chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Epistaxis, Nasal congestion, Oropharyngeal pain
Clinical narrative: Dry throat; little bloody nose; Sore throat; congested nose; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (congested nose), DRY THROAT (Dry throat), EPISTAXIS (little bloody nose) and OROPHARYNGEAL PAIN (Sore throat) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced NASAL CONGESTION (congested nose) and OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced DRY THROAT (Dry throat) and EPISTAXIS (little bloody nose). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) on 11-May-2021 for Allergy, at a dose of 10 mg and LORATADINE (LORATADIN) on 12-May-2021 for Allergy, at a dose of 10 mg. At the time of the report, NASAL CONGESTION (congested nose), DRY THROAT (Dry throat), EPISTAXIS (little bloody nose) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: A taste in my mouth you wouldn't believe, affected my taste; Parosmia, a rancid smelling aftermath of COVID-19, affected my smell; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (A taste in my mouth you wouldn't believe, affected my taste) and PAROSMIA (Parosmia, a rancid smelling aftermath of COVID-19, affected my smell) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included POTASSIUM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced TASTE DISORDER (A taste in my mouth you wouldn't believe, affected my taste) and PAROSMIA (Parosmia, a rancid smelling aftermath of COVID-19, affected my smell). The patient was treated with CALCIUM LEVOMEFOLATE (METHYL FOLATE) at an unspecified dose and frequency and THIOCTIC ACID (ALPHA LIPOIC SUSTAIN) at an unspecified dose and frequency. At the time of the report, TASTE DISORDER (A taste in my mouth you wouldn't believe, affected my taste) and PAROSMIA (Parosmia, a rancid smelling aftermath of COVID-19, affected my smell) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication included unspecified medications for hypertension and cholesterol.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-JUN-2021. TCR received: all the events updated to not recovered.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling started immediately on the right side of my entire body; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingling started immediately on the right side of my entire body) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 032B21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (Tingling started immediately on the right side of my entire body). At the time of the report, PARAESTHESIA (Tingling started immediately on the right side of my entire body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication information was not provided.  Treatment medication information was not provided.   This case was linked to MOD-2021-127235 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash on back and legs.; Hives on back and legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back and legs.) and URTICARIA (Hives on back and legs) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced RASH (Rash on back and legs.) and URTICARIA (Hives on back and legs). At the time of the report, RASH (Rash on back and legs.) and URTICARIA (Hives on back and legs) outcome was unknown.            No concomitant medication was reported. The treatment information was unknown. Action taken with mRNA-1273 in response to the events were not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: did not feel well enough to go in for her second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well enough to go in for her second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (did not feel well enough to go in for her second shot). At the time of the report, MALAISE (did not feel well enough to go in for her second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Chills
Clinical narrative: temperature changes; a lot of chills; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE FLUCTUATION (temperature changes) and CHILLS (a lot of chills) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced BODY TEMPERATURE FLUCTUATION (temperature changes) and CHILLS (a lot of chills). At the time of the report, BODY TEMPERATURE FLUCTUATION (temperature changes) and CHILLS (a lot of chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was Not Applicable.  No concomitant medication was reported.     This case was linked to US-MODERNATX, INC.-MOD-2021-127314 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127314:wife's case
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eating disorder, Feeling abnormal, Headache, Insomnia
Clinical narrative: ¨i have terror symptoms¨; ¨could not eat anything¨; ¨My stomach aches a lot ¨; ¨ i could not sleep at night¨; ¨a lot of nauseas, urge to vomit¨; ¨my head is splitting ¨; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (¨i have terror symptoms¨), EATING DISORDER (¨could not eat anything¨), ABDOMINAL PAIN UPPER (¨My stomach aches a lot ¨), INSOMNIA (¨ i could not sleep at night¨) and NAUSEA (¨a lot of nauseas, urge to vomit¨) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and ASCORBIC ACID (VIT C) for an unknown indication.   On 12-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced FEELING ABNORMAL (¨i have terror symptoms¨), EATING DISORDER (¨could not eat anything¨), ABDOMINAL PAIN UPPER (¨My stomach aches a lot ¨), INSOMNIA (¨ i could not sleep at night¨), NAUSEA (¨a lot of nauseas, urge to vomit¨) and HEADACHE (¨my head is splitting ¨). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 UNK. At the time of the report, FEELING ABNORMAL (¨i have terror symptoms¨), EATING DISORDER (¨could not eat anything¨), ABDOMINAL PAIN UPPER (¨My stomach aches a lot ¨), INSOMNIA (¨ i could not sleep at night¨), NAUSEA (¨a lot of nauseas, urge to vomit¨) and HEADACHE (¨my head is splitting ¨) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment information was unknown. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-127310 (E2B Linked Report). This case was linked to MOD-2021-083394 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127310:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: ¨i have terror symptoms¨; ¨could not eat anything¨; ¨My stomach aches a lot ¨; ¨ i could not sleep at night¨; ¨a lot of nauseas, urge to vomit¨; ¨my head is splitting ¨; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (¨i have terror symptoms¨), EATING DISORDER (¨could not eat anything¨), ABDOMINAL PAIN UPPER (¨My stomach aches a lot ¨), INSOMNIA (¨ i could not sleep at night¨) and NAUSEA (¨a lot of nauseas, urge to vomit¨) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and ASCORBIC ACID (VIT C) for an unknown indication.   On 12-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced FEELING ABNORMAL (¨i have terror symptoms¨), EATING DISORDER (¨could not eat anything¨), ABDOMINAL PAIN UPPER (¨My stomach aches a lot ¨), INSOMNIA (¨ i could not sleep at night¨), NAUSEA (¨a lot of nauseas, urge to vomit¨) and HEADACHE (¨my head is splitting ¨). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 UNK. At the time of the report, FEELING ABNORMAL (¨i have terror symptoms¨), EATING DISORDER (¨could not eat anything¨), ABDOMINAL PAIN UPPER (¨My stomach aches a lot ¨), INSOMNIA (¨ i could not sleep at night¨), NAUSEA (¨a lot of nauseas, urge to vomit¨) and HEADACHE (¨my head is splitting ¨) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment information was unknown. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-127310 (E2B Linked Report). This case was linked to MOD-2021-083394 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127310:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Myalgia, Pyrexia
Clinical narrative: Beyond sick; Fever; Chills; Arm hurt; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Beyond sick), MYALGIA (Arm hurt), FATIGUE (Felt tired), PYREXIA (Fever) and CHILLS (Chills) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced MYALGIA (Arm hurt) and FATIGUE (Felt tired). On 10-May-2021, the patient experienced ILLNESS (Beyond sick), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 11-May-2021, ILLNESS (Beyond sick), MYALGIA (Arm hurt), FATIGUE (Felt tired), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-127663 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127663:fiancé case
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Soft tissue pain; Body pain in leg, arm, and back; back pain; Headaches; Fatigue; Body pain in leg, arm, and back; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Soft tissue pain), PAIN IN EXTREMITY (Body pain in leg, arm, and back), BACK PAIN (back pain), HEADACHE (Headaches) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), OMEPRAZOLE and LORAZEPAM for an unknown indication.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Soft tissue pain), PAIN IN EXTREMITY (Body pain in leg, arm, and back), BACK PAIN (back pain), HEADACHE (Headaches), FATIGUE (Fatigue) and MYALGIA (Body pain in leg, arm, and back). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, PAIN (Soft tissue pain), PAIN IN EXTREMITY (Body pain in leg, arm, and back), BACK PAIN (back pain), HEADACHE (Headaches), FATIGUE (Fatigue) and MYALGIA (Body pain in leg, arm, and back) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soft tissue pain; Body pain in leg, arm, and back; back pain; Headaches; Fatigue; Body pain in leg, arm, and back; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Soft tissue pain), PAIN IN EXTREMITY (Body pain in leg, arm, and back), BACK PAIN (back pain), HEADACHE (Headaches) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), OMEPRAZOLE and LORAZEPAM for an unknown indication.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Soft tissue pain), PAIN IN EXTREMITY (Body pain in leg, arm, and back), BACK PAIN (back pain), HEADACHE (Headaches), FATIGUE (Fatigue) and MYALGIA (Body pain in leg, arm, and back). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, PAIN (Soft tissue pain), PAIN IN EXTREMITY (Body pain in leg, arm, and back), BACK PAIN (back pain), HEADACHE (Headaches), FATIGUE (Fatigue) and MYALGIA (Body pain in leg, arm, and back) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were not applicable.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Feeling abnormal, Myalgia, Vomiting
Clinical narrative: Felt I was on steroids; Totally dehydrated; Threw up; Chills; Both arms sore; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Felt I was on steroids), DEHYDRATION (Totally dehydrated), VOMITING (Threw up), CHILLS (Chills) and MYALGIA (Both arms sore) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (Felt I was on steroids), DEHYDRATION (Totally dehydrated), VOMITING (Threw up), CHILLS (Chills) and MYALGIA (Both arms sore). The patient was treated with MECLIZINE [MECLOZINE] ongoing since an unknown date at an unspecified dose and frequency. On 11-Apr-2021, FEELING ABNORMAL (Felt I was on steroids), DEHYDRATION (Totally dehydrated), VOMITING (Threw up) and CHILLS (Chills) had resolved. At the time of the report, MYALGIA (Both arms sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The patient did a CAT scan and blood test.   This case was linked to MOD-2021-127380 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Left arm pain/right arm pain; shingles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm pain/right arm pain) and HERPES ZOSTER (shingles) in a 78-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Left arm pain/right arm pain) and HERPES ZOSTER (shingles). At the time of the report, PAIN IN EXTREMITY (Left arm pain/right arm pain) and HERPES ZOSTER (shingles) outcome was unknown.            Treatment information was not provided. No concomitant medications were reported. Patient stated that she was fully vaccinated.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up received on 13 May 2021 included no new information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of throat irritation (itchy throat) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 17, 2021, patient experienced throat irritation (itchy throat). The patient treated with Benadryl (diphenhydramine hydrochloride); 1 dosage form. On Apr 17, 2021, throat irritation (itchy throat) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. No concomitant medication reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Rash on my chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (Rash on my chest) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Hydroxizine PRN and Xolair- 1 injection monthly for an unknown indication.   On 13-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced URTICARIA (Hives) and RASH (Rash on my chest). The patient was treated with HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, URTICARIA (Hives) and RASH (Rash on my chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pharyngeal swelling, Product dose omission issue
Clinical narrative: Not getting 2nd dose; Sensation in back of throat after the 1st dose; Throat started to swell ,Throat felt swollen after 1st dose; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Sensation in back of throat after the 1st dose), PHARYNGEAL SWELLING (Throat started to swell ,Throat felt swollen after 1st dose) and PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Sensation in back of throat after the 1st dose) and PHARYNGEAL SWELLING (Throat started to swell ,Throat felt swollen after 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose). On 09-Mar-2021, OROPHARYNGEAL DISCOMFORT (Sensation in back of throat after the 1st dose) and PHARYNGEAL SWELLING (Throat started to swell ,Throat felt swollen after 1st dose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication information was not provided.  treatment medication information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine dose leaked out onto patient; Vaccine dose leaked out onto patient; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine dose leaked out onto patient) and DEVICE CONNECTION ISSUE (Vaccine dose leaked out onto patient) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced UNDERDOSE (Vaccine dose leaked out onto patient). 13-May-2021, the patient experienced DEVICE CONNECTION ISSUE (Vaccine dose leaked out onto patient). On 13-May-2021, UNDERDOSE (Vaccine dose leaked out onto patient) and DEVICE CONNECTION ISSUE (Vaccine dose leaked out onto patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Hypoaesthesia, Limb discomfort, Pyrexia
Clinical narrative: Felt hot; Knees aching; Fever; Sore arm/arm pain; Could not move her arm; whole arm went numb; Arm felt weird and painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (whole arm went numb), LIMB DISCOMFORT (Arm felt weird and painful), FEELING HOT (Felt hot), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) and ARTHRALGIA (Knees aching) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus systemic. Concomitant products included HYDROXYCHLOROQUINE for Lupus syndrome.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HYPOAESTHESIA (whole arm went numb), LIMB DISCOMFORT (Arm felt weird and painful), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) and VACCINATION SITE PAIN (Sore arm/arm pain). On 17-Apr-2021, the patient experienced FEELING HOT (Felt hot), ARTHRALGIA (Knees aching) and PYREXIA (Fever). The patient was treated with IBUPROFEN on 17-Apr-2021 at a dose of 200 mg three times a day. On 18-Apr-2021, FEELING HOT (Felt hot), ARTHRALGIA (Knees aching) and PYREXIA (Fever) had resolved. On 19-Apr-2021, HYPOAESTHESIA (whole arm went numb), LIMB DISCOMFORT (Arm felt weird and painful), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) and VACCINATION SITE PAIN (Sore arm/arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-JUN-2021. TCR received: updated events.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Felt hot; Knees aching; Fever; Sore arm/arm pain; Could not move her arm; whole arm went numb; Arm felt weird and painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (whole arm went numb), LIMB DISCOMFORT (Arm felt weird and painful), FEELING HOT (Felt hot), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) and ARTHRALGIA (Knees aching) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus systemic. Concomitant products included HYDROXYCHLOROQUINE for Lupus syndrome.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HYPOAESTHESIA (whole arm went numb), LIMB DISCOMFORT (Arm felt weird and painful), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) and VACCINATION SITE PAIN (Sore arm/arm pain). On 17-Apr-2021, the patient experienced FEELING HOT (Felt hot), ARTHRALGIA (Knees aching) and PYREXIA (Fever). The patient was treated with IBUPROFEN on 17-Apr-2021 at a dose of 200 mg three times a day. On 18-Apr-2021, FEELING HOT (Felt hot), ARTHRALGIA (Knees aching) and PYREXIA (Fever) had resolved. On 19-Apr-2021, HYPOAESTHESIA (whole arm went numb), LIMB DISCOMFORT (Arm felt weird and painful), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) and VACCINATION SITE PAIN (Sore arm/arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-JUN-2021. TCR received: updated events.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: Welts that were raised; Very itchy,rash came back and was all on my arms, super itchy; Aches, pains, the sheet on the bed could not lay on my arm, that's how bad it hurt; I was pretty miserable for a week,; Bone aches; I felt like I had the flu or COVID; Super bad rash on my upper body, especially arms; Nauseous for one day; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts that were raised), PRURITUS (Very itchy,rash came back and was all on my arms, super itchy), PAIN (Aches, pains, the sheet on the bed could not lay on my arm, that's how bad it hurt), FEELING ABNORMAL (I was pretty miserable for a week,) and BONE PAIN (Bone aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HIV disease (undetectable for 10 years) and Immunocompromised. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for Antiretroviral therapy, ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder, MELOXICAM (MOBIC) for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced URTICARIA (Welts that were raised), PRURITUS (Very itchy,rash came back and was all on my arms, super itchy), PAIN (Aches, pains,the sheet on the bed could not lay on my arm, that's how bad it hurt), FEELING ABNORMAL (I was pretty miserable for a week,), BONE PAIN (Bone aches), INFLUENZA LIKE ILLNESS (I felt like I had the flu or COVID), RASH (Super bad rash on my upper body, especially arms), NAUSEA (Nauseous for one day), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. On 20-Apr-2021, NAUSEA (Nauseous for one day) had resolved. On 26-Apr-2021, URTICARIA (Welts that were raised), PRURITUS (Very itchy,rash came back and was all on my arms, super itchy), PAIN (Aches, pains,the sheet on the bed could not lay on my arm, that's how bad it hurt), FEELING ABNORMAL (I was pretty miserable for a week,), BONE PAIN (Bone aches), INFLUENZA LIKE ILLNESS (I felt like I had the flu or COVID), RASH (Super bad rash on my upper body, especially arms), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pruritus, Rash, Urticaria
Clinical narrative: Welts that were raised; Very itchy,rash came back and was all on my arms, super itchy; Aches, pains, the sheet on the bed could not lay on my arm, that's how bad it hurt; I was pretty miserable for a week,; Bone aches; I felt like I had the flu or COVID; Super bad rash on my upper body, especially arms; Nauseous for one day; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts that were raised), PRURITUS (Very itchy,rash came back and was all on my arms, super itchy), PAIN (Aches, pains, the sheet on the bed could not lay on my arm, that's how bad it hurt), FEELING ABNORMAL (I was pretty miserable for a week,) and BONE PAIN (Bone aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HIV disease (undetectable for 10 years) and Immunocompromised. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for Antiretroviral therapy, ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder, MELOXICAM (MOBIC) for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced URTICARIA (Welts that were raised), PRURITUS (Very itchy,rash came back and was all on my arms, super itchy), PAIN (Aches, pains,the sheet on the bed could not lay on my arm, that's how bad it hurt), FEELING ABNORMAL (I was pretty miserable for a week,), BONE PAIN (Bone aches), INFLUENZA LIKE ILLNESS (I felt like I had the flu or COVID), RASH (Super bad rash on my upper body, especially arms), NAUSEA (Nauseous for one day), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. On 20-Apr-2021, NAUSEA (Nauseous for one day) had resolved. On 26-Apr-2021, URTICARIA (Welts that were raised), PRURITUS (Very itchy,rash came back and was all on my arms, super itchy), PAIN (Aches, pains,the sheet on the bed could not lay on my arm, that's how bad it hurt), FEELING ABNORMAL (I was pretty miserable for a week,), BONE PAIN (Bone aches), INFLUENZA LIKE ILLNESS (I felt like I had the flu or COVID), RASH (Super bad rash on my upper body, especially arms), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Gait disturbance
Clinical narrative: I felt dizzy; Walked like if I was drunk,Felt like I was unbalanced; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I felt dizzy) and GAIT DISTURBANCE (Walked like if I was drunk,Felt like I was unbalanced) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced DIZZINESS (I felt dizzy) and GAIT DISTURBANCE (Walked like if I was drunk,Felt like I was unbalanced). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 1 dosage form as required. On 13-May-2021, DIZZINESS (I felt dizzy) and GAIT DISTURBANCE (Walked like if I was drunk,Felt like I was unbalanced) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) unknown. On an unknown date, Computerised tomogram: unknown (Inconclusive) unknown.         Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  Patient was put some fluid but patient was not  able to tell the name of the fluid.   This case was linked to MOD-2021-127338 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Drewup a dose from an expired punctured vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Drewup a dose from an expired punctured vial) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Drewup a dose from an expired punctured vial). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (Drewup a dose from an expired punctured vial) 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.   Concomitant product was not provided by the reporter.  The pharmacist reported that accidentally the immunization technician drew up a dose from an expired punctured vial which was kept for more than 12 hours and was given to patient. As per the pharmacist the patient was doing fine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Movement disorder, Nausea, Neck pain, Pain in extremity
Clinical narrative: Arm hurts,arm still hurts,Sore all the time; Hard to lift it,cannot do much with right arm,barely can lift, have hard time outing her clothes; The pain went into the right side of the neck; Feeling nauseous; First Dose taken on 03Mar2021 and second dose received on 28Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose taken on 03Mar2021 and second dose received on 28Apr2021), PAIN IN EXTREMITY (Arm hurts,arm still hurts,Sore all the time), MOVEMENT DISORDER (Hard to lift it,cannot do much with right arm,barely can lift, have hard time outing her clothes), NECK PAIN (The pain went into the right side of the neck) and NAUSEA (Feeling nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 611A21A and 014C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Cholesterol, Blood pressure high and Heart disorder.   On 03-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 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose taken on 03Mar2021 and second dose received on 28Apr2021). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts,arm still hurts,Sore all the time), MOVEMENT DISORDER (Hard to lift it,cannot do much with right arm,barely can lift, have hard time outing her clothes), NECK PAIN (The pain went into the right side of the neck) and NAUSEA (Feeling nauseous). On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose taken on 03Mar2021 and second dose received on 28Apr2021) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts,arm still hurts,Sore all the time), MOVEMENT DISORDER (Hard to lift it,cannot do much with right arm,barely can lift, have hard time outing her clothes) and NECK PAIN (The pain went into the right side of the neck) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. Concomitant medication reported included medication for cholesterol, medication for heart problem and medication for high blood pressure.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Lymphadenopathy, Musculoskeletal stiffness, Tenderness
Clinical narrative: Glands under arm are swollen; Glands under arm are tender; "chills, but they seem to be in just lower extremities, below my waist."; Jaw went numb; Stiff neck just on one side and not for a long period of time; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Jaw went numb), MUSCULOSKELETAL STIFFNESS (Stiff neck just on one side and not for a long period of time), LYMPHADENOPATHY (Glands under arm are swollen), TENDERNESS (Glands under arm are tender) and CHILLS ("chills, but they seem to be in just lower extremities, below my waist.") in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration. Concomitant products included BILBERRY [VACCINIUM MYRTILLUS], GINKGO BILOBA and CALCIUM for an unknown indication.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced HYPOAESTHESIA (Jaw went numb), MUSCULOSKELETAL STIFFNESS (Stiff neck just on one side and not for a long period of time) and CHILLS ("chills, but they seem to be in just lower extremities, below my waist."). On 12-May-2021, the patient experienced LYMPHADENOPATHY (Glands under arm are swollen) and TENDERNESS (Glands under arm are tender). On 07-May-2021, HYPOAESTHESIA (Jaw went numb), MUSCULOSKELETAL STIFFNESS (Stiff neck just on one side and not for a long period of time) and CHILLS ("chills, but they seem to be in just lower extremities, below my waist.") had resolved. At the time of the report, LYMPHADENOPATHY (Glands under arm are swollen) and TENDERNESS (Glands under arm are tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported also included Complete Eye Health and OPC Synergy. No treatment information was reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Ankle fracture, Fall, Feeling abnormal, Myalgia, SARS-CoV-2 test
Clinical narrative: COVID Fog and was out of it; slipped and fell; fractured my ankle; Pain in the left Arm; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (COVID Fog and was out of it), FALL (slipped and fell), ANKLE FRACTURE (fractured my ankle), VACCINATION SITE PAIN (Pain in the left Arm) and MYALGIA (Body ache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 02-Feb-2021.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced FEELING ABNORMAL (COVID Fog and was out of it), FALL (slipped and fell), ANKLE FRACTURE (fractured my ankle), VACCINATION SITE PAIN (Pain in the left Arm) and MYALGIA (Body ache). On 17-Apr-2021, FALL (slipped and fell) had resolved. On 18-Apr-2021, VACCINATION SITE PAIN (Pain in the left Arm) and MYALGIA (Body ache) had resolved. On 20-Apr-2021, FEELING ABNORMAL (COVID Fog and was out of it) had resolved. At the time of the report, ANKLE FRACTURE (fractured my ankle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.  On an unknown date, the patient was seen by his cardiologist and had an electrocardiogram performed which showed a new finding of a left bundle branch block.  On 17 Apr 2021, approximately 25 minutes after receiving the first dose of the Moderna COVID-19 vaccine, the patient slipped and fell and fractured the ankle. The patient has been seen by physical therapy and had 14 treatments of electro stimulus on the ankle.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14 Jun 2021, included lab data and addition of two new events.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: COVID Fog and was out of it; slipped and fell; fractured my ankle; Pain in the left Arm; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (COVID Fog and was out of it), FALL (slipped and fell), ANKLE FRACTURE (fractured my ankle), VACCINATION SITE PAIN (Pain in the left Arm) and MYALGIA (Body ache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 02-Feb-2021.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced FEELING ABNORMAL (COVID Fog and was out of it), FALL (slipped and fell), ANKLE FRACTURE (fractured my ankle), VACCINATION SITE PAIN (Pain in the left Arm) and MYALGIA (Body ache). On 17-Apr-2021, FALL (slipped and fell) had resolved. On 18-Apr-2021, VACCINATION SITE PAIN (Pain in the left Arm) and MYALGIA (Body ache) had resolved. On 20-Apr-2021, FEELING ABNORMAL (COVID Fog and was out of it) had resolved. At the time of the report, ANKLE FRACTURE (fractured my ankle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.  On an unknown date, the patient was seen by his cardiologist and had an electrocardiogram performed which showed a new finding of a left bundle branch block.  On 17 Apr 2021, approximately 25 minutes after receiving the first dose of the Moderna COVID-19 vaccine, the patient slipped and fell and fractured the ankle. The patient has been seen by physical therapy and had 14 treatments of electro stimulus on the ankle.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14 Jun 2021, included lab data and addition of two new events.