chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Chills, Dizziness, Heart rate
Clinical narrative: slight adverse effect; a little dizzy; Shoulder pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (slight adverse effect), DIZZINESS (a little dizzy), ARTHRALGIA (Shoulder pain) and CHILLS (chills) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) 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 08-Jan-2021, the patient experienced DIZZINESS (a little dizzy), ARTHRALGIA (Shoulder pain) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION COMPLICATION (slight adverse effect). At the time of the report, VACCINATION COMPLICATION (slight adverse effect), DIZZINESS (a little dizzy), ARTHRALGIA (Shoulder pain) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased (80-120 mmHg): mmHg High. On an unknown date, Heart rate: increased (High) rapid heart rate of 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Adverse events related information was updated.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: slight adverse effect; a little dizzy; Shoulder pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (slight adverse effect), DIZZINESS (a little dizzy), ARTHRALGIA (Shoulder pain) and CHILLS (chills) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) 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 08-Jan-2021, the patient experienced DIZZINESS (a little dizzy), ARTHRALGIA (Shoulder pain) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION COMPLICATION (slight adverse effect). At the time of the report, VACCINATION COMPLICATION (slight adverse effect), DIZZINESS (a little dizzy), ARTHRALGIA (Shoulder pain) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased (80-120 mmHg): mmHg High. On an unknown date, Heart rate: increased (High) rapid heart rate of 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Adverse events related information was updated.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hepatic enzyme, Lymphadenopathy, Vaccination site pain
Clinical narrative: feeling bad; swelling of lymph nodes; soreness at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (feeling bad), LYMPHADENOPATHY (swelling of lymph nodes) and VACCINATION SITE PAIN (soreness at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-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 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 07-Feb-2021, the patient experienced LYMPHADENOPATHY (swelling of lymph nodes). On 14-Feb-2021, the patient experienced FEELING ABNORMAL (feeling bad). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling bad), LYMPHADENOPATHY (swelling of lymph nodes) and VACCINATION SITE PAIN (soreness at the injection site) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Hepatic enzyme: elevated (High) elevated.         No concomitant medication details was reported. Treatment include IV fluids
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sinus headache, Throat irritation
Clinical narrative: tired later in the day; Sinus Headache; Bumps on the back of my throat; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Sinus Headache), THROAT IRRITATION (Bumps on the back of my throat) and FATIGUE (tired later in the day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus headache.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced SINUS HEADACHE (Sinus Headache) and THROAT IRRITATION (Bumps on the back of my throat). On an unknown date, the patient experienced FATIGUE (tired later in the day). The patient was treated with CETIRIZINE HYDROCHLORIDE (ALLERGY & HAYFEVER RELIEF) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, SINUS HEADACHE (Sinus Headache), THROAT IRRITATION (Bumps on the back of my throat) and FATIGUE (tired later in the day) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       concomitant medications were not provided by reporter. Upon internal review on 21May2021, the age was corrected to unknown age.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Dosage information was updated, AE contact information update, event was updated. patient reported she believes she had more of an anxiety related experience then an reaction to the Moderna covid vaccine. causality updated.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Arm was sore; Vomited a lot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and VOMITING (Vomited a lot) 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 PAIN IN EXTREMITY (Arm was sore) and VOMITING (Vomited a lot). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and VOMITING (Vomited a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site discolouration, Vaccination site pain, Vaccination site warmth
Clinical narrative: purple around injection site; warm at injection site; sore arm; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (purple around injection site), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PAIN (sore arm) and FATIGUE (feeling tired) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (purple around injection site), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PAIN (sore arm) and FATIGUE (feeling tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (purple around injection site), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PAIN (sore arm) and FATIGUE (feeling tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, SARS-CoV-2 test, Vision blurred
Clinical narrative: blurred vision; shortness of breath; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision), DYSPNOEA (shortness of breath) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD.    On 09-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 VISION BLURRED (blurred vision), DYSPNOEA (shortness of breath) and FATIGUE (fatigue). At the time of the report, VISION BLURRED (blurred vision), DYSPNOEA (shortness of breath) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Myalgia
Clinical narrative: my body hurts all over; flu-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (my body hurts all over) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). On 23-Jan-2021, the patient experienced MYALGIA (my body hurts all over). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (my body hurts all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: (High) 98.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm) 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 03-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 PERIPHERAL SWELLING (swelling arm). At the time of the report, PERIPHERAL SWELLING (swelling arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: very fast heart beats; A spontaneous report received from a consumer concerning, 79-year-old, female patient who received dose of Moderna COVID-19 vaccine and experienced very fast heart beats [Increased Heart Rate].   The patient's medical history was not included. Patient's concomitant was not included.    On unknown date, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm intramuscularly for prophylaxis of COVID-19 infection.   Patient took Moderna COVID-19 vaccine 3 weeks ago and immediately after receiving the vaccine she experienced very fast heart beats. Patient was taken to ER and was treated in the ICU from 11 am to 9 pm.  Patient decided not to take the 2nd dose of the Moderna COVID-19 vaccine.   Action taken with mRNA-1273 in response to the event was withdrawn for planned second dose.   The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis bullous, Pruritus
Clinical narrative: itchiness; raised bubbles in their rash; A spontaneous report was received from a consumer concerning an unknown age of male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchiness, raised bubbles in their rash.  The patient's medical history was not reported.   No Relevant concomitant medications were reported like  On 15-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch - unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, after vaccination the patient experienced itchiness, raised bubbles in their rash.  Laboratory details not provided. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event were unknown for all events.; Reporter's Comments: This case concerns a male patient of unknown age who experienced a NS unexpected event of pruritus and NS expected event of dermatitis bullous.  The events occurred unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-014532:same reporter, different patient
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: delayed hypersensitivityreaction (itchy, burning and swollen arm from shoulder down to elbo); This spontaneous case was reported by a physician and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivityreaction (itchy, burning and swollen arm from shoulder down to elbo)) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivityreaction (itchy, burning and swollen arm from shoulder down to elbo)). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivityreaction (itchy, burning and swollen arm from shoulder down to elbo)) 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.   Reporter did not allow further contact; 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Pyrexia
Clinical narrative: felt cold; Fever at 100.2; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold) and PYREXIA (Fever at 100.2) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever at 100.2). On 12-Feb-2021, the patient experienced FEELING COLD (felt cold). The patient was treated with PARACETAMOL (TYLENOL) (oral) ongoing since an unknown date for Fever, at a dose of 500 mg and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. On 12-Feb-2021, FEELING COLD (felt cold) had resolved. At the time of the report, PYREXIA (Fever at 100.2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 100 (High) 100 F and 100.2 (High) 100.2 at 7 PM. On 12-Feb-2021, Body temperature: 101.3 (High) 101.3 F.         No concomitant medication reported. On 11 Feb 2021, patient started with fever 100 F. Patient took two Advil and monitored her fever at 100.2 and took a Tylenol at 7 PM and 3 AM, during the night felt cold. Fever was 101.3 F and she took Tylenol 500 mg.   This case was linked to MOD-2021-087479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Follow up received on 12-FEB-2021 contains information about first dose and AE after first dose. On 21-May-2021: Follow up received on 21-MAY-2021 via TCT patient stated she was feeling fine now and has nothing else to report.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; A spontaneous report was received from a consumer, female patient who received Moderna's COVID-19 vaccine and experienced headaches.   Patient's medical history was not provided, and no concomitant medicines taken by the patient.   The patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  The patient experienced headaches and treatment include Ibuprofen.  Action taken with mRNA-1273 was not reported.  The outcome of the events, headaches is unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness
Clinical narrative: flu like symptoms; sweat a lot; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and HYPERHIDROSIS (sweat a lot) in a 79-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) , while the parent received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): unknown.     No Medical History information was reported.    On 13-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Jan-2021, the elderly was diagnosed with INFLUENZA LIKE ILLNESS (flu like symptoms) and HYPERHIDROSIS (sweat a lot). The Elderly was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  The elderly was treated with PARACETAMOL (TYLENOL) on 14-Jan-2021 at a dose of 1 dosage form. On 14-Jan-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) and HYPERHIDROSIS (sweat a lot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15-Apr-2021 did not contain any new information. On 08-Jun-2021: Follow up received on 08-Jun-2021. Patient responded email stating, would rather not take the time to complete another form and was feeling fine and having no problems at all at the time of this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: rash that is 5 inches long and 5 inches wide; Injection site is Itchy; Injection site is red/injection site hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash that is 5 inches long and 5 inches wide), VACCINATION SITE PRURITUS (Injection site is Itchy) and VACCINATION SITE ERYTHEMA (Injection site is red/injection site hot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Historical conditions were reported.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced RASH (rash that is 5 inches long and 5 inches wide), VACCINATION SITE PRURITUS (Injection site is Itchy) and VACCINATION SITE ERYTHEMA (Injection site is red/injection site hot). The patient was treated with IBUPROFEN for Injection site itching, at an unspecified dose and frequency. At the time of the report, RASH (rash that is 5 inches long and 5 inches wide), VACCINATION SITE PRURITUS (Injection site is Itchy) and VACCINATION SITE ERYTHEMA (Injection site is red/injection site hot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. On 14 Feb 2021, patient started having side effects.  Patient took Ibuprofen one tablet in the morning and one at night, however nothing has changed. Patient has called healthcare provider and they are yet to call her back.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Erythema, Urticaria
Clinical narrative: hives; red; blood pressure raised; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and ERYTHEMA (red) in an 83-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) , while the parent received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): unknown.     MEDICAL HISTORY (Patient): Concomitant product exposures included APIXABAN (ELIQUIS) and CARVEDILOL for an unknown indication.    On 12-Feb-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Feb-2021, the elderly was diagnosed with URTICARIA (hives) and ERYTHEMA (red). At the time of the report, URTICARIA (hives) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications also include  Medication for heart.  Treatment medications include Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Injection site swelling
Clinical narrative: injection site swollen; injection site pain; chills; A spontaneous report was received from a consumer concerning 83 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site swollen, injection site painful and chills.  The patient's medical history was not reported.  Concomitant medications were not reported.  On 04 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via intramuscular for prophylaxis of COVID-19 infection.  On 04 Feb 2021, same day of first dose of vaccination the patient experienced injection site swollen, injection site pain and chills.  Laboratory test was not done.  Treatment information was provided as the patient took tylenol but for what event is not reported.  All the events occurred after first dose of vaccination.  The outcomes of the event remain unknown.  Action taken with mRNA-1273 in response to the events are unknown
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sorearm; Fatigue; A spontaneous report was received from a consumer, concerning a female patient of  71 age , who received Moderna's COVID-19 vaccine and experienced Pain in extremity/ Sorearm, Fatigue.  History of the patient was not provided. Concomitant product use was not provided by the reporter.  On 13Jan2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot no. unknown) via intramuscular route for COVID-19 infection prophylaxis.  On an unspecified date, after first dose of vaccine, the patient  reports she and the husband developed sore arm and fatigue, but are fine now. She also confirmed that they took Tylenol .    Action taken with mRNA-1273 in response to the event Pain in extremity, Fatigue was unknown.  The outcome of the event Pain in extremity, Fatigue was considered to be recovered/ resolved at the time of this report.  It was reported that she had taken Tylenol as treatment medication.
Sex: F
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: of Covid-19 vaccine for the prophylaxis of Covid-19 infection.   According to her husband, the injection looked  like water instead of white to off-white like he read on Moderna's website. The date of the first dose of the vaccine was not provided.   Action taken with the vaccine was not applicable as the consumer received both the doses of the vaccine.  The outcome of the event, injection looks like water, not white, was considered recovered/resolved.   Follow up information is expected.; Reporter's Comments: This report refers to a case of product quality issuefor mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; A spontaneous report was received from a consumer concerning a  patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events adverse reaction.  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) Adverse reaction.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), adverse reaction was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Pain; Redness; Itchiness; Swelling; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness that has slowly spread over arm) and VACCINATION SITE PRURITUS (Itchiness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Pain), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness that has slowly spread over arm) and VACCINATION SITE PRURITUS (Itchiness). At the time of the report, PAIN (Pain), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PRURITUS (Itchiness) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness that has slowly spread over arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.; 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: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Painful rash; A Spontaneous report was received from a consumer, concerning her mother, a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced a painful rash.  The patient's medical history and concomitant medication were not reported.  On 11-Jan-2021, 15 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 25-Jan 2021, after the administration of vaccine, the patient experienced painful rash that seem to be moving from one arm to another. These rashes were of white patches, which seemed to be hot. Treatment information was not reported.  Action taken with the mRNA-1273 in response to the event was unknown.  The outcome of event painful rash was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site little itchy; Injection site swelling and raised area (size half dollar); Arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE PRURITUS (Injection site little itchy) and VACCINATION SITE SWELLING (Injection site swelling and raised area (size half dollar)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site little itchy) and VACCINATION SITE SWELLING (Injection site swelling and raised area (size half dollar)). At the time of the report, PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE PRURITUS (Injection site little itchy) and VACCINATION SITE SWELLING (Injection site swelling and raised area (size half dollar)) 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.
Sex: M
Vaccine: COVID19
Symptoms: Hypogeusia, Therapeutic response unexpected
Clinical narrative: Regained total feeling of lip and chin (L); Diminished Taste; A spontaneous report was received from a consumer concerning a 76-year-old, male patient who received Moderna's COVID-19 vaccine and regained sensation in lower lip and chin and diminished taste.   The patient's medical history included cancer, Meniere, tinnitus and vertigo. No relevant concomitant medications were reported.   On 15-Feb-2021, prior to the onset of the event, patient received their first of two planned doses of mRNA-1273 (Lot number:023M20A) Intramuscularly for prophylaxis of COVID-19 infection.   On 15-Feb-2021, after injection, patient experienced symptoms included regaining sensation in the lower lip and chin and diminished taste. Patient mentioned about previous history of cancer and chemotherapy treatment had affected lip nerve. No treatment information was provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The event, regained sensation in lower lip and chin and diminished taste were considered unknown.; Reporter's Comments: This case concerns a 76-year-old male with PMH of cancer, Meniere, tinnitus, vertigo, who had NS unexpected events of "regaining sensation in the lower lip and diminished taste". Events occurred 2 days after first dose of mRNA-1273. Very limited information on the events has been provided at this time. Further information requested. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on the injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain on the injection site). At the time of the report, VACCINATION SITE PAIN (pain on the injection site) 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 and treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Headache, Pain, Pain in extremity
Clinical narrative: Arm hurt; Ache in the side of the back; Miserable; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), BACK PAIN (Ache in the side of the back), FEELING ABNORMAL (Miserable), PAIN (Body aches) and HEADACHE (Headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), BACK PAIN (Ache in the side of the back), FEELING ABNORMAL (Miserable), PAIN (Body aches) and HEADACHE (Headaches). At the time of the report, PAIN IN EXTREMITY (Arm hurt), BACK PAIN (Ache in the side of the back), FEELING ABNORMAL (Miserable), PAIN (Body aches) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional information received regarding second dose and events of 2nd dose
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Pain, Pain in extremity
Clinical narrative: No appetite; Aching; Temperature of 100F; Chills; Sore arm (left arm); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (left arm)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (left arm)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm (left arm)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: 100 (High) 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient stated she was not taking other medications.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No new information
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: No appetite; Aching; Temperature of 100F; Chills; Sore arm (left arm); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (left arm)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (left arm)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm (left arm)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: 100 (High) 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient stated she was not taking other medications.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No new information
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: arm was sore/arm pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm was sore/arm pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles, Colonoscopy in February 2021 and Abdomen CT. Concomitant products included CHLORHEXIDINE GLUCONATE (ORAL C) for an unknown indication.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced INJECTION SITE PAIN (arm was sore/arm pain). At the time of the report, INJECTION SITE PAIN (arm was sore/arm pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Primary Reporter Email  address added
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Batch / lot number of vaccine was unknown  No concomitant medications were reported Treatment medications was not provided   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: shoulder sore; Sore: Vaccination Site and All over the body; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Sore: Vaccination Site and All over the body) and ARTHRALGIA (shoulder sore) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): unknown.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore: Vaccination Site and All over the body). On an unknown date, the patient experienced ARTHRALGIA (shoulder sore). At the time of the report, VACCINATION SITE PAIN (Sore: Vaccination Site and All over the body) and ARTHRALGIA (shoulder sore) outcome was unknown. 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.   Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up contain NNI.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Vaccination site erythema, Vaccination site pain
Clinical narrative: blister developed in the roof of mouth; soreness at injection site; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (blister developed in the roof of mouth), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (injection site redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (injection site redness). On 24-Jan-2021, the patient experienced ORAL MUCOSAL BLISTERING (blister developed in the roof of mouth). On 23-Jan-2021, VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (blister developed in the roof of mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included medication for thyroid.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: ThPatient had some discomfort in the stomach prior the administration of 2nd dose of vaccine. On 16-FEB-2021, Patient developed nausea after the administration of second dose of vaccine .e patient's medical history was not provided. No relevant concomitant medications were reported   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcoms of events were not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Pruritus, Swelling face
Clinical narrative: redness; Itchy; face is swollen; arm is hurting underneath; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (Itchy), SWELLING FACE (face is swollen) and AXILLARY PAIN (arm is hurting underneath) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), PRURITUS (Itchy), SWELLING FACE (face is swollen) and AXILLARY PAIN (arm is hurting underneath). At the time of the report, ERYTHEMA (redness), PRURITUS (Itchy), SWELLING FACE (face is swollen) and AXILLARY PAIN (arm is hurting underneath) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Reporter did not allow further contact there is no information provided. There is no batch number provided.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the reported events has been provided at this time. Based on the current available information, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product colour issue
Clinical narrative: The patient received their first of two planned doses of mRNA-1273 (lot number unknown) on an unknown date.  On 14 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (lot number: 022M20A) for prophylaxis of COVID-19 infection.   When the patient received the second dose of the vaccine, the content of the vial was not milky white.  The vaccine was not drawn from a vial, but the syringe was already filled.  He stated the injection was like water, not white.  He also reported that looking at the syringe, he noticed he may have gotten more than the 0.5 ml recommended dose (he then changed his mind and said he thought he got the right dose).  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, the action taken with the drug in response to the event was not applicable.  The event, content of the vial was not milky white/injection was like water, not white, was considered recovered/resolved on 14 Feb 2021.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Hyperhidrosis, Nausea
Clinical narrative: diarrhea; chills; nausea; weakness; sweating; thought she was going to pass out; A spontaneous report was received from a Consumer concerning 92 years of  age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, chills, nausea, weakness,sweating and thought she was going to pass out.  The patient's medical history was not provided. No Concomitant medications were  provided.   On 07,feb,2021 on the same day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (batch 012M20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 7,feb,2021, the patient experienced the events diarrhea, chills, nausea, weakness, sweating and thought she was going to pass out.  No Laboratory details  provided. Action taken with mRNA-1273 in response to the events was not provided.  At the time of this report, the events outcomes  diarrhea, chills, nausea, weakness, sweating and thought she was going to pass out were unknown.