chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Gait disturbance, Hypersomnia, Pain in extremity
Clinical narrative: Left Arm hurts; Very weak; Trouble Walking; Slept for 12 hours; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Arm hurts), ASTHENIA (Very weak), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and FATIGUE (Fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-Dec-2020.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left Arm hurts), ASTHENIA (Very weak), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Left Arm hurts), ASTHENIA (Very weak), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and FATIGUE (Fatigue) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2020, SARS-CoV-2 test: positive (Positive) She had a positive PCR Test and Covid-19 in Dec-2020.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.    This case was linked to IN-MODERNATX, INC.-MOD-2021-064921 (E2B Linked Report). This case was linked to MOD-2021-171345 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021: Patient reported that she got her second shot on 27-Feb-2021 and was feeling very tired and weak after that. She was provided with Moderna phone number to report any further information. On 06-Aug-2021: Follow-up document was received and had significant information. Updated medical history, event start date, Lab data, event outcome to recovered/resolved; Sender's Comments:  IN-MODERNATX, INC.-MOD-2021-064921:Mother case
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Left Arm hurts; Very weak; Trouble Walking; Slept for 12 hours; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Arm hurts), ASTHENIA (Very weak), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and FATIGUE (Fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-Dec-2020.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left Arm hurts), ASTHENIA (Very weak), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Left Arm hurts), ASTHENIA (Very weak), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and FATIGUE (Fatigue) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2020, SARS-CoV-2 test: positive (Positive) She had a positive PCR Test and Covid-19 in Dec-2020.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.    This case was linked to IN-MODERNATX, INC.-MOD-2021-064921 (E2B Linked Report). This case was linked to MOD-2021-171345 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021: Patient reported that she got her second shot on 27-Feb-2021 and was feeling very tired and weak after that. She was provided with Moderna phone number to report any further information. On 06-Aug-2021: Follow-up document was received and had significant information. Updated medical history, event start date, Lab data, event outcome to recovered/resolved; Sender's Comments:  IN-MODERNATX, INC.-MOD-2021-064921:Mother case
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea one day after taking vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea one day after taking vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced DIARRHOEA (Diarrhea one day after taking vaccine). At the time of the report, DIARRHOEA (Diarrhea one day after taking vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Rash
Clinical narrative: violent rash on both arms, hands, torso, behind the knees, buttocks; lips also started to swell; This spontaneous case was reported by a consumer and describes the occurrence of RASH (violent rash on both arms, hands, torso, behind the knees, buttocks) and LIP SWELLING (lips also started to swell) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced RASH (violent rash on both arms, hands, torso, behind the knees, buttocks) and LIP SWELLING (lips also started to swell). The patient was treated with PREDNISOLONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH (violent rash on both arms, hands, torso, behind the knees, buttocks) and LIP SWELLING (lips also started to swell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little achiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little achiness at injection site) in a 77-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) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (little achiness at injection site). On 02-Mar-2021, VACCINATION SITE PAIN (little achiness at injection site) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-064123 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Illness
Clinical narrative: felt so cold; became sick; kidney pain; very weak; headache; kind of tired; vomited which smelled like rotten eggs; body aches; joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt so cold), ILLNESS (became sick), RENAL PAIN (kidney pain), ASTHENIA (very weak) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 043A21A /045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced NASOPHARYNGITIS (felt so cold), ILLNESS (became sick), RENAL PAIN (kidney pain), ASTHENIA (very weak), HEADACHE (headache), FATIGUE (kind of tired), VOMITING (vomited which smelled like rotten eggs), MYALGIA (body aches) and ARTHRALGIA (joints hurt). At the time of the report, NASOPHARYNGITIS (felt so cold), ILLNESS (became sick), RENAL PAIN (kidney pain), ASTHENIA (very weak), HEADACHE (headache), VOMITING (vomited which smelled like rotten eggs), MYALGIA (body aches) and ARTHRALGIA (joints hurt) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.  Patient went to doctor says this may last a week. Patient had missed two days of work.  Action taken with mRNA-1273 in response to the events was not Applicable
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Renal pain, Vomiting
Clinical narrative: felt so cold; became sick; kidney pain; very weak; headache; kind of tired; vomited which smelled like rotten eggs; body aches; joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt so cold), ILLNESS (became sick), RENAL PAIN (kidney pain), ASTHENIA (very weak) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 043A21A /045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced NASOPHARYNGITIS (felt so cold), ILLNESS (became sick), RENAL PAIN (kidney pain), ASTHENIA (very weak), HEADACHE (headache), FATIGUE (kind of tired), VOMITING (vomited which smelled like rotten eggs), MYALGIA (body aches) and ARTHRALGIA (joints hurt). At the time of the report, NASOPHARYNGITIS (felt so cold), ILLNESS (became sick), RENAL PAIN (kidney pain), ASTHENIA (very weak), HEADACHE (headache), VOMITING (vomited which smelled like rotten eggs), MYALGIA (body aches) and ARTHRALGIA (joints hurt) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.  Patient went to doctor says this may last a week. Patient had missed two days of work.  Action taken with mRNA-1273 in response to the events was not Applicable
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Herpes zoster, Hypertension, Pain in extremity
Clinical narrative: dizziness; Shingles; my arms feeling like there's needlesticks.; high blood pressure; vertigo; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (my arms feeling like there's needlesticks.), HYPERTENSION (high blood pressure) and VERTIGO (vertigo) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 034A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (my arms feeling like there's needlesticks.), HYPERTENSION (high blood pressure), VERTIGO (vertigo) and PYREXIA (Fever). At the time of the report, DIZZINESS (dizziness), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (my arms feeling like there's needlesticks.), HYPERTENSION (high blood pressure), VERTIGO (vertigo) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.9 f (High) 102.9 F.         Concomitants were not provided. Treatment was not provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: dizziness; Shingles; my arms feeling like there's needlesticks.; high blood pressure; vertigo; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (my arms feeling like there's needlesticks.), HYPERTENSION (high blood pressure) and VERTIGO (vertigo) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 034A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (my arms feeling like there's needlesticks.), HYPERTENSION (high blood pressure), VERTIGO (vertigo) and PYREXIA (Fever). At the time of the report, DIZZINESS (dizziness), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (my arms feeling like there's needlesticks.), HYPERTENSION (high blood pressure), VERTIGO (vertigo) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.9 f (High) 102.9 F.         Concomitants were not provided. Treatment was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate, Respiration abnormal, Respiratory rate
Clinical narrative: Fatigue; dizzy; very slight change in breathing; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), DIZZINESS (dizzy) and RESPIRATION ABNORMAL (very slight change in breathing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Muscle disorder since an unknown date, Asthma since an unknown date, Type 2 diabetes mellitus since an unknown date, Anaphylactic reaction and Bone marrow transplant.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (dizzy) and RESPIRATION ABNORMAL (very slight change in breathing). On 21-Mar-2021, the patient experienced FATIGUE (Fatigue). On 20-Mar-2021, DIZZINESS (dizzy) and RESPIRATION ABNORMAL (very slight change in breathing) had resolved. At the time of the report, FATIGUE (Fatigue) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: normal Normal. On an unknown date, Respiratory rate: normal Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced serious anaphylaxis in the past brought on by oral medications and sometimes injectables, but never before to a vaccine. No information on treatment was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurry vision; This spontaneous case was reported by an other health care professional and describes the occurrence of VISION BLURRED (blurry vision) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VISION BLURRED (blurry vision). At the time of the report, VISION BLURRED (blurry vision) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicines were not reported
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Product administered to patient of inappropriate age
Clinical narrative: 16 Year old son received 1st dose; He was little fatigued; He had headaches; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 Year old son received 1st dose), FATIGUE (He was little fatigued) and HEADACHE (He had headaches) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 Year old son received 1st dose), FATIGUE (He was little fatigued) and HEADACHE (He had headaches). On 09-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 Year old son received 1st dose) had resolved. At the time of the report, FATIGUE (He was little fatigued) and HEADACHE (He had headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case refers to a 16-year-old male patient who experienced headache and fatigue following the administration of Covid-19 vaccine. 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.   This report also refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 014M20A.   This case was linked to MOD21-066509, MOD21-066510 (E2B Linked Report).; Sender's Comments: This case refers to a 16-year-old male patient who experienced headache and fatigue following the administration of Covid-19 vaccine. 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.   This report also refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 014M20A. MOD21-066509: MOD21-066510:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Blisters on hands; Blisters on fingers; Blisters on palms; This spontaneous case was reported by a health care professional and describes the occurrence of BLISTER (Blisters on hands), BLISTER (Blisters on fingers) and BLISTER (Blisters on palms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (Blisters on hands), BLISTER (Blisters on fingers) and BLISTER (Blisters on palms). At the time of the report, BLISTER (Blisters on hands), BLISTER (Blisters on fingers) and BLISTER (Blisters on palms) 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 Treatment Medication was available.  No Concomitant Medication was available.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Intense pain, on left arm (underarm, breast area)/ Intense lymph node pain on the axilla on the same side of injection; Intense swelling, on left arm (underarm, breast area)/ Intense lymph node swelling on the axilla on the same side of injection; Mild soreness on injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPH NODE PAIN (Intense pain, on left arm (underarm, breast area)/ Intense lymph node pain on the axilla on the same side of injection), LYMPHADENOPATHY (Intense swelling, on left arm (underarm, breast area)/ Intense lymph node swelling on the axilla on the same side of injection) and VACCINATION SITE PAIN (Mild soreness on injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness on injection site). On 25-Mar-2021, the patient experienced LYMPH NODE PAIN (Intense pain, on left arm (underarm, breast area)/ Intense lymph node pain on the axilla on the same side of injection) and LYMPHADENOPATHY (Intense swelling, on left arm (underarm, breast area)/ Intense lymph node swelling on the axilla on the same side of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, VACCINATION SITE PAIN (Mild soreness on injection site) had resolved. At the time of the report, LYMPH NODE PAIN (Intense pain, on left arm (underarm, breast area)/ Intense lymph node pain on the axilla on the same side of injection) and LYMPHADENOPATHY (Intense swelling, on left arm (underarm, breast area)/ Intense lymph node swelling on the axilla on the same side of injection) was resolving.        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: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-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 EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose schedule 49 days later; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose schedule 49 days later) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included TETANUS VACCINE from 29-Mar-2021 to an unknown date, LEVOTHYROXINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose schedule 49 days later). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose schedule 49 days later) outcome was unknown.            No treatment medication was reported by the reporter.   This case was linked to MOD-2021-060938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received: contains NNI, thyroid medication and dose number was added from the initial
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: tender; severe pain in arm; hard nodule about 4 inches down from injection site; fatigue; nausea; flushing feverish; injection site is red; little achiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender), PAIN IN EXTREMITY (severe pain in arm), VACCINATION SITE INDURATION (hard nodule about 4 inches down from injection site), FATIGUE (fatigue) and NAUSEA (nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tender), PAIN IN EXTREMITY (severe pain in arm), VACCINATION SITE INDURATION (hard nodule about 4 inches down from injection site), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (flushing feverish), VACCINATION SITE ERYTHEMA (injection site is red) and INJECTION SITE PAIN (little achiness at injection site). At the time of the report, TENDERNESS (tender), PAIN IN EXTREMITY (severe pain in arm), VACCINATION SITE INDURATION (hard nodule about 4 inches down from injection site), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (flushing feverish), VACCINATION SITE ERYTHEMA (injection site is red) and INJECTION SITE PAIN (little achiness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products and treatment medication were provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-064112 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064112:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site induration
Clinical narrative: tender; severe pain in arm; hard nodule about 4 inches down from injection site; fatigue; nausea; flushing feverish; injection site is red; little achiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender), PAIN IN EXTREMITY (severe pain in arm), VACCINATION SITE INDURATION (hard nodule about 4 inches down from injection site), FATIGUE (fatigue) and NAUSEA (nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tender), PAIN IN EXTREMITY (severe pain in arm), VACCINATION SITE INDURATION (hard nodule about 4 inches down from injection site), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (flushing feverish), VACCINATION SITE ERYTHEMA (injection site is red) and INJECTION SITE PAIN (little achiness at injection site). At the time of the report, TENDERNESS (tender), PAIN IN EXTREMITY (severe pain in arm), VACCINATION SITE INDURATION (hard nodule about 4 inches down from injection site), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (flushing feverish), VACCINATION SITE ERYTHEMA (injection site is red) and INJECTION SITE PAIN (little achiness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products and treatment medication were provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-064112 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064112:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nasopharyngitis, Sinusitis, Somnolence
Clinical narrative: sinus infection with pain below the eyes; felt like he had a cold; dizzy; took a nap; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), SOMNOLENCE (took a nap), NASOPHARYNGITIS (felt like he had a cold) and SINUSITIS (sinus infection with pain below the eyes) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.  The patient's past medical history included No adverse event. Concomitant products were not provided.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DIZZINESS (dizzy) and SOMNOLENCE (took a nap). On 14-Mar-2021, the patient experienced NASOPHARYNGITIS (felt like he had a cold). On 15-Mar-2021, the patient experienced SINUSITIS (sinus infection with pain below the eyes). Not Provided  Treatment products included Flonase, Afrin.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: low grade fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and MYALGIA (muscle aches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (low grade fever) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 31-Mar-2021, PYREXIA (low grade fever) and MYALGIA (muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Pyrexia: (Low) 99-100.         Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Felt Sluggish; Chills; joint pain; Sore arm; Fever with temperature of 98.8 and 99.9; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt Sluggish), PYREXIA (Fever with temperature of 98.8 and 99.9), MYALGIA (Sore arm/  Joint pain), CHILLS (Chills) and ARTHRALGIA (joint pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 immunisation.     The patient's past medical history included Arthritis since an unknown date. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]), ALLOPURINOL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 23-Mar-2021, the patient experienced PYREXIA (Fever with temperature of 98.8 and 99.9). On 24-Mar-2021, the patient experienced MYALGIA (Sore arm/  Joint pain) and ARTHRALGIA (joint pain). On 26-Mar-2021, the patient experienced SLUGGISHNESS (Felt Sluggish) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (Felt Sluggish) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Felt Sluggish; Chills; joint pain; Sore arm; Fever with temperature of 98.8 and 99.9; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt Sluggish), PYREXIA (Fever with temperature of 98.8 and 99.9), MYALGIA (Sore arm/  Joint pain), CHILLS (Chills) and ARTHRALGIA (joint pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 immunisation.     The patient's past medical history included Arthritis since an unknown date. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]), ALLOPURINOL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 23-Mar-2021, the patient experienced PYREXIA (Fever with temperature of 98.8 and 99.9). On 24-Mar-2021, the patient experienced MYALGIA (Sore arm/  Joint pain) and ARTHRALGIA (joint pain). On 26-Mar-2021, the patient experienced SLUGGISHNESS (Felt Sluggish) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (Felt Sluggish) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Laziness, Pain in extremity
Clinical narrative: sore arm; some laziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and LAZINESS (some laziness) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and LAZINESS (some laziness). On 28-Feb-2021, PAIN IN EXTREMITY (sore arm) and LAZINESS (some laziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Has not tried any treatment and does not take prescription medication.   This case was linked to MOD21-066614 (E2B Linked Report).; Sender's Comments:  MOD21-066614:MOD-2021-064178- 2nd Dose of Vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE; COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and FLUOCINONIDE for an unknown indication. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 12-Dec-2020 and the estimated date of delivery was 18-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Maternal exposure during pregnancy, Pain in extremity, Pregnancy test
Clinical narrative: Maternal exposure during pregnancy; Very sore arm; Couldn't lift arm more than 80 degrees; Mild fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN IN EXTREMITY (Very sore arm), LIMB DISCOMFORT (Couldn't lift arm more than 80 degrees) and FATIGUE (Mild fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 11-Jul-2021. On 09-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN IN EXTREMITY (Very sore arm), LIMB DISCOMFORT (Couldn't lift arm more than 80 degrees) and FATIGUE (Mild fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 10-Mar-2021, PAIN IN EXTREMITY (Very sore arm), LIMB DISCOMFORT (Couldn't lift arm more than 80 degrees) and FATIGUE (Mild fatigue) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment details were reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: face swollen; rash under arms and on groin; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swollen) and RASH (rash under arms and on groin) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, POTASSIUM, METOPROLOL, CLOPIDOGREL, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SWELLING FACE (face swollen) and RASH (rash under arms and on groin). At the time of the report, SWELLING FACE (face swollen) and RASH (rash under arms and on groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (quite sore), vaccination site swelling (swollen) and vaccination site warmth (hot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 018B21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 23, 2021, patient experienced vaccination site pain (quite sore). On Mar 30, 2021, patient experienced vaccination site swelling (swollen) and vaccination site warmth (hot). At the time of the report, vaccination site pain (quite sore), vaccination site swelling (swollen) and vaccination site warmth (hot) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: have diarrhea since Monday; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (have diarrhea since Monday) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DIARRHOEA (have diarrhea since Monday). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (have diarrhea since Monday) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Flatulence
Clinical narrative: Diarrhea; Gas in Stomach; Bloating; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (Gas in Stomach), ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FLATULENCE (Gas in Stomach), ABDOMINAL DISTENSION (Bloating) and ABDOMINAL PAIN UPPER (Stomach pain). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with CALCIUM CARBONATE for Adverse event, at a dose of UNK dosage form. At the time of the report, FLATULENCE (Gas in Stomach), ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Other treatment included peppermint water.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Myalgia, Night sweats, Paraesthesia
Clinical narrative: night time sweats; headache; muscle pain; shots of pain at injection site; skin has pins and needles; muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night time sweats), HEADACHE (headache), MYALGIA (muscle pain), VACCINATION SITE PAIN (shots of pain at injection site) and PARAESTHESIA (skin has pins and needles) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 26-Feb-2021, the patient experienced NIGHT SWEATS (night time sweats), HEADACHE (headache), MYALGIA (muscle pain), VACCINATION SITE PAIN (shots of pain at injection site), PARAESTHESIA (skin has pins and needles) and MUSCLE SPASMS (muscle cramps). At the time of the report, NIGHT SWEATS (night time sweats), HEADACHE (headache), MYALGIA (muscle pain), VACCINATION SITE PAIN (shots of pain at injection site), PARAESTHESIA (skin has pins and needles) and MUSCLE SPASMS (muscle cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: night time sweats; headache; muscle pain; shots of pain at injection site; skin has pins and needles; muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night time sweats), HEADACHE (headache), MYALGIA (muscle pain), VACCINATION SITE PAIN (shots of pain at injection site) and PARAESTHESIA (skin has pins and needles) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 26-Feb-2021, the patient experienced NIGHT SWEATS (night time sweats), HEADACHE (headache), MYALGIA (muscle pain), VACCINATION SITE PAIN (shots of pain at injection site), PARAESTHESIA (skin has pins and needles) and MUSCLE SPASMS (muscle cramps). At the time of the report, NIGHT SWEATS (night time sweats), HEADACHE (headache), MYALGIA (muscle pain), VACCINATION SITE PAIN (shots of pain at injection site), PARAESTHESIA (skin has pins and needles) and MUSCLE SPASMS (muscle cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Inappropriate schedule of product administration
Clinical narrative: Back pain; 44 days since receiving dose 1 of vaccine; Pounding Headache; This spontaneous case was reported by a nurse and describes the occurrence of BACK PAIN (Back pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days since receiving dose 1 of vaccine) and HEADACHE (Pounding Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days since receiving dose 1 of vaccine) and HEADACHE (Pounding Headache). At the time of the report, BACK PAIN (Back pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days since receiving dose 1 of vaccine) and HEADACHE (Pounding Headache) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not 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 events, headache and back pain, a causal relationship cannot be excluded.  This report also refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 023M20A.