chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Therapeutic response unexpected, Underdose
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (She thinks this triggered an immune response that helped with inflammation she had), UNDERDOSE (She then had the vaccine where she got the half dose booster) and PYREXIA (fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 025B21A and 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Fibromyalgia and Cervical spine degeneration. Concomitant products included DULOXETINE, PREGABALIN (LYRICA), AMFETAMINE SULFATE (AMPHETAMINE SALTS), ATENOLOL, FLUTICASONE and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021 at 10:50 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced UNDERDOSE (She then had the vaccine where she got the half dose booster). On 14-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She thinks this triggered an immune response that helped with inflammation she had). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She thinks this triggered an immune response that helped with inflammation she had) and UNDERDOSE (She then had the vaccine where she got the half dose booster) outcome was unknown and PYREXIA (fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received half dose booster of Moderna COVID-19 vaccine. She drank a lot of water and the next day she got a fever and she woke up in the middle of the night to take Tylenol. She went back to sleep and she woke up feeling better. Her neck felt better than she had since Sep-2021. She thinks this triggered an immune response that helped with inflammation she had.  Patient had comorbidities that that were diagnosed years prior receiving any Moderna COVID-19 vaccination (about 8 years prior   This case was linked to MOD-2021-418615 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004c21a and 027b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-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 (soreness in her arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) 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, PAIN IN EXTREMITY (soreness in her arm) outcome was unknown.            No concomitant medication was reported by the reporter.   This case was linked to MOD-2021-416998, MOD-2021-417005 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: both legs swelled after she received her second Moderna Covid-19 vaccine,Both of the patient's feet  were swollen.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (both legs swelled after she received her second Moderna Covid-19 vaccine,Both of the patient's feet  were swollen.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu shot (Patient states that the flu shot always takes her out.). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Chronic kidney disease stage 4 and Sodium. Concomitant products included LOSARTAN, CLONIDINE, ALLOPURINOL and FUROSEMIDE 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 01-Apr-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 PERIPHERAL SWELLING (both legs swelled after she received her second Moderna Covid-19 vaccine,Both of the patient's feet  were swollen.). At the time of the report, PERIPHERAL SWELLING (both legs swelled after she received her second Moderna Covid-19 vaccine,Both of the patient's feet  were swollen.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications are provided.  The patients Doctor says that the shot had nothing to do with it and that the patient's Blood Pressure medication is too blame. The patients feet are no longer swollen. The feet swelling got better after 3 weeks. The right leg swelling is better. The right leg swelling improved 3 to 5 weeks after the second Moderna Covid-19 vaccine. Left leg swelling remains an issue.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Myalgia, Ocular discomfort
Clinical narrative: Headache like a pressure on the back of her eyes; Back pain; Pain in her hands; Physical myalgia, muscle pain; Headache like a pressure on the back of her eyes, pain in her temples; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Headache like a pressure on the back of her eyes), BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain in her hands), MYALGIA (Physical myalgia, muscle pain) and HEADACHE (Headache like a pressure on the back of her eyes, pain in her temples) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer covid-19 vaccine (intramuscular injection) on 03-Mar-2021 and Pfizer covid-19 vaccine (intramuscular injection) on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer covid-19 vaccine and Pfizer covid-19 vaccine.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Dec-2021, the patient experienced OCULAR DISCOMFORT (Headache like a pressure on the back of her eyes), BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain in her hands), MYALGIA (Physical myalgia, muscle pain), HEADACHE (Headache like a pressure on the back of her eyes, pain in her temples) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 16-Dec-2021 for Pain, at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (Headache like a pressure on the back of her eyes), BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain in her hands), MYALGIA (Physical myalgia, muscle pain), HEADACHE (Headache like a pressure on the back of her eyes, pain in her temples) and ARTHRALGIA (Joint pain) had not resolved.            Concomitant drugs were not reported.   This case was linked to MOD-2021-417512 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Headache like a pressure on the back of her eyes; Back pain; Pain in her hands; Physical myalgia, muscle pain; Headache like a pressure on the back of her eyes, pain in her temples; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Headache like a pressure on the back of her eyes), BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain in her hands), MYALGIA (Physical myalgia, muscle pain) and HEADACHE (Headache like a pressure on the back of her eyes, pain in her temples) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer covid-19 vaccine (intramuscular injection) on 03-Mar-2021 and Pfizer covid-19 vaccine (intramuscular injection) on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer covid-19 vaccine and Pfizer covid-19 vaccine.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Dec-2021, the patient experienced OCULAR DISCOMFORT (Headache like a pressure on the back of her eyes), BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain in her hands), MYALGIA (Physical myalgia, muscle pain), HEADACHE (Headache like a pressure on the back of her eyes, pain in her temples) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 16-Dec-2021 for Pain, at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (Headache like a pressure on the back of her eyes), BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain in her hands), MYALGIA (Physical myalgia, muscle pain), HEADACHE (Headache like a pressure on the back of her eyes, pain in her temples) and ARTHRALGIA (Joint pain) had not resolved.            Concomitant drugs were not reported.   This case was linked to MOD-2021-417512 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Nasal congestion, Nasal inflammation
Clinical narrative: inside of my nostril was swelled up; couldn't pass anything through; problems breathing through left nostril/during the night patient noticed breathing in the left nostril was not there; tied up around my body; tired; runny nose that is running like crazy; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose that is running like crazy), NASAL INFLAMMATION (inside of my nostril was swelled up), NASAL CONGESTION (couldn't pass anything through), DYSPNOEA (problems breathing through left nostril/during the night patient noticed breathing in the left nostril was not there) and FEELING ABNORMAL (tied up around my body) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (It was reported that patient does have a problem with his left nostril in terms of getting a runny nose, depending on conditions of climate).   On 26-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 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced RHINORRHOEA (runny nose that is running like crazy). On 16-Dec-2021, the patient experienced NASAL INFLAMMATION (inside of my nostril was swelled up), NASAL CONGESTION (couldn't pass anything through), DYSPNOEA (problems breathing through left nostril/during the night patient noticed breathing in the left nostril was not there), FEELING ABNORMAL (tied up around my body) and FATIGUE (tired). At the time of the report, RHINORRHOEA (runny nose that is running like crazy), NASAL INFLAMMATION (inside of my nostril was swelled up), NASAL CONGESTION (couldn't pass anything through), DYSPNOEA (problems breathing through left nostril/during the night patient noticed breathing in the left nostril was not there), FEELING ABNORMAL (tied up around my body) and FATIGUE (tired) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided. .
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: inside of my nostril was swelled up; couldn't pass anything through; problems breathing through left nostril/during the night patient noticed breathing in the left nostril was not there; tied up around my body; tired; runny nose that is running like crazy; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose that is running like crazy), NASAL INFLAMMATION (inside of my nostril was swelled up), NASAL CONGESTION (couldn't pass anything through), DYSPNOEA (problems breathing through left nostril/during the night patient noticed breathing in the left nostril was not there) and FEELING ABNORMAL (tied up around my body) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (It was reported that patient does have a problem with his left nostril in terms of getting a runny nose, depending on conditions of climate).   On 26-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 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced RHINORRHOEA (runny nose that is running like crazy). On 16-Dec-2021, the patient experienced NASAL INFLAMMATION (inside of my nostril was swelled up), NASAL CONGESTION (couldn't pass anything through), DYSPNOEA (problems breathing through left nostril/during the night patient noticed breathing in the left nostril was not there), FEELING ABNORMAL (tied up around my body) and FATIGUE (tired). At the time of the report, RHINORRHOEA (runny nose that is running like crazy), NASAL INFLAMMATION (inside of my nostril was swelled up), NASAL CONGESTION (couldn't pass anything through), DYSPNOEA (problems breathing through left nostril/during the night patient noticed breathing in the left nostril was not there), FEELING ABNORMAL (tied up around my body) and FATIGUE (tired) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided. .
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Stomatitis, Swelling, Swelling face
Clinical narrative: Facial swelling after booster; Swollen Mouth; Open sores in the mouth after booster; Swollen Throat; Very uncomfortable after booster; Swollen after booster//swollen Head after booster; Itchy after booster; Allergic reaction after booster; Fever 101F after booster; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling after booster), MOUTH SWELLING (Swollen Mouth), STOMATITIS (Open sores in the mouth after booster), PHARYNGEAL SWELLING (Swollen Throat) and DISCOMFORT (Very uncomfortable after booster) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 045B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic shock. Concurrent medical conditions included Soy allergy (She thinks that PEG 2000 in the vaccine came from Soy).   On 30-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 13-Dec-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced SWELLING FACE (Facial swelling after booster), MOUTH SWELLING (Swollen Mouth), STOMATITIS (Open sores in the mouth after booster), PHARYNGEAL SWELLING (Swollen Throat), DISCOMFORT (Very uncomfortable after booster), SWELLING (Swollen after booster//swollen Head after booster), PRURITUS (Itchy after booster), HYPERSENSITIVITY (Allergic reaction after booster) and PYREXIA (Fever 101F after booster). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 15-Dec-2021, PYREXIA (Fever 101F after booster) had resolved. At the time of the report, SWELLING FACE (Facial swelling after booster), MOUTH SWELLING (Swollen Mouth), PHARYNGEAL SWELLING (Swollen Throat), SWELLING (Swollen after booster//swollen Head after booster) and PRURITUS (Itchy after booster) had not resolved and STOMATITIS (Open sores in the mouth after booster), DISCOMFORT (Very uncomfortable after booster) and HYPERSENSITIVITY (Allergic reaction after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2021, Body temperature: 101 (abnormal) Fever 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported.  Patient thinks that PEG 2000 in the vaccine came from Soy and say she did not have anything else at the time that would cause an allergic reaction. Patient also stated  many years ago patient took Tylenol FLU blue liquid and had a anaphylactic reaction to it and had to use EpiPen at the ER
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Pain in extremity, Vaccination complication
Clinical narrative: minor problems after vaccination; sore arm,little sore after other doses; she felt blah; chills for about 2 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (minor problems after vaccination), PAIN IN EXTREMITY (sore arm,little sore after other doses), DISCOMFORT (she felt blah) and CHILLS (chills for about 2 hours) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03121A, 027A214 and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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. In December 2021, the patient experienced VACCINATION COMPLICATION (minor problems after vaccination), PAIN IN EXTREMITY (sore arm,little sore after other doses), DISCOMFORT (she felt blah) and CHILLS (chills for about 2 hours). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. In December 2021, VACCINATION COMPLICATION (minor problems after vaccination), PAIN IN EXTREMITY (sore arm,little sore after other doses), DISCOMFORT (she felt blah) and CHILLS (chills for about 2 hours) had resolved.            Concomitant product use was not provided by the reporter.  Also confirmed the email address.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: waves of pain a week after the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (waves of pain a week after the shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 028L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (waves of pain a week after the shot). At the time of the report, PAIN (waves of pain a week after the shot) outcome was unknown.            No concomitant drug medication was reported.  No treatment medication was provided.   This case was linked to MOD-2021-417554, MOD-2021-058152 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: had been fatigue the day after getting the first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (had been fatigue the day after getting the first and second dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (had been fatigue the day after getting the first and second dose). At the time of the report, FATIGUE (had been fatigue the day after getting the first and second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-417520, MOD-2021-058152 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  No treatment information was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: not feeling good; very tired; no appetite; started with severe horrible pain over her entire body; body aches; chills/severe chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), PAIN (started with severe horrible pain over her entire body), FEELING ABNORMAL (not feeling good), FATIGUE (very tired) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: jhonson and jhonson. Past adverse reactions to the above products included No adverse event with jhonson and jhonson.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PAIN (started with severe horrible pain over her entire body), MYALGIA (body aches) and CHILLS (chills/severe chills). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), FEELING ABNORMAL (not feeling good) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (no appetite), FEELING ABNORMAL (not feeling good) and FATIGUE (very tired) outcome was unknown and PAIN (started with severe horrible pain over her entire body), MYALGIA (body aches) and CHILLS (chills/severe chills) had not resolved.            Patient is taking some concomitant medication but did not specify what they are.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: not feeling good; very tired; no appetite; started with severe horrible pain over her entire body; body aches; chills/severe chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), PAIN (started with severe horrible pain over her entire body), FEELING ABNORMAL (not feeling good), FATIGUE (very tired) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: jhonson and jhonson. Past adverse reactions to the above products included No adverse event with jhonson and jhonson.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PAIN (started with severe horrible pain over her entire body), MYALGIA (body aches) and CHILLS (chills/severe chills). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), FEELING ABNORMAL (not feeling good) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (no appetite), FEELING ABNORMAL (not feeling good) and FATIGUE (very tired) outcome was unknown and PAIN (started with severe horrible pain over her entire body), MYALGIA (body aches) and CHILLS (chills/severe chills) had not resolved.            Patient is taking some concomitant medication but did not specify what they are.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fall, Gait disturbance
Clinical narrative: collapse; was awake but couldn't  stand; when was able to stand couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of FALL (collapse), DYSSTASIA (was awake but couldn't  stand) and GAIT DISTURBANCE (when was able to stand couldn't walk) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced FALL (collapse), DYSSTASIA (was awake but couldn't  stand) and GAIT DISTURBANCE (when was able to stand couldn't walk). At the time of the report, FALL (collapse), DYSSTASIA (was awake but couldn't  stand) and GAIT DISTURBANCE (when was able to stand couldn't walk) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Patient reported that she had the events again on the 01-Apr-2021, and fell for two days.   This case was linked to MOD-2021-417742 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm reaction) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Covid arm reaction). At the time of the report, VACCINATION SITE REACTION (Covid arm reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.  The patient had COVID arm reaction on the arm that came 7 days later but went away after a couple of days.   This case was linked to MOD-2021-418247 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: HCP stated that she administered a vaccine to a patient, and then they had a leak out from the syringe (she applied less than the recommended dose); they had a leak out from the syring; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (HCP stated that she administered a vaccine to a patient, and then they had a leak out from the syringe (she applied less than the recommended dose)) and SYRINGE ISSUE (they had a leak out from the syring) 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 UNDERDOSE (HCP stated that she administered a vaccine to a patient, and then they had a leak out from the syringe (she applied less than the recommended dose)) and SYRINGE ISSUE (they had a leak out from the syring). At the time of the report, UNDERDOSE (HCP stated that she administered a vaccine to a patient, and then they had a leak out from the syringe (she applied less than the recommended dose)) and SYRINGE ISSUE (they had a leak out from the syring) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was an HCP stated that they administered a vaccine to a patient, and they had a leak out from the syringe, the reporter applied less than the recommended dose and stated that they don't have the information of the patient, but they think it was a booster dose.  Later, the reporter stated that they really didn't administered the vaccine, and they were probing the syringes and they had a leak.  No Concomitant product use was reported. No treatment information was provided.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Duodenogastric reflux, Hyperhidrosis, Mobility decreased, Palpitations
Clinical narrative: a lot of times I am weak; sweating; Had to lie down; Throwing out bile; Heart beats really fast; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (a lot of times I am weak), HYPERHIDROSIS (sweating), MOBILITY DECREASED (Had to lie down), DUODENOGASTRIC REFLUX (Throwing out bile) and PALPITATIONS (Heart beats really fast) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A, lot 032B21A and lot 036B21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-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 ASTHENIA (a lot of times I am weak), HYPERHIDROSIS (sweating), MOBILITY DECREASED (Had to lie down), DUODENOGASTRIC REFLUX (Throwing out bile) and PALPITATIONS (Heart beats really fast). At the time of the report, ASTHENIA (a lot of times I am weak), HYPERHIDROSIS (sweating), MOBILITY DECREASED (Had to lie down), DUODENOGASTRIC REFLUX (Throwing out bile) and PALPITATIONS (Heart beats really fast) outcome was unknown.            Patient was scheduled for a colonoscopy. Patient heart beats really fast, so she has to lie down in order to feel better. No concomitant medications were reported. Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-417298 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Fatigue, Vaccination site pain
Clinical narrative: Experienced sore arms for a few days; Some general fatigue for a few days, but no other effects from the booster; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Experienced sore arms for a few days) and FATIGUE (Some general fatigue for a few days, but no other effects from the booster) in a 72-year-old female patient 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) (Intramuscular) 1 dosage form. In October 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 VACCINATION SITE PAIN (Experienced sore arms for a few days) and FATIGUE (Some general fatigue for a few days, but no other effects from the booster). At the time of the report, VACCINATION SITE PAIN (Experienced sore arms for a few days) and FATIGUE (Some general fatigue for a few days, but no other effects from the booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antibody test: 440 440 S antibodies. In December 2021, Antibody test: 2500 2500 S antibodies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  The patient was not tested positive for the N antibodies indicating that she did not had COVID.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Previously administered products included for Tetanus: Tetanus (104 fever 1 week). Past adverse reactions to the above products included Fever with Tetanus. Concurrent medical conditions included Hay fever.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that the patient visited emergency room on 18-Mar-2021 and was prescribed a cream and was given a shot. It was also reported that by 20-Mar-2021 the symptom was worse and the patient was back to emergency room on 21-Mar-2021 and was prescribed with Proctozone pills. Patient had no medical conditions like anaphylaxis reaction, asthma and hypersensitivity reactions. Patient had received a call to get third booster and she stated that she was going to ask her GP about this.   This case was linked to MOD-2021-385778 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Scab
Clinical narrative: Had this sise effect where a scab came over the top of where the shot was/fall off but then come back again; This spontaneous case was reported by a consumer and describes the occurrence of SCAB (Had this sise effect where a scab came over the top of where the shot was/fall off but then come back again) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A, 022M20A and 939903) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (MULTIVITAMINUM), VITAMIN C [ASCORBIC ACID], METFORMIN, LETROZOLE, EZETIMIBE (ZETIA), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), CARVEDILOL (COREG), ACETYLSALICYLIC ACID (ASPIRIN 81) and AMLODIPINE BESILATE (NORVASC) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-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 SCAB (Had this sise effect where a scab came over the top of where the shot was/fall off but then come back again). At the time of the report, SCAB (Had this sise effect where a scab came over the top of where the shot was/fall off but then come back again) outcome was unknown.            No medical history information was provided by the reporter. No treatment medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired booster shot of moderna vaccine administered to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster shot of moderna vaccine administered to a patient) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 15-Apr-2021 and Pfizer on 08-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster shot of moderna vaccine administered to a patient). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired booster shot of moderna vaccine administered to a patient) had resolved.        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.  Vaccine was given to a patient on 17 Dec 2021 after it was expired on 16 Dec 2021. The vial was initially stored in the refrigerator on 14 Dec 2021 and it was first punctured on 16 Dec 2021 at 10am PST and administered on 17 Dec 2021 at 10am PST.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects (pretty long term); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects (pretty long term)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects (pretty long term)). At the time of the report, VACCINATION COMPLICATION (Side effects (pretty long term)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Pyrexia
Clinical narrative: a horrible migraine for a few days; Fever 100.2 F after first shot; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (a horrible migraine for a few days) and PYREXIA (Fever 100.2 F after first shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MIGRAINE (a horrible migraine for a few days) and PYREXIA (Fever 100.2 F after first shot). On 24-Jan-2021, MIGRAINE (a horrible migraine for a few days) and PYREXIA (Fever 100.2 F after first shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 100.2 f (High) 100.2 F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-022019 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arms hurts a lot; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arms hurts a lot) 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 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (arms hurts a lot). At the time of the report, PAIN IN EXTREMITY (arms hurts a lot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided.   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hypersensitivity, Pain, Pruritus, Pyrexia
Clinical narrative: A little bit of fever of 100.1 degrees Fahrenheit; Bad covid arm reaction; Painful/pain is very bad; Itchy; Warm to the touch; Swollen; Was like an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad covid arm reaction), PAIN (Painful/pain is very bad), PRURITUS (Itchy), SKIN WARM (Warm to the touch) and SWELLING (Swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 036B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION SITE REACTION (Bad covid arm reaction), PAIN (Painful/pain is very bad), PRURITUS (Itchy), SKIN WARM (Warm to the touch), SWELLING (Swollen) and HYPERSENSITIVITY (Was like an allergic reaction). On 16-Dec-2021, the patient experienced PYREXIA (A little bit of fever of 100.1 degrees Fahrenheit). At the time of the report, VACCINATION SITE REACTION (Bad covid arm reaction), PAIN (Painful/pain is very bad), PRURITUS (Itchy), SKIN WARM (Warm to the touch), SWELLING (Swollen), HYPERSENSITIVITY (Was like an allergic reaction) and PYREXIA (A little bit of fever of 100.1 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, Body temperature: 100.1 (High) 100.1 degrees Fahrenheit.         No any concomitant medications were reported. No any treatment medications were reported.  The patient stated that the reaction circle grew every day.   This case was linked to MOD-2021-417907 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling, Vaccination site reaction
Clinical narrative: A little bit of fever of 100.1 degrees Fahrenheit; Bad covid arm reaction; Painful/pain is very bad; Itchy; Warm to the touch; Swollen; Was like an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad covid arm reaction), PAIN (Painful/pain is very bad), PRURITUS (Itchy), SKIN WARM (Warm to the touch) and SWELLING (Swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 036B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION SITE REACTION (Bad covid arm reaction), PAIN (Painful/pain is very bad), PRURITUS (Itchy), SKIN WARM (Warm to the touch), SWELLING (Swollen) and HYPERSENSITIVITY (Was like an allergic reaction). On 16-Dec-2021, the patient experienced PYREXIA (A little bit of fever of 100.1 degrees Fahrenheit). At the time of the report, VACCINATION SITE REACTION (Bad covid arm reaction), PAIN (Painful/pain is very bad), PRURITUS (Itchy), SKIN WARM (Warm to the touch), SWELLING (Swollen), HYPERSENSITIVITY (Was like an allergic reaction) and PYREXIA (A little bit of fever of 100.1 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, Body temperature: 100.1 (High) 100.1 degrees Fahrenheit.         No any concomitant medications were reported. No any treatment medications were reported.  The patient stated that the reaction circle grew every day.   This case was linked to MOD-2021-417907 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart damage; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIAC DISORDER (Heart damage) in a 37-year-old male patient 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 CARDIAC DISORDER (Heart damage). At the time of the report, CARDIAC DISORDER (Heart damage) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. No treatment medication were reported.