chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Impaired quality of life, Malaise, Musculoskeletal stiffness
Clinical narrative: the vaccine has ruined her life; she can´t breath; she feels she is going to die; Her body is stiffening up; Her body is hurting; Her weight is dropping really fast/she is losing a lot of weight; She is feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED QUALITY OF LIFE (the vaccine has ruined her life), DYSPNOEA (she can´t breath), FEELING ABNORMAL (she feels she is going to die), MUSCULOSKELETAL STIFFNESS (Her body is stiffening up) and PAIN (Her body is hurting) in a 51-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.     Previously administered products included for Drug use for unknown indication: Pfizer Vaccine and Pfizer Vaccine. Past adverse reactions to the above products included No adverse drug reaction with Pfizer Vaccine and Pfizer Vaccine.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED QUALITY OF LIFE (the vaccine has ruined her life), DYSPNOEA (she can´t breath), FEELING ABNORMAL (she feels she is going to die), MUSCULOSKELETAL STIFFNESS (Her body is stiffening up), PAIN (Her body is hurting), WEIGHT DECREASED (Her weight is dropping really fast/she is losing a lot of weight) and MALAISE (She is feeling sick). At the time of the report, IMPAIRED QUALITY OF LIFE (the vaccine has ruined her life), DYSPNOEA (she can´t breath), FEELING ABNORMAL (she feels she is going to die), MUSCULOSKELETAL STIFFNESS (Her body is stiffening up), PAIN (Her body is hurting), WEIGHT DECREASED (Her weight is dropping really fast/she is losing a lot of weight) and MALAISE (She is feeling sick) outcome was unknown.            Concomitant medications and treatment information were not provided by reporter.  The patient received two doses of the Pfizer Vaccine and that patient received a third dose against patient will. It was injected illegally by a shelter worker. The patient believed the third dose that patient received was a Moderna COVID-19 Vaccine, because patient was having side effects.  The vaccine was administered two weeks ago.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Weight decreased
Clinical narrative: the vaccine has ruined her life; she can´t breath; she feels she is going to die; Her body is stiffening up; Her body is hurting; Her weight is dropping really fast/she is losing a lot of weight; She is feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED QUALITY OF LIFE (the vaccine has ruined her life), DYSPNOEA (she can´t breath), FEELING ABNORMAL (she feels she is going to die), MUSCULOSKELETAL STIFFNESS (Her body is stiffening up) and PAIN (Her body is hurting) in a 51-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.     Previously administered products included for Drug use for unknown indication: Pfizer Vaccine and Pfizer Vaccine. Past adverse reactions to the above products included No adverse drug reaction with Pfizer Vaccine and Pfizer Vaccine.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED QUALITY OF LIFE (the vaccine has ruined her life), DYSPNOEA (she can´t breath), FEELING ABNORMAL (she feels she is going to die), MUSCULOSKELETAL STIFFNESS (Her body is stiffening up), PAIN (Her body is hurting), WEIGHT DECREASED (Her weight is dropping really fast/she is losing a lot of weight) and MALAISE (She is feeling sick). At the time of the report, IMPAIRED QUALITY OF LIFE (the vaccine has ruined her life), DYSPNOEA (she can´t breath), FEELING ABNORMAL (she feels she is going to die), MUSCULOSKELETAL STIFFNESS (Her body is stiffening up), PAIN (Her body is hurting), WEIGHT DECREASED (Her weight is dropping really fast/she is losing a lot of weight) and MALAISE (She is feeling sick) outcome was unknown.            Concomitant medications and treatment information were not provided by reporter.  The patient received two doses of the Pfizer Vaccine and that patient received a third dose against patient will. It was injected illegally by a shelter worker. The patient believed the third dose that patient received was a Moderna COVID-19 Vaccine, because patient was having side effects.  The vaccine was administered two weeks ago.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine that was given,  it was expired after 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine that was given,  it was expired after 12 hours) 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 (vaccine that was given,  it was expired after 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine that was given,  it was expired after 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No concomitant medication was provided.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Tingling in left arm; Soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in left arm) and PAIN IN EXTREMITY (Soreness in left arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A, 029L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced PARAESTHESIA (Tingling in left arm) and PAIN IN EXTREMITY (Soreness in left arm). On 30-Dec-2021, PARAESTHESIA (Tingling in left arm) had resolved. On 31-Dec-2021, PAIN IN EXTREMITY (Soreness in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was reported that the patient received the vaccine in her left arm shoulder deltoid muscle. It was reported that there was no product complaint associated with this case   This case was linked to MOD-2022-459082, MOD-2022-459098 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Tingling in left arm; Soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in left arm) and PAIN IN EXTREMITY (Soreness in left arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A, 029L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced PARAESTHESIA (Tingling in left arm) and PAIN IN EXTREMITY (Soreness in left arm). On 30-Dec-2021, PARAESTHESIA (Tingling in left arm) had resolved. On 31-Dec-2021, PAIN IN EXTREMITY (Soreness in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was reported that the patient received the vaccine in her left arm shoulder deltoid muscle. It was reported that there was no product complaint associated with this case   This case was linked to MOD-2022-459082, MOD-2022-459098 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: soreness in her left arm and the left side of her neck; patients neck was stiff, neck stiffness; soreness in her left arm and the left side of her neck; left shoulder was sore.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm and the left side of her neck), MUSCULOSKELETAL STIFFNESS (patients neck was stiff, neck stiffness), NECK PAIN (soreness in her left arm and the left side of her neck) and ARTHRALGIA (left shoulder was sore.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm and the left side of her neck), MUSCULOSKELETAL STIFFNESS (patients neck was stiff, neck stiffness), NECK PAIN (soreness in her left arm and the left side of her neck) and ARTHRALGIA (left shoulder was sore.). On 28-Jan-2021, PAIN IN EXTREMITY (soreness in her left arm and the left side of her neck), MUSCULOSKELETAL STIFFNESS (patients neck was stiff, neck stiffness) and NECK PAIN (soreness in her left arm and the left side of her neck) had resolved. At the time of the report, ARTHRALGIA (left shoulder was sore.) outcome was unknown.            No concomitant medication was reported. The treatment information was unknown.  Patient stated she received vaccine on her left arm shoulder deltoid muscle.   This case was linked to MOD-2022-459041, MOD-2022-459098 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: soreness in her left arm and the left side of her neck; patients neck was stiff, neck stiffness; soreness in her left arm and the left side of her neck; left shoulder was sore.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm and the left side of her neck), MUSCULOSKELETAL STIFFNESS (patients neck was stiff, neck stiffness), NECK PAIN (soreness in her left arm and the left side of her neck) and ARTHRALGIA (left shoulder was sore.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm and the left side of her neck), MUSCULOSKELETAL STIFFNESS (patients neck was stiff, neck stiffness), NECK PAIN (soreness in her left arm and the left side of her neck) and ARTHRALGIA (left shoulder was sore.). On 28-Jan-2021, PAIN IN EXTREMITY (soreness in her left arm and the left side of her neck), MUSCULOSKELETAL STIFFNESS (patients neck was stiff, neck stiffness) and NECK PAIN (soreness in her left arm and the left side of her neck) had resolved. At the time of the report, ARTHRALGIA (left shoulder was sore.) outcome was unknown.            No concomitant medication was reported. The treatment information was unknown.  Patient stated she received vaccine on her left arm shoulder deltoid muscle.   This case was linked to MOD-2022-459041, MOD-2022-459098 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine  used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine  used) 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 (Expired vaccine  used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine  used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. No Treatment medication reported.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: severe itching; Hives; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (severe itching) and URTICARIA (Hives) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A, 004M20A and 022C21A) 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced PRURITUS (severe itching) and URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 05-Jan-2022, URTICARIA (Hives) had resolved. At the time of the report, PRURITUS (severe itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient received the Moderna vaccine on 26-Nov-2021 (dose no. of vaccine not reported). The patient experienced adverse events from the steroids and stopped it's therapy. The patient took prednisone and Benadryl for about 12 days.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling drained and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling drained and 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feeling drained and fatigue). At the time of the report, FATIGUE (feeling drained and fatigue) outcome was unknown.            No treatment medication details was provided.  Patient took booster dose on Friday but had prior infection and was taking antibiotics at the same time before Patient got the booster
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: pretty bad side effects pretty severe side effects third  dose also did  second dose last year; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (pretty bad side effects pretty severe side effects third  dose also did  second dose last year) 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 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (pretty bad side effects pretty severe side effects third  dose also did  second dose last year). At the time of the report, VACCINATION COMPLICATION (pretty bad side effects pretty severe side effects third  dose also did  second dose last year) outcome was unknown.            No concomitant drug were reported.  Patient had pretty severe side effects that took place this week after received their third dose also did  second dose last year and  had pretty bad side effects back then as well.   No treatment drug were reported.   This case was linked to MOD-2022-459022 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: achiness through out her body; Fatigue; achiness through her joints; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achiness through out her body), FATIGUE (Fatigue) and ARTHRALGIA (achiness through her joints) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 025J20-2A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced MYALGIA (achiness through out her body), FATIGUE (Fatigue) and ARTHRALGIA (achiness through her joints). In December 2021, MYALGIA (achiness through out her body), FATIGUE (Fatigue) and ARTHRALGIA (achiness through her joints) had resolved.            No concomitant product was reported.  No treatment medication was reported.  It was reported that symptoms lasted for 2 hours.   This case was linked to MOD-2022-459082, MOD-2022-459041 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vial opened 1/19 at 430pm, a dose was given 1/20 at 10am; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial opened 1/19 at 430pm, a dose was given 1/20 at 10am) 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 20-Jan-2022 at 10:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial opened 1/19 at 430pm, a dose was given 1/20 at 10am). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Vial opened 1/19 at 430pm, a dose was given 1/20 at 10am) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient was having shortness of breath about 35 hours after getting the Moderna booster.  No treatment information was provided.   Reporter did not allow further contact
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Feeling abnormal, Headache, Hyperaesthesia teeth, Pain in jaw
Clinical narrative: not feeling that good/it was awful; both of her ears were really hurting; her jaw was hurting; lower teeth started hurting/Teeth hurt when she drank tea/Teeth hurt when she drank cold water; headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling that good/it was awful), EAR PAIN (both of her ears were really hurting), PAIN IN JAW (her jaw was hurting), HYPERAESTHESIA TEETH (lower teeth started hurting/Teeth hurt when she drank tea/Teeth hurt when she drank cold water) and HEADACHE (headaches) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SIMVASTATIN for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LISINOPRIL for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (not feeling that good/it was awful), EAR PAIN (both of her ears were really hurting), PAIN IN JAW (her jaw was hurting), HYPERAESTHESIA TEETH (lower teeth started hurting/Teeth hurt when she drank tea/Teeth hurt when she drank cold water) and HEADACHE (headaches). At the time of the report, FEELING ABNORMAL (not feeling that good/it was awful), EAR PAIN (both of her ears were really hurting), PAIN IN JAW (her jaw was hurting), HYPERAESTHESIA TEETH (lower teeth started hurting/Teeth hurt when she drank tea/Teeth hurt when she drank cold water) and HEADACHE (headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported. The patient stated symptoms were strange. She didn´t experience any symptoms after receiving the second dose.The patient´s dominant arm was the right arm. The patient states she didn´t receive the vaccination card and doesn´t remember when was the second dose administered. She just kept herself going and was okay little by little, but it took time for all this symptoms to go.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: we accidentally give someone a half dose of Moderna instead of full dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (we accidentally give someone a half dose of Moderna instead of full dose) 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 ACCIDENTAL UNDERDOSE (we accidentally give someone a half dose of Moderna instead of full dose). At the time of the report, ACCIDENTAL UNDERDOSE (we accidentally give someone a half dose of Moderna instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided. No Concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Throwing up; Horrible headache; This spontaneous case was reported by a pharmacist and describes the occurrence of VOMITING (Throwing up) and HEADACHE (Horrible 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 information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Throwing up) and HEADACHE (Horrible headache). At the time of the report, VOMITING (Throwing up) and HEADACHE (Horrible headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Feeling abnormal, Hypopnoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Having shortness of breath), FEELING ABNORMAL (Not feeling good), PALPITATIONS (fast heartbeat), CHEST PAIN (pain on back and chest) and HYPOPNOEA (shallowbreathing) in a 62-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 Hypercholesterolemia.Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Hyperlipidaemia, ALPRAZOLAM (XANAX), COLECALCIFEROL (VITAMIN D3) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2022, the patient experienced DYSPNOEA (Having shortness of breath), FEELING ABNORMAL (Not feeling good) and PALPITATIONS (fast heartbeat). On 23-Jan-2022, the patient experienced CHEST PAIN (pain on back and chest). 23-Jan-2022, the patient experienced HYPOPNOEA (shallowbreathing), BACK PAIN (pain on back and chest) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Having shortness of breath), FEELING ABNORMAL (Not feeling good), PALPITATIONS (fast heartbeat), CHEST PAIN (pain on back and chest), HYPOPNOEA (shallowbreathing) and MYALGIA (Body aches) outcome was unknown and BACK PAIN (pain on back and chest) was resolving. On 22 Jan 2022, patient was not feeling good, having shortness of breath, fast heartbeat and on 23 Jan 2022 had body aches, shortness of breath, pain on back and chest and shallow breathing.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Having shortness of breath), FEELING ABNORMAL (Not feeling good), PALPITATIONS (fast heartbeat), CHEST PAIN (pain on back and chest) and HYPOPNOEA (shallowbreathing) in a 62-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 Hypercholesterolemia.Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Hyperlipidaemia, ALPRAZOLAM (XANAX), COLECALCIFEROL (VITAMIN D3) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2022, the patient experienced DYSPNOEA (Having shortness of breath), FEELING ABNORMAL (Not feeling good) and PALPITATIONS (fast heartbeat). On 23-Jan-2022, the patient experienced CHEST PAIN (pain on back and chest). 23-Jan-2022, the patient experienced HYPOPNOEA (shallowbreathing), BACK PAIN (pain on back and chest) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Having shortness of breath), FEELING ABNORMAL (Not feeling good), PALPITATIONS (fast heartbeat), CHEST PAIN (pain on back and chest), HYPOPNOEA (shallowbreathing) and MYALGIA (Body aches) outcome was unknown and BACK PAIN (pain on back and chest) was resolving. On 22 Jan 2022, patient was not feeling good, having shortness of breath, fast heartbeat and on 23 Jan 2022 had body aches, shortness of breath, pain on back and chest and shallow breathing.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration
Clinical narrative: allergic reaction; first dose was months ago; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (allergic reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was months ago) 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 HYPERSENSITIVITY (allergic reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was months ago). At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was months ago) had resolved.        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.   Concomitant medication of the patient was not reported .  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain
Clinical narrative: Just under my left arm pit, i have a large lump come up on Saturday. Now it has gone down but is real sore.; Just under my left arm pit, i have a large lump come up on Saturday. Now it has gone down but is real sore.; This spontaneous case was reported by a nurse and describes the occurrence of AXILLARY PAIN (Just under my left arm pit, i have a large lump come up on Saturday. Now it has gone down but is real sore.) and AXILLARY MASS (Just under my left arm pit, i have a large lump come up on Saturday. Now it has gone down but is real sore.) 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 20-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced AXILLARY PAIN (Just under my left arm pit, i have a large lump come up on Saturday. Now it has gone down but is real sore.). On 22-Jan-2022, the patient experienced AXILLARY MASS (Just under my left arm pit, i have a large lump come up on Saturday. Now it has gone down but is real sore.). On 23-Jan-2022, AXILLARY MASS (Just under my left arm pit, i have a large lump come up on Saturday. Now it has gone down but is real sore.) had resolved. At the time of the report, AXILLARY PAIN (Just under my left arm pit, i have a large lump come up on Saturday. Now it has gone down but is real sore.) had not resolved.        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 product use was reported.  It was reported that the patient took the vaccine on 20-Jan-2022 and just under their left arm pit, the patient was having large lump which come up on 22-Jan-2022 and now it had gone down but was real sore.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Mild headache, slight headache; Little bit of joint pain; Slight muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache, slight headache), ARTHRALGIA (Little bit of joint pain) and MYALGIA (Slight muscle pain) 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 21-Jan-2022 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced HEADACHE (Mild headache, slight headache), ARTHRALGIA (Little bit of joint pain) and MYALGIA (Slight muscle pain). At the time of the report, HEADACHE (Mild headache, slight headache), ARTHRALGIA (Little bit of joint pain) and MYALGIA (Slight muscle pain) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient got the booster and was asking if it is ok to take aspirin for some of the mild headache and little bit of joint pain that patient got since had the booster. Patient had reported nothing from the original shots but, the booster gave slight headache and slight muscle pain.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: given a booster dose of an expired vial punctured for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given a booster dose of an expired vial punctured for more than 12 hours) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given a booster dose of an expired vial punctured for more than 12 hours). On 22-Jan-2022, EXPIRED PRODUCT ADMINISTERED (given a booster dose of an expired vial punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Patients was given a booster dose of an expired vial punctured for more than 12 hours.   This case was linked to MOD-2022-459581 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 booster doses given from an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 booster doses given from an expired vial) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 booster doses given from an expired vial). On 22-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 booster doses given from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-459566, MOD-2022-458939 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   In February 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargic). At the time of the report, LETHARGY (lethargic) outcome was unknown.            Concomitant medications includes birth control pills. No treatment medication were reported.  Patient states the first dose of the Moderna Covid-19 Vaccine was administered on Feb2021, and the second dose 4 weeks later.   This case was linked to MOD-2022-459618, MOD-2022-459640 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all from her head down,hives started to come back again after treatment; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all from her head down,hives started to come back again after treatment) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, 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. In January 2022, the patient experienced URTICARIA (hives all from her head down,hives started to come back again after treatment). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all from her head down,hives started to come back again after treatment) outcome was unknown.            Concomitant medication included Bbrth control pills and treatment medication also included Steroid shot.   This case was linked to MOD-2022-459639, MOD-2022-459618 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: Headache; nausea; vomiting; fever; sweats; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 22Oct2021 09:00 (Lot number: 320803D) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy: food intolerances" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination= Yes; "known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: METHENAMINE; CELECOXIB; VIT C. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 24Mar2021, when the patient was 63 years old, for COVID-19 immunization; Comirnaty (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 07:45 AM), administration date: 04Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "Headache"; NAUSEA (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "nausea"; VOMITING (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "vomiting"; PYREXIA (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "fever"; HYPERHIDROSIS (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "sweats"; CHILLS (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "chills"; PAIN (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "body aches". Therapeutic measures were taken as a result of nausea, vomiting.  Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache; nausea; vomiting; fever; sweats; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 22Oct2021 09:00 (Lot number: 320803D) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy: food intolerances" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination= Yes; "known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: METHENAMINE; CELECOXIB; VIT C. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 24Mar2021, when the patient was 63 years old, for COVID-19 immunization; Comirnaty (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 07:45 AM), administration date: 04Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "Headache"; NAUSEA (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "nausea"; VOMITING (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "vomiting"; PYREXIA (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "fever"; HYPERHIDROSIS (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "sweats"; CHILLS (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "chills"; PAIN (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "body aches". Therapeutic measures were taken as a result of nausea, vomiting.  Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Body temperature, Chills, Decreased appetite
Clinical narrative: chills; headache; sore arm/ arm pain; fatigue; weakness; not having an appetite to eat school lunch; she spiked a high fever of 102 degrees/  fever returned to 100 degrees; severe stomach pains that led to vomiting; severe stomach pains that led to vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old female patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (Batch/Lot number: unknown) at the age of 9 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 07Dec2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 07Dec2021, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "unknown", described as "sore arm/ arm pain"; FATIGUE (non-serious) with onset 07Dec2021, outcome "unknown", described as "fatigue"; ASTHENIA (non-serious) with onset 07Dec2021, outcome "unknown", described as "weakness"; DECREASED APPETITE (non-serious) with onset 07Dec2021, outcome "unknown", described as "not having an appetite to eat school lunch"; PYREXIA (non-serious) with onset 07Dec2021, outcome "not recovered", described as "she spiked a high fever of 102 degrees/  fever returned to 100 degrees"; ABDOMINAL PAIN UPPER (non-serious), VOMITING (non-serious) all with onset 07Dec2021, outcome "unknown" and all described as "severe stomach pains that led to vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: chills; headache; sore arm/ arm pain; fatigue; weakness; not having an appetite to eat school lunch; she spiked a high fever of 102 degrees/  fever returned to 100 degrees; severe stomach pains that led to vomiting; severe stomach pains that led to vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old female patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (Batch/Lot number: unknown) at the age of 9 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 07Dec2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 07Dec2021, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "unknown", described as "sore arm/ arm pain"; FATIGUE (non-serious) with onset 07Dec2021, outcome "unknown", described as "fatigue"; ASTHENIA (non-serious) with onset 07Dec2021, outcome "unknown", described as "weakness"; DECREASED APPETITE (non-serious) with onset 07Dec2021, outcome "unknown", described as "not having an appetite to eat school lunch"; PYREXIA (non-serious) with onset 07Dec2021, outcome "not recovered", described as "she spiked a high fever of 102 degrees/  fever returned to 100 degrees"; ABDOMINAL PAIN UPPER (non-serious), VOMITING (non-serious) all with onset 07Dec2021, outcome "unknown" and all described as "severe stomach pains that led to vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.