chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Reporter stated she had a very bad rash./ ever since she received the vaccine her skin has been breaking out.; Sore arm; Redness all over the body except the face like wheal; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Redness all over the body except the face like wheal) and RASH (Reporter stated she had a very bad rash./ ever since she received the vaccine her skin has been breaking out.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Redness all over the body except the face like wheal). On an unknown date, the patient experienced RASH (Reporter stated she had a very bad rash./ ever since she received the vaccine her skin has been breaking out.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 24-Feb-2021 for Adverse event, at an unspecified dose and frequency; CORTISONE on 24-Feb-2021 for Adverse event, at an unspecified dose and frequency; PREDNISONE on 24-Feb-2021 for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) on 24-Feb-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Redness all over the body except the face like wheal) and RASH (Reporter stated she had a very bad rash./ ever since she received the vaccine her skin has been breaking out.) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Additional event of rash added. Patient verbalized consent to FU with her HCP and contact information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Oropharyngeal pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: a lot of that (injection) arm is red; vaccination site pain; headache; redness at injection site; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ERYTHEMA (a lot of that (injection) arm is red), VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006m20a or 066m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness at injection site). On 24-Feb-2021, the patient experienced ERYTHEMA (a lot of that (injection) arm is red). On 14-Feb-2021, OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved. At the time of the report, ERYTHEMA (a lot of that (injection) arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itching at injection site; Soreness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Toothache
Clinical narrative: migraine behind the eyes; pain in the teeth; Nausea; A spontaneous report was received from a consumer concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events migraine behid the eyes, pain in the teeth, nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273  via unknown route for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced the event(s) migraine behid the eyes, pain in the teeth, nausea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), migraine behid the eyes, pain in the teeth, nausea was Not Recovered/Not Resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at the injection arm; Swelling at the injection arm; Pain at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at the injection arm), INJECTION SITE SWELLING (Swelling at the injection arm) and INJECTION SITE PAIN (Pain at the injection arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at the injection arm), INJECTION SITE SWELLING (Swelling at the injection arm) and INJECTION SITE PAIN (Pain at the injection arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (Redness at the injection arm), INJECTION SITE SWELLING (Swelling at the injection arm) and INJECTION SITE PAIN (Pain at the injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator; 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Limb discomfort
Clinical narrative: Felt warm; Arm was itchy; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was itchy, arm was more itchy, felt warm.  The patient's medical history was not provided. Concomitant medications reported were metoprolol 25mg, Eliquis 5mg, digoxin 125mcg, furosemide 40mg, Tylenol ES for drug use for unknown indication.  On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) arm was itchy. On 24 Feb 2021, the patient experienced the event(s) arm was more itchy, felt warm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm was itchy, arm was more itchy, felt warm was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Headache
Clinical narrative: coughing; chills; fever; fatigue; headache; arm sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced COUGH (coughing), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE PAIN (arm sore to touch). On 06-Feb-2021, CHILLS (chills) had resolved. On 08-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, COUGH (coughing), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE PAIN (arm sore to touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: The follow-up received on 5th May 2021: Patient contact details was updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: coughing; chills; fever; fatigue; headache; arm sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced COUGH (coughing), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE PAIN (arm sore to touch). On 06-Feb-2021, CHILLS (chills) had resolved. On 08-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, COUGH (coughing), FATIGUE (fatigue), HEADACHE (headache) and VACCINATION SITE PAIN (arm sore to touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: The follow-up received on 5th May 2021: Patient contact details was updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Flu like Symptoms; Fever; Achiness; Red and itchy at injection site; Red and itchy at injection site; Warm at injection site; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu like symptoms, fever/pyrexia, achiness/pain, red at injection site/vaccination site erythema and itchy /vaccination site pruritis , warm at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (Batch number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events Flu like symptoms, fever, achiness, red and itchy at injection site, warm at injection site.  Treatment medications Not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events flu like symptoms, fever, achiness, red and itchy at injection site, warm at injection site was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Flu like Symptoms; Fever; Achiness; Red and itchy at injection site; Red and itchy at injection site; Warm at injection site; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu like symptoms, fever/pyrexia, achiness/pain, red at injection site/vaccination site erythema and itchy /vaccination site pruritis , warm at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (Batch number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events Flu like symptoms, fever, achiness, red and itchy at injection site, warm at injection site.  Treatment medications Not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events flu like symptoms, fever, achiness, red and itchy at injection site, warm at injection site was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Physical Aches; This spontaneous case was reported by a consumer and describes the occurrence of   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 No adverse event (No medical history provided.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.            No treatment medications were provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: severe sweating on his head; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (severe sweating on his head) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HYPERHIDROSIS (severe sweating on his head). At the time of the report, HYPERHIDROSIS (severe sweating on his head) 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.   No treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Telephone Contact Report- Incorrect contact information.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2 doses about one hour apart; A spontaneous report was received from  a healthcare professional concerning an unidentified patient (demographics not provided), who received Moderna's COVID-19 vaccine (mRNA-1273) and received two doses of the Moderna COVID 19 vaccine about one hour apart.  The patient's medical history was not reported by the reporter. Concomitant product use was not provided.  On an unknown date, the patient received their first and second of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route at unspecified site for prophylaxis of COVID-19 infection.  On an unknown date, the patient received two doses of the Moderna COVID 19 vaccine about one hour apart.  Treatment for events was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug is not applicable.   The outcome of event, received 2 doses of the Moderna COVID 19 vaccine about one hour apart was resolved on an unknown date.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: pain, redness, itching, and hotness in the vaccination site.; pain, redness, itching, and hotness in the vaccination site.; pain, redness, itching, and hotness in the vaccination site.; pain, redness, itching, and hotness in the vaccination site.; spread and gotten worse.; still painful, red, and swollen.; still painful, red, and swollen.; still painful, red, and swollen.; A spontaneous report  was received from a consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain, redness, itching, and hotness in the vaccination site, spread and gotten worse, still painful, red, and swollen,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch:011M20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the events,pain, redness, itching, and hotness in the vaccination site, spread and gotten worse, still painful, red, and swollen.  Treatment details included Antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, pain, redness, itching, and hotness in the vaccination site, spread and gotten worse, still painful, red, and swollen was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: pain, redness, itching, and hotness in the vaccination site.; pain, redness, itching, and hotness in the vaccination site.; pain, redness, itching, and hotness in the vaccination site.; pain, redness, itching, and hotness in the vaccination site.; spread and gotten worse.; still painful, red, and swollen.; still painful, red, and swollen.; still painful, red, and swollen.; A spontaneous report  was received from a consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain, redness, itching, and hotness in the vaccination site, spread and gotten worse, still painful, red, and swollen,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch:011M20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the events,pain, redness, itching, and hotness in the vaccination site, spread and gotten worse, still painful, red, and swollen.  Treatment details included Antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, pain, redness, itching, and hotness in the vaccination site, spread and gotten worse, still painful, red, and swollen was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: site is red, lil tender but did not hurt; site is red, lil tender but did not hurt; A spontaneous report was received from a consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events site is red, lil tender but did not hurt.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (batch number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) site is red, lil tender but did not hurt.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), site is red, lil tender but did not hurt was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itchy at the injection site; Red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy at the injection site) and INJECTION SITE ERYTHEMA (Red at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itchy at the injection site) and INJECTION SITE ERYTHEMA (Red at the injection site). On 19-Mar-2021, INJECTION SITE PRURITUS (Itchy at the injection site) and INJECTION SITE ERYTHEMA (Red at the injection site) had resolved.            No Concomitant medications were reported.  No treatment medications were reported.  Patient took the second dose on 15-MAR-2021 (lot no. 002D21A)   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up information received on 16 Jul 2021 contains updated contact information, updated date of first dose, second dose information and updated outcome of all the events as recovered with stop date.
Sex: F
Vaccine: COVID19
Symptoms: Excessive eye blinking
Clinical narrative: Fluttering eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXCESSIVE EYE BLINKING (Fluttering eyes) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Previously administered products included for an unreported indication: FIORICET. Concurrent medical conditions included Migraine. Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET).  No treatment information was reported.  On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced EXCESSIVE EYE BLINKING (Fluttering eyes). At the time of the report, EXCESSIVE EYE BLINKING (Fluttering eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: accidentally administered an expired dose to 50 patients; A spontaneous report was received from a nurse concerning 50 patients of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and were accidentally administered an expired dose.  The patients' medical histories were not provided.  Concomitant product use was not provided.  On 22 Feb 2021, 50 patients accidentally received an expired dose of mRNA-1273 (batch number 012M20A; expiration date 21 Feb 2021) intramuscularly for prophylaxis of COVID-19 infection.   Treatment information was not provided.  Action taken with mRNA-1273 in the response to the event was not applicable.  The event was considered resolved on 22 Feb 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 012M20A) with no associated AEs reported in a group of 50 patients with unknown age and gender.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Neck pain
Clinical narrative: Neck ache; Headache; Muscle ache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NECK PAIN (Neck ache), HEADACHE (Headache) and MYALGIA (Muscle ache) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 DIARRHOEA (Diarrhea), NECK PAIN (Neck ache), HEADACHE (Headache) and MYALGIA (Muscle ache). At the time of the report, DIARRHOEA (Diarrhea), NECK PAIN (Neck ache), HEADACHE (Headache) and MYALGIA (Muscle ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received on 28 Apr 2021:  Second dose was reported and Event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold
Clinical narrative: Hand & feet feeling ice cold; Severe joint ache that hurt; A spontaneous report was received from a female patient of unspecified age concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hand & feet feeling ice cold and severe joint ache that hurt.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, the patient experienced the events hand & feet feeling ice cold and severe joint ache that hurt.  Treatment details included Advil liquid gel 200 mg.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, hand & feet feeling ice cold, and sever joint ache that hurt was  considered recovering.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: When nurse was administering the vaccine, some of the vaccine liquid leaked out on to the patient's arm; A spontaneous report was received from pharmacist concerning a 38-years old female patient who experienced underdose (when nurse was administering the vaccine, some of the vaccine liquid leaked out on to the patient's arm).  The patient's relevant medical history was not provided. Concomitant product use was not provided by the reporter.   On 25-Feb-2021, prior to the event onset, the patient received their second of two planned doses of mRNA-1273 (Batch number: 023M20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   On 25-Feb-2021, the pharmacist reported, that a nurse injected a second dose to a female on her left upper arm, and during administration some of the vaccine liquid leaked out on to the patient's arm. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event of underdose was unknown.  The reporter did not provide any causality assessments for the event of underdose.; Sender's Comments: This report refers to a case of accidental underdose for mRNA -1273 lot#  023M20A with no AEs reported
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm hurts; Tired; A spontaneous report was received from a healthcare professional concerning a 79-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurts, tired.  The patient's medical history was not provided. Concomitant medications reported were eloquist 2.5 mg twice a day, gleecax for stomach cancer for drug use for unknown indication.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) arm hurts, tired.  Treatment details included not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm hurts, tired was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Disorientation, Fatigue, Heart rate increased
Clinical narrative: "No energy" persists; Severe fatigue; No energy; "Loss of 6 pounds"; Vomiting for 2 days; Severe shaking for 18 hours; Disoriented; Diarrhea for 2 days; High pulse (90's); Sweating; A spontaneous report was received from a consumer concerning a 81-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe shaking for 18 hours, disoriented, vomiting for 2 days, diarrhea for 2 days, high pulse (90's), sweating, severe fatigue, no energy, loss of 6 pounds, no energy persists.  The patient's medical history was not provided. Concomitant medications reported were Vitamin B3, Calcium, Magnesium for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events severe shaking for 18 hours, disoriented, vomiting for 2 days, diarrhea for 2 days, high pulse (90's), sweating. On 16 Feb 2021, the patient experienced the events severe fatigue, no energy, loss of 6 pounds. On 25 Feb 2021, the patient experienced the event no energy persists.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, severe shaking for 18 hours, disoriented, vomiting for 2 days, diarrhea for 2 days, high pulse (90's), sweating, severe fatigue, no energy, loss of 6 pounds, no energy persists was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Tremor, Vomiting, Weight decreased
Clinical narrative: "No energy" persists; Severe fatigue; No energy; "Loss of 6 pounds"; Vomiting for 2 days; Severe shaking for 18 hours; Disoriented; Diarrhea for 2 days; High pulse (90's); Sweating; A spontaneous report was received from a consumer concerning a 81-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe shaking for 18 hours, disoriented, vomiting for 2 days, diarrhea for 2 days, high pulse (90's), sweating, severe fatigue, no energy, loss of 6 pounds, no energy persists.  The patient's medical history was not provided. Concomitant medications reported were Vitamin B3, Calcium, Magnesium for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events severe shaking for 18 hours, disoriented, vomiting for 2 days, diarrhea for 2 days, high pulse (90's), sweating. On 16 Feb 2021, the patient experienced the events severe fatigue, no energy, loss of 6 pounds. On 25 Feb 2021, the patient experienced the event no energy persists.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, severe shaking for 18 hours, disoriented, vomiting for 2 days, diarrhea for 2 days, high pulse (90's), sweating, severe fatigue, no energy, loss of 6 pounds, no energy persists was unknown.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive after their first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Patient tested positive after their first dose) in an 83-year-old patient of an unknown 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 COVID-19 (Patient tested positive after their first dose). At the time of the report, COVID-19 (Patient tested positive after their first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: Positive.     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 relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Follow up information was received on 4 Feb 2021. Significant Follow up/ Patient info (Date of birth, age) added, reporter address and E-mail added, route of vaccine administration and anatomical location added. On 21-Apr-2021: No new information
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Nail bed tenderness, Skin discolouration, Skin exfoliation, Vaccination complication
Clinical narrative: Skin in that area is flaking; Feet are purple; Nail beds are sensitive; COVID toe; Hypersensitivity to the vaccine; A spontaneous report was received from a consumer concerning a 61-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid toe, nail beds are sensitive, four toes are affected, skin in that area is flaking, feet are purple, hypersensitivity to the vaccine.  The patient's medical history reported included geographic tongue and hypersensitivity to other vaccines. Concomitant medications reported were Aspirin, Statins, Fish oil for drug use for unknown indication.  On 31 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) COVID toe, nail beds are sensitive, four toes are affected, skin in that area is flaking, feet are purple, hypersensitivity to the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, covid toe, nail beds are sensitive, four toes are affected, skin in that area is flaking, feet are purple, hypersensitivity to the vaccine was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on her torso; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on her torso.  The patient's medical history was not provided. Concomitant medications reported were gabapentin, trazadone, duloxetine for drug use for unknown indication.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 014M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) rash on her torso.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash on her torso was Not Recovered/Not Resolved.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Wife has been experiencing reactions to the Moderna Vaccine; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events wife has been experiencing reactions to the moderna vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) wife has been experiencing reactions to the Moderna Vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), wife has been experiencing reactions to the moderna vaccine was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy around the injection site; Red arm around injection site; Swollen around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy around the injection site), INJECTION SITE ERYTHEMA (Red arm around injection site) and INJECTION SITE SWELLING (Swollen around the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchy around the injection site), INJECTION SITE ERYTHEMA (Red arm around injection site) and INJECTION SITE SWELLING (Swollen around the injection site). At the time of the report, INJECTION SITE PRURITUS (Itchy around the injection site), INJECTION SITE ERYTHEMA (Red arm around injection site) and INJECTION SITE SWELLING (Swollen around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhausted) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced FATIGUE (Exhausted). On 28-Jan-2021, FATIGUE (Exhausted) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-026568 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M209) for COVID-19 vaccination.     No medical history was provided by the reporter.   Concomitant products included PRAVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING COLD (Cold). At the time of the report, FEELING COLD (Cold) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   Concomitant product also include unspecified blood pressure pills (in the morning).  Treatment medication was not reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Event outcome was updated.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: All of a sudden his hands swelled up; hand swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (All of a sudden his hands swelled up) and PERIPHERAL SWELLING (hand swelling) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 experienced PERIPHERAL SWELLING (All of a sudden his hands swelled up) and PERIPHERAL SWELLING (hand swelling). At the time of the report, PERIPHERAL SWELLING (All of a sudden his hands swelled up) and PERIPHERAL SWELLING (hand swelling) outcome was unknown.            patient have a event sore hand after taking the 2nd dose.  No concomitant medications reported by investigator.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Diarrhoea, Headache, Lethargy
Clinical narrative: Body aches, lethargy, headache, fever, chills, nausea, vomiting and diarrhea. Began approx. 72 hours after receiving vaccine. Started with body aches as the days continued additional symptoms followed.  Lasted roughly 4 -6 days - I am still experiencing body aches and lethargy 10 days later. These were unrelieved by Tylenol, Ibuprofen and Ondansetron, muscle rub (Icy Hot), and heating pad
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Body aches, lethargy, headache, fever, chills, nausea, vomiting and diarrhea. Began approx. 72 hours after receiving vaccine. Started with body aches as the days continued additional symptoms followed.  Lasted roughly 4 -6 days - I am still experiencing body aches and lethargy 10 days later. These were unrelieved by Tylenol, Ibuprofen and Ondansetron, muscle rub (Icy Hot), and heating pad
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 12 hours after injection, experienced fever 100.8F, chills, generalized muscle soreness and ache, injection sight tenderness.  24 hours after injection, fever/chills/body ache resolved, but injection sight pain worsened, reddened, hot to touch, and swelling. 48 hours after injection, no systemic symptoms, but injection sight more swollen, painful, hot to touch, redness expanding. Also 48 hours after injection, developed NEUTROPENIA as evidence by WBC 2.4 and ANC 0.7.  Repeat labs at approximately 12 hours resulted WBC 2.9 and ANC 1.2.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neutrophil count decreased, Pain, Pyrexia, White blood cell count increased
Clinical narrative: 12 hours after injection, experienced fever 100.8F, chills, generalized muscle soreness and ache, injection sight tenderness.  24 hours after injection, fever/chills/body ache resolved, but injection sight pain worsened, reddened, hot to touch, and swelling. 48 hours after injection, no systemic symptoms, but injection sight more swollen, painful, hot to touch, redness expanding. Also 48 hours after injection, developed NEUTROPENIA as evidence by WBC 2.4 and ANC 0.7.  Repeat labs at approximately 12 hours resulted WBC 2.9 and ANC 1.2.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Vomiting
Clinical narrative: Severe pain in arm of injection.  Fatigue.  Headache. Vomiting.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Influenza like illness
Clinical narrative: AFter first dose, when I was working and wearing N95 mask I was sweating profusely and feeling overheated.  I ascribed it to my job, however, I would feel these symptoms at home too off and on.  After the second dose, the day after, I had flu like symptoms which subsided in 24 hours.  However, I feel overheated all the time and sweating.  I need to sleep with my blankets off and the windows open to not feel overheated.  It's not a feeling of fever or chills, its more like hormonal or something.  I'm drinking ice cold drinks to keep me feeling cooler.  Anyways, hopefully, it will go away.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Joint noise, Musculoskeletal discomfort
Clinical narrative: Left knee joint clicking and mild discomfort started mid to end of January 2021. Similar symptoms in right knee but very mild. Not sure if it is related to vaccine or not.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm started to feel more tender; Arm became swollen and red; A bump formed near the injection site; Arm became swollen and red; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm started to feel more tender, arm became swollen and red, a bump formed near the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events arm started to feel more tender, arm became swollen and red, a bump formed near the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, arm started to feel more tender, arm became swollen and red, a bump formed near the injection site was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection Site got big and bigger (Ping Pong Ball size); Red Mark on the Injection Site/ Red injection site; Raised Injection Site; Itchy Injection Site; Sore Arm; A spontaneous report was received from a 37-years-old female patient  concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, red mark on the injection site, injection site got big and bigger (ping pong ball size), raised injection site, red injection site and itchy injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the event sore arm. On 1 Feb 2021, the patient experienced the events red mark on the injection site, injection site got big and bigger (ping pong ball size), raised injection site, red injection site and itchy injection site.  Treatment details included Augmentin.  Action taken with mRNA-1273 in response to the events was not reported.  On 27 Jan 2021 the outcome of event, sore arm was resolved. The outcome of events, red mark on the injection site, injection site got big and bigger (ping pong ball size), raised injection site, red injection site and itchy injection site was unknown.