chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Tremor, Vaccination complication
Clinical narrative: Cramps all over (mainly in leg and feet at night); Brain fog; Depression; Tremors; Memory loss; 24 to 36 hours after vaccination had a sever reaction; Chronic fatigue (after walks); Muscle pain (comes on at night or hour after walk); This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps all over (mainly in leg and feet at night)), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), TREMOR (Tremors) and AMNESIA (Memory loss) in a 72-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.     Concomitant products included LOTEPREDNOL ETABONATE (LOTREL [LOTEPREDNOL ETABONATE]), ROSUVASTATIN CALCIUM (CRESTOR) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 14-Feb-2001, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Cramps all over (mainly in leg and feet at night)), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), TREMOR (Tremors), AMNESIA (Memory loss), VACCINATION COMPLICATION (24 to 36 hours after vaccination had a sever reaction), FATIGUE (Chronic fatigue (after walks)) and MYALGIA (Muscle pain (comes on at night or hour after walk)). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Cramps all over (mainly in leg and feet at night)), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), TREMOR (Tremors), AMNESIA (Memory loss), FATIGUE (Chronic fatigue (after walks)) and MYALGIA (Muscle pain (comes on at night or hour after walk)) had not resolved and VACCINATION COMPLICATION (24 to 36 hours after vaccination had a sever reaction) had resolved.            This case was linked to MOD-2021-289860 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain, Product dose omission issue
Clinical narrative: Had achiness; Therefore did not get 2nd shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Had achiness) and PRODUCT DOSE OMISSION ISSUE (Therefore did not get 2nd shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 PAIN (Had achiness) and PRODUCT DOSE OMISSION ISSUE (Therefore did not get 2nd shot). At the time of the report, PAIN (Had achiness) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Therefore did not get 2nd shot) had resolved.      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.   No concomitant medication information was provided.  No treatment medication information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Lower-than-authorized dose volume administered; needle broke; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Lower-than-authorized dose volume administered) and DEVICE CONNECTION ISSUE (needle broke) in a 42-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 17-Aug-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 UNDERDOSE (Lower-than-authorized dose volume administered) and DEVICE CONNECTION ISSUE (needle broke). At the time of the report, UNDERDOSE (Lower-than-authorized dose volume administered) and DEVICE CONNECTION ISSUE (needle broke) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Age: 81.0
Sex: M
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 an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V deficiency. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN [METFORMIN HYDROCHLORIDE]), LOSARTAN, LEVOTHYROXINE, SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medications were not provided by reporter.   This case was linked to MOD-2021-290159 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: achy up until this morning; weak; slight temperature increase, from 96 degrees Fahrenheit normally to 99.2 degrees Fahrenheit; soreness in the arm; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy up until this morning), ASTHENIA (weak), PYREXIA (slight temperature increase, from 96 degrees Fahrenheit normally to 99.2 degrees Fahrenheit), MYALGIA (soreness in the arm) and HEADACHE (headaches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V deficiency (clotting factor deficiency). Concomitant products included METFORMIN, LOSARTAN, LEVOTHYROXINE, SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy up until this morning), ASTHENIA (weak), PYREXIA (slight temperature increase, from 96 degrees Fahrenheit normally to 99.2 degrees Fahrenheit) and HEADACHE (headaches). an unknown date, the patient experienced MYALGIA (soreness in the arm). At the time of the report, PAIN (achy up until this morning), ASTHENIA (weak), PYREXIA (slight temperature increase, from 96 degrees Fahrenheit normally to 99.2 degrees Fahrenheit), MYALGIA (soreness in the arm) and HEADACHE (headaches) outcome was unknown.            No treatment information was reported.  Patient received third dose on 16-AUG-2021, Lot #: 066D21A.   This case was linked to MOD-2021-290147 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nasal congestion, Product administered to patient of inappropriate age, Product dose omission issue, Pyrexia
Clinical narrative: 1st dose 30Apr2021; no 2nd dose; Sleeping the whole time; Congested; Trouble breathing; Low grade fever; 16 years old administered with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping the whole time), NASAL CONGESTION (Congested), DYSPNOEA (Trouble breathing), PYREXIA (Low grade fever) and PRODUCT DOSE OMISSION ISSUE (1st dose 30Apr2021; no 2nd dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21N) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old administered with the vaccine). On 01-May-2021, the patient experienced SOMNOLENCE (Sleeping the whole time), NASAL CONGESTION (Congested), DYSPNOEA (Trouble breathing) and PYREXIA (Low grade fever). On 17-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 30Apr2021; no 2nd dose). On 30-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old administered with the vaccine) had resolved. On 01-May-2021, SOMNOLENCE (Sleeping the whole time), NASAL CONGESTION (Congested), DYSPNOEA (Trouble breathing) and PYREXIA (Low grade fever) had resolved. On 17-Aug-2021, PRODUCT DOSE OMISSION ISSUE (1st dose 30Apr2021; no 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: 1st dose 30Apr2021; no 2nd dose; Sleeping the whole time; Congested; Trouble breathing; Low grade fever; 16 years old administered with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping the whole time), NASAL CONGESTION (Congested), DYSPNOEA (Trouble breathing), PYREXIA (Low grade fever) and PRODUCT DOSE OMISSION ISSUE (1st dose 30Apr2021; no 2nd dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21N) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old administered with the vaccine). On 01-May-2021, the patient experienced SOMNOLENCE (Sleeping the whole time), NASAL CONGESTION (Congested), DYSPNOEA (Trouble breathing) and PYREXIA (Low grade fever). On 17-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 30Apr2021; no 2nd dose). On 30-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old administered with the vaccine) had resolved. On 01-May-2021, SOMNOLENCE (Sleeping the whole time), NASAL CONGESTION (Congested), DYSPNOEA (Trouble breathing) and PYREXIA (Low grade fever) had resolved. On 17-Aug-2021, PRODUCT DOSE OMISSION ISSUE (1st dose 30Apr2021; no 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose > 35 days ago) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose > 35 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose > 35 days ago) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hypokinesia, Myalgia
Clinical narrative: Could hardly raise his arm; Injection area felt like he was hit with a hammer in the arm; Fatigue; Muscle pain; Nausea; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could hardly raise his arm), VACCINATION SITE PAIN (Injection area felt like he was hit with a hammer in the arm), FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Heart disorder.    On 17-Jun-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 HYPOKINESIA (Could hardly raise his arm), VACCINATION SITE PAIN (Injection area felt like he was hit with a hammer in the arm), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and CHILLS (Chills). At the time of the report, HYPOKINESIA (Could hardly raise his arm), VACCINATION SITE PAIN (Injection area felt like he was hit with a hammer in the arm), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient taking medicines for heart problem and high blood pressure No treatment information was reported by reporter   This case was linked to MOD-2021-290283 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Could hardly raise his arm; Injection area felt like he was hit with a hammer in the arm; Fatigue; Muscle pain; Nausea; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could hardly raise his arm), VACCINATION SITE PAIN (Injection area felt like he was hit with a hammer in the arm), FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Heart disorder.    On 17-Jun-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 HYPOKINESIA (Could hardly raise his arm), VACCINATION SITE PAIN (Injection area felt like he was hit with a hammer in the arm), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and CHILLS (Chills). At the time of the report, HYPOKINESIA (Could hardly raise his arm), VACCINATION SITE PAIN (Injection area felt like he was hit with a hammer in the arm), FATIGUE (Fatigue), MYALGIA (Muscle pain), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient taking medicines for heart problem and high blood pressure No treatment information was reported by reporter   This case was linked to MOD-2021-290283 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Nausea
Clinical narrative: First dose on 17June2021 ,second on 11July2021; Fatigue; Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17June2021 ,second on 11July2021), FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17June2021 ,second on 11July2021), FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (Nausea). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17June2021 ,second on 11July2021), FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (Nausea) had resolved.      Patient took medicines for heart and high blood pressure. No treatment medications were provided.   This case was linked to MOD-2021-290279 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Myalgia, Peripheral swelling, Vaccination site pain
Clinical narrative: swollen hands; sore left arm injection site; achiness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen hands), VACCINATION SITE PAIN (sore left arm injection site) and MYALGIA (achiness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Neutrophil count decreased.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left arm injection site) and MYALGIA (achiness). On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen hands). On 21-Jan-2021, VACCINATION SITE PAIN (sore left arm injection site) and MYALGIA (achiness) had resolved. On 25-Jan-2021, PERIPHERAL SWELLING (swollen hands) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Blood test: normal (normal) Blood work came normal for everything..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-290967 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days in between Moderna Covid-19 vaccinations.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Moderna Covid-19 vaccinations.) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Moderna Covid-19 vaccinations.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Moderna Covid-19 vaccinations.) had resolved.            No concomitant medications were provided by reporter. No treatment details were provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Little bit of diarrhea; Mild fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Little bit of diarrhea) and FATIGUE (Mild fatigue) 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 18-Aug-2021, the patient experienced DIARRHOEA (Little bit of diarrhea) and FATIGUE (Mild fatigue). At the time of the report, DIARRHOEA (Little bit of diarrhea) and FATIGUE (Mild fatigue) 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 medication reported .  No treatment medication reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got her first dose about 4 months ago and did not get the second dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got her first dose about 4 months ago and did not get the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got her first dose about 4 months ago and did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got her first dose about 4 months ago and did not get the second dose) 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 considered PRODUCT DOSE OMISSION ISSUE (got her first dose about 4 months ago and did not get the second dose) to be not applicable.    Treatment product information was not provided. Concomitant product use was not provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: significant follow-up appended, as reporter information added as HCP
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Gait disturbance, General physical health deterioration, Inflammation
Clinical narrative: really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life; her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life; it affected her joints and her knee were severely inflamed; could not walk down the stairs; The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life; spine hurt; she could not sit down or bend over; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), BACK PAIN (her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), ARTHRITIS (it affected her joints and her knee were severely inflamed), GAIT DISTURBANCE (could not walk down the stairs) and MOBILITY DECREASED (she could not sit down or bend over) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MOBILITY DECREASED (she could not sit down or bend over). On an unknown date, the patient experienced INFLAMMATION (really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), BACK PAIN (her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), ARTHRITIS (it affected her joints and her knee were severely inflamed), GAIT DISTURBANCE (could not walk down the stairs), GENERAL PHYSICAL HEALTH DETERIORATION (The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life) and SPINAL PAIN (spine hurt). In May 2021, MOBILITY DECREASED (she could not sit down or bend over) had resolved. At the time of the report, INFLAMMATION (really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), BACK PAIN (her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), ARTHRITIS (it affected her joints and her knee were severely inflamed), GAIT DISTURBANCE (could not walk down the stairs), GENERAL PHYSICAL HEALTH DETERIORATION (The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life) and SPINAL PAIN (spine hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Spinal pain
Clinical narrative: really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life; her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life; it affected her joints and her knee were severely inflamed; could not walk down the stairs; The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life; spine hurt; she could not sit down or bend over; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), BACK PAIN (her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), ARTHRITIS (it affected her joints and her knee were severely inflamed), GAIT DISTURBANCE (could not walk down the stairs) and MOBILITY DECREASED (she could not sit down or bend over) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MOBILITY DECREASED (she could not sit down or bend over). On an unknown date, the patient experienced INFLAMMATION (really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), BACK PAIN (her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), ARTHRITIS (it affected her joints and her knee were severely inflamed), GAIT DISTURBANCE (could not walk down the stairs), GENERAL PHYSICAL HEALTH DETERIORATION (The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life) and SPINAL PAIN (spine hurt). In May 2021, MOBILITY DECREASED (she could not sit down or bend over) had resolved. At the time of the report, INFLAMMATION (really severe inflammation in her lower body /  The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), BACK PAIN (her back hurt / The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life), ARTHRITIS (it affected her joints and her knee were severely inflamed), GAIT DISTURBANCE (could not walk down the stairs), GENERAL PHYSICAL HEALTH DETERIORATION (The inflammation at the base of her spine hurt so bad that she could not do her job and impacted her life) and SPINAL PAIN (spine hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 36.0
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 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral palsy, Bipolar disorder and Generalized anxiety disorder. Concomitant products included LITHIUM, LAMOTRIGINE (LAMICTAL), LORAZEPAM, DARIFENACIN and LEVOCETIRIZINE for an unknown indication.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Birth control was used as concomitant medication.  After the first dose, the patient experienced headache. The patient had surgery the same day on her finger, so had medications from the surgery.  No treatment medications was provided.   This case was linked to MOD-2021-291046 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Pain, Pain in extremity
Clinical narrative: Left arm hurts more than when they got the second dose; Pain feels muscular and inflamed and has spread across the chest, mostly over the left breast area; The pain feels muscular and inflamed; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm hurts more than when they got the second dose), PAIN (Pain feels muscular and inflamed and has spread across the chest, mostly over the left breast area), INFLAMMATION (The pain feels muscular and inflamed) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), PREGABALIN, PREDNISONE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), CELECOXIB (CELEBREX), VITAMIN B12 NOS, BELIMUMAB, LANSOPRAZOLE, IRON and RIBOFLAVIN for an unknown indication.    On 17-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm hurts more than when they got the second dose), PAIN (Pain feels muscular and inflamed and has spread across the chest, mostly over the left breast area) and INFLAMMATION (The pain feels muscular and inflamed). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 18-Aug-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm hurts more than when they got the second dose), PAIN (Pain feels muscular and inflamed and has spread across the chest, mostly over the left breast area) and INFLAMMATION (The pain feels muscular and inflamed) outcome was unknown.            This case was linked to MOD-2021-290856 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Pain in extremity
Clinical narrative: Sore arm; Loss of energy; She felt like she had to lay down and rest.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Loss of energy) and FEELING ABNORMAL (She felt like she had to lay down and rest.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ASTHENIA (Loss of energy) and FEELING ABNORMAL (She felt like she had to lay down and rest.). At the time of the report, PAIN IN EXTREMITY (Sore arm), ASTHENIA (Loss of energy) and FEELING ABNORMAL (She felt like she had to lay down and rest.) outcome was unknown.            No concomitant medication details were provided. No treatment information was mentioned by the reporter.   This case was linked to INC.-MOD-2021-291257 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  INC.-MOD-2021-291257:Dose 2 case
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Mobility decreased
Clinical narrative: BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow; A lump developed and it looked the size of a bicep muscle except it was in the wrong place; I could barely get out of the bed to eat something or go to the bathroom; Chills; body aches that day and next/Very sore arm for 2 weeks.; Felt very tired/Felt exhausted for 3 days; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow), SKIN MASS (A lump developed and it looked the size of a bicep muscle except it was in the wrong place), MOBILITY DECREASED (I could barely get out of the bed to eat something or go to the bathroom), CHILLS (Chills) and MYALGIA (body aches that day and next/Very sore arm for 2 weeks.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (NSAIDS), Food allergy (eggs allergy) and Food allergy (dairy products allergy). Concomitant products included VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for Vitamin B complex supplementation, VIT D [VITAMIN D NOS] for Vitamin D supplementation, PREBIOTICS NOS and CARBINOXAMINE MALEATE (OMEGA 100) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow), SKIN MASS (A lump developed and it looked the size of a bicep muscle except it was in the wrong place), MOBILITY DECREASED (I could barely get out of the bed to eat something or go to the bathroom), CHILLS (Chills), MYALGIA (body aches that day and next/Very sore arm for 2 weeks.), FATIGUE (Felt very tired/Felt exhausted for 3 days) and HEADACHE (Headache). At the time of the report, ERYTHEMA (BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow), SKIN MASS (A lump developed and it looked the size of a bicep muscle except it was in the wrong place), MOBILITY DECREASED (I could barely get out of the bed to eat something or go to the bathroom), CHILLS (Chills), MYALGIA (body aches that day and next/Very sore arm for 2 weeks.), FATIGUE (Felt very tired/Felt exhausted for 3 days) and HEADACHE (Headache) outcome was unknown.            No treatment medications were provided. Indications for the concomitants Omega and Pre-biotics were supplements.   This case was linked to MOD-2021-057826 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Skin mass
Clinical narrative: BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow; A lump developed and it looked the size of a bicep muscle except it was in the wrong place; I could barely get out of the bed to eat something or go to the bathroom; Chills; body aches that day and next/Very sore arm for 2 weeks.; Felt very tired/Felt exhausted for 3 days; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow), SKIN MASS (A lump developed and it looked the size of a bicep muscle except it was in the wrong place), MOBILITY DECREASED (I could barely get out of the bed to eat something or go to the bathroom), CHILLS (Chills) and MYALGIA (body aches that day and next/Very sore arm for 2 weeks.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (NSAIDS), Food allergy (eggs allergy) and Food allergy (dairy products allergy). Concomitant products included VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for Vitamin B complex supplementation, VIT D [VITAMIN D NOS] for Vitamin D supplementation, PREBIOTICS NOS and CARBINOXAMINE MALEATE (OMEGA 100) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow), SKIN MASS (A lump developed and it looked the size of a bicep muscle except it was in the wrong place), MOBILITY DECREASED (I could barely get out of the bed to eat something or go to the bathroom), CHILLS (Chills), MYALGIA (body aches that day and next/Very sore arm for 2 weeks.), FATIGUE (Felt very tired/Felt exhausted for 3 days) and HEADACHE (Headache). At the time of the report, ERYTHEMA (BIG red circle showed up days later/arm immediately turned red at vaccine site from shoulder to elbow), SKIN MASS (A lump developed and it looked the size of a bicep muscle except it was in the wrong place), MOBILITY DECREASED (I could barely get out of the bed to eat something or go to the bathroom), CHILLS (Chills), MYALGIA (body aches that day and next/Very sore arm for 2 weeks.), FATIGUE (Felt very tired/Felt exhausted for 3 days) and HEADACHE (Headache) outcome was unknown.            No treatment medications were provided. Indications for the concomitants Omega and Pre-biotics were supplements.   This case was linked to MOD-2021-057826 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Little arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little arm soreness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced MYALGIA (Little arm soreness). At the time of the report, MYALGIA (Little arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided by reporter. Non drug medication include ice.   This case was linked to MOD-2021-291070 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Extrasystoles, Fatigue
Clinical narrative: discomfort in their chest; had no energy; felt they could not work out as usual; at night felt like their heart skip a beat; shortness of breath; very fatigue; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (discomfort in their chest), ASTHENIA (had no energy), FEELING ABNORMAL (felt they could not work out as usual), EXTRASYSTOLES (at night felt like their heart skip a beat) and DYSPNOEA (shortness of breath) in a 59-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.     Concurrent medical conditions included Egg allergy. Concomitant products included LOSARTAN for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced MYALGIA (arm was a little sore). On an unknown date, the patient experienced CHEST DISCOMFORT (discomfort in their chest), ASTHENIA (had no energy), FEELING ABNORMAL (felt they could not work out as usual), EXTRASYSTOLES (at night felt like their heart skip a beat), DYSPNOEA (shortness of breath) and FATIGUE (very fatigue). On 25-Jul-2021, MYALGIA (arm was a little sore) had resolved. At the time of the report, CHEST DISCOMFORT (discomfort in their chest), ASTHENIA (had no energy), FEELING ABNORMAL (felt they could not work out as usual), EXTRASYSTOLES (at night felt like their heart skip a beat), DYSPNOEA (shortness of breath) and FATIGUE (very fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reported that all the symptoms lasted a couple of weeks.  No treatment information was provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: discomfort in their chest; had no energy; felt they could not work out as usual; at night felt like their heart skip a beat; shortness of breath; very fatigue; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (discomfort in their chest), ASTHENIA (had no energy), FEELING ABNORMAL (felt they could not work out as usual), EXTRASYSTOLES (at night felt like their heart skip a beat) and DYSPNOEA (shortness of breath) in a 59-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.     Concurrent medical conditions included Egg allergy. Concomitant products included LOSARTAN for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced MYALGIA (arm was a little sore). On an unknown date, the patient experienced CHEST DISCOMFORT (discomfort in their chest), ASTHENIA (had no energy), FEELING ABNORMAL (felt they could not work out as usual), EXTRASYSTOLES (at night felt like their heart skip a beat), DYSPNOEA (shortness of breath) and FATIGUE (very fatigue). On 25-Jul-2021, MYALGIA (arm was a little sore) had resolved. At the time of the report, CHEST DISCOMFORT (discomfort in their chest), ASTHENIA (had no energy), FEELING ABNORMAL (felt they could not work out as usual), EXTRASYSTOLES (at night felt like their heart skip a beat), DYSPNOEA (shortness of breath) and FATIGUE (very fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reported that all the symptoms lasted a couple of weeks.  No treatment information was provided by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram, Influenza like illness, Pyrexia, Sluggishness
Clinical narrative: severe flu like symptoms; felt sluggish for first 24 hours; low grade fever; severe lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (severe flu like symptoms), SLUGGISHNESS (felt sluggish for first 24 hours), BACK PAIN (severe lower back pain) and PYREXIA (low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had chronic breathing issues. Patient had to go to a pulmonologist and a physical therapist to get better.) on 15-Dec-2020, Ovary removal (Patient had  surgery to get, her left ovary and  fallopian  tube, removed.) in September 2020 and Salpingectomy (Patient had  surgery to get, her left ovary and  fallopian  tube, removed.) in September 2020.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced BACK PAIN (severe lower back pain). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (severe flu like symptoms), SLUGGISHNESS (felt sluggish for first 24 hours) and PYREXIA (low grade fever). At the time of the report, INFLUENZA LIKE ILLNESS (severe flu like symptoms) had resolved and SLUGGISHNESS (felt sluggish for first 24 hours), BACK PAIN (severe lower back pain) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal. On an unknown date, X-ray: normal (normal) Normal.         No concomitant medication was reported. Reported that the patient went  to her primary care physician and he  gave her anti-inflammatory and muscle relaxer, not other wise specified.   This case was linked to MOD-2021-291036 (Patient Link).