chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received their booster doses as 0.5ml instead of 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received their booster doses as 0.5ml instead of 0.25 ml) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received their booster doses as 0.5ml instead of 0.25 ml). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Received their booster doses as 0.5ml instead of 0.25 ml) 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.  Nurse reported, three patients received their booster doses as 0.5 ml instead of 0.25 ml on 02-Nov-2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Vaccination site pain
Clinical narrative: weak; soreness in the left (injection) arm; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, VACCINATION SITE PAIN, and FATIGUE in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Began using Humira on 13-May-2021, paused between 24-Jun-2021 and 23-Sep-2021).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA, VACCINATION SITE PAIN, and FATIGUE. At the time of the report, ASTHENIA, VACCINATION SITE PAIN, and FATIGUE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and treatment medications provided.   This case was linked to MOD-2021-381984, MOD-2021-382083 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 3 patients were given full dose as a booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (3 patients were given full dose as a booster) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (3 patients were given full dose as a booster). On 02-Nov-2021, ACCIDENTAL OVERDOSE (3 patients were given full dose as a booster) 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 provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Urticaria
Clinical narrative: Felt crummy; Had hives; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt crummy) and URTICARIA (Had hives) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included ORAL CONTRACEPTIVE NOS, MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] and FISH OIL for an unknown indication.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt crummy) and URTICARIA (Had hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MALAISE (Felt crummy) and URTICARIA (Had hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-382252 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: rapid heart beat and pulse of 128; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (rapid heart beat and pulse of 128) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (rapid heart beat and pulse of 128). At the time of the report, TACHYCARDIA (rapid heart beat and pulse of 128) outcome was unknown.            No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: Felt a little under the weather; Bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt a little under the weather) and MYALGIA (Bit of sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-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 FEELING ABNORMAL (Felt a little under the weather) and MYALGIA (Bit of sore arm). At the time of the report, FEELING ABNORMAL (Felt a little under the weather) and MYALGIA (Bit of sore arm) outcome was unknown.            No concomitant medications were reported No Treatment medications were reported   This case was linked to MOD-2021-382225 (Patient Link).
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Patient had 1st dose with no side effects No concomitant medications were provided. No treatment medications were provided. Patient experienced mild symptoms after second dose ,which patient thinks those symptoms are normal.   This case was linked to MOD-2021-381878 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: Pain under the right breast; This spontaneous case was reported by an other health care professional and describes the occurrence of BREAST PAIN (Pain under the right breast) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Pain under the right breast). At the time of the report, BREAST PAIN (Pain under the right breast) 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 medication was reported. No treatment medication was reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Ear pain, Headache
Clinical narrative: Pains everywhere; Ear pain; Back pain; Joint pain; Headaches; Fever of 100 to 101 degree Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN, EAR PAIN, BACK PAIN, ARTHRALGIA, and HEADACHE in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2021.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced PAIN, EAR PAIN, BACK PAIN, ARTHRALGIA, HEADACHE, and PYREXIA. At the time of the report, PAIN, EAR PAIN, BACK PAIN, ARTHRALGIA, HEADACHE and PYREXIA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 10-Nov-2021, Body temperature 100 to 101 degrees farenheight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were Reported.  Patient felt like Covid-19 again.  No Treatments were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Pains everywhere; Ear pain; Back pain; Joint pain; Headaches; Fever of 100 to 101 degree Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN, EAR PAIN, BACK PAIN, ARTHRALGIA, and HEADACHE in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2021.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced PAIN, EAR PAIN, BACK PAIN, ARTHRALGIA, HEADACHE, and PYREXIA. At the time of the report, PAIN, EAR PAIN, BACK PAIN, ARTHRALGIA, HEADACHE and PYREXIA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 10-Nov-2021, Body temperature 100 to 101 degrees farenheight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were Reported.  Patient felt like Covid-19 again.  No Treatments were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Skin discolouration
Clinical narrative: Discoloration; Rash on both arms and Little spots on patient's arm; Sore arm right after the shot; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Discoloration), PAIN IN EXTREMITY (Sore arm right after the shot) and RASH (Rash on both arms and Little spots on patient's arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.No Medical History information was reported.In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (Sore arm right after the shot). In August 2021, the patient experienced SKIN DISCOLOURATION (Discoloration) and RASH (Rash on both arms and Little spots on patient's arm). At the time of the report, SKIN DISCOLOURATION (Discoloration), PAIN IN EXTREMITY (Sore arm right after the shot) and RASH (Rash on both arms and Little spots on patient's arm) was resolving. Treatment details include Cream.Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: achy; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.In August 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.In September 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy) and PYREXIA (fever). At the time of the report, PAIN (achy) and PYREXIA (fever) had resolved. No concomitant medications were reported. No treatment information was provided.This case was linked to MOD-2021-382345 (Patient Link).
Age: 99.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Dysarthria, Fatigue, Gait inability
Clinical narrative: Adverse effect; Nausea; Vomiting; Could not walk; Very sick; Gargled words; Did not sleep all night; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse effect), GAIT INABILITY (Could not walk), ILLNESS (Very sick), DYSARTHRIA (Gargled words) and INSOMNIA (Did not sleep all night) in a 99-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 026A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL 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 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced GAIT INABILITY (Could not walk), ILLNESS (Very sick), DYSARTHRIA (Gargled words), INSOMNIA (Did not sleep all night) and FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse effect), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, VACCINATION COMPLICATION (Adverse effect), GAIT INABILITY (Could not walk), ILLNESS (Very sick), DYSARTHRIA (Gargled words), INSOMNIA (Did not sleep all night), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) normal. On an unknown date, Body temperature: 97.6 (normal) No fever 97 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant therapy included blood pressure medication. No treatment medication was reported by reporter.  Patient's adverse events except fatigue were recovered by the date of reporting.
Age: 99.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Insomnia, Nausea, Vaccination complication, Vomiting
Clinical narrative: Adverse effect; Nausea; Vomiting; Could not walk; Very sick; Gargled words; Did not sleep all night; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse effect), GAIT INABILITY (Could not walk), ILLNESS (Very sick), DYSARTHRIA (Gargled words) and INSOMNIA (Did not sleep all night) in a 99-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 026A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL 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 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced GAIT INABILITY (Could not walk), ILLNESS (Very sick), DYSARTHRIA (Gargled words), INSOMNIA (Did not sleep all night) and FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse effect), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, VACCINATION COMPLICATION (Adverse effect), GAIT INABILITY (Could not walk), ILLNESS (Very sick), DYSARTHRIA (Gargled words), INSOMNIA (Did not sleep all night), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) normal. On an unknown date, Body temperature: 97.6 (normal) No fever 97 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant therapy included blood pressure medication. No treatment medication was reported by reporter.  Patient's adverse events except fatigue were recovered by the date of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in calf; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in calf) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in calf). At the time of the report, PAIN IN EXTREMITY (pain in calf) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Bone pain, Cough, Crying, Feeling abnormal
Clinical narrative: suffering, feels terrible; Hurts so bad, she never hurt that bad; bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking; Feels sick, can't get out of the bed; emotional and crying; Coughed; Can't walk but is getting better; feels anger and fury.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (suffering, feels terrible,), PAIN (Hurts so bad, she never hurt that bad), BONE PAIN (bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking), ILLNESS (Feels sick, can't get out of the bed) and CRYING (emotional and crying) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 032B21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM, AMLODIPINE, LAMOTRIGINE and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Blood pressure, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Coughing after drug inhalation.   On 07-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 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (suffering, feels terrible,), PAIN (Hurts so bad, she never hurt that bad), BONE PAIN (bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking), ILLNESS (Feels sick, can't get out of the bed), CRYING (emotional and crying), COUGH (Coughed), GAIT DISTURBANCE (Can't walk but is getting better) and ANGER (feels anger and fury.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (suffering, feels terrible,), PAIN (Hurts so bad, she never hurt that bad), BONE PAIN (bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking), ILLNESS (Feels sick, can't get out of the bed), CRYING (emotional and crying), COUGH (Coughed), GAIT DISTURBANCE (Can't walk but is getting better) and ANGER (feels anger and fury.) outcome was unknown.            The Albuterol was provided as treatment for a rescue inhaler.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Illness, Pain
Clinical narrative: suffering, feels terrible; Hurts so bad, she never hurt that bad; bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking; Feels sick, can't get out of the bed; emotional and crying; Coughed; Can't walk but is getting better; feels anger and fury.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (suffering, feels terrible,), PAIN (Hurts so bad, she never hurt that bad), BONE PAIN (bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking), ILLNESS (Feels sick, can't get out of the bed) and CRYING (emotional and crying) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 032B21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM, AMLODIPINE, LAMOTRIGINE and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Blood pressure, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Coughing after drug inhalation.   On 07-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 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (suffering, feels terrible,), PAIN (Hurts so bad, she never hurt that bad), BONE PAIN (bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking), ILLNESS (Feels sick, can't get out of the bed), CRYING (emotional and crying), COUGH (Coughed), GAIT DISTURBANCE (Can't walk but is getting better) and ANGER (feels anger and fury.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (suffering, feels terrible,), PAIN (Hurts so bad, she never hurt that bad), BONE PAIN (bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking), ILLNESS (Feels sick, can't get out of the bed), CRYING (emotional and crying), COUGH (Coughed), GAIT DISTURBANCE (Can't walk but is getting better) and ANGER (feels anger and fury.) outcome was unknown.            The Albuterol was provided as treatment for a rescue inhaler.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Laryngitis, Nasopharyngitis
Clinical narrative: head cold; laryngitis; second vaccination >42 days after the first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination >42 days after the first), NASOPHARYNGITIS (head cold) and LARYNGITIS (laryngitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021321A and 006C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination >42 days after the first). On an unknown date, the patient experienced NASOPHARYNGITIS (head cold) and LARYNGITIS (laryngitis). On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination >42 days after the first) had resolved. At the time of the report, NASOPHARYNGITIS (head cold) and LARYNGITIS (laryngitis) outcome was unknown.            Patient tested negative for COVID-19. Concomitant medications also included antihypertensives .  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired booster dose was given to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment  information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Eustachian tube dysfunction, Injection site pain
Clinical narrative: eustachian tube dysfunction; pain after the injections; This spontaneous case was reported by a consumer and describes the occurrence of EUSTACHIAN TUBE DYSFUNCTION (eustachian tube dysfunction) and INJECTION SITE PAIN (pain after the injections) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (two years ago) in 2019.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced EUSTACHIAN TUBE DYSFUNCTION (eustachian tube dysfunction) and INJECTION SITE PAIN (pain after the injections). At the time of the report, EUSTACHIAN TUBE DYSFUNCTION (eustachian tube dysfunction) and INJECTION SITE PAIN (pain after the injections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. Concomitant medications included medications for the heart condition since two years following heart attack.   This case was linked to MOD-2021-382440, MOD-2021-382441 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia
Clinical narrative: In bed for a day and a half; chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (In bed for a day and a half), CHILLS (chills) and MYALGIA (Body aches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 021C21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack in 2019.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-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 ASTHENIA (In bed for a day and a half), CHILLS (chills) and MYALGIA (Body aches). On 10-Nov-2021, CHILLS (chills) and MYALGIA (Body aches) had resolved. At the time of the report, ASTHENIA (In bed for a day and a half) had resolved.            No treatment medications were reported.  Patient stated that he was taking a string of medications following a heart attack two years ago.   This case was linked to MOD-2021-382440, MOD-2021-382420 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received 0.25ml for the 3rd dose and should have received 0.5ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25ml for the 3rd dose and should have received 0.5ml) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25ml for the 3rd dose and should have received 0.5ml). On 22-Oct-2021, ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25ml for the 3rd dose and should have received 0.5ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: severe aching joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe aching joints) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Asthma and Kidney disorder.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ARTHRALGIA (severe aching joints) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (severe aching joints) had not resolved.            No concomitant medication was provided by reporter.  No treatment drug was provided by reporter.  Within 24-48 hours, patient began experiencing severe aching joints. it been almost constant.  Company comment: This is a spontaneous case concerning a 63 years old, female patient with no clinical history who experienced the unexpected event of ARTHRALGIA The events occurred unknown days after the third dose of mRNA-1273 vaccine The rechallenge is not applicable" as the events occurred after the third dose and no details were provided about the first dose The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-382423 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 63 years old, female patient with no clinical history who experienced the unexpected event of ARTHRALGIA The events occurred unknown days after the third dose of mRNA-1273 vaccine The rechallenge is not applicable" as the events occurred after the third dose and no details were provided about the first dose The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the first shot she only had a sore left arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After the first shot she only had a sore left arm for a couple of days) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy (Surgery Hysterectomy 2017 or 2018). Concurrent medical conditions included Breathing difficult (not gotten worst after vaccination) and Low blood pressure.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (After the first shot she only had a sore left arm for a couple of days). On 08-May-2021, PAIN IN EXTREMITY (After the first shot she only had a sore left arm for a couple of days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-382581 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Inappropriate schedule of product administration
Clinical narrative: she was experiencing arthritic pain and discomfort; Inappropriate schedule of vaccine administered; she was experiencing arthritic pain and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (she was experiencing arthritic pain and discomfort), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ARTHRALGIA (she was experiencing arthritic pain and discomfort) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21a) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (Johnson and Johnsons COVID-19 Vaccine (1st dose)) on 29-Mar-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26 (JNJ 78436735). Concurrent medical conditions included Pain (had problems with her right hip). Concomitant products included IBUPROFEN for Hip discomfort.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced DISCOMFORT (she was experiencing arthritic pain and discomfort), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ARTHRALGIA (she was experiencing arthritic pain and discomfort). On 10-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, DISCOMFORT (she was experiencing arthritic pain and discomfort) and ARTHRALGIA (she was experiencing arthritic pain and discomfort) outcome was unknown.            No treatment medication was given.  Patient is taking booster dose of Moderna COVID-19 Vaccine. Patient had arthritic pain 3 and half hours after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received on 10-Nov-2021, contains no new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Minor soreness/minor pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (minor soreness/minor pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN HCL, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), FOSINOPRIL, ROSUVASTATIN, TROSPIUM CHLORIDE, SERTRALINE, ANASTROZOLE, AMLODIPINE, MAGNESIUM, ZINC, COLECALCIFEROL (D3), VITAMIN B12 [VITAMIN B12 NOS] and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (minor soreness/minor pain). On 24-Jan-2021, VACCINATION SITE PAIN (minor soreness/minor pain) 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 Treatment information was reported.   This case was linked to MOD-2021-381883, MOD-2021-382532 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: minor pain / soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor pain / soreness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN HCL, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), FOSINOPRIL, ROSUVASTATIN, TROSPIUM CHLORIDE, SERTRALINE, ANASTROZOLE, AMLODIPINE, MAGNESIUM, ZINC, COLECALCIFEROL (D3), CYANOCOBALAMIN (B12-VITAMIIN) and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (minor pain / soreness). At the time of the report, PAIN (minor pain / soreness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-382531, MOD-2021-381883 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever days after booster dose; Patient felt nauseated; Felt achy days after booster dose; Patient received first dose of Moderna on 28/Jan/2021 and second dose on 25/Jun/2021; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Felt achy days after booster dose), PYREXIA (Fever days after booster dose), NAUSEA (Patient felt nauseated) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna on 28/Jan/2021 and second dose on 25/Jun/2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 002A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS, Cough and Sinus disorder (Sinus issue).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna on 28/Jan/2021 and second dose on 25/Jun/2021). On 08-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Felt achy days after booster dose). On 09-Nov-2021, the patient experienced NAUSEA (Patient felt nauseated). On 10-Nov-2021, the patient experienced PYREXIA (Fever days after booster dose). On 25-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna on 28/Jan/2021 and second dose on 25/Jun/2021) had resolved. At the time of the report, MYALGIA (Felt achy days after booster dose), PYREXIA (Fever days after booster dose) and NAUSEA (Patient felt nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: negative (Negative) Negative.         No Concomitant medications were reported. No Treatment information was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: a bit of a sore throat; very achy; upset stomach; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (a bit of a sore throat), PAIN (very achy), ABDOMINAL DISCOMFORT (upset stomach) and PYREXIA (low-grade fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (a bit of a sore throat), PAIN (very achy), ABDOMINAL DISCOMFORT (upset stomach) and PYREXIA (low-grade fever). At the time of the report, OROPHARYNGEAL PAIN (a bit of a sore throat), PAIN (very achy), ABDOMINAL DISCOMFORT (upset stomach) and PYREXIA (low-grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Body temperature: low (Low) fever.         No treatment details were reported.  She was not a fever person; she did not get fever when she gets the flu.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure fluctuation, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Felt miserable; up and down blood pressure; difficulty breathing/shortness of breath; swelling of the throat; dizziness; weakness; memory would come and go; rash all over her body; headache; swelling of the glands; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt miserable), BLOOD PRESSURE FLUCTUATION (up and down blood pressure), DYSPNOEA (difficulty breathing/shortness of breath), PHARYNGEAL SWELLING (swelling of the throat) and DIZZINESS (dizziness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson COVID-19 Vaccine (The vaccine was given by Intramuscular route and anatomical approach site is left deltoid. Lot and expiration date unknown.) on 09-May-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 Vaccine. Concurrent medical conditions included Hypertension.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Nov-2021, the patient experienced FEELING ABNORMAL (Felt miserable), BLOOD PRESSURE FLUCTUATION (up and down blood pressure), DYSPNOEA (difficulty breathing/shortness of breath), PHARYNGEAL SWELLING (swelling of the throat), DIZZINESS (dizziness), ASTHENIA (weakness), MEMORY IMPAIRMENT (memory would come and go), RASH (rash all over her body), HEADACHE (headache) and LYMPHADENOPATHY (swelling of the glands). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt miserable), BLOOD PRESSURE FLUCTUATION (up and down blood pressure), DYSPNOEA (difficulty breathing/shortness of breath), PHARYNGEAL SWELLING (swelling of the throat), DIZZINESS (dizziness), ASTHENIA (weakness), MEMORY IMPAIRMENT (memory would come and go), HEADACHE (headache) and LYMPHADENOPATHY (swelling of the glands) was resolving and RASH (rash all over her body) had not resolved.            Concomitant product code is given has blood pressure medication and description is given has Once daily.  Patient stated she did not have a fast heartbeat.  On 10 NOV 2021, Patient reported she still has the rash but it is not as bad.   Reporter did not allow further contact