chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye irritation, Feeling cold, Headache
Clinical narrative: Felt burning around left eye; left eye was watering; Feel constantly cold; muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head; nausea; headache/head is killing; chills; joint pain in upper left arm and knees; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Felt burning around left eye), LACRIMATION INCREASED (left eye was watering), FEELING COLD (Feel constantly cold), MYALGIA (muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head) and NAUSEA (nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer-BioNTech COVID-19 Vaccine (lot number - ER8727) on 24-Mar-2021 and Pfizer-BioNTech COVID-19 Vaccine (lot number - EW0153) on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EYE IRRITATION (Felt burning around left eye), LACRIMATION INCREASED (left eye was watering), FEELING COLD (Feel constantly cold), MYALGIA (muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head), NAUSEA (nausea), HEADACHE (headache/head is killing), CHILLS (chills) and ARTHRALGIA (joint pain in upper left arm and knees). The patient was treated with IBUPROFEN at a dose of 800 milligram; 1 or 2. At the time of the report, EYE IRRITATION (Felt burning around left eye), LACRIMATION INCREASED (left eye was watering), FEELING COLD (Feel constantly cold), MYALGIA (muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head), NAUSEA (nausea), HEADACHE (headache/head is killing), CHILLS (chills) and ARTHRALGIA (joint pain in upper left arm and knees) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Myalgia, Nausea
Clinical narrative: Felt burning around left eye; left eye was watering; Feel constantly cold; muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head; nausea; headache/head is killing; chills; joint pain in upper left arm and knees; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Felt burning around left eye), LACRIMATION INCREASED (left eye was watering), FEELING COLD (Feel constantly cold), MYALGIA (muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head) and NAUSEA (nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer-BioNTech COVID-19 Vaccine (lot number - ER8727) on 24-Mar-2021 and Pfizer-BioNTech COVID-19 Vaccine (lot number - EW0153) on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EYE IRRITATION (Felt burning around left eye), LACRIMATION INCREASED (left eye was watering), FEELING COLD (Feel constantly cold), MYALGIA (muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head), NAUSEA (nausea), HEADACHE (headache/head is killing), CHILLS (chills) and ARTHRALGIA (joint pain in upper left arm and knees). The patient was treated with IBUPROFEN at a dose of 800 milligram; 1 or 2. At the time of the report, EYE IRRITATION (Felt burning around left eye), LACRIMATION INCREASED (left eye was watering), FEELING COLD (Feel constantly cold), MYALGIA (muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head), NAUSEA (nausea), HEADACHE (headache/head is killing), CHILLS (chills) and ARTHRALGIA (joint pain in upper left arm and knees) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Lymph node pain, Myalgia
Clinical narrative: it is itching; very uncomfortable; so much pain; skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere; fatigue; body aches; headaches; pain in the lymph nodes under the arm; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH PRURITIC (it is itching), DISCOMFORT (very uncomfortable), PAIN (so much pain), RASH (skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere) and FATIGUE (fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 013M20A or 0BM20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and BETA VULGARIS, FOLIC ACID, MALUS SPP. VINEGAR EXTRACT, PUNICA GRANATUM, VITAMIN B12 NOS (GOLI APPLE CIDER VINEGAR) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, 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 experienced RASH PRURITIC (it is itching), DISCOMFORT (very uncomfortable), PAIN (so much pain), RASH (skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and LYMPH NODE PAIN (pain in the lymph nodes under the arm). The patient was treated with HYDROCORTISONE ACETATE, LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCORTISONE) (topical) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (it is itching), DISCOMFORT (very uncomfortable), PAIN (so much pain), RASH (skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and LYMPH NODE PAIN (pain in the lymph nodes under the arm) outcome was unknown.            second night after booster shot the patient developed a skin rash in the palm of their hands and the palm of their feet and everywhere.   This case was linked to MOD-2021-404412, MOD-2021-404413 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Rash pruritic
Clinical narrative: it is itching; very uncomfortable; so much pain; skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere; fatigue; body aches; headaches; pain in the lymph nodes under the arm; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH PRURITIC (it is itching), DISCOMFORT (very uncomfortable), PAIN (so much pain), RASH (skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere) and FATIGUE (fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 013M20A or 0BM20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and BETA VULGARIS, FOLIC ACID, MALUS SPP. VINEGAR EXTRACT, PUNICA GRANATUM, VITAMIN B12 NOS (GOLI APPLE CIDER VINEGAR) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, 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 experienced RASH PRURITIC (it is itching), DISCOMFORT (very uncomfortable), PAIN (so much pain), RASH (skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and LYMPH NODE PAIN (pain in the lymph nodes under the arm). The patient was treated with HYDROCORTISONE ACETATE, LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCORTISONE) (topical) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (it is itching), DISCOMFORT (very uncomfortable), PAIN (so much pain), RASH (skin rash in the palm of the hands/ At one point they could not touch/skin rash in the palm their feet and everywhere), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and LYMPH NODE PAIN (pain in the lymph nodes under the arm) outcome was unknown.            second night after booster shot the patient developed a skin rash in the palm of their hands and the palm of their feet and everywhere.   This case was linked to MOD-2021-404412, MOD-2021-404413 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms after the booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms after the booster shot). At the time of the report, VACCINATION COMPLICATION (Symptoms after the booster shot) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 0.25 ml administered as primary series dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25 ml administered as primary series dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 02-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (0.25 ml administered as primary series dose). On 02-Dec-2021, ACCIDENTAL UNDERDOSE (0.25 ml administered as primary series dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: have a rash from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (have a rash from the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (have a rash from the vaccine). At the time of the report, RASH (have a rash from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Underdose
Clinical narrative: Expired Dose given; 0.25 mL second dose given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Dose given) and UNDERDOSE (0.25 mL second dose given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Dose given) and UNDERDOSE (0.25 mL second dose given). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired Dose given) and UNDERDOSE (0.25 mL second dose given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.  Patient was not experiencing any side effects.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient that came to get their second dose, received a half a dose instead of a full dose for their second vaccine series; This spontaneous case was reported by a physician assistant and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient that came to get their second dose, received a half a dose instead of a full dose for their second vaccine series) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient that came to get their second dose, received a half a dose instead of a full dose for their second vaccine series). At the time of the report, ACCIDENTAL UNDERDOSE (Patient that came to get their second dose, received a half a dose instead of a full dose for their second vaccine series) had resolved.            No concomitant product use was provided by the reporter. No treatment medication was provided. No medical history was reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: fatigue; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 013M20A or 0BM20A) for COVID-19 vaccination.     no medical history was reported by reporter.  Concomitant products included BETA VULGARIS, FOLIC ACID, MALUS SPP. VINEGAR EXTRACT, PUNICA GRANATUM, VITAMIN B12 NOS (GOLI APPLE CIDER VINEGAR) and COLECALCIFEROL, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RETINOL, RIBOFLAVIN, VITAMIN B1 NOS (MULTIVITAMIN [COLECALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS]) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches). The patient was treated with HYDROCORTISONE, LIDOCAINE HYDROCHLORIDE (LIDOCAINE/HYDROCORTISONE) for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches) outcome was unknown.            Treatment medications included antibiotic. No historical condition was reported.   This case was linked to MOD-2021-404412, MOD-2021-404309 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Myalgia, Nausea, Pyrexia
Clinical narrative: pretty sick; achiness; nausea; chills; slightly fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (pretty sick), MYALGIA (achiness), NAUSEA (nausea), CHILLS (chills) and PYREXIA (slightly fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 012A21A) for COVID-19 vaccination.     Concomitant products included VALACYCLOVIR [VALACICLOVIR] and SPIRONOLACTONE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ILLNESS (pretty sick), MYALGIA (achiness), NAUSEA (nausea), CHILLS (chills) and PYREXIA (slightly fever). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (pretty sick), MYALGIA (achiness), NAUSEA (nausea), CHILLS (chills) and PYREXIA (slightly fever) was resolving.            This case was linked to MOD-2021-404394, MOD-2021-404423, MOD-2021-404534 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Vaccination site reaction
Clinical narrative: injection site reactions; Hands will turn bright red/Ankles and calves get red marks; It feels like they (hands) are on fire/symptoms seems to be getting worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reactions), ERYTHEMA (Hands will turn bright red/Ankles and calves get red marks) and BURNING SENSATION (It feels like they (hands) are on fire/symptoms seems to be getting worse) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced ERYTHEMA (Hands will turn bright red/Ankles and calves get red marks) and BURNING SENSATION (It feels like they (hands) are on fire/symptoms seems to be getting worse). On an unknown date, the patient experienced VACCINATION SITE REACTION (injection site reactions). At the time of the report, VACCINATION SITE REACTION (injection site reactions), ERYTHEMA (Hands will turn bright red/Ankles and calves get red marks) and BURNING SENSATION (It feels like they (hands) are on fire/symptoms seems to be getting worse) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE REACTION (injection site reactions), ERYTHEMA (Hands will turn bright red/Ankles and calves get red marks) and BURNING SENSATION (It feels like they (hands) are on fire/symptoms seems to be getting worse) to be related.    No concomitant medications were reported.  Treatment information was not provided. Patient was healthy except for the COVID time and did not take any medications and believes the reactions were related to the vaccine. The symptoms lasted for 3 to 4 days.   This case was linked to MOD-2021-404647 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Gait inability, Incontinence, Muscle discomfort
Clinical narrative: Loss of muscle control; couldn't walk; incontinence; fell in shower hurting knee; Vomiting; hurting  knee; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (Loss of muscle control), GAIT INABILITY (couldn't walk), INCONTINENCE (incontinence), FALL (fell in shower hurting knee) and VOMITING (Vomiting) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 023M20A and 0MB0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]), AMLODIPINE, BUPROPION, FLUOXETINE, LEVOTHYROXINE, METHYLPHENIDATE, OMEPRAZOLE, PRAVASTATIN, TOPIRAMATE, TRAZODONE, ZIPRASIDONE, DIAZEPAM, ACICLOVIR (ZOVIRAX [ACICLOVIR]) and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, 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 experienced MUSCLE DISCOMFORT (Loss of muscle control), GAIT INABILITY (couldn't walk), INCONTINENCE (incontinence), FALL (fell in shower hurting knee), VOMITING (Vomiting) and ARTHRALGIA (hurting  knee). The patient was treated with BUTALBITAL for Adverse event, at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency and CAFFEINE for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE DISCOMFORT (Loss of muscle control), GAIT INABILITY (couldn't walk), INCONTINENCE (incontinence), FALL (fell in shower hurting knee), VOMITING (Vomiting) and ARTHRALGIA (hurting  knee) outcome was unknown.            concomitant products reported included Butalbital Codeine for an unknown indication.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Loss of muscle control; couldn't walk; incontinence; fell in shower hurting knee; Vomiting; hurting  knee; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (Loss of muscle control), GAIT INABILITY (couldn't walk), INCONTINENCE (incontinence), FALL (fell in shower hurting knee) and VOMITING (Vomiting) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 023M20A and 0MB0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]), AMLODIPINE, BUPROPION, FLUOXETINE, LEVOTHYROXINE, METHYLPHENIDATE, OMEPRAZOLE, PRAVASTATIN, TOPIRAMATE, TRAZODONE, ZIPRASIDONE, DIAZEPAM, ACICLOVIR (ZOVIRAX [ACICLOVIR]) and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, 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 experienced MUSCLE DISCOMFORT (Loss of muscle control), GAIT INABILITY (couldn't walk), INCONTINENCE (incontinence), FALL (fell in shower hurting knee), VOMITING (Vomiting) and ARTHRALGIA (hurting  knee). The patient was treated with BUTALBITAL for Adverse event, at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency and CAFFEINE for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE DISCOMFORT (Loss of muscle control), GAIT INABILITY (couldn't walk), INCONTINENCE (incontinence), FALL (fell in shower hurting knee), VOMITING (Vomiting) and ARTHRALGIA (hurting  knee) outcome was unknown.            concomitant products reported included Butalbital Codeine for an unknown indication.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Booster dose given to a 17 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (1st and 2nd doses were Pfizer vaccines). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 17 year old). On 30-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stayed for 15 minutes after the administration of vaccine and did not show any signs and symptoms. No medical history was provided by the reporter. No concomitant medication were given. No treatment information were given.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Pain in extremity
Clinical narrative: severe severe severe pain in my legs/severe severe severe pain in the back of my thigh; for months I could hardly walk/for months I could hardly sit down and get up/it went into my shoulders; severe severe severe pain on the top of the joint; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe severe severe pain in my legs/severe severe severe pain in the back of my thigh), HYPOKINESIA (for months I could hardly walk/for months I could hardly sit down and get up/it went into my shoulders) and ARTHRALGIA (severe severe severe pain on the top of the joint) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 IN EXTREMITY (severe severe severe pain in my legs/severe severe severe pain in the back of my thigh), HYPOKINESIA (for months I could hardly walk/for months I could hardly sit down and get up/it went into my shoulders) and ARTHRALGIA (severe severe severe pain on the top of the joint). At the time of the report, PAIN IN EXTREMITY (severe severe severe pain in my legs/severe severe severe pain in the back of my thigh), HYPOKINESIA (for months I could hardly walk/for months I could hardly sit down and get up/it went into my shoulders) and ARTHRALGIA (severe severe severe pain on the top of the joint) had not resolved.            No concomitant medications provided. No treatment medications provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: experiencing swelling at injection site, pain and arm is hot to touch; experiencing swelling at injection site, pain and arm is hot to touch; experiencing swelling at injection site, pain and arm is hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (experiencing swelling at injection site, pain and arm is hot to touch), VACCINATION SITE SWELLING (experiencing swelling at injection site, pain and arm is hot to touch) and VACCINATION SITE PAIN (experiencing swelling at injection site, pain and arm is hot to touch) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905 and 015M20A) for COVID-19 vaccination.     Concomitant products included CAPTOPRIL, CARVEDILOL (COREG), POTASSIUM, FUROSEMIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LEVOTHYROXINE, ROSUVASTATIN, ESCITALOPRAM and OMEPRAZOLE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, 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 experienced VACCINATION SITE WARMTH (experiencing swelling at injection site, pain and arm is hot to touch), VACCINATION SITE SWELLING (experiencing swelling at injection site, pain and arm is hot to touch) and VACCINATION SITE PAIN (experiencing swelling at injection site, pain and arm is hot to touch). At the time of the report, VACCINATION SITE WARMTH (experiencing swelling at injection site, pain and arm is hot to touch), VACCINATION SITE SWELLING (experiencing swelling at injection site, pain and arm is hot to touch) and VACCINATION SITE PAIN (experiencing swelling at injection site, pain and arm is hot to touch) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Blood pressure measurement, Cough, Hypotension, Nasal congestion
Clinical narrative: blood pressure running low in morning; coughing up clear or white mucus; coughing up clear or white mucus; lost her voice; congested,getting more congested; dry cough; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested,getting more congested), COUGH (dry cough), COUGH (coughing up clear or white mucus), APHONIA (lost her voice) and SECRETION DISCHARGE (coughing up clear or white mucus) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 036A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine (every year). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Pneumonia and Atrial fibrillation. Concomitant products included LEVOTHYROXINE, AMIODARONE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), APIXABAN (ELIQUIS), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), METOPROLOL SUCCINATE and COLESTYRAMINE (CHOLESTYRAMINE) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced COUGH (dry cough). On 02-Dec-2021, the patient experienced NASAL CONGESTION (congested,getting more congested) and APHONIA (lost her voice). On 03-Dec-2021, the patient experienced COUGH (coughing up clear or white mucus) and SECRETION DISCHARGE (coughing up clear or white mucus). On an unknown date, the patient experienced HYPOTENSION (blood pressure running low in morning). At the time of the report, NASAL CONGESTION (congested,getting more congested) had not resolved and COUGH (dry cough), COUGH (coughing up clear or white mucus), APHONIA (lost her voice), SECRETION DISCHARGE (coughing up clear or white mucus) and HYPOTENSION (blood pressure running low in morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) blood pressure has been running low in the morning.         Patient stated she had no drug of food allergies and took other vaccines too.  Treatment medications reported that going to use Mucinex EX and cough drops.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: blood pressure running low in morning; coughing up clear or white mucus; coughing up clear or white mucus; lost her voice; congested,getting more congested; dry cough; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested,getting more congested), COUGH (dry cough), COUGH (coughing up clear or white mucus), APHONIA (lost her voice) and SECRETION DISCHARGE (coughing up clear or white mucus) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 036A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine (every year). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Pneumonia and Atrial fibrillation. Concomitant products included LEVOTHYROXINE, AMIODARONE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), APIXABAN (ELIQUIS), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), METOPROLOL SUCCINATE and COLESTYRAMINE (CHOLESTYRAMINE) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced COUGH (dry cough). On 02-Dec-2021, the patient experienced NASAL CONGESTION (congested,getting more congested) and APHONIA (lost her voice). On 03-Dec-2021, the patient experienced COUGH (coughing up clear or white mucus) and SECRETION DISCHARGE (coughing up clear or white mucus). On an unknown date, the patient experienced HYPOTENSION (blood pressure running low in morning). At the time of the report, NASAL CONGESTION (congested,getting more congested) had not resolved and COUGH (dry cough), COUGH (coughing up clear or white mucus), APHONIA (lost her voice), SECRETION DISCHARGE (coughing up clear or white mucus) and HYPOTENSION (blood pressure running low in morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) blood pressure has been running low in the morning.         Patient stated she had no drug of food allergies and took other vaccines too.  Treatment medications reported that going to use Mucinex EX and cough drops.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse side effect) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 VACCINATION COMPLICATION (adverse side effect). At the time of the report, VACCINATION COMPLICATION (adverse side effect) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and NAUSEA (Nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 026L20A and 004M20A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) had not resolved.            Treatment information was not reported.  It has been three weeks since the booster shot and since that she was with dizziness and nausea.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Have been subscribed an antibiotic for an issue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Have been subscribed an antibiotic for an issue) 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 VACCINATION COMPLICATION (Have been subscribed an antibiotic for an issue). At the time of the report, VACCINATION COMPLICATION (Have been subscribed an antibiotic for an issue) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Vaccination site reaction
Clinical narrative: temperature changes her ankles and lower calves get red marks; injection site reactions; Whenever I touch metal or cold my hands will turn bright red and it feels like they are on fire."/seems to be getting worse; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (temperature changes her ankles and lower calves get red marks), VACCINATION SITE REACTION (injection site reactions) and BURNING SENSATION (Whenever I touch metal or cold my hands will turn bright red and it feels like they are on fire."/seems to be getting worse) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 022C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced ERYTHEMA (temperature changes her ankles and lower calves get red marks), VACCINATION SITE REACTION (injection site reactions) and BURNING SENSATION (Whenever I touch metal or cold my hands will turn bright red and it feels like they are on fire."/seems to be getting worse). At the time of the report, ERYTHEMA (temperature changes her ankles and lower calves get red marks), VACCINATION SITE REACTION (injection site reactions) and BURNING SENSATION (Whenever I touch metal or cold my hands will turn bright red and it feels like they are on fire."/seems to be getting worse) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ERYTHEMA (temperature changes her ankles and lower calves get red marks), VACCINATION SITE REACTION (injection site reactions) and BURNING SENSATION (Whenever I touch metal or cold my hands will turn bright red and it feels like they are on fire."/seems to be getting worse) to be related.    Concomitant medications were not provided.  Treatment information was not provided.  Patient otherwise is healthy except the Covid time and did not take any medications and believes this reaction is related to the vaccine. The symptoms lasted for 3-4 days.   This case was linked to MOD-2021-404463 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion/ Vaccinated after the excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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) (Intramuscular) .5 ml. On 28-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Product storage error). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion). On 28-Nov-2021, PRODUCT STORAGE ERROR (Product storage error) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The facility had a 20 minute excursion in the freezer that their Moderna vials are stored in.  No concomitant drugs were reported. No treatment drugs were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bronchitis, Chest discomfort, Dyspnoea, Malaise
Clinical narrative: "real stiff"; like having bronchitis; arms sore; brought him down a little; neck sore; like someone is sitting on his chest/a feeling of pressure on his chest; nose has been "clogged up"; having problems breathing/breathing easier; shoulders sore; "real sore"/whole body is sore/like he has been beat all over; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS ("real stiff"), BRONCHITIS (like having bronchitis), PAIN IN EXTREMITY (arms sore), MALAISE (brought him down a little) and NECK PAIN (neck sore) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A, 017B21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis and Ragweed allergy.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS ("real stiff"), BRONCHITIS (like having bronchitis), PAIN IN EXTREMITY (arms sore), MALAISE (brought him down a little), NECK PAIN (neck sore), CHEST DISCOMFORT (like someone is sitting on his chest/a feeling of pressure on his chest), NASAL CONGESTION (nose has been "clogged up"), DYSPNOEA (having problems breathing/breathing easier), ARTHRALGIA (shoulders sore) and MYALGIA ("real sore"/whole body is sore/like he has been beat all over). On 03-Dec-2021, DYSPNOEA (having problems breathing/breathing easier) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS ("real stiff"), BRONCHITIS (like having bronchitis), PAIN IN EXTREMITY (arms sore), MALAISE (brought him down a little), NECK PAIN (neck sore), CHEST DISCOMFORT (like someone is sitting on his chest/a feeling of pressure on his chest), NASAL CONGESTION (nose has been "clogged up"), ARTHRALGIA (shoulders sore) and MYALGIA ("real sore"/whole body is sore/like he has been beat all over) outcome was unknown.            Concomitant medication was not provided.  Treatment medication include blood thinner (40 mg daily), inhaler.   This case was linked to MOD-2021-404563 (Patient Link).