breathing problems) and TACHYCARDIA (She still has tachycardia) had not resolved and PRODUCT DOSE OMISSION ISSUE (She didn't receive the 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 antibody test: positive (Positive) tested positive twice for Covid-19. On an unknown date, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: First shot in April do I need to start the process again; Just getting over having COVID; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First shot in April do I need to start the process again) and COVID-19 (Just getting over having COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First shot in April do I need to start the process again) and COVID-19 (Just getting over having COVID). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First shot in April do I need to start the process again) outcome was unknown and COVID-19 (Just getting over having COVID) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported.   Reporter did not allow further contact
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Rash erythematous, Rash pruritic
Clinical narrative: Shortness of breath when he was sleeping; Red rash on back of his legs (left and right)/Red rash on left hands; Red rash on his stomach that was very itchy//Rash also started to develop on the back of his legs (both left and right) and left hands which was very itchy also; Red rash on stomach; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath when he was sleeping), RASH ERYTHEMATOUS (Red rash on stomach), RASH ERYTHEMATOUS (Red rash on back of his legs (left and right)/Red rash on left hands) and RASH PRURITIC (Red rash on his stomach that was very itchy//Rash also started to develop on the back of his legs (both left and right) and left hands which was very itchy also) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Food allergy to yellow peppers).    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on stomach). 04-Aug-2021, the patient experienced RASH PRURITIC (Red rash on his stomach that was very itchy//Rash also started to develop on the back of his legs (both left and right) and left hands which was very itchy also). On 11-Aug-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on back of his legs (left and right)/Red rash on left hands). On 18-Aug-2021, the patient experienced DYSPNOEA (Shortness of breath when he was sleeping). On 20-Aug-2021, RASH ERYTHEMATOUS (Red rash on stomach), RASH ERYTHEMATOUS (Red rash on back of his legs (left and right)/Red rash on left hands) and RASH PRURITIC (Red rash on his stomach that was very itchy//Rash also started to develop on the back of his legs (both left and right) and left hands which was very itchy also) had resolved. At the time of the report, DYSPNOEA (Shortness of breath when he was sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Heart rate: increased High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Nausea, Photophobia
Clinical narrative: My head feels like weird; It feels light my eyes are sensitive to the sun; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (My head feels like weird), PHOTOPHOBIA (It feels light my eyes are sensitive to the sun) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (My head feels like weird), PHOTOPHOBIA (It feels light my eyes are sensitive to the sun) and NAUSEA (Nausea). At the time of the report, HEAD DISCOMFORT (My head feels like weird), PHOTOPHOBIA (It feels light my eyes are sensitive to the sun) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not provided by the reporter.  Patient was not sure but received the first shot about a week ago.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Feeling abnormal, Headache, Influenza
Clinical narrative: Like  I had the flu; Like I was hit by a brick; Terrible headache; Muscular aches and pains; Chills; After receiving the 3rd dose of the vaccine; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA (Like  I had the flu), FEELING ABNORMAL (Like I was hit by a brick), HEADACHE (Terrible headache), MYALGIA (Muscular aches and pains) and CHILLS (Chills) in a 69-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 information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (After receiving the 3rd dose of the vaccine). On 15-Aug-2021, the patient experienced INFLUENZA (Like  I had the flu), FEELING ABNORMAL (Like I was hit by a brick), HEADACHE (Terrible headache), MYALGIA (Muscular aches and pains) and CHILLS (Chills). On 14-Aug-2021, EXTRA DOSE ADMINISTERED (After receiving the 3rd dose of the vaccine) had resolved. On 16-Aug-2021, INFLUENZA (Like  I had the flu), FEELING ABNORMAL (Like I was hit by a brick), HEADACHE (Terrible headache), MYALGIA (Muscular aches and pains) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided.  Patient was not taken any treatment medication.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Like  I had the flu; Like I was hit by a brick; Terrible headache; Muscular aches and pains; Chills; After receiving the 3rd dose of the vaccine; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA (Like  I had the flu), FEELING ABNORMAL (Like I was hit by a brick), HEADACHE (Terrible headache), MYALGIA (Muscular aches and pains) and CHILLS (Chills) in a 69-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 information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (After receiving the 3rd dose of the vaccine). On 15-Aug-2021, the patient experienced INFLUENZA (Like  I had the flu), FEELING ABNORMAL (Like I was hit by a brick), HEADACHE (Terrible headache), MYALGIA (Muscular aches and pains) and CHILLS (Chills). On 14-Aug-2021, EXTRA DOSE ADMINISTERED (After receiving the 3rd dose of the vaccine) had resolved. On 16-Aug-2021, INFLUENZA (Like  I had the flu), FEELING ABNORMAL (Like I was hit by a brick), HEADACHE (Terrible headache), MYALGIA (Muscular aches and pains) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided.  Patient was not taken any treatment medication.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after just just getting the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after just just getting the second shot). At the time of the report, HEADACHE (Headache after just just getting the second shot) outcome was unknown.            No concomitant medication information was provided by the reporter.   No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had experienced many side effects following first dose of moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had experienced many side effects following first dose of moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Had experienced many side effects following first dose of moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was reported. No concomitant medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: an expired dose of the vaccine was administered; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired dose of the vaccine was administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (an expired dose of the vaccine was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (an expired dose of the vaccine was administered) had resolved.            Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Product dose omission issue
Clinical narrative: More than 36 days after the first dose without receiving the second dose.; Had covid; got sick; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.), COVID-19 (Had covid) and ILLNESS (got sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 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 PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.), COVID-19 (Had covid) and ILLNESS (got sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.) had resolved and COVID-19 (Had covid) and ILLNESS (got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment included a monoclonal antibodies infusion (Regeneron).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Headache, Nausea
Clinical narrative: had all of the side effects after the 3rd dose; upset stomach; headache; Fever; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had all of the side effects after the 3rd dose), ABDOMINAL DISCOMFORT (upset stomach), HEADACHE (headache), PYREXIA (Fever) and NAUSEA (nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021 at 9:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION COMPLICATION (had all of the side effects after the 3rd dose), ABDOMINAL DISCOMFORT (upset stomach), HEADACHE (headache), PYREXIA (Fever), NAUSEA (nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Fever, at a dose of 1 dosage form. On 19-Aug-2021, CHILLS (chills) had resolved. At the time of the report, VACCINATION COMPLICATION (had all of the side effects after the 3rd dose), ABDOMINAL DISCOMFORT (upset stomach), HEADACHE (headache), PYREXIA (Fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Body temperature: 99 (High) Fever was 99 to 99.7 degrees F. On 19-Aug-2021, Body temperature: 101.2 (High) Fever went up to 101.2 degrees F.         Concomitant product use was not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: had all of the side effects after the 3rd dose; upset stomach; headache; Fever; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had all of the side effects after the 3rd dose), ABDOMINAL DISCOMFORT (upset stomach), HEADACHE (headache), PYREXIA (Fever) and NAUSEA (nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021 at 9:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION COMPLICATION (had all of the side effects after the 3rd dose), ABDOMINAL DISCOMFORT (upset stomach), HEADACHE (headache), PYREXIA (Fever), NAUSEA (nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Fever, at a dose of 1 dosage form. On 19-Aug-2021, CHILLS (chills) had resolved. At the time of the report, VACCINATION COMPLICATION (had all of the side effects after the 3rd dose), ABDOMINAL DISCOMFORT (upset stomach), HEADACHE (headache), PYREXIA (Fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Body temperature: 99 (High) Fever was 99 to 99.7 degrees F. On 19-Aug-2021, Body temperature: 101.2 (High) Fever went up to 101.2 degrees F.         Concomitant product use was not provided by the reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: little bit of headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (little bit of headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Injury (due to which he ended up gaining weight). Concurrent medical conditions included Blood pressure high. Concomitant products included TAMSULOSIN and PRAVASTATIN for an unknown indication.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2020, the patient experienced HEADACHE (little bit of headache). On 21-Dec-2020, HEADACHE (little bit of headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product includes Water pill and blood pressure medications.  Treatment information was not provided.  Patient had mild headache which got better by closing his eyes. When he was in his 50s he had some injuries due to which he ended up gaining weight and became 250 lbs. Patient took second dose on the right dominant arm on 21-JAN-2021.   This case was linked to MOD-2021-292993 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: was sleepy for a couple days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (was sleepy for a couple days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (was sleepy for a couple days). At the time of the report, SOMNOLENCE (was sleepy for a couple days) had resolved.            Patient got the second shot on 15-FEB-2021 and the patient is awaiting for the third dose.  Concomitant medication not provided by reporter.  Treatment information not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: little red dots in my thighs; they are kind of itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (little red dots in my thighs) and PRURITUS (they are kind of itchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (little red dots in my thighs) and PRURITUS (they are kind of itchy). At the time of the report, ERYTHEMA (little red dots in my thighs) and PRURITUS (they are kind of itchy) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant and has had both vaccines; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant and has had both vaccines) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant and has had both vaccines). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant and has had both vaccines) had resolved.            No concomitant medication was reported.  No treatment details were provided.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Illness, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), PAIN (hurt everywhere/Pain), COUGH (coughing), PYREXIA (fever) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939202) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by reporter.  Concomitant products included GLIPIZIDE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ), PANTOPRAZOLE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely sick), PAIN (hurt everywhere/Pain), COUGH (coughing), PYREXIA (fever), CHILLS (chills) and HEADACHE (very bad headache). At the time of the report, ILLNESS (Extremely sick), PAIN (hurt everywhere/Pain), COUGH (coughing), PYREXIA (fever), CHILLS (chills) and HEADACHE (very bad headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided by reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), PAIN (hurt everywhere/Pain), COUGH (coughing), PYREXIA (fever) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939202) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by reporter.  Concomitant products included GLIPIZIDE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ), PANTOPRAZOLE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely sick), PAIN (hurt everywhere/Pain), COUGH (coughing), PYREXIA (fever), CHILLS (chills) and HEADACHE (very bad headache). At the time of the report, ILLNESS (Extremely sick), PAIN (hurt everywhere/Pain), COUGH (coughing), PYREXIA (fever), CHILLS (chills) and HEADACHE (very bad headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lumpy Knot at injection site on my arm that hurts) and VACCINATION SITE PAIN (lumpy Knot at injection site on my arm that hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (lumpy Knot at injection site on my arm that hurts) and VACCINATION SITE PAIN (lumpy Knot at injection site on my arm that hurts). At the time of the report, VACCINATION SITE MASS (lumpy Knot at injection site on my arm that hurts) and VACCINATION SITE PAIN (lumpy Knot at injection site on my arm that hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information was not reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Myalgia, Weight decreased
Clinical narrative: dizziness; losing weight when I was not trying to; little soreness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), WEIGHT DECREASED (losing weight when I was not trying to) and MYALGIA (little soreness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included PRAVASTATIN for Cholesterol, TAMSULOSIN for an unknown indication.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (little soreness). In July 2021, the patient experienced DIZZINESS (dizziness) and WEIGHT DECREASED (losing weight when I was not trying to). On 21-Jan-2021, MYALGIA (little soreness) had resolved. At the time of the report, DIZZINESS (dizziness) and WEIGHT DECREASED (losing weight when I was not trying to) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 106 (Low) systolic pressure-106- low, 95/48 (Low) 95/48- low and 127/70 (Low) 127/70-low. On an unknown date, Weight decreased: 200 (Low) 200 lbs -  weight decreased.         Relevant concomitant medications were also included water pill and  blood pressure medications.  It was reported that when patient  was put on blood pressure medication, he was physically fit with 175 lbs , and when he was in his 50s he had some injuries due to which he ended up gaining weight and became 250 lbs.  Patient  took his blood pressure medicine when he experienced dizziness for the second time and the blood pressure dropped to 95/48. He stopped his blood pressure medication when the blood pressure started dropping and he had been off his medication for 11-12 days .  The treatment information was  not provided.   This case was linked to MOD-2021-292974.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Influenza like illness, Myalgia
Clinical narrative: Stomach started hurting really bad; Feel flu like; Bodyaches; I have a really bad headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach started hurting really bad), INFLUENZA LIKE ILLNESS (Feel flu like), MYALGIA (Bodyaches) and HEADACHE (I have a really bad headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach started hurting really bad), INFLUENZA LIKE ILLNESS (Feel flu like), MYALGIA (Bodyaches) and HEADACHE (I have a really bad headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach started hurting really bad), INFLUENZA LIKE ILLNESS (Feel flu like), MYALGIA (Bodyaches) and HEADACHE (I have a really bad headache) outcome was unknown.            No Concomitant Medications were provided. No Treatment Medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Patient is experiencing deep pain in torso after receiving moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Patient is experiencing deep pain in torso after receiving moderna vaccine.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Patient is experiencing deep pain in torso after receiving moderna vaccine.). At the time of the report, PAIN (Patient is experiencing deep pain in torso after receiving moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Massaged his hands all night), FATIGUE (Fatigue), ARTHRALGIA (Severe pain in every joint of his body from the top of his head to his toes except his spinal, Ankes hurt, Hips hurt, Toes hurt), HEADACHE (Headache) and CHILLS (Chills) in a 63-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 information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (Massaged his hands all night), FATIGUE (Fatigue), ARTHRALGIA (Severe pain in every joint of his body from the top of his head to his toes except his spinal, Ankes hurt, Hips hurt, Toes hurt), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle pain), VACCINATION SITE PAIN (Site tenderness/ injection site hurt) and OFF LABEL USE (off label use). At the time of the report, PAIN IN EXTREMITY (Massaged his hands all night), FATIGUE (Fatigue), ARTHRALGIA (Severe pain in every joint of his body from the top of his head to his toes except his spinal, Ankes hurt, Hips hurt, Toes hurt), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle pain), VACCINATION SITE PAIN (Site tenderness/ injection site hurt) and OFF LABEL USE (off label use) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Massaged his hands all night), FATIGUE (Fatigue), ARTHRALGIA (Severe pain in every joint of his body from the top of his head to his toes except his spinal, Ankes hurt, Hips hurt, Toes hurt), HEADACHE (Headache) and CHILLS (Chills) in a 63-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 information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (Massaged his hands all night), FATIGUE (Fatigue), ARTHRALGIA (Severe pain in every joint of his body from the top of his head to his toes except his spinal, Ankes hurt, Hips hurt, Toes hurt), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle pain), VACCINATION SITE PAIN (Site tenderness/ injection site hurt) and OFF LABEL USE (off label use). At the time of the report, PAIN IN EXTREMITY (Massaged his hands all night), FATIGUE (Fatigue), ARTHRALGIA (Severe pain in every joint of his body from the top of his head to his toes except his spinal, Ankes hurt, Hips hurt, Toes hurt), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle pain), VACCINATION SITE PAIN (Site tenderness/ injection site hurt) and OFF LABEL USE (off label use) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache; Bodyaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (Bodyaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and MYALGIA (Bodyaches). At the time of the report, HEADACHE (Headache) and MYALGIA (Bodyaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Same low grade fever, had fever for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Same low grade fever, had fever for a couple of days) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Same low grade fever, had fever for a couple of days). At the time of the report, PYREXIA (Same low grade fever, had fever for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was provided.  No treatment medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Included reporter details, narrative details
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Nurse received the Moderna vaccine after receiving the Johnson and Johnson vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Nurse received the Moderna vaccine after receiving the Johnson and Johnson vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa).    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Nurse received the Moderna vaccine after receiving the Johnson and Johnson vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Nurse received the Moderna vaccine after receiving the Johnson and Johnson vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment details reported.  Patient received the dose of the Johnson and Johnson vaccine on 07JUL2021 (Historical vaccine).   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: additional information received updated patient details, relevant history, product information
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: My arm is very sore since the injection, can barely life it above my head; Soreness in her arm and it has not gone away it is very painful.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is very sore since the injection, can barely life it above my head) and PAIN IN EXTREMITY (Soreness in her arm and it has not gone away it is very painful.) 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 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is very sore since the injection, can barely life it above my head) and PAIN IN EXTREMITY (Soreness in her arm and it has not gone away it is very painful.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is very sore since the injection, can barely life it above my head) outcome was unknown and PAIN IN EXTREMITY (Soreness in her arm and it has not gone away it is very painful.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication  was provided.  Treatment information was not provided.  The patient reported that while receiving the vaccine the health care provider administering it asked if had anything in shoulder like plastic or rubber as it was very difficult for them to inject the vaccine into arm and the patient had had soreness in arm and it has not gone away it was very painful. The patient's arm was still hurting.   Reporter did not allow further contact
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle ache.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache.) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (muscle ache.). At the time of the report, MYALGIA (muscle ache.) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.