chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Pain in extremity
Clinical narrative: Pain in leg right; Pain in right leg from hip to knee; 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 PAIN IN EXTREMITY (Pain in leg right) and ARTHRALGIA (Pain in right leg from hip to knee) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Father is on High Blood pressure medications  (unspecified)).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in leg right) and ARTHRALGIA (Pain in right leg from hip to knee). The patient was treated with PARACETAMOL (TYLENOL) for Pain in hip and Pain in leg, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in leg right) and ARTHRALGIA (Pain in right leg from hip to knee) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment for the Pain included Tylenol.   It was reported that patients mother had loss of taste just in evening of the day of vaccination and she felt sleepy. She was sleeping for 3/4 hours, and when she woke up she was feeling okay.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: lymph nodes of her knees are swollen/Swollen lymph nodes inguinal; Swollen lymph nodes in arms/swollen lymph nodes knee; Lymph nodes in her both arms were swollen and tender/ inguinal lymph nodes are swollen and tender; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in arms/swollen lymph nodes knee), LYMPH NODE PAIN (Lymph nodes in her both arms were swollen and tender/ inguinal lymph nodes are swollen and tender) and LYMPHADENOPATHY (lymph nodes of her knees are swollen/Swollen lymph nodes inguinal) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic disease (Multiple chronic diseases).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in arms/swollen lymph nodes knee). 11-Mar-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes in her both arms were swollen and tender/ inguinal lymph nodes are swollen and tender). On 12-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes of her knees are swollen/Swollen lymph nodes inguinal). The patient was treated with KETOROLAC for Lymph node pain, at a dose of UNK dosage form. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in arms/swollen lymph nodes knee), LYMPH NODE PAIN (Lymph nodes in her both arms were swollen and tender/ inguinal lymph nodes are swollen and tender) and LYMPHADENOPATHY (lymph nodes of her knees are swollen/Swollen lymph nodes inguinal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on unspecified concomitant medications. It was reported that on 11-Mar-2021, patient's lymph nodes in her both arms were swollen and tender. On 12-Mar-2021 she felt the lymph nodes of her knew are swollen and inguinal lymph nodes were swollen and tender.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia
Clinical narrative: numbness in both hands; tired; light headache; hands turning numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hands turning numb), FATIGUE (tired), HEADACHE (light headache) and HYPOAESTHESIA (numbness in both hands) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HYPOAESTHESIA (hands turning numb). On 11-Mar-2021, the patient experienced FATIGUE (tired) and HEADACHE (light headache). On 12-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in both hands). At the time of the report, HYPOAESTHESIA (hands turning numb), FATIGUE (tired), HEADACHE (light headache) and HYPOAESTHESIA (numbness in both hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Severe blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Severe blurred vision) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03621A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VISION BLURRED (Severe blurred vision). The patient was treated with NAPROXEN SODIUM at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 11-Mar-2021, VISION BLURRED (Severe blurred vision) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Injection site pain, Pain
Clinical narrative: Felt weird; Body ache; Hurt very bad at the injection site; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt weird), PAIN (Body ache), INJECTION SITE PAIN (Hurt very bad at the injection site), CHILLS (Chills) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol and Blood pressure.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING ABNORMAL (Felt weird), PAIN (Body ache), INJECTION SITE PAIN (Hurt very bad at the injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. On 07-Mar-2021, FEELING ABNORMAL (Felt weird), PAIN (Body ache), INJECTION SITE PAIN (Hurt very bad at the injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Felt weird; Body ache; Hurt very bad at the injection site; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt weird), PAIN (Body ache), INJECTION SITE PAIN (Hurt very bad at the injection site), CHILLS (Chills) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol and Blood pressure.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING ABNORMAL (Felt weird), PAIN (Body ache), INJECTION SITE PAIN (Hurt very bad at the injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. On 07-Mar-2021, FEELING ABNORMAL (Felt weird), PAIN (Body ache), INJECTION SITE PAIN (Hurt very bad at the injection site), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Somnolence
Clinical narrative: loss of taste; Sleepy , slept for 4 hours after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) and SOMNOLENCE (Sleepy , slept for 4 hours after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste) and SOMNOLENCE (Sleepy , slept for 4 hours after vaccination). At the time of the report, AGEUSIA (loss of taste) and SOMNOLENCE (Sleepy , slept for 4 hours after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Myalgia
Clinical narrative: Couldn't get out the bed; Severe joint and muscle are aching; Severe joint and muscle are aching; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Couldn't get out the bed), ARTHRALGIA (Severe joint and muscle are aching) and MYALGIA (Severe joint and muscle are aching) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Couldn't get out the bed), ARTHRALGIA (Severe joint and muscle are aching) and MYALGIA (Severe joint and muscle are aching). At the time of the report, GAIT INABILITY (Couldn't get out the bed), ARTHRALGIA (Severe joint and muscle are aching) and MYALGIA (Severe joint and muscle are aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Neck pain, Pyrexia
Clinical narrative: Neck pain; Back pain; Fever; This spontaneous case was reported by a physician and describes the occurrence of NECK PAIN (Neck pain), BACK PAIN (Back pain) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included AMLODIPINE, FLECAINIDE, METOPROLOL and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain), BACK PAIN (Back pain) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain), BACK PAIN (Back pain) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-052077 (E2B Linked Report).; Sender's Comments:  MOD21-052077:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had COVID-19 virus in the past.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness in the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Rash
Clinical narrative: surge of high blood pressure; rash on the side of her body/Rash on back, sides, butt, stomach; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (surge of high blood pressure) and RASH (rash on the side of her body/Rash on back, sides, butt, stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (surge of high blood pressure) and RASH (rash on the side of her body/Rash on back, sides, butt, stomach). The patient was treated with STEROIDS at an unspecified dose and frequency. At the time of the report, HYPERTENSION (surge of high blood pressure) had resolved and RASH (rash on the side of her body/Rash on back, sides, butt, stomach) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm was sore after receiving 1st dose n 22Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore after receiving 1st dose n 22Feb2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 022M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left arm was sore after receiving 1st dose n 22Feb2021). At the time of the report, PAIN IN EXTREMITY (Left arm was sore after receiving 1st dose n 22Feb2021) outcome was unknown. Not Provided          Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Not able to get the 2nd shot in the recommended timeframe; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not able to get the 2nd shot in the recommended timeframe) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not able to get the 2nd shot in the recommended timeframe). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not able to get the 2nd shot in the recommended timeframe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, Rhinorrhoea
Clinical narrative: FOGGY BRAIN; RUNNY NOSE; RAPID HEART BEAT; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (FOGGY BRAIN), RHINORRHOEA (RUNNY NOSE) and HEART RATE INCREASED (RAPID HEART BEAT) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (FOGGY BRAIN), RHINORRHOEA (RUNNY NOSE) and HEART RATE INCREASED (RAPID HEART BEAT). At the time of the report, FEELING ABNORMAL (FOGGY BRAIN), RHINORRHOEA (RUNNY NOSE) and HEART RATE INCREASED (RAPID HEART BEAT) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment was reported for the events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot at the site of injection; itching at the site of injection; swollen arm at the site of injection which is size of golf ball; little sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot at the site of injection), VACCINATION SITE PRURITUS (itching at the site of injection), VACCINATION SITE PAIN (little sore at the injection site) and VACCINATION SITE SWELLING (swollen arm at the site of injection which is size of golf ball) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (little sore at the injection site). On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot at the site of injection), VACCINATION SITE PRURITUS (itching at the site of injection) and VACCINATION SITE SWELLING (swollen arm at the site of injection which is size of golf ball). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site pain, Vaccination site swelling, Vaccination site pruritus and Vaccination site warmth, at an unspecified dose and frequency. On 21-Feb-2021, VACCINATION SITE PAIN (little sore at the injection site) had resolved. On 26-Feb-2021, VACCINATION SITE SWELLING (swollen arm at the site of injection which is size of golf ball) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot at the site of injection) and VACCINATION SITE PRURITUS (itching at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Illness
Clinical narrative: sick; dizzy; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DIZZINESS (dizzy) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Fibromyalgia. Concomitant products included DICLOFENAC SODIUM, MISOPROSTOL (ARTHROTEC) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ILLNESS (sick), DIZZINESS (dizzy) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Mar-2021, ILLNESS (sick) and DIZZINESS (dizzy) had resolved. At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: Left side of my face feels numb; Left side of my face feels weird; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left side of my face feels numb) and FEELING ABNORMAL (Left side of my face feels weird) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HYPOAESTHESIA (Left side of my face feels numb) and FEELING ABNORMAL (Left side of my face feels weird). At the time of the report, HYPOAESTHESIA (Left side of my face feels numb) and FEELING ABNORMAL (Left side of my face feels weird) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Abdominal pain; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Diarrhea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Pepto-Bismol was administered as treatment for the events.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt sick). At the time of the report, MALAISE (felt sick) outcome was unknown.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patients received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eye swelling
Clinical narrative: Eye Swelling; Stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye Swelling) and ABDOMINAL PAIN UPPER (Stomach ache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eye Swelling) and ABDOMINAL PAIN UPPER (Stomach ache). At the time of the report, EYE SWELLING (Eye Swelling) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Onset of Shingles - Between first and second dose of Moderna Vaccine; A spontaneous report  was received from a pharamcist dear concerning a patient (age and gender unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shingles.   The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) for prophylaxis of COVID-19 infection.  On Mar 2021, the patient experienced shingles.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events shingles was considered as unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender with a medically significant event of serious unexpected Herpes zoster. Event onset with unknown latency after the first dose of mRNA-1273. Treatment not reported. Events outcome unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: arm soreness; couldn't sleep at night; firey red and hot; arm swelled up about the size of a baseball; hard knot; painful shoulder; nausea; firey red and hot; very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), INSOMNIA (couldn't sleep at night), VACCINATION SITE WARMTH (firey red and hot), PERIPHERAL SWELLING (arm swelled up about the size of a baseball) and LYMPHADENOPATHY (hard knot) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Anxiety and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), PIROXICAM (PAXIL [PIROXICAM]) for Anxiety, ATORVASTATIN for Cholesterol, ESTRADIOL for Hormone level NOS abnormal, LOSARTAN and AMLODIPINE for Hypertension, DONEPEZIL HYDROCHLORIDE (ARICEPT) for Memory disturbance (excl dementia), GABAPENTIN, BUPROPION and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 12-Mar-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 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), INSOMNIA (couldn't sleep at night), VACCINATION SITE WARMTH (firey red and hot), PERIPHERAL SWELLING (arm swelled up about the size of a baseball), LYMPHADENOPATHY (hard knot), ARTHRALGIA (painful shoulder), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (firey red and hot) and VACCINATION SITE PAIN (very painful). At the time of the report, PAIN IN EXTREMITY (arm soreness), INSOMNIA (couldn't sleep at night), VACCINATION SITE WARMTH (firey red and hot), PERIPHERAL SWELLING (arm swelled up about the size of a baseball), LYMPHADENOPATHY (hard knot), ARTHRALGIA (painful shoulder), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (firey red and hot) and VACCINATION SITE PAIN (very painful) outcome was unknown.            No treatment was taken. The reaction had recovered but at it still hurts sometimes. After the 2nd shot, her arm swelled up about the size of a baseball and it went down to her elbow. It got firey red and hot. It was very painful. She could not sleep at night.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional Events Insomnia, Vaccination site warmth, Peripheral Swelling, Vaccination site erythema, Vaccination site pain are updated.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: arm soreness; couldn't sleep at night; firey red and hot; arm swelled up about the size of a baseball; hard knot; painful shoulder; nausea; firey red and hot; very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), INSOMNIA (couldn't sleep at night), VACCINATION SITE WARMTH (firey red and hot), PERIPHERAL SWELLING (arm swelled up about the size of a baseball) and LYMPHADENOPATHY (hard knot) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Anxiety and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), PIROXICAM (PAXIL [PIROXICAM]) for Anxiety, ATORVASTATIN for Cholesterol, ESTRADIOL for Hormone level NOS abnormal, LOSARTAN and AMLODIPINE for Hypertension, DONEPEZIL HYDROCHLORIDE (ARICEPT) for Memory disturbance (excl dementia), GABAPENTIN, BUPROPION and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 12-Mar-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 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), INSOMNIA (couldn't sleep at night), VACCINATION SITE WARMTH (firey red and hot), PERIPHERAL SWELLING (arm swelled up about the size of a baseball), LYMPHADENOPATHY (hard knot), ARTHRALGIA (painful shoulder), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (firey red and hot) and VACCINATION SITE PAIN (very painful). At the time of the report, PAIN IN EXTREMITY (arm soreness), INSOMNIA (couldn't sleep at night), VACCINATION SITE WARMTH (firey red and hot), PERIPHERAL SWELLING (arm swelled up about the size of a baseball), LYMPHADENOPATHY (hard knot), ARTHRALGIA (painful shoulder), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (firey red and hot) and VACCINATION SITE PAIN (very painful) outcome was unknown.            No treatment was taken. The reaction had recovered but at it still hurts sometimes. After the 2nd shot, her arm swelled up about the size of a baseball and it went down to her elbow. It got firey red and hot. It was very painful. She could not sleep at night.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional Events Insomnia, Vaccination site warmth, Peripheral Swelling, Vaccination site erythema, Vaccination site pain are updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Nausea, Vaccination site pruritus
Clinical narrative: I was adversely sick like when I had covid.; I have a big red rash on my arm; Today still feel squeezy; I have a big red rash on my arm, very very itchy; Wednesday morning when I got up, I had chills and headache; Wednesday morning when I got up, I had chills and headache; I felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Wednesday morning when I got up, I had chills and headache), HEADACHE (Wednesday morning when I got up, I had chills and headache), ILLNESS (I was adversely sick like when I had covid.), NAUSEA (I felt nauseated) and VACCINATION SITE PRURITUS (I have a big red rash on my arm, very very itchy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Left) and COVID-19 in November 2020.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CHILLS (Wednesday morning when I got up, I had chills and headache), HEADACHE (Wednesday morning when I got up, I had chills and headache), NAUSEA (I felt nauseated), VACCINATION SITE PRURITUS (I have a big red rash on my arm, very very itchy) and WHEEZING (Today still feel squeezy). On an unknown date, the patient experienced ILLNESS (I was adversely sick like when I had covid.) and VACCINATION SITE RASH (I have a big red rash on my arm). At the time of the report, CHILLS (Wednesday morning when I got up, I had chills and headache), HEADACHE (Wednesday morning when I got up, I had chills and headache), ILLNESS (I was adversely sick like when I had covid.), NAUSEA (I felt nauseated), VACCINATION SITE PRURITUS (I have a big red rash on my arm, very very itchy), WHEEZING (Today still feel squeezy) and VACCINATION SITE RASH (I have a big red rash on my arm) outcome was unknown. Unknown    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Wheezing
Clinical narrative: I was adversely sick like when I had covid.; I have a big red rash on my arm; Today still feel squeezy; I have a big red rash on my arm, very very itchy; Wednesday morning when I got up, I had chills and headache; Wednesday morning when I got up, I had chills and headache; I felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Wednesday morning when I got up, I had chills and headache), HEADACHE (Wednesday morning when I got up, I had chills and headache), ILLNESS (I was adversely sick like when I had covid.), NAUSEA (I felt nauseated) and VACCINATION SITE PRURITUS (I have a big red rash on my arm, very very itchy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Left) and COVID-19 in November 2020.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CHILLS (Wednesday morning when I got up, I had chills and headache), HEADACHE (Wednesday morning when I got up, I had chills and headache), NAUSEA (I felt nauseated), VACCINATION SITE PRURITUS (I have a big red rash on my arm, very very itchy) and WHEEZING (Today still feel squeezy). On an unknown date, the patient experienced ILLNESS (I was adversely sick like when I had covid.) and VACCINATION SITE RASH (I have a big red rash on my arm). At the time of the report, CHILLS (Wednesday morning when I got up, I had chills and headache), HEADACHE (Wednesday morning when I got up, I had chills and headache), ILLNESS (I was adversely sick like when I had covid.), NAUSEA (I felt nauseated), VACCINATION SITE PRURITUS (I have a big red rash on my arm, very very itchy), WHEEZING (Today still feel squeezy) and VACCINATION SITE RASH (I have a big red rash on my arm) outcome was unknown. Unknown    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Product dose omission issue
Clinical narrative: Angina-type pains on left side; First dose on 13 Feb 2021 and refused to take second dose because headaches continued for about 3 weeks.; Shooting pain in the back of their head, had more headaches than normal/constant and unusual headaches in the back of my head; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Angina-type pains on left side), PRODUCT DOSE OMISSION ISSUE (First dose on 13 Feb 2021 and refused to take second dose because headaches continued for about 3 weeks.) and HEADACHE (Shooting pain in the back of their head, had more headaches than normal/constant and unusual headaches in the back of my head) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified. Concurrent medical conditions included Breast cancer. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HEADACHE (Shooting pain in the back of their head, had more headaches than normal/constant and unusual headaches in the back of my head). On an unknown date, the patient experienced CHEST PAIN (Angina-type pains on left side) and PRODUCT DOSE OMISSION ISSUE (First dose on 13 Feb 2021 and refused to take second dose because headaches continued for about 3 weeks.). The patient was treated with ACETAMINOPHEN for Headache, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form once a day. At the time of the report, CHEST PAIN (Angina-type pains on left side) and PRODUCT DOSE OMISSION ISSUE (First dose on 13 Feb 2021 and refused to take second dose because headaches continued for about 3 weeks.) outcome was unknown and HEADACHE (Shooting pain in the back of their head, had more headaches than normal/constant and unusual headaches in the back of my head) 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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Significant Follow up; event outcome provided and denied second dose.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on medication like nasal spray and allergy shot.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Asthenia, Cold sweat, Dizziness, Feeling hot
Clinical narrative: dizzy; felt warm; extremely weak; extremely hot; clammy; sore left arm; "typical" side effects; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), ADVERSE DRUG REACTION ("typical" side effects), DIZZINESS (dizzy), FEELING HOT (felt warm) and ASTHENIA (extremely weak) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease, Allergy, Allergy, Allergy, Latex allergy and Bee sting. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3, VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm) and ADVERSE DRUG REACTION ("typical" side effects). On 12-Mar-2021, the patient experienced DIZZINESS (dizzy), FEELING HOT (felt warm), ASTHENIA (extremely weak), FEELING HOT (extremely hot) and COLD SWEAT (clammy). At the time of the report, PAIN IN EXTREMITY (sore left arm), ADVERSE DRUG REACTION ("typical" side effects), DIZZINESS (dizzy), FEELING HOT (felt warm), ASTHENIA (extremely weak), FEELING HOT (extremely hot) and COLD SWEAT (clammy) outcome was unknown. Not Provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: dizzy; felt warm; extremely weak; extremely hot; clammy; sore left arm; "typical" side effects; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), ADVERSE DRUG REACTION ("typical" side effects), DIZZINESS (dizzy), FEELING HOT (felt warm) and ASTHENIA (extremely weak) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease, Allergy, Allergy, Allergy, Latex allergy and Bee sting. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3, VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm) and ADVERSE DRUG REACTION ("typical" side effects). On 12-Mar-2021, the patient experienced DIZZINESS (dizzy), FEELING HOT (felt warm), ASTHENIA (extremely weak), FEELING HOT (extremely hot) and COLD SWEAT (clammy). At the time of the report, PAIN IN EXTREMITY (sore left arm), ADVERSE DRUG REACTION ("typical" side effects), DIZZINESS (dizzy), FEELING HOT (felt warm), ASTHENIA (extremely weak), FEELING HOT (extremely hot) and COLD SWEAT (clammy) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site reaction, Nausea
Clinical narrative: woke up with a rash; had a bad reaction initially; felt queasy but did not vomit; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (woke up with a rash), INJECTION SITE REACTION (had a bad reaction initially) and NAUSEA (felt queasy but did not vomit) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE REACTION (had a bad reaction initially) and NAUSEA (felt queasy but did not vomit). On 12-Mar-2021, the patient experienced INJECTION SITE RASH (woke up with a rash). At the time of the report, INJECTION SITE RASH (woke up with a rash), INJECTION SITE REACTION (had a bad reaction initially) and NAUSEA (felt queasy but did not vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Non significant follow up received on 15-JUN-2021, no new information