chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Feeling abnormal, Headache, Myalgia
Clinical narrative: Unable to lay on the injection site; Overall I am feeling awful; Whole body aches; All joint pain; Muscle ache; I am experiencing fever of 100; Nauseated; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Unable to lay on the injection site), FEELING ABNORMAL (Overall I am feeling awful), PAIN (Whole body aches), ARTHRALGIA (All joint pain) and MYALGIA (Muscle ache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 626A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (Unable to lay on the injection site), FEELING ABNORMAL (Overall I am feeling awful), PAIN (Whole body aches), ARTHRALGIA (All joint pain), MYALGIA (Muscle ache), PYREXIA (I am experiencing fever of 100), NAUSEA (Nauseated) and HEADACHE (Bad headache). At the time of the report, VACCINATION SITE DISCOMFORT (Unable to lay on the injection site), FEELING ABNORMAL (Overall I am feeling awful), PAIN (Whole body aches), ARTHRALGIA (All joint pain), MYALGIA (Muscle ache), PYREXIA (I am experiencing fever of 100), NAUSEA (Nauseated) and HEADACHE (Bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 100 (High) 100 F.         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site discomfort
Clinical narrative: Unable to lay on the injection site; Overall I am feeling awful; Whole body aches; All joint pain; Muscle ache; I am experiencing fever of 100; Nauseated; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Unable to lay on the injection site), FEELING ABNORMAL (Overall I am feeling awful), PAIN (Whole body aches), ARTHRALGIA (All joint pain) and MYALGIA (Muscle ache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 626A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (Unable to lay on the injection site), FEELING ABNORMAL (Overall I am feeling awful), PAIN (Whole body aches), ARTHRALGIA (All joint pain), MYALGIA (Muscle ache), PYREXIA (I am experiencing fever of 100), NAUSEA (Nauseated) and HEADACHE (Bad headache). At the time of the report, VACCINATION SITE DISCOMFORT (Unable to lay on the injection site), FEELING ABNORMAL (Overall I am feeling awful), PAIN (Whole body aches), ARTHRALGIA (All joint pain), MYALGIA (Muscle ache), PYREXIA (I am experiencing fever of 100), NAUSEA (Nauseated) and HEADACHE (Bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 100 (High) 100 F.         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: could not move her arm up and down; stiffness left arm; slightly swollen arm/minor swelling in the left arm; painful arm/tender to touch/severe pain in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm up and down), MUSCULOSKELETAL STIFFNESS (stiffness left arm), VACCINATION SITE SWELLING (slightly swollen arm/minor swelling in the left arm) and VACCINATION SITE PAIN (painful arm/tender to touch/severe pain in left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinusitis, Bronchitis, Seasonal allergy and Blood pressure high. Concomitant products included ATENOLOL for Blood pressure high.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm up and down), MUSCULOSKELETAL STIFFNESS (stiffness left arm), VACCINATION SITE SWELLING (slightly swollen arm/minor swelling in the left arm) and VACCINATION SITE PAIN (painful arm/tender to touch/severe pain in left arm). The patient was treated with PARACETAMOL (ACETAMINOFEN) at an unspecified dose and frequency. On 02-Apr-2021, MUSCULOSKELETAL STIFFNESS (stiffness left arm) and VACCINATION SITE SWELLING (slightly swollen arm/minor swelling in the left arm) had resolved, VACCINATION SITE PAIN (painful arm/tender to touch/severe pain in left arm) outcome was unknown. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm up and down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-118279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021, contains Significant information. Added Medical History, Concomitant Medication, Suspect drug details, Second dose details, Event outcome On 16-Jun-2021: Follow-up information received on 16-Jun-2021, contains non-significant information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Heart rate, Malaise, Oxygen saturation
Clinical narrative: itching during the waiting period after the vaccine; itching through the night; chest hurts; chest discomfort; pain in the center of her chest; feels achy; felt like she had COVID again; head starting hurting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching during the waiting period after the vaccine; itching through the night), CHEST DISCOMFORT (chest hurts; chest discomfort; pain in the center of her chest), PAIN (feels achy), MALAISE (felt like she had COVID again) and HEADACHE (head starting hurting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (itching during the waiting period after the vaccine; itching through the night), CHEST DISCOMFORT (chest hurts; chest discomfort; pain in the center of her chest), PAIN (feels achy), MALAISE (felt like she had COVID again) and HEADACHE (head starting hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and VITAMIN D3 at an unspecified dose and frequency. At the time of the report, PRURITUS (itching during the waiting period after the vaccine; itching through the night), CHEST DISCOMFORT (chest hurts; chest discomfort; pain in the center of her chest), PAIN (feels achy), MALAISE (felt like she had COVID again) and HEADACHE (head starting hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 110 (High) 110. On an unknown date, Oxygen saturation: 98 (Inconclusive) 98.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: itching during the waiting period after the vaccine; itching through the night; chest hurts; chest discomfort; pain in the center of her chest; feels achy; felt like she had COVID again; head starting hurting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching during the waiting period after the vaccine; itching through the night), CHEST DISCOMFORT (chest hurts; chest discomfort; pain in the center of her chest), PAIN (feels achy), MALAISE (felt like she had COVID again) and HEADACHE (head starting hurting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (itching during the waiting period after the vaccine; itching through the night), CHEST DISCOMFORT (chest hurts; chest discomfort; pain in the center of her chest), PAIN (feels achy), MALAISE (felt like she had COVID again) and HEADACHE (head starting hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and VITAMIN D3 at an unspecified dose and frequency. At the time of the report, PRURITUS (itching during the waiting period after the vaccine; itching through the night), CHEST DISCOMFORT (chest hurts; chest discomfort; pain in the center of her chest), PAIN (feels achy), MALAISE (felt like she had COVID again) and HEADACHE (head starting hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 110 (High) 110. On an unknown date, Oxygen saturation: 98 (Inconclusive) 98.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pain
Clinical narrative: weak; nauseous; pain all over her whole body; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), NAUSEA (nauseous) and PAIN (pain all over her whole body) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-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 26-Mar-2021, the patient experienced ASTHENIA (weak), NAUSEA (nauseous) and PAIN (pain all over her whole body). On 26-Mar-2021, ASTHENIA (weak), NAUSEA (nauseous) and PAIN (pain all over her whole body) had resolved. Not Provided          Treatment information not provided. Concomitant medications were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccination outside of 42 days) in a patient of an unknown age and gender 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 was reported.). On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). On 01-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccination outside of 42 days). On 01-Apr-2021, PRODUCT DOSE OMISSION ISSUE (2nd Moderna Vaccination outside of 42 days) had resolved. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Feeling abnormal, Nasal discomfort, Oropharyngeal pain
Clinical narrative: Tested positive for COVID; Dry cough; Started feeling off; Sore throat; Really runny nose; Burning feeling in my nose; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID), COUGH (Dry cough), FEELING ABNORMAL (Started feeling off), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Really runny nose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced COUGH (Dry cough), FEELING ABNORMAL (Started feeling off), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Really runny nose), NASAL DISCOMFORT (Burning feeling in my nose) and FATIGUE (Fatigue). On 29-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID), COUGH (Dry cough), FEELING ABNORMAL (Started feeling off), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Really runny nose), NASAL DISCOMFORT (Burning feeling in my nose) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Dry cough; Started feeling off; Sore throat; Really runny nose; Burning feeling in my nose; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID), COUGH (Dry cough), FEELING ABNORMAL (Started feeling off), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Really runny nose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced COUGH (Dry cough), FEELING ABNORMAL (Started feeling off), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Really runny nose), NASAL DISCOMFORT (Burning feeling in my nose) and FATIGUE (Fatigue). On 29-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID), COUGH (Dry cough), FEELING ABNORMAL (Started feeling off), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Really runny nose), NASAL DISCOMFORT (Burning feeling in my nose) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Peripheral swelling
Clinical narrative: swollen arms; headache; red patch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arms), ERYTHEMA (red patch) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0071321A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LORATADINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), SPIRONOLACTONE (SPIROLACTON), GABAPENTIN (NEURONTIN), CARVEDILOL (COREG), INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (red patch). On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arms) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen arms), ERYTHEMA (red patch) and HEADACHE (headache) outcome was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pain in feet; Extreme tiredness continued/ fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in feet) and FATIGUE (Extreme tiredness continued/ fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-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) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in feet) and FATIGUE (Extreme tiredness continued/ fatigue). At the time of the report, PAIN IN EXTREMITY (Pain in feet) and FATIGUE (Extreme tiredness continued/ fatigue) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-065561 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Soreness in the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-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 VACCINATION SITE PAIN (Soreness in the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness in the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: TCR was added.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Pain in extremity
Clinical narrative: exposed to my daughter who tested positive for Covid-19; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and EXPOSURE TO SARS-COV-2 (exposed to my daughter who tested positive for Covid-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 31-Mar-2021, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to my daughter who tested positive for Covid-19). At the time of the report, PAIN IN EXTREMITY (arm was sore) and EXPOSURE TO SARS-COV-2 (exposed to my daughter who tested positive for Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. The Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Eye pruritus, Sinusitis
Clinical narrative: Ear and sinus infection; Ear and sinus infection; eye itchiness; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Ear and sinus infection), EAR INFECTION (Ear and sinus infection) and EYE PRURITUS (eye itchiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (eye itchiness).    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 SINUSITIS (Ear and sinus infection), EAR INFECTION (Ear and sinus infection) and EYE PRURITUS (eye itchiness). At the time of the report, SINUSITIS (Ear and sinus infection), EAR INFECTION (Ear and sinus infection) and EYE PRURITUS (eye itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products reported.  Patient reported that  she would  start antibiotics after first dose on 1 apr 2021.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sharp pain; stabbing pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sharp pain) and VACCINATION SITE PAIN (stabbing pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 Dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (sharp pain) and VACCINATION SITE PAIN (stabbing pain). At the time of the report, VACCINATION SITE PAIN (sharp pain) and VACCINATION SITE PAIN (stabbing pain) outcome was unknown.            no concomitant medications reported. no treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Rash
Clinical narrative: little jiffy on my nose; funny rash and a little on the upper chest; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (little jiffy on my nose) and RASH (funny rash and a little on the upper chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-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 NASAL DISCOMFORT (little jiffy on my nose) and RASH (funny rash and a little on the upper chest). At the time of the report, NASAL DISCOMFORT (little jiffy on my nose) and RASH (funny rash and a little on the upper chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No allergies was reported.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Musculoskeletal stiffness
Clinical narrative: Inflammation to hand; Stiff neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) and INFLAMMATION (Inflammation to hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included METHOTREXATE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck). On 01-Apr-2021, the patient experienced INFLAMMATION (Inflammation to hand). On 05-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff neck) had resolved. At the time of the report, INFLAMMATION (Inflammation to hand) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) 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 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). The patient was treated with AMOXICILLIN for Urinary tract infection, at a dose of 1 dosage form. At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dental discomfort, Gingival swelling, Mastication disorder, Myalgia
Clinical narrative: feels like a tooth infected; hard to eat-have to eat soft (baked potato)-can't chew; body aches; knee started hurting; gums in her mouth swollen; fluid blisters under tongue; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL SWELLING (gums in her mouth swollen), ORAL MUCOSAL BLISTERING (fluid blisters under tongue), DENTAL DISCOMFORT (feels like a tooth infected), MASTICATION DISORDER (hard to eat-have to eat soft (baked potato)-can't chew) and MYALGIA (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced GINGIVAL SWELLING (gums in her mouth swollen) and ORAL MUCOSAL BLISTERING (fluid blisters under tongue). On 31-Mar-2021, the patient experienced MYALGIA (body aches) and ARTHRALGIA (knee started hurting). On 01-Apr-2021, the patient experienced DENTAL DISCOMFORT (feels like a tooth infected) and MASTICATION DISORDER (hard to eat-have to eat soft (baked potato)-can't chew). At the time of the report, GINGIVAL SWELLING (gums in her mouth swollen), ORAL MUCOSAL BLISTERING (fluid blisters under tongue), DENTAL DISCOMFORT (feels like a tooth infected), MASTICATION DISORDER (hard to eat-have to eat soft (baked potato)-can't chew), MYALGIA (body aches) and ARTHRALGIA (knee started hurting) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering
Clinical narrative: feels like a tooth infected; hard to eat-have to eat soft (baked potato)-can't chew; body aches; knee started hurting; gums in her mouth swollen; fluid blisters under tongue; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL SWELLING (gums in her mouth swollen), ORAL MUCOSAL BLISTERING (fluid blisters under tongue), DENTAL DISCOMFORT (feels like a tooth infected), MASTICATION DISORDER (hard to eat-have to eat soft (baked potato)-can't chew) and MYALGIA (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced GINGIVAL SWELLING (gums in her mouth swollen) and ORAL MUCOSAL BLISTERING (fluid blisters under tongue). On 31-Mar-2021, the patient experienced MYALGIA (body aches) and ARTHRALGIA (knee started hurting). On 01-Apr-2021, the patient experienced DENTAL DISCOMFORT (feels like a tooth infected) and MASTICATION DISORDER (hard to eat-have to eat soft (baked potato)-can't chew). At the time of the report, GINGIVAL SWELLING (gums in her mouth swollen), ORAL MUCOSAL BLISTERING (fluid blisters under tongue), DENTAL DISCOMFORT (feels like a tooth infected), MASTICATION DISORDER (hard to eat-have to eat soft (baked potato)-can't chew), MYALGIA (body aches) and ARTHRALGIA (knee started hurting) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness, Pyrexia
Clinical narrative: Joints hurt a lot; Chills; Feels cruddy, like I have the flu; slight fever, 100F; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joints hurt a lot), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Feels cruddy, like I have the flu) and PYREXIA (slight fever, 100F) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ARTHRALGIA (Joints hurt a lot), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Feels cruddy, like I have the flu) and PYREXIA (slight fever, 100F). At the time of the report, ARTHRALGIA (Joints hurt a lot), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Feels cruddy, like I have the flu) and PYREXIA (slight fever, 100F) 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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Interchange of vaccine products
Clinical narrative: a little freaked out; second dose moderna; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (a little freaked out) and INTERCHANGE OF VACCINE PRODUCTS (second dose moderna) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 FEAR (a little freaked out) and INTERCHANGE OF VACCINE PRODUCTS (second dose moderna). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form. At the time of the report, FEAR (a little freaked out) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (second dose moderna) had resolved.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. Patient received a dose of the Pfizer covid-19 vaccine by IM injection to the left arm on 4-Mar-2021 (batch:EH9899).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: big welt; injection site is red and itchy; injection site is red and itchy; swelling in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (big welt), VACCINATION SITE PRURITUS (injection site is red and itchy), VACCINATION SITE ERYTHEMA (injection site is red and itchy) and VACCINATION SITE SWELLING (swelling in the arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (big welt), VACCINATION SITE PRURITUS (injection site is red and itchy), VACCINATION SITE ERYTHEMA (injection site is red and itchy) and VACCINATION SITE SWELLING (swelling in the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and CORTISONE at a dose of 1 dosage form. At the time of the report, VACCINATION SITE URTICARIA (big welt), VACCINATION SITE PRURITUS (injection site is red and itchy), VACCINATION SITE ERYTHEMA (injection site is red and itchy) and VACCINATION SITE SWELLING (swelling in the arm) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Concomitant drug was not reported. Treatment  included antibacterial cream.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-MAY-2021 and does not contain any new information
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Fatigue, Mass, Vaccination site pain
Clinical narrative: Patient is having problems controlling her blood sugar levels; Had a lump on her neck; Felt "so tired" she had to lay down all day; Arm hurt where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE FLUCTUATION (Patient is having problems controlling her blood sugar levels), MASS (Had a lump on her neck), FATIGUE (Felt "so tired" she had to lay down all day) and VACCINATION SITE PAIN (Arm hurt where she got the shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (borderline).   On 12-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. On 12-Mar-2021, the patient experienced BLOOD GLUCOSE FLUCTUATION (Patient is having problems controlling her blood sugar levels), MASS (Had a lump on her neck), FATIGUE (Felt "so tired" she had to lay down all day) and VACCINATION SITE PAIN (Arm hurt where she got the shot). The patient was treated with METFORMIN for Diabetes mellitus management, at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE FLUCTUATION (Patient is having problems controlling her blood sugar levels), MASS (Had a lump on her neck), FATIGUE (Felt "so tired" she had to lay down all day) and VACCINATION SITE PAIN (Arm hurt where she got the shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information included metformin for about three weeks then with no success.  Action taken with mRNA-1273 in response to events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: May not get the second dose on time (may be greater than 36 days) for second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No reported medical history).    On 04-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Treatment medications were unknown   This case was linked to MOD21-066487, MOD21-066488 (Patient Link).; Sender's Comments: This report refers to a case of Inappropriate schedule of Product administration, for mRNA-1273, lot # unknown,  with no associated AEs.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: real bad muscle problem on the left leg; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (real bad muscle problem on the left leg) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  The patient's past medical history included Heart disorder.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MYALGIA (real bad muscle problem on the left leg). At the time of the report, MYALGIA (real bad muscle problem on the left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product included heart medication. Treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: He is a little achy today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (He is a little achy today) in a 57-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 (No reported medical history).    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (He is a little achy today). At the time of the report, PAIN (He is a little achy today) outcome was unknown.            No relevant concomitant medications were reported. The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: left side of face numb/nose numb; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (left side of face numb/nose numb) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HYPOAESTHESIA (left side of face numb/nose numb). At the time of the report, HYPOAESTHESIA (left side of face numb/nose numb) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No new information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Dizziness; Sore arm; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A.) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Dyslipidemia.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). On 30-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 31-Mar-2021, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, DIZZINESS (Dizziness) had not resolved.            Concomitant medications included blood pressure and cholesterol medications. Treatment information included Tylenol.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash is itchy; Rash near the injection site, which is 4 inches long and 2 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is itchy) and RASH (Rash near the injection site, which is 4 inches long and 2 inches wide) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced RASH PRURITIC (Rash is itchy) and RASH (Rash near the injection site, which is 4 inches long and 2 inches wide). At the time of the report, RASH PRURITIC (Rash is itchy) and RASH (Rash near the injection site, which is 4 inches long and 2 inches wide) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included anti-itch topical product for itching.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Feeling abnormal, Feeling hot, Pain
Clinical narrative: was burning up; certain parts of his body were hot like stomach and back; still feels achy; run down; had chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (was burning up), FEELING HOT (certain parts of his body were hot like stomach and back), PAIN (still feels achy), FEELING ABNORMAL (run down) and CHILLS (had chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (was burning up), FEELING HOT (certain parts of his body were hot like stomach and back), PAIN (still feels achy), FEELING ABNORMAL (run down) and CHILLS (had chills). At the time of the report, BURNING SENSATION (was burning up), FEELING HOT (certain parts of his body were hot like stomach and back), PAIN (still feels achy), FEELING ABNORMAL (run down) and CHILLS (had chills) outcome was unknown.            No concomitant medication provided. Patient received Tylenol treatment for the symptoms.  Patient has registered for Vsafe.   Reporter did not allow further contact