chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient reported an incorrect DOB, which lead us to believe that they were 18 or over,  therefore given their first dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient reported an incorrect DOB, which lead us to believe that they were 18 or over,  therefore given their first dose.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient reported an incorrect DOB, which lead us to believe that they were 18 or over,  therefore given their first dose.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient reported an incorrect DOB, which lead us to believe that they were 18 or over,  therefore given their first dose.) outcome was unknown. Not Provided      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 products were not provided by the reporter Treatment information was not provided by the reporter. No lab data was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: The swollen part on my arm keeps getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (The swollen part on my arm keeps getting bigger) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (The swollen part on my arm keeps getting bigger). At the time of the report, VACCINATION SITE SWELLING (The swollen part on my arm keeps getting bigger) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications and No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Vertigo; Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo), DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. No treatment medication were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: sore arm; breathing off a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DYSPNOEA (breathing off a little) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS for an unknown indication.   On 30-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and DYSPNOEA (breathing off a little). At the time of the report, PAIN IN EXTREMITY (sore arm) and DYSPNOEA (breathing off a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient history was not provided.  Concomitant medication also contain Antacid.  Treatment medication not provided.   This case was linked to MOD-2021-038179 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Cough; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and RHINORRHOEA (Runny nose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Sneezing. Concurrent medical conditions included Chronic cough.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced COUGH (Cough) and RHINORRHOEA (Runny nose). The patient was treated with CODEINE PHOSPHATE, GUAIFENESIN, PHENIRAMINE MALEATE (ROBITUSSIN WITH CODEINE) at an unspecified dose and frequency and CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE WITH CODEINE) at an unspecified dose and frequency. At the time of the report, COUGH (Cough) and RHINORRHOEA (Runny nose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.     This case was linked to US-MODERNATX, INC.-MOD-2021-226183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-226183:Dose 1 case
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021) 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 03-May-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 (Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose, and now its more than 42 days and will possibly come on 21JUN2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Little pain on shoulder; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Little pain on shoulder) and FATIGUE (Tired) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ARTHRALGIA (Little pain on shoulder) and FATIGUE (Tired). On 06-Feb-2021, ARTHRALGIA (Little pain on shoulder) and FATIGUE (Tired) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was not applicable. No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-014536 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101.5; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.5) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced PYREXIA (Fever of 101.5). At the time of the report, PYREXIA (Fever of 101.5) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jun-2021, Body temperature: 101.5 (High) 101.5.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  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.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Influenza like illness, Nausea
Clinical narrative: felt like something foreign put in my body; hard to describe, felt like a steroid shot; severe flu like symptoms; sweats; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF FOREIGN BODY (felt like something foreign put in my body), FEELING ABNORMAL (hard to describe, felt like a steroid shot), INFLUENZA LIKE ILLNESS (severe flu like symptoms), HYPERHIDROSIS (sweats) and CHILLS (chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SENSATION OF FOREIGN BODY (felt like something foreign put in my body), FEELING ABNORMAL (hard to describe, felt like a steroid shot), INFLUENZA LIKE ILLNESS (severe flu like symptoms), HYPERHIDROSIS (sweats), CHILLS (chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SENSATION OF FOREIGN BODY (felt like something foreign put in my body), FEELING ABNORMAL (hard to describe, felt like a steroid shot), INFLUENZA LIKE ILLNESS (severe flu like symptoms), HYPERHIDROSIS (sweats), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.  The patient took Ibuprofen which didn't help.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: felt like something foreign put in my body; hard to describe, felt like a steroid shot; severe flu like symptoms; sweats; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF FOREIGN BODY (felt like something foreign put in my body), FEELING ABNORMAL (hard to describe, felt like a steroid shot), INFLUENZA LIKE ILLNESS (severe flu like symptoms), HYPERHIDROSIS (sweats) and CHILLS (chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SENSATION OF FOREIGN BODY (felt like something foreign put in my body), FEELING ABNORMAL (hard to describe, felt like a steroid shot), INFLUENZA LIKE ILLNESS (severe flu like symptoms), HYPERHIDROSIS (sweats), CHILLS (chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SENSATION OF FOREIGN BODY (felt like something foreign put in my body), FEELING ABNORMAL (hard to describe, felt like a steroid shot), INFLUENZA LIKE ILLNESS (severe flu like symptoms), HYPERHIDROSIS (sweats), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.  The patient took Ibuprofen which didn't help.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Magnet stick to my erect penis but not when it's flaccid after my second injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Magnet stick to my erect penis but not when it's flaccid after my second injection) 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, 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 VACCINATION COMPLICATION (Magnet stick to my erect penis but not when it's flaccid after my second injection). At the time of the report, VACCINATION COMPLICATION (Magnet stick to my erect penis but not when it's flaccid after my second injection) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  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.
Sex: U
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia
Clinical narrative: Injection site numb; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOESTHESIA (Injection site numb) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HYPOESTHESIA (Injection site numb). At the time of the report, INJECTION SITE HYPOESTHESIA (Injection site numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter.  No Treatment medications were provided by the reporter. For mRNA-1273 (COVID 19 Vaccine Moderna) (unknown), the reporter did not provide any causality assessments.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt for 24 hours) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, DILTIAZEM and PANTOPRAZOLE SODIUM for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt for 24 hours). At the time of the report, PAIN IN EXTREMITY (arm hurt for 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-054585 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, X-ray
Clinical narrative: heart started beating fast and it felt really off / Her heart is racing again; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart started beating fast and it felt really off / Her heart is racing again) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A and 009C21N) for COVID-19 vaccination.     The patient's past medical history included Cancer, Heart disorder (UNKNOWN CARDIAC ISSUES REPORTED .) and Emergency care (on Tuesday, 04May2021,patient  went to her personal doctor and once the HCP listened to her heart he sent her to the ER.). Concurrent medical conditions included Type 2 diabetes mellitus and Asthma.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-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 HEART RATE INCREASED (heart started beating fast and it felt really off / Her heart is racing again). At the time of the report, HEART RATE INCREASED (heart started beating fast and it felt really off / Her heart is racing again) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Heart rate irregular:. In May 2021, X-ray:.         No concomitant medications were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; 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 FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TOFACITINIB CITRATE (XELJANZ) 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.            No treatment information was provided   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: persistent cough, like a coughing spam that was persistent and it was; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (persistent cough, like a coughing spam that was persistent and it was) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB for Asthma.    Concurrent medical conditions included Asthma.   On 28-Apr-2021, the patient started DUPILUMAB (Subcutaneous) 300 milligram every two weeks. In May 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 COUGH (persistent cough, like a coughing spam that was persistent and it was). The patient was treated with BUDESONIDE for Cough, at a dose of 1 UNK. At the time of the report, COUGH (persistent cough, like a coughing spam that was persistent and it was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had two doses of dupilumab, then he received his first Moderna shot (date unknown) and two weeks later, On 26-May-2021, Patient took third shot of  dupilumab.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: mild symptoms due to Covid-19 after having first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (mild symptoms due to Covid-19 after having first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced COVID-19 (mild symptoms due to Covid-19 after having first dose). On 16-Jun-2021, COVID-19 (mild symptoms due to Covid-19 after having first dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. On 25-Jun-2021, the patient's second dose was scheduled. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Event outcome updated, event stop date added
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain, Joint injury
Clinical narrative: Trauma in left knee; Groin Pain; joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10); This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (Trauma in left knee), GROIN PAIN (Groin Pain) and ARTHRALGIA (joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10)) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Back pain. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, CANNABIS for Chronic back pain, ATORVASTATIN and METFORMIN for Type 2 diabetes mellitus.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced JOINT INJURY (Trauma in left knee), GROIN PAIN (Groin Pain) and ARTHRALGIA (joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10)). On 23-Apr-2021, ARTHRALGIA (joint tenderness/Elbow Pain/ both shoulder /Hip Pain started to become sore/painful (3 - 5 out of 10)) had resolved. At the time of the report, JOINT INJURY (Trauma in left knee) outcome was unknown and GROIN PAIN (Groin Pain) was resolving.            No treatment information were provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-227257 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Patient demographics, medical history , concomitant medications and new events were added.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Vaccination site inflammation; Hives; itch left arm; left arm red; inflammed left arm; Rash; Injection site itching; Injection site redness; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Vaccination site inflammation), URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red) and INFLAMMATION (inflammed left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer on 07-Jun-2015. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 07-Jun-2015 to an unknown date and LIOTHYRONINE for Hormone replacement therapy, CALCITRIOL and CALCIUM CITRATE for Hypoparathyroidism.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced VACCINATION SITE INFLAMMATION (Vaccination site inflammation), URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red), INFLAMMATION (inflammed left arm), RASH (Rash), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) (oral) on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at a dose of 1 dosage form; HYDROCORTISONE on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form. On 17-Jun-2021, VACCINATION SITE INFLAMMATION (Vaccination site inflammation), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 18-Jun-2021, URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red) and RASH (Rash) had resolved. At the time of the report, INFLAMMATION (inflammed left arm) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow up On 09-Aug-2021: Follow up received and contains No new information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccination site inflammation; Hives; itch left arm; left arm red; inflammed left arm; Rash; Injection site itching; Injection site redness; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Vaccination site inflammation), URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red) and INFLAMMATION (inflammed left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer on 07-Jun-2015. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 07-Jun-2015 to an unknown date and LIOTHYRONINE for Hormone replacement therapy, CALCITRIOL and CALCIUM CITRATE for Hypoparathyroidism.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced VACCINATION SITE INFLAMMATION (Vaccination site inflammation), URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red), INFLAMMATION (inflammed left arm), RASH (Rash), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) (oral) on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at a dose of 1 dosage form; HYDROCORTISONE on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form. On 17-Jun-2021, VACCINATION SITE INFLAMMATION (Vaccination site inflammation), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 18-Jun-2021, URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red) and RASH (Rash) had resolved. At the time of the report, INFLAMMATION (inflammed left arm) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow up On 09-Aug-2021: Follow up received and contains No new information.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Diarrhoea
Clinical narrative: diarrhea; did not have a voice at all / whispering; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and APHONIA (did not have a voice at all / whispering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced DIARRHOEA (diarrhea) and APHONIA (did not have a voice at all / whispering). On 17-Jun-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, APHONIA (did not have a voice at all / whispering) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Myalgia
Clinical narrative: Heart pain / chest pain; muscle pain; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Heart pain / chest pain), MYALGIA (muscle pain) and FATIGUE (tiredness) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced CHEST PAIN (Heart pain / chest pain), MYALGIA (muscle pain) and FATIGUE (tiredness). On 12-Jun-2021, CHEST PAIN (Heart pain / chest pain) had resolved. On 13-Jun-2021, MYALGIA (muscle pain) and FATIGUE (tiredness) had resolved. Not Provided          No concomitant medications were reported by the reporter.  No treatment medications were reported by the reporter.  Does not have any information regarding the first dose   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-significant follow up appended - New Reporter (Consumer) added
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little arm pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea.    On 20-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 (little arm pain). At the time of the report, VACCINATION SITE PAIN (little arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medication was reported .   This case was linked to MOD-2021-187569 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: MISS TO TAKE SECOND DOSE IN 6 WEEKS; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (MISS TO TAKE SECOND DOSE IN 6 WEEKS) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (MISS TO TAKE SECOND DOSE IN 6 WEEKS). At the time of the report, PRODUCT DOSE OMISSION ISSUE (MISS TO TAKE SECOND DOSE IN 6 WEEKS) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: got 0.7 ml not 0.5 ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (got 0.7 ml not 0.5 ml) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .7 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (got 0.7 ml not 0.5 ml). At the time of the report, ACCIDENTAL OVERDOSE (got 0.7 ml not 0.5 ml) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information about concomitant medications was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibromyalgia, Hypersomnia
Clinical narrative: Fibromyalgia; extremely tired; Slept almost all day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FIBROMYALGIA (Fibromyalgia), HYPERSOMNIA (Slept almost all day) and FATIGUE (extremely tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included DUPILUMAB from 04-Mar-2021 to an unknown date for Asthma.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSOMNIA (Slept almost all day). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia) and FATIGUE (extremely tired). At the time of the report, FIBROMYALGIA (Fibromyalgia), HYPERSOMNIA (Slept almost all day) and FATIGUE (extremely tired) had not resolved.            Concomitant medications also included unspecified steroids.  Patient reported that she experiences fatigue and hypersomnia every time she gets her dupilumab dose.  No treatment medications were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abscess, Blood pressure measurement, Cardiac stress test, Computerised tomogram, Infected fistula
Clinical narrative: Infected fistula in buttocks; Abscess; This spontaneous case was reported by a physician and describes the occurrence of INFECTED FISTULA (Infected fistula in buttocks) and ABSCESS (Abscess) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    The patient's past medical history included Coronary artery occlusion in November 2019, Stoma creation in 2017, Colon cancer in 2017, Cardiac arrhythmia in December 2019, Dehydration in August 2017, Night sweats on 19-Mar-2021, Chronic kidney disease stage 3, Alcohol use (FIVE COCKTAILS A WEEk) in 1975, Smoker (A PACK A WEEK) in 2006, Obstruction, Ostomy obstruction in 2017, Stent placement (he had blockage in heart artery and cardiologist placed a stent in the heart) in December 2019, Stent placement (he had heart stent placement) in 2021 and Surgery (surgery to reconnect intestines and remove ostomy because of dehydration.) in August 2019. Concomitant products included PRASUGREL for Coagulation disorder, METOPROLOL for Heart rate abnormal, ATORVASTATIN for Hypercholesteraemia, FENOFIBRATE, ATORVASTATIN CALCIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), OMEPRAZOLE, METOPROLOL SUCCINATE, PRASUGREL HCL and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. In May 2021, the patient experienced ABSCESS (Abscess). On 11-Jun-2021, the patient experienced INFECTED FISTULA (Infected fistula in buttocks). At the time of the report, INFECTED FISTULA (Infected fistula in buttocks) and ABSCESS (Abscess) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, Blood pressure measurement: high (High) ELEVATED BLOOD PRESSURE. In November 2019, Computerised tomogram: abnormal (abnormal) Blockage in the artery of the heart. In February 2020, Cardiac stress test: normal (normal) Basically ok.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's lab data included: November 2019 CHEST X-RAY: Unknown results. December 2020 STRESS TEST: Unknown result.  The patient was treated with FLAGYL.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: past due 2nd dose 64 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past due 2nd dose 64 days) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (past due 2nd dose 64 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past due 2nd dose 64 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: pain in her chest while breathing in; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (pain in her chest while breathing in) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 031L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LINACLOTIDE (LINZESS) and SUCRALFATE (CARAFATE) for Gastrointestinal disorder NOS, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced CHEST PAIN (pain in her chest while breathing in). At the time of the report, CHEST PAIN (pain in her chest while breathing in) outcome was unknown.            Treatment include extra strength Tylenol.   This case was linked to MOD-2021-033826 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown.            No concomitant medications was provided by the reporter.  Patient reported he previously filled out a lengthy ADR form and had no interest in filling out another form. He only reported the above response via email.  No treatment was provided by the reporter.   This case was linked to MOD-2021-020244, MOD-2021-020244 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: warm injection site; swelling injection site; redness injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE WARMTH (warm injection site), INJECTION SITE SWELLING (swelling injection site) and INJECTION SITE ERYTHEMA (redness injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (warm injection site), INJECTION SITE SWELLING (swelling injection site) and INJECTION SITE ERYTHEMA (redness injection site). At the time of the report, INJECTION SITE WARMTH (warm injection site), INJECTION SITE SWELLING (swelling injection site) and INJECTION SITE ERYTHEMA (redness injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 102 degrees Fahrenheit; 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 PYREXIA (fever of 102 degrees Fahrenheit) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (fever of 102 degrees Fahrenheit). At the time of the report, PYREXIA (fever of 102 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Laboratory test, Muscle spasms
Clinical narrative: Leg cramps; Nausea; Chills; Pounding headache; Vomiting; Tired; sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (Leg cramps), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Pounding headache) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anemia (Stable) and Thalassemia (Stable). Concomitant products included IRON from 17-Feb-2021 to an unknown date for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Jan-2021 and the estimated date of delivery was 23-Oct-2021. On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-May-2021, the patient experienced MUSCLE SPASMS (Leg cramps), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Pounding headache), VOMITING (Vomiting) and FATIGUE (Tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred  on 08-Sep-2021.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 28-May-2021, MUSCLE SPASMS (Leg cramps), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Pounding headache), VOMITING (Vomiting) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Laboratory test: normal normal. On 08-Jun-2021, Ultrasound scan: normal normal.         Concomitant medication included Prenatal from 17-FEB-2021 once a day.    This case was linked to MOD-2021-095487, MOD-2021-095487 (Patient Link).