chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: cannot lift injection arm; pain at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB DISCOMFORT (cannot lift injection arm) and VACCINATION SITE PAIN (pain at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 042L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, TRIAMTERENE, AMLODIPINE and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced LIMB DISCOMFORT (cannot lift injection arm) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, LIMB DISCOMFORT (cannot lift injection arm) and VACCINATION SITE PAIN (pain at injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional 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.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-036255 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-036255:husband case (male patient)
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eye pain, Eye swelling, Pain assessment
Clinical narrative: swollen on left eye lid; redness on left eye lid; left eye lid was feeling sore; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (left eye lid was feeling sore), EYE SWELLING (swollen on left eye lid) and ERYTHEMA OF EYELID (redness on left eye lid) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced EYE PAIN (left eye lid was feeling sore). On 04-Mar-2021, the patient experienced EYE SWELLING (swollen on left eye lid) and ERYTHEMA OF EYELID (redness on left eye lid). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, EYE PAIN (left eye lid was feeling sore), EYE SWELLING (swollen on left eye lid) and ERYTHEMA OF EYELID (redness on left eye lid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Pain assessment: 2-3 (Inconclusive) 2-3.     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 reported.  Patient took Benadryl to help subside the adverse event.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Erythema, Headache, Injection site induration, Myalgia
Clinical narrative: Soreness; Stiffness in Injection Arm; Redness; Chills; Headaches; Muscle Pains; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), INJECTION SITE INDURATION (Stiffness in Injection Arm), ERYTHEMA (Redness), CHILLS (Chills) and HEADACHE (Headaches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0132LOA and 030M2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2OA) for an unknown indication.    No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 11-Feb-2021, the patient experienced PAIN (Soreness), INJECTION SITE INDURATION (Stiffness in Injection Arm), ERYTHEMA (Redness), CHILLS (Chills), HEADACHE (Headaches), MYALGIA (Muscle Pains) and PYREXIA (Fever). At the time of the report, PAIN (Soreness), INJECTION SITE INDURATION (Stiffness in Injection Arm), ERYTHEMA (Redness), CHILLS (Chills), HEADACHE (Headaches), MYALGIA (Muscle Pains) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Soreness; Stiffness in Injection Arm; Redness; Chills; Headaches; Muscle Pains; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), INJECTION SITE INDURATION (Stiffness in Injection Arm), ERYTHEMA (Redness), CHILLS (Chills) and HEADACHE (Headaches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0132LOA and 030M2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2OA) for an unknown indication.    No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 11-Feb-2021, the patient experienced PAIN (Soreness), INJECTION SITE INDURATION (Stiffness in Injection Arm), ERYTHEMA (Redness), CHILLS (Chills), HEADACHE (Headaches), MYALGIA (Muscle Pains) and PYREXIA (Fever). At the time of the report, PAIN (Soreness), INJECTION SITE INDURATION (Stiffness in Injection Arm), ERYTHEMA (Redness), CHILLS (Chills), HEADACHE (Headaches), MYALGIA (Muscle Pains) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Blood pressure measurement, Headache, Heart rate increased
Clinical narrative: balance was off; Headache; very weak; pretty incoherent; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (balance was off), HEADACHE (Headache), ASTHENIA (very weak) and INCOHERENT (pretty incoherent) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced BALANCE DISORDER (balance was off), HEADACHE (Headache), ASTHENIA (very weak) and INCOHERENT (pretty incoherent). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 02-Mar-2021, BALANCE DISORDER (balance was off) and INCOHERENT (pretty incoherent) outcome was unknown. At the time of the report, HEADACHE (Headache) and ASTHENIA (very weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: increased (High) Blood pressure increased. On 02-Mar-2021, Heart rate increased: high (High) Pulse was high. On 02-Mar-2021, Pyrexia: 102 (Inconclusive) Fever 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are not reported.
Sex: M
Vaccine: COVID19
Symptoms: Incoherent, Pyrexia
Clinical narrative: balance was off; Headache; very weak; pretty incoherent; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (balance was off), HEADACHE (Headache), ASTHENIA (very weak) and INCOHERENT (pretty incoherent) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced BALANCE DISORDER (balance was off), HEADACHE (Headache), ASTHENIA (very weak) and INCOHERENT (pretty incoherent). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 02-Mar-2021, BALANCE DISORDER (balance was off) and INCOHERENT (pretty incoherent) outcome was unknown. At the time of the report, HEADACHE (Headache) and ASTHENIA (very weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: increased (High) Blood pressure increased. On 02-Mar-2021, Heart rate increased: high (High) Pulse was high. On 02-Mar-2021, Pyrexia: 102 (Inconclusive) Fever 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; achy; A spontaneous report was received from a consumer concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, achy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) headache. achy.  Treatment details included tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, achy was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received the vaccine; A spontaneous report was received from a healthcare Professional concerning a 17 years old female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and Patient was told that she could not receive her 2nd dose until she had an authorization from Moderna to do so.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05-03-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 03-03-2021, The Patient was told that she could not receive her 2nd dose until she had an authorization from Moderna to do so.   Treatment details if provided or No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event is resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration   for mRNA-1273, lot #013A21A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Peripheral swelling, Pyrexia
Clinical narrative: arm is swelling; fever (99.3-99.5°F); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swelling) and PYREXIA (fever (99.3-99.5°F)) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is swelling) and PYREXIA (fever (99.3-99.5°F)). At the time of the report, PERIPHERAL SWELLING (arm is swelling) and PYREXIA (fever (99.3-99.5°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3-99.5°f (High) fever (99.3-99.5°F).         Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Arm hurts so bad; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts so bad), CHILLS (Chills) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Blood pressure high.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts so bad), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm hurts so bad), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment of these events were not reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: sleepy; Arm hurt; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), PAIN IN EXTREMITY (Arm hurt) and FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SOMNOLENCE (sleepy), PAIN IN EXTREMITY (Arm hurt) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleepy), PAIN IN EXTREMITY (Arm hurt) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash pruritic, Vaccination site pain
Clinical narrative: rash with itching; tired; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash with itching), FATIGUE (tired), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included BISMUTH SUBSALICYLATE (PEPTOBISMOL) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced RASH PRURITIC (rash with itching), FATIGUE (tired), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm). On 05-Feb-2021, RASH PRURITIC (rash with itching), FATIGUE (tired) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Additional information include email address provided.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Nausea
Clinical narrative: Can't move around without her walker; Dizzy; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can't move around without her walker), DIZZINESS (Dizzy) and NAUSEA (Nauseous) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A211A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Dizzy) and NAUSEA (Nauseous). On an unknown date, the patient experienced GAIT DISTURBANCE (Can't move around without her walker). At the time of the report, GAIT DISTURBANCE (Can't move around without her walker), DIZZINESS (Dizzy) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: Just last night arm starting to itch, itching comes and goes; Some redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Just last night arm starting to itch, itching comes and goes) and VACCINATION SITE ERYTHEMA (Some redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042LZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DULAGLUTIDE (TRULICITY), METFORMIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), PREGABALIN (LYRICA) and VITAMINS NOS for an unknown indication.    On 04-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 PRURITUS (Just last night arm starting to itch, itching comes and goes) and VACCINATION SITE ERYTHEMA (Some redness). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (Just last night arm starting to itch, itching comes and goes) and VACCINATION SITE ERYTHEMA (Some redness) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Changed event outcome from unknown to recovering/resolving
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: achy; a fever of 101.5; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), PYREXIA (a fever of 101.5) and CHILLS (chills) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (achy), PYREXIA (a fever of 101.5) and CHILLS (chills). At the time of the report, PAIN (achy), PYREXIA (a fever of 101.5) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information received on 23-APR-2021 and contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain
Clinical narrative: muscle ache; Headache; Chills; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), MYALGIA (muscle ache), the second episode of HEADACHE (Headache), CHILLS (Chills) and the first episode of HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (Body aches), CHILLS (Chills) and the first episode of HEADACHE (Headache). On 04-Mar-2021, the patient experienced the second episode of HEADACHE (Headache). On an unknown date, the patient experienced MYALGIA (muscle ache). The patient was treated with PARACETAMOL (TYLENOL) on 27-Feb-2021 for Headache, at a dose of 1 dosage form. On 01-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN (Body aches), MYALGIA (muscle ache) and the last episode of HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth
Clinical narrative: Her arm is red and warm feeling today where it was done; Her arm is red and warm feeling today where it was done; A spontaneous report was received from a consumer ms concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events her arm is red and warm feeling today where it was done.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.   on unknown date the patient experienced the event Her arm is red and warm feeling today where it was done.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), her arm is red and warm feeling today where it was done,  was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse effects; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events adverse effects.  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 their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   on unknown date patient experienced the adverse effects.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), adverse effects,  was unknown.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Blood creatinine increased, Blood urea, Decreased appetite, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) and FATIGUE (Extreme fatigue) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder cancer.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-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 DECREASED APPETITE (Loss of appetite) and FATIGUE (Extreme fatigue). At the time of the report, DECREASED APPETITE (Loss of appetite) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine increased: 4 (High) high. On an unknown date, Blood urea: high (High) high.         Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site pain
Clinical narrative: Left arm was extremely painful; Pain on his left arm up and down and that is getting worse; A spontaneous report was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain on his left arm up and down and that is getting worse and left arm was extremely painful.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011A21A) in the left arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient experienced the events pain on left arm up and down and that was getting worse. On 04 Mar 2021, left arm was extremely painful. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events pain on his left arm up and down and that is getting worse and left arm was extremely painful was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: the needle leaked because the patient pulled their arm away; A spontaneous report was received from  a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had the needle leaked because the patient pulled their arm away.   No medical history was reported. No relevant concomitant medications were reported.  On an unknown date, the patient received their a dose of mRNA-1273 (Batch number: not provided), intramuscularly for the prophylaxis of COVID-19 infection.   On an unknown date, the reporter stated that the needle leaked because the patient pulled their arm away. No further information was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  On an unknown date, the needle leaked because the patient pulled their arm away was considered resolved.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273 (lot # 024M20A) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever). At the time of the report, PYREXIA (slight fever) had resolved.            No concomitant medication reported. No treatment was provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Updated the outcome of the event (slight fever) from unknown to recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Myalgia, Nausea
Clinical narrative: Trigger finger miraculously gets better; Could not get herself warm; Body ache; Headache; Nausea; Chills; Fever; This spontaneous case was reported by an other and describes the occurrence of TRIGGER FINGER (Trigger finger miraculously gets better), FEELING COLD (Could not get herself warm), MYALGIA (Body ache), HEADACHE (Headache) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 23-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. On 23-Feb-2021, the patient experienced TRIGGER FINGER (Trigger finger miraculously gets better), FEELING COLD (Could not get herself warm), MYALGIA (Body ache), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, TRIGGER FINGER (Trigger finger miraculously gets better) had resolved and FEELING COLD (Could not get herself warm), MYALGIA (Body ache), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Trigger finger
Clinical narrative: Trigger finger miraculously gets better; Could not get herself warm; Body ache; Headache; Nausea; Chills; Fever; This spontaneous case was reported by an other and describes the occurrence of TRIGGER FINGER (Trigger finger miraculously gets better), FEELING COLD (Could not get herself warm), MYALGIA (Body ache), HEADACHE (Headache) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 23-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. On 23-Feb-2021, the patient experienced TRIGGER FINGER (Trigger finger miraculously gets better), FEELING COLD (Could not get herself warm), MYALGIA (Body ache), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, TRIGGER FINGER (Trigger finger miraculously gets better) had resolved and FEELING COLD (Could not get herself warm), MYALGIA (Body ache), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: The injection site is all red; The injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (The injection site is all red) and VACCINATION SITE SWELLING (The injection site is swollen) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (The injection site is all red) and VACCINATION SITE SWELLING (The injection site is swollen). At the time of the report, VACCINATION SITE ERYTHEMA (The injection site is all red) and VACCINATION SITE SWELLING (The injection site is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: breaking into hives, hives all over body, hive come back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking into hives, hives all over body, hive come back) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unkown) 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 11-Feb-2021, the patient experienced URTICARIA (breaking into hives, hives all over body, hive come back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of UNK dosage form. At the time of the report, URTICARIA (breaking into hives, hives all over body, hive come back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   It was reported that, hives started 24 hours after getting vaccine. She took Benadryl and when she does not take it, hives come back.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema
Clinical narrative: Redness is spreading and is even bigger than it was 2 weeks ago; Redness is spreading and is even bigger than it was 2 weeks ago; A spontaneous report (United States) was received from a consumer concerning a 76-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness was spreading and was even bigger than it was 2 weeks ago/ vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 18 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 016M20A) intramuscularly in right deltoid for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced redness was spreading and was even bigger than it was 2 weeks ago.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, redness was spreading and was even bigger than it was 2 weeks ago was 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 these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Vaccination complication
Clinical narrative: rougher reactions to the second dose compared to the first; had to take off work the next day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Some leakage from the syringe druing administration; it went down the arm; Some leakage from the syringe druing administration; it went down the arm; A spontaneous report was received from a consumer who was a 68-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who during drug administration, experienced some leakage from the syringe occurred and it went down her arm  (vaccine underdose and device connection issue).  The patient's medical history were not provided. Concomitant medications reported included multivitamins, levothyroxine sodium, anastrozole, propranolol and oxazepam.   On 04-Mar-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 040A21A) intramuscularly in the right deltoid muscle for prophylaxis of COVID-19 infection.   On 04-Mar-2021, during vaccine administration, some leakage from the syringe occurred and it went down her arm. The head nurse over the facility confirms that it should not matter how much she got because the second shot was like a booster.  Treatmment information was not provided  The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, vaccine underdose and device connection issue, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of a 68-year-old, female patient who experienced some leakage from the syringe occurred and it went down her arm  ((Syringe issue and Incomplete dose administered) for mRNA-1273 (Lot number: 040A21A). There were no reported AEs associated with this case of syringe issue and incomplete dose administered.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Blood pressure measurement, Body temperature, Dizziness
Clinical narrative: sore arm; achy, headache, dizzy and would not eat; dizzy; felt weak-ish; upset stomach; headache ,felt weak-ish, upset stomach and a temperature of 103.8; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt weak-ish), ABDOMINAL DISCOMFORT (upset stomach), PAIN (achy, headache, dizzy and would not eat), DIZZINESS (dizzy) and ARTHRALGIA (sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE, LUBIPROSTONE (AMITIZA), POTASSIUM, DOCUSATE SODIUM (STOOL SOFTENER) and CALCIUM for an unknown indication.    On 09-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 MALAISE (felt weak-ish), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache ,felt weak-ish, upset stomach and a temperature of 103.8). On 11-Feb-2021, the patient experienced PAIN (achy, headache, dizzy and would not eat) and DIZZINESS (dizzy). On 12-Feb-2021, the patient experienced ARTHRALGIA (sore arm). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MALAISE (felt weak-ish), ABDOMINAL DISCOMFORT (upset stomach), PAIN (achy, headache, dizzy and would not eat), DIZZINESS (dizzy) and HEADACHE (headache ,felt weak-ish, upset stomach and a temperature of 103.8) outcome was unknown and ARTHRALGIA (sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Blood pressure measurement: 152/92 mmHg (High) 152/92. On 10-Feb-2021, Body temperature: 103.8 (High) temperature of 103.8. On 10-Feb-2021, Heart rate (60-100): 103 (High) 103. On 10-Feb-2021, Oxygen saturation: 89-90 (abnormal) 89-90. On 11-Feb-2021, Body temperature: 98.6 (Borderline) 98.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications reported were blood pressure, thyroid and antidepressant and bipolar medications (unspecified).  It was reported that, the patient was treated symptoms with cold towels on his extremities, gave fluids and acetaminophen. Caregiver stated patient was feeling better on 12-Feb-2021, but still has a sore arm.   This case was linked to MOD-2021-089359 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Malaise, Oxygen saturation, Pain
Clinical narrative: sore arm; achy, headache, dizzy and would not eat; dizzy; felt weak-ish; upset stomach; headache ,felt weak-ish, upset stomach and a temperature of 103.8; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt weak-ish), ABDOMINAL DISCOMFORT (upset stomach), PAIN (achy, headache, dizzy and would not eat), DIZZINESS (dizzy) and ARTHRALGIA (sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE, LUBIPROSTONE (AMITIZA), POTASSIUM, DOCUSATE SODIUM (STOOL SOFTENER) and CALCIUM for an unknown indication.    On 09-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 MALAISE (felt weak-ish), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache ,felt weak-ish, upset stomach and a temperature of 103.8). On 11-Feb-2021, the patient experienced PAIN (achy, headache, dizzy and would not eat) and DIZZINESS (dizzy). On 12-Feb-2021, the patient experienced ARTHRALGIA (sore arm). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MALAISE (felt weak-ish), ABDOMINAL DISCOMFORT (upset stomach), PAIN (achy, headache, dizzy and would not eat), DIZZINESS (dizzy) and HEADACHE (headache ,felt weak-ish, upset stomach and a temperature of 103.8) outcome was unknown and ARTHRALGIA (sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Blood pressure measurement: 152/92 mmHg (High) 152/92. On 10-Feb-2021, Body temperature: 103.8 (High) temperature of 103.8. On 10-Feb-2021, Heart rate (60-100): 103 (High) 103. On 10-Feb-2021, Oxygen saturation: 89-90 (abnormal) 89-90. On 11-Feb-2021, Body temperature: 98.6 (Borderline) 98.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications reported were blood pressure, thyroid and antidepressant and bipolar medications (unspecified).  It was reported that, the patient was treated symptoms with cold towels on his extremities, gave fluids and acetaminophen. Caregiver stated patient was feeling better on 12-Feb-2021, but still has a sore arm.   This case was linked to MOD-2021-089359 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I don't feel good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I don't feel good) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CORTISONE for an unknown indication.    On 07-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 MALAISE (I don't feel good). At the time of the report, MALAISE (I don't feel good) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Headache, Nausea, Pyrexia
Clinical narrative: red arm; fever, temperaures; very nauseated; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever, temperaures), ERYTHEMA (red arm), NAUSEA (very nauseated) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever, temperaures), ERYTHEMA (red arm), NAUSEA (very nauseated) and HEADACHE (headache). At the time of the report, PYREXIA (fever, temperaures), ERYTHEMA (red arm), NAUSEA (very nauseated) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.   No corrective treatment was provided.