chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Underdose
Clinical narrative: vaccine fluid came out of top of syringe; Repeat of 2nd dose per CDC recommendation; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (vaccine fluid came out of top of syringe) and IMMUNISATION (Repeat of 2nd dose per CDC recommendation) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. v012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 22-Apr-2021, the patient experienced UNDERDOSE (vaccine fluid came out of top of syringe) and IMMUNISATION (Repeat of 2nd dose per CDC recommendation). At the time of the report, UNDERDOSE (vaccine fluid came out of top of syringe) and IMMUNISATION (Repeat of 2nd dose per CDC recommendation) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination site discomfort
Clinical narrative: discomfort in the injection arm; her left hand is warm; her left hand is red; her left hand hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort in the injection arm), INJECTION SITE WARMTH (her left hand is warm), INJECTION SITE ERYTHEMA (her left hand is red) and INJECTION SITE PAIN (her left hand hurts) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (discomfort in the injection arm), INJECTION SITE WARMTH (her left hand is warm), INJECTION SITE ERYTHEMA (her left hand is red) and INJECTION SITE PAIN (her left hand hurts). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort in the injection arm), INJECTION SITE WARMTH (her left hand is warm), INJECTION SITE ERYTHEMA (her left hand is red) and INJECTION SITE PAIN (her left hand hurts) outcome was unknown. Not Provided          Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Head discomfort, Headache, Myalgia, Pruritus
Clinical narrative: Itchy left arm; Swollen face; Red face; Head pressure; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy left arm), SWELLING FACE (Swollen face), ERYTHEMA (Red face), HEAD DISCOMFORT (Head pressure) and MYALGIA (Body aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-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 started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 22-Apr-2021, the patient experienced PRURITUS (Itchy left arm), SWELLING FACE (Swollen face), ERYTHEMA (Red face), HEAD DISCOMFORT (Head pressure), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PRURITUS (Itchy left arm), SWELLING FACE (Swollen face), ERYTHEMA (Red face), HEAD DISCOMFORT (Head pressure), MYALGIA (Body aches) and HEADACHE (Headache) had not resolved. Concomitant product use was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Itchy left arm; Swollen face; Red face; Head pressure; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy left arm), SWELLING FACE (Swollen face), ERYTHEMA (Red face), HEAD DISCOMFORT (Head pressure) and MYALGIA (Body aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-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 started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 22-Apr-2021, the patient experienced PRURITUS (Itchy left arm), SWELLING FACE (Swollen face), ERYTHEMA (Red face), HEAD DISCOMFORT (Head pressure), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PRURITUS (Itchy left arm), SWELLING FACE (Swollen face), ERYTHEMA (Red face), HEAD DISCOMFORT (Head pressure), MYALGIA (Body aches) and HEADACHE (Headache) had not resolved. Concomitant product use was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Epistaxis
Clinical narrative: Slight nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Slight nose bleed) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included Syndrome Guillain-Barre in 1986 and COVID-19 in 2020. Concomitant products included SIMVASTATIN, LISINOPRIL and HYDROCHLOROTHIAZIDE for Product used for unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 21-Apr-2021, the patient experienced EPISTAXIS (Slight nose bleed). At the time of the report, EPISTAXIS (Slight nose bleed) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19 (other-other): NEGATIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment. treatment medications were not reported    Reporter did not allow further contact
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: body aches; swollen lymph nodes under left arm, under chin, and by left hip bone; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and LYMPHADENOPATHY (swollen lymph nodes under left arm, under chin, and by left hip bone) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (body aches) and LYMPHADENOPATHY (swollen lymph nodes under left arm, under chin, and by left hip bone). At the time of the report, MYALGIA (body aches) and LYMPHADENOPATHY (swollen lymph nodes under left arm, under chin, and by left hip bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment related information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: A little tired/I was tired; Headache/I had a continuous dull, throbbing headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little tired/I was tired) and HEADACHE (Headache/I had a continuous dull, throbbing headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Hand operation. Concurrent medical conditions included Osteoarthritis and Writing impaired.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (A little tired/I was tired) and HEADACHE (Headache/I had a continuous dull, throbbing headache). On 18-Mar-2021, FATIGUE (A little tired/I was tired) and HEADACHE (Headache/I had a continuous dull, throbbing headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow-up included: updated email address of the primary reporter, updated other relevant history, Event verbatim and event outcome updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Labia enlarged, Nipple pain, Vaginal discharge, Vaginal haemorrhage
Clinical narrative: sticky blood clogged in the toilet bowl,small amount on the pantyliner,blood on bathroom tissues used for peeing and pooping.; undigested; hurt nipple pain; vaginal discharge of white colour; labia minora was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL DISCHARGE (vaginal discharge of white colour), LABIA ENLARGED (labia minora was swollen), NIPPLE PAIN (hurt nipple pain), DYSPEPSIA (undigested) and VAGINAL HAEMORRHAGE (sticky blood clogged in the toilet bowl,small amount on the pantyliner,blood on bathroom tissues used for peeing and pooping.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VAGINAL DISCHARGE (vaginal discharge of white colour) and LABIA ENLARGED (labia minora was swollen). On 11-Apr-2021, the patient experienced NIPPLE PAIN (hurt nipple pain). On 19-Apr-2021, the patient experienced DYSPEPSIA (undigested). On 20-Apr-2021, the patient experienced VAGINAL HAEMORRHAGE (sticky blood clogged in the toilet bowl,small amount on the pantyliner,blood on bathroom tissues used for peeing and pooping.). On 08-Apr-2021, LABIA ENLARGED (labia minora was swollen) had resolved. On 15-Apr-2021, NIPPLE PAIN (hurt nipple pain) had resolved. At the time of the report, VAGINAL DISCHARGE (vaginal discharge of white colour), DYSPEPSIA (undigested) and VAGINAL HAEMORRHAGE (sticky blood clogged in the toilet bowl,small amount on the pantyliner,blood on bathroom tissues used for peeing and pooping.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Eye swelling, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Blood shot eyes; Pus/white stuff from eyes; Clear water pouring from eyes; Swelling of eyes; Right side neck stiffness; Lights hurt eyes; Nauseated; Headache; Fatigue / Exhaustion; Sleeping 14 hours; Left arm soreness; Sweats; Sleeping 16 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats), SOMNOLENCE (Sleeping 16 hours), SOMNOLENCE (Sleeping 14 hours) and OCULAR HYPERAEMIA (Blood shot eyes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0481321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Influenza: Flu shot (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down); for Tetanus: Tetanus shot (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down); for Pneumococcal infection: Pneumococcal (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down). Past adverse reactions to the above products included Headache with Flu shot, Pneumococcal and Tetanus shot. Concomitant products included FEXOFENADINE HCL for Seasonal allergy, VALPROATE SEMISODIUM (DEPAKOTE), SERTRALINE HYDROCHLORIDE (ZOLOFT) and CLONAZEPAM for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats) and SOMNOLENCE (Sleeping 16 hours). On 21-Apr-2021, the patient experienced SOMNOLENCE (Sleeping 14 hours). On 22-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Blood shot eyes), EYE DISCHARGE (Pus/white stuff from eyes), LACRIMATION INCREASED (Clear water pouring from eyes), EYE SWELLING (Swelling of eyes), MUSCULOSKELETAL STIFFNESS (Right side neck stiffness), PHOTOPHOBIA (Lights hurt eyes), NAUSEA (Nauseated), HEADACHE (Headache) and FATIGUE (Fatigue / Exhaustion). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 20-Apr-2021 for Pain in arm, at an unspecified dose and frequency. On 22-Apr-2021, EYE DISCHARGE (Pus/white stuff from eyes) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats), SOMNOLENCE (Sleeping 16 hours), SOMNOLENCE (Sleeping 14 hours), OCULAR HYPERAEMIA (Blood shot eyes), LACRIMATION INCREASED (Clear water pouring from eyes), EYE SWELLING (Swelling of eyes), MUSCULOSKELETAL STIFFNESS (Right side neck stiffness), PHOTOPHOBIA (Lights hurt eyes), NAUSEA (Nauseated), HEADACHE (Headache) and FATIGUE (Fatigue / Exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Musculoskeletal stiffness, Nausea, Ocular hyperaemia, Pain in extremity
Clinical narrative: Blood shot eyes; Pus/white stuff from eyes; Clear water pouring from eyes; Swelling of eyes; Right side neck stiffness; Lights hurt eyes; Nauseated; Headache; Fatigue / Exhaustion; Sleeping 14 hours; Left arm soreness; Sweats; Sleeping 16 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats), SOMNOLENCE (Sleeping 16 hours), SOMNOLENCE (Sleeping 14 hours) and OCULAR HYPERAEMIA (Blood shot eyes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0481321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Influenza: Flu shot (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down); for Tetanus: Tetanus shot (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down); for Pneumococcal infection: Pneumococcal (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down). Past adverse reactions to the above products included Headache with Flu shot, Pneumococcal and Tetanus shot. Concomitant products included FEXOFENADINE HCL for Seasonal allergy, VALPROATE SEMISODIUM (DEPAKOTE), SERTRALINE HYDROCHLORIDE (ZOLOFT) and CLONAZEPAM for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats) and SOMNOLENCE (Sleeping 16 hours). On 21-Apr-2021, the patient experienced SOMNOLENCE (Sleeping 14 hours). On 22-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Blood shot eyes), EYE DISCHARGE (Pus/white stuff from eyes), LACRIMATION INCREASED (Clear water pouring from eyes), EYE SWELLING (Swelling of eyes), MUSCULOSKELETAL STIFFNESS (Right side neck stiffness), PHOTOPHOBIA (Lights hurt eyes), NAUSEA (Nauseated), HEADACHE (Headache) and FATIGUE (Fatigue / Exhaustion). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 20-Apr-2021 for Pain in arm, at an unspecified dose and frequency. On 22-Apr-2021, EYE DISCHARGE (Pus/white stuff from eyes) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats), SOMNOLENCE (Sleeping 16 hours), SOMNOLENCE (Sleeping 14 hours), OCULAR HYPERAEMIA (Blood shot eyes), LACRIMATION INCREASED (Clear water pouring from eyes), EYE SWELLING (Swelling of eyes), MUSCULOSKELETAL STIFFNESS (Right side neck stiffness), PHOTOPHOBIA (Lights hurt eyes), NAUSEA (Nauseated), HEADACHE (Headache) and FATIGUE (Fatigue / Exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Somnolence
Clinical narrative: Blood shot eyes; Pus/white stuff from eyes; Clear water pouring from eyes; Swelling of eyes; Right side neck stiffness; Lights hurt eyes; Nauseated; Headache; Fatigue / Exhaustion; Sleeping 14 hours; Left arm soreness; Sweats; Sleeping 16 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats), SOMNOLENCE (Sleeping 16 hours), SOMNOLENCE (Sleeping 14 hours) and OCULAR HYPERAEMIA (Blood shot eyes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0481321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Influenza: Flu shot (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down); for Tetanus: Tetanus shot (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down); for Pneumococcal infection: Pneumococcal (Experienced headache and could not open eyes and hospitalized because her kidneys started to shut down). Past adverse reactions to the above products included Headache with Flu shot, Pneumococcal and Tetanus shot. Concomitant products included FEXOFENADINE HCL for Seasonal allergy, VALPROATE SEMISODIUM (DEPAKOTE), SERTRALINE HYDROCHLORIDE (ZOLOFT) and CLONAZEPAM for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats) and SOMNOLENCE (Sleeping 16 hours). On 21-Apr-2021, the patient experienced SOMNOLENCE (Sleeping 14 hours). On 22-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Blood shot eyes), EYE DISCHARGE (Pus/white stuff from eyes), LACRIMATION INCREASED (Clear water pouring from eyes), EYE SWELLING (Swelling of eyes), MUSCULOSKELETAL STIFFNESS (Right side neck stiffness), PHOTOPHOBIA (Lights hurt eyes), NAUSEA (Nauseated), HEADACHE (Headache) and FATIGUE (Fatigue / Exhaustion). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 20-Apr-2021 for Pain in arm, at an unspecified dose and frequency. On 22-Apr-2021, EYE DISCHARGE (Pus/white stuff from eyes) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm soreness), HYPERHIDROSIS (Sweats), SOMNOLENCE (Sleeping 16 hours), SOMNOLENCE (Sleeping 14 hours), OCULAR HYPERAEMIA (Blood shot eyes), LACRIMATION INCREASED (Clear water pouring from eyes), EYE SWELLING (Swelling of eyes), MUSCULOSKELETAL STIFFNESS (Right side neck stiffness), PHOTOPHOBIA (Lights hurt eyes), NAUSEA (Nauseated), HEADACHE (Headache) and FATIGUE (Fatigue / Exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Vaccination site erythema
Clinical narrative: itchiness; swelling; redder and redder in that area/bright red/red area getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redder and redder in that area/bright red/red area getting worse) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for Depression.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PRURITUS (itchiness), SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redder and redder in that area/bright red/red area getting worse). On 22-Apr-2021, PRURITUS (itchiness) was resolving. At the time of the report, SWELLING (swelling) outcome was unknown and VACCINATION SITE ERYTHEMA (redder and redder in that area/bright red/red area getting worse) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included anti-itch cream for pruritus.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Non-Significant follow-up (Contact Information) appended.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: underage dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage dose). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.   This case was linked to MOD-2021-086147 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Patient demographic details has been updated including race, ethnicity, height and weight.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Feeling abnormal, Headache, Myalgia, Nasal congestion
Clinical narrative: feels like he can't smell as well; Stuffy nose; Feeling horrible; arm is sore; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (feels like he can't smell as well), NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Feeling horrible), VACCINATION SITE PAIN (arm is sore) and HEADACHE (Headache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced ANOSMIA (feels like he can't smell as well), NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Feeling horrible), VACCINATION SITE PAIN (arm is sore), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, ANOSMIA (feels like he can't smell as well), NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Feeling horrible), VACCINATION SITE PAIN (arm is sore), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown.            Patient's weight is given as 220. No concomitant medications were provided. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up contains seriousness information as non serious and denied for further follow up.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feels like he can't smell as well; Stuffy nose; Feeling horrible; arm is sore; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (feels like he can't smell as well), NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Feeling horrible), VACCINATION SITE PAIN (arm is sore) and HEADACHE (Headache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced ANOSMIA (feels like he can't smell as well), NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Feeling horrible), VACCINATION SITE PAIN (arm is sore), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, ANOSMIA (feels like he can't smell as well), NASAL CONGESTION (Stuffy nose), FEELING ABNORMAL (Feeling horrible), VACCINATION SITE PAIN (arm is sore), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown.            Patient's weight is given as 220. No concomitant medications were provided. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up contains seriousness information as non serious and denied for further follow up.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: hardness at injection site; pain at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.    This case was linked to MOD-2021-086149 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: great than 42 days since the first vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (great than 42 days since the first vaccine) 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 06-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (great than 42 days since the first vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (great than 42 days since the first vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Pain in extremity
Clinical narrative: Loss of taste; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), AGEUSIA (Loss of taste) and FATIGUE (Fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included WARFARIN, METOPROLOL, OXYBUTYNIN and LEVOTHYROXINE for an unknown indication.    On 13-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 FATIGUE (Fatigue). On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Feb-2021, the patient experienced AGEUSIA (Loss of taste). At the time of the report, PAIN IN EXTREMITY (Sore arm), AGEUSIA (Loss of taste) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Pain, Tremor
Clinical narrative: both hands shaking a little bit; minor aches all over; pains all over; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (both hands shaking a little bit), MYALGIA (minor aches all over), PAIN (pains all over) and DIZZINESS (dizziness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced TREMOR (both hands shaking a little bit), MYALGIA (minor aches all over), PAIN (pains all over) and DIZZINESS (dizziness). At the time of the report, TREMOR (both hands shaking a little bit), MYALGIA (minor aches all over), PAIN (pains all over) and DIZZINESS (dizziness) outcome was unknown. Not Provided          No concomitant medication was provided  Treatment medication was not provided by the reporter
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: a moderate amount of the vaccine "squirted out" onto the patient's arm.; 2nd dose given 25 days after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (a moderate amount of the vaccine "squirted out" onto the patient's arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25 days after the 1st dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced UNDERDOSE (a moderate amount of the vaccine "squirted out" onto the patient's arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25 days after the 1st dose). On 21-Apr-2021, UNDERDOSE (a moderate amount of the vaccine "squirted out" onto the patient's arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25 days after the 1st dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash all over the body) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH PRURITIC (itchy rash all over the body). The patient was treated with SALICYLIC ACID (EUCERIN [SALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rash all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up contains Non-Significant Information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Hot flush, Influenza like illness, Myalgia
Clinical narrative: Flu- like symptoms; Stinging; cold; Infection at the injection site; muscle pain/body hurt; chilis; Itching; hot flashes; Burning; injection site ( left arm) was sore; injection was hot feeling; Redness; injection site became more swollen, got as big as a size of a grapefruit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection was hot feeling), PRURITUS (Itching), ERYTHEMA (Redness), HOT FLUSH (hot flashes) and INFLUENZA LIKE ILLNESS (Flu- like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection was hot feeling), ERYTHEMA (Redness), VACCINATION SITE SWELLING (injection site became more swollen, got as big as a size of a grapefruit) and VACCINATION SITE PAIN (injection site ( left arm) was sore). On 19-Apr-2021, the patient experienced PRURITUS (Itching), HOT FLUSH (hot flashes) and VACCINATION SITE PAIN (Burning). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu- like symptoms), PAIN (Stinging), NASOPHARYNGITIS (cold), VACCINATION SITE REACTION (Infection at the injection site), MYALGIA (muscle pain/body hurt) and CHILLS (chilis). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at a dose of 300 milligram; IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) at a dose of 1 dosage form and DOXYCYCLINE HYCLATE at a dose of 100 milligram twice a day. At the time of the report, VACCINATION SITE WARMTH (injection was hot feeling), PRURITUS (Itching), ERYTHEMA (Redness), HOT FLUSH (hot flashes), INFLUENZA LIKE ILLNESS (Flu- like symptoms), PAIN (Stinging), NASOPHARYNGITIS (cold), VACCINATION SITE REACTION (Infection at the injection site), MYALGIA (muscle pain/body hurt), CHILLS (chilis), VACCINATION SITE SWELLING (injection site became more swollen, got as big as a size of a grapefruit), VACCINATION SITE PAIN (Burning) and VACCINATION SITE PAIN (injection site ( left arm) was sore) outcome was unknown.            The concomitant medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071541, US-MODERNATX, INC.-MOD-2021-085860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071541:crosslinked US-MODERNATX, INC.-MOD-2021-085860:crosslinked
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pruritus, Vaccination site pain, Vaccination site reaction
Clinical narrative: Flu- like symptoms; Stinging; cold; Infection at the injection site; muscle pain/body hurt; chilis; Itching; hot flashes; Burning; injection site ( left arm) was sore; injection was hot feeling; Redness; injection site became more swollen, got as big as a size of a grapefruit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection was hot feeling), PRURITUS (Itching), ERYTHEMA (Redness), HOT FLUSH (hot flashes) and INFLUENZA LIKE ILLNESS (Flu- like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection was hot feeling), ERYTHEMA (Redness), VACCINATION SITE SWELLING (injection site became more swollen, got as big as a size of a grapefruit) and VACCINATION SITE PAIN (injection site ( left arm) was sore). On 19-Apr-2021, the patient experienced PRURITUS (Itching), HOT FLUSH (hot flashes) and VACCINATION SITE PAIN (Burning). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu- like symptoms), PAIN (Stinging), NASOPHARYNGITIS (cold), VACCINATION SITE REACTION (Infection at the injection site), MYALGIA (muscle pain/body hurt) and CHILLS (chilis). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at a dose of 300 milligram; IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) at a dose of 1 dosage form and DOXYCYCLINE HYCLATE at a dose of 100 milligram twice a day. At the time of the report, VACCINATION SITE WARMTH (injection was hot feeling), PRURITUS (Itching), ERYTHEMA (Redness), HOT FLUSH (hot flashes), INFLUENZA LIKE ILLNESS (Flu- like symptoms), PAIN (Stinging), NASOPHARYNGITIS (cold), VACCINATION SITE REACTION (Infection at the injection site), MYALGIA (muscle pain/body hurt), CHILLS (chilis), VACCINATION SITE SWELLING (injection site became more swollen, got as big as a size of a grapefruit), VACCINATION SITE PAIN (Burning) and VACCINATION SITE PAIN (injection site ( left arm) was sore) outcome was unknown.            The concomitant medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071541, US-MODERNATX, INC.-MOD-2021-085860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071541:crosslinked US-MODERNATX, INC.-MOD-2021-085860:crosslinked
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Flu- like symptoms; Stinging; cold; Infection at the injection site; muscle pain/body hurt; chilis; Itching; hot flashes; Burning; injection site ( left arm) was sore; injection was hot feeling; Redness; injection site became more swollen, got as big as a size of a grapefruit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection was hot feeling), PRURITUS (Itching), ERYTHEMA (Redness), HOT FLUSH (hot flashes) and INFLUENZA LIKE ILLNESS (Flu- like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection was hot feeling), ERYTHEMA (Redness), VACCINATION SITE SWELLING (injection site became more swollen, got as big as a size of a grapefruit) and VACCINATION SITE PAIN (injection site ( left arm) was sore). On 19-Apr-2021, the patient experienced PRURITUS (Itching), HOT FLUSH (hot flashes) and VACCINATION SITE PAIN (Burning). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu- like symptoms), PAIN (Stinging), NASOPHARYNGITIS (cold), VACCINATION SITE REACTION (Infection at the injection site), MYALGIA (muscle pain/body hurt) and CHILLS (chilis). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at a dose of 300 milligram; IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) at a dose of 1 dosage form and DOXYCYCLINE HYCLATE at a dose of 100 milligram twice a day. At the time of the report, VACCINATION SITE WARMTH (injection was hot feeling), PRURITUS (Itching), ERYTHEMA (Redness), HOT FLUSH (hot flashes), INFLUENZA LIKE ILLNESS (Flu- like symptoms), PAIN (Stinging), NASOPHARYNGITIS (cold), VACCINATION SITE REACTION (Infection at the injection site), MYALGIA (muscle pain/body hurt), CHILLS (chilis), VACCINATION SITE SWELLING (injection site became more swollen, got as big as a size of a grapefruit), VACCINATION SITE PAIN (Burning) and VACCINATION SITE PAIN (injection site ( left arm) was sore) outcome was unknown.            The concomitant medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071541, US-MODERNATX, INC.-MOD-2021-085860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071541:crosslinked US-MODERNATX, INC.-MOD-2021-085860:crosslinked
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: shooting pains in the left arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (shooting pains in the left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (shooting pains in the left arm). At the time of the report, PAIN IN EXTREMITY (shooting pains in the left arm) had resolved.            No concomitant medications were reported.  No treatment of events was reported.   This case was linked to MOD-2021-060149 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore arm at injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A and 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drugs were reported. She is concerned about why she doesn't have antibodies to the vaccine and wants answers.   This case was linked to US-MODERNATX, INC.-MOD-2021-086192 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086192:Case for dose 2
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Pain, Pain in extremity
Clinical narrative: after the 2nd dose he felt achy the following day; after the 2nd dose he had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after the 2nd dose he had a sore arm) and PAIN (after the 2nd dose he felt achy the following day) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], NIACIN, TRAMADOL HYDROCHLORIDE (DOLUS) and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (after the 2nd dose he had a sore arm). On 07-Mar-2021, the patient experienced PAIN (after the 2nd dose he felt achy the following day). On 07-Mar-2021, PAIN IN EXTREMITY (after the 2nd dose he had a sore arm) had resolved. On 08-Mar-2021, PAIN (after the 2nd dose he felt achy the following day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Alanine aminotransferase: 79 (High) Elevated. On 14-Apr-2021, Aspartate aminotransferase: 49 (High) Elevated.         Treatment included Ibuprofen.