chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: ear ringing; woozy; swelling; pain; tiredness; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ear ringing), DIZZINESS (woozy), INJECTION SITE SWELLING (swelling), INJECTION SITE PAIN (pain) and FATIGUE (tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced TINNITUS (ear ringing), DIZZINESS (woozy), INJECTION SITE SWELLING (swelling), INJECTION SITE PAIN (pain), FATIGUE (tiredness), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with IBUPROFEN at a dose of 1 dosage form and ACETAMINOPHEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, TINNITUS (ear ringing), DIZZINESS (woozy), INJECTION SITE SWELLING (swelling), INJECTION SITE PAIN (pain), FATIGUE (tiredness), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Ibuprofen, Acetaminophen, Allergy Medication
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: ear ringing; woozy; swelling; pain; tiredness; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ear ringing), DIZZINESS (woozy), INJECTION SITE SWELLING (swelling), INJECTION SITE PAIN (pain) and FATIGUE (tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced TINNITUS (ear ringing), DIZZINESS (woozy), INJECTION SITE SWELLING (swelling), INJECTION SITE PAIN (pain), FATIGUE (tiredness), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with IBUPROFEN at a dose of 1 dosage form and ACETAMINOPHEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, TINNITUS (ear ringing), DIZZINESS (woozy), INJECTION SITE SWELLING (swelling), INJECTION SITE PAIN (pain), FATIGUE (tiredness), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Ibuprofen, Acetaminophen, Allergy Medication
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritus (felt a little itchy that day) and vaccination site rash (developed a rash on the arm where the injection was) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040B21A) for COVID-19 immunization. Previously administered products (used for unknown indication): Tetanus (she had a rash years ago from a tetanus shot). Past adverse reactions to the above products included rash with Tetanus. On Apr 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  unknown route; 1 dosage form. On Apr 8, 2021, patient experienced pruritus (felt a little itchy that day). On Apr 19, 2021, patient experienced vaccination site rash (developed a rash on the arm where the injection was). At the time of the report, pruritus (felt a little itchy that day) and vaccination site rash (developed a rash on the arm where the injection was) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: Upset stomach; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and FATIGUE (Tired) had not resolved.            Concomitant product use and treatment information was not provided.  There was no information regarding consent for followup.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: rash in her face; up her left eye and swelling; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in her face) and SWELLING (up her left eye and swelling) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash in her face) and SWELLING (up her left eye and swelling). At the time of the report, RASH (rash in her face) and SWELLING (up her left eye and swelling) outcome was unknown. Unknown          For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Patient was treated with Benadryl and topical.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 75.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthma, Dry skin, Eating disorder, Erythema, Insomnia
Clinical narrative: very red skin; dry and frizzy skin; asthma attack that could not control it, she gave him Albuterol.; she told that was with ups his brain is asleep; he does not eat and has problems with phlegm for years; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (very red skin), DRY SKIN (dry and frizzy skin), ASTHMA (asthma attack that could not control it, she gave him Albuterol.), INSOMNIA (she told that was with ups his brain is asleep) and EATING DISORDER (he does not eat and has problems with phlegm for years) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product ALBUTEROL [SALBUTAMOL] for Asthma.    The patient's past medical history included Stroke. Concurrent medical conditions included Dementia, Asthmatic attack, Anxiety, Alzheimer's disease and Itching.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ALBUTEROL [SALBUTAMOL] (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (very red skin), DRY SKIN (dry and frizzy skin), ASTHMA (asthma attack that could not control it, she gave him Albuterol.), INSOMNIA (she told that was with ups his brain is asleep) and EATING DISORDER (he does not eat and has problems with phlegm for years). At the time of the report, ERYTHEMA (very red skin), DRY SKIN (dry and frizzy skin), ASTHMA (asthma attack that could not control it, she gave him Albuterol.), INSOMNIA (she told that was with ups his brain is asleep) and EATING DISORDER (he does not eat and has problems with phlegm for years) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs include Anxiety medicines,itching medicine Alzheimer's medicine dementia medicine (2 per day)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Headache, Limb discomfort, Musculoskeletal stiffness
Clinical narrative: weak; arm was swollen; big blotches; Arm swelled up; got really hard; got like a bruise; itchy; headache; feverish; couldn't move arm; felt like someone smashed it off/it hurts; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't move arm), PAIN (felt like someone smashed it off/it hurts), ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen) and RASH MACULAR (big blotches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol. Concomitant products included SIMVASTATIN for Hyperlipidemia.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced LIMB DISCOMFORT (couldn't move arm) and PAIN (felt like someone smashed it off/it hurts). On 17-Apr-2021, the patient experienced ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen), RASH MACULAR (big blotches), SWELLING (Arm swelled up), MUSCULOSKELETAL STIFFNESS (got really hard), CONTUSION (got like a bruise), PRURITUS (itchy), HEADACHE (headache) and PYREXIA (feverish). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (couldn't move arm), PAIN (felt like someone smashed it off/it hurts), ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen), RASH MACULAR (big blotches), SWELLING (Arm swelled up), MUSCULOSKELETAL STIFFNESS (got really hard), CONTUSION (got like a bruise), PRURITUS (itchy), HEADACHE (headache) and PYREXIA (feverish) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pruritus, Pyrexia, Rash macular
Clinical narrative: weak; arm was swollen; big blotches; Arm swelled up; got really hard; got like a bruise; itchy; headache; feverish; couldn't move arm; felt like someone smashed it off/it hurts; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't move arm), PAIN (felt like someone smashed it off/it hurts), ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen) and RASH MACULAR (big blotches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol. Concomitant products included SIMVASTATIN for Hyperlipidemia.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced LIMB DISCOMFORT (couldn't move arm) and PAIN (felt like someone smashed it off/it hurts). On 17-Apr-2021, the patient experienced ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen), RASH MACULAR (big blotches), SWELLING (Arm swelled up), MUSCULOSKELETAL STIFFNESS (got really hard), CONTUSION (got like a bruise), PRURITUS (itchy), HEADACHE (headache) and PYREXIA (feverish). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (couldn't move arm), PAIN (felt like someone smashed it off/it hurts), ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen), RASH MACULAR (big blotches), SWELLING (Arm swelled up), MUSCULOSKELETAL STIFFNESS (got really hard), CONTUSION (got like a bruise), PRURITUS (itchy), HEADACHE (headache) and PYREXIA (feverish) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: weak; arm was swollen; big blotches; Arm swelled up; got really hard; got like a bruise; itchy; headache; feverish; couldn't move arm; felt like someone smashed it off/it hurts; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't move arm), PAIN (felt like someone smashed it off/it hurts), ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen) and RASH MACULAR (big blotches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol. Concomitant products included SIMVASTATIN for Hyperlipidemia.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced LIMB DISCOMFORT (couldn't move arm) and PAIN (felt like someone smashed it off/it hurts). On 17-Apr-2021, the patient experienced ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen), RASH MACULAR (big blotches), SWELLING (Arm swelled up), MUSCULOSKELETAL STIFFNESS (got really hard), CONTUSION (got like a bruise), PRURITUS (itchy), HEADACHE (headache) and PYREXIA (feverish). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (couldn't move arm), PAIN (felt like someone smashed it off/it hurts), ASTHENIA (weak), PERIPHERAL SWELLING (arm was swollen), RASH MACULAR (big blotches), SWELLING (Arm swelled up), MUSCULOSKELETAL STIFFNESS (got really hard), CONTUSION (got like a bruise), PRURITUS (itchy), HEADACHE (headache) and PYREXIA (feverish) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: received 2nd dose of Moderna covid-19 vaccine one week after receiving 1st dose; sore arm; fever; body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna covid-19 vaccine one week after receiving 1st dose), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-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) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches). On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna covid-19 vaccine one week after receiving 1st dose). On 29-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna covid-19 vaccine one week after receiving 1st dose) had resolved. On 16-Apr-2021, PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant drugs included no treatment drugs included
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Somnolence
Clinical narrative: drowsiness; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsiness), ASTHENIA (weakness) and DIZZINESS (dizziness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   '4  On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced SOMNOLENCE (drowsiness), ASTHENIA (weakness) and DIZZINESS (dizziness). At the time of the report, SOMNOLENCE (drowsiness), ASTHENIA (weakness) and DIZZINESS (dizziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received and contains significant information updated event outcome and patient denied further follow-up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: rash; Erythema; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Erythema) and RASH (rash) in a 62-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 17-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 ERYTHEMA (Erythema) and RASH (rash). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Erythema) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Tylenol is being  taken as a treatment medication. no concomitant medication provided by the reporter. patient denied follow-up.   This case was linked to MOD-2021-080060 (E2B Linked Report).; Sender's Comments:  MOD-2021-080060:Second dose of vaccine case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive
Clinical narrative: covid-19 virus test positive; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and HEADACHE (Headache). At the time of the report, SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant  medication and treatment information provided.  Patient was advised by his doctor to not take the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up TCR attached. Outcome of events updated to recovered/resolved.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Myalgia, Nasal congestion
Clinical narrative: sore throat that has progressively gotten worse; low grade fever; cough; congestion; phlegm from cough; body aches; fatigue; chills; initially had sore arm at injection site but when away; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat that has progressively gotten worse), PYREXIA (low grade fever), COUGH (cough), NASAL CONGESTION (congestion) and PRODUCTIVE COUGH (phlegm from cough) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-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 VACCINATION SITE PAIN (initially had sore arm at injection site but when away). On 17-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat that has progressively gotten worse), PYREXIA (low grade fever), COUGH (cough), NASAL CONGESTION (congestion), PRODUCTIVE COUGH (phlegm from cough), MYALGIA (body aches), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, OROPHARYNGEAL PAIN (sore throat that has progressively gotten worse), PYREXIA (low grade fever), COUGH (cough), NASAL CONGESTION (congestion), PRODUCTIVE COUGH (phlegm from cough), MYALGIA (body aches), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (initially had sore arm at injection site but when away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Productive cough, Pyrexia, Vaccination site pain
Clinical narrative: sore throat that has progressively gotten worse; low grade fever; cough; congestion; phlegm from cough; body aches; fatigue; chills; initially had sore arm at injection site but when away; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat that has progressively gotten worse), PYREXIA (low grade fever), COUGH (cough), NASAL CONGESTION (congestion) and PRODUCTIVE COUGH (phlegm from cough) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-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 VACCINATION SITE PAIN (initially had sore arm at injection site but when away). On 17-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat that has progressively gotten worse), PYREXIA (low grade fever), COUGH (cough), NASAL CONGESTION (congestion), PRODUCTIVE COUGH (phlegm from cough), MYALGIA (body aches), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, OROPHARYNGEAL PAIN (sore throat that has progressively gotten worse), PYREXIA (low grade fever), COUGH (cough), NASAL CONGESTION (congestion), PRODUCTIVE COUGH (phlegm from cough), MYALGIA (body aches), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (initially had sore arm at injection site but when away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling jittery, Nausea, Night sweats, Vaccination site pain
Clinical narrative: diarrhea; jitteriness; night sweats but is not sure if she had those before or if it is the result of the vaccine; queasiness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FEELING JITTERY (jitteriness), NIGHT SWEATS (night sweats but is not sure if she had those before or if it is the result of the vaccine), NAUSEA (queasiness) and VACCINATION SITE PAIN (sore arm) in a 48-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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced FEELING JITTERY (jitteriness), NIGHT SWEATS (night sweats but is not sure if she had those before or if it is the result of the vaccine), NAUSEA (queasiness) and VACCINATION SITE PAIN (sore arm). On 16-Apr-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea), FEELING JITTERY (jitteriness), NIGHT SWEATS (night sweats but is not sure if she had those before or if it is the result of the vaccine), NAUSEA (queasiness) and VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There is no relevant treatment and concomitant medication provided.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gastritis, Labyrinthitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GASTRITIS (the infection is going into my stomach) and LABYRINTHITIS (inner ear infection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced GASTRITIS (the infection is going into my stomach) and LABYRINTHITIS (inner ear infection). At the time of the report, GASTRITIS (the infection is going into my stomach) and LABYRINTHITIS (inner ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. The patient stated he knows he has an inner ear infection based on his symptoms (symptoms not provided).  He also stated he could tell "the infection is going into my stomach". Treatment information was not provided. The second dose of mRNA-1273 (Moderna Covid-19 vaccine) was scheduled for 20 Apr 2021. The patient was scheduled to see his doctor on 21 Apr 2021.  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.; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: sweating; loss of appetite; positive covid test; not feeling up to par; chills; fatigue; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), COVID-19 (positive covid test), FEELING ABNORMAL (not feeling up to par) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) 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 10-Apr-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 HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), COVID-19 (positive covid test), FEELING ABNORMAL (not feeling up to par), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), COVID-19 (positive covid test), FEELING ABNORMAL (not feeling up to par), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pyrexia
Clinical narrative: sweating; loss of appetite; positive covid test; not feeling up to par; chills; fatigue; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), COVID-19 (positive covid test), FEELING ABNORMAL (not feeling up to par) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) 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 10-Apr-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 HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), COVID-19 (positive covid test), FEELING ABNORMAL (not feeling up to par), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), COVID-19 (positive covid test), FEELING ABNORMAL (not feeling up to par), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Vomiting
Clinical narrative: Vomiting; Chills; Really sore arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Really sore arm), HEADACHE (Slight headache), VOMITING (Vomiting) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Really sore arm), HEADACHE (Slight headache) and CHILLS (Chills). On 16-Apr-2021, the patient experienced VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Really sore arm), HEADACHE (Slight headache), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            Concomitant products information was not provided by the reporter. Action taken with mRNA-1273 in response to the events is not applicable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Swelling
Clinical narrative: Arm started hurting; Lump started hurting; it is two times the size it was before; Lump got bigger; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), PAIN (Lump started hurting), SWELLING (it is two times the size it was before) and LYMPHADENOPATHY (Lump got bigger) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Renal agenesis and Lymphoma.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm started hurting), PAIN (Lump started hurting), SWELLING (it is two times the size it was before) and LYMPHADENOPATHY (Lump got bigger). At the time of the report, PAIN IN EXTREMITY (Arm started hurting), PAIN (Lump started hurting), SWELLING (it is two times the size it was before) and LYMPHADENOPATHY (Lump got bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not take any medications. Concomitant product information was not provided. Patient already had a lump doctor described as "lymphoma" on the bone of her left shoulder next to her neck, but it was very small.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Salty taste under his tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Salty taste under his tongue) in a 37-year-old male 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 12-Apr-2021, the patient experienced DYSGEUSIA (Salty taste under his tongue). At the time of the report, DYSGEUSIA (Salty taste under his tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided. Patient stated that having a salty taste under his tongue for week.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight pain when he touched in right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight pain when he touched in right arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025BUN) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 VACCINATION SITE PAIN (Slight pain when he touched in right arm). At the time of the report, VACCINATION SITE PAIN (Slight pain when he touched in right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080086 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080086:dose 1
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Hyperhidrosis, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Sweating; Coughing; Headache; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), HYPERHIDROSIS (Sweating), COUGH (Coughing), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm). On 13-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), COUGH (Coughing) and HEADACHE (Headache). On 19-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19), HYPERHIDROSIS (Sweating), COUGH (Coughing), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tested positive for COVID-19; Sweating; Coughing; Headache; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), HYPERHIDROSIS (Sweating), COUGH (Coughing), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm). On 13-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), COUGH (Coughing) and HEADACHE (Headache). On 19-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19), HYPERHIDROSIS (Sweating), COUGH (Coughing), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: Sore arm; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and PAIN IN EXTREMITY (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung disease.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath). On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, DYSPNOEA (Shortness of breath) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymph node pain, Myalgia, Nausea
Clinical narrative: Pain and tenderness of the lymph nodes in left armpit; Fatigue; Muscle pain; Chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Pain and tenderness of the lymph nodes in left armpit), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included ALPRENOLOL, AMLODIPINE BESYLATE and THIAMINE HYDROCHLORIDE (B1 VITAMIN) for an unknown indication.    On 24-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 LYMPH NODE PAIN (Pain and tenderness of the lymph nodes in left armpit), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). On 28-Mar-2021, LYMPH NODE PAIN (Pain and tenderness of the lymph nodes in left armpit), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included none.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain and tenderness of the lymph nodes in left armpit; Fatigue; Muscle pain; Chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Pain and tenderness of the lymph nodes in left armpit), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included ALPRENOLOL, AMLODIPINE BESYLATE and THIAMINE HYDROCHLORIDE (B1 VITAMIN) for an unknown indication.    On 24-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 LYMPH NODE PAIN (Pain and tenderness of the lymph nodes in left armpit), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). On 28-Mar-2021, LYMPH NODE PAIN (Pain and tenderness of the lymph nodes in left armpit), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included none.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Throat irritation
Clinical narrative: Sore arm; noticed odd sensation in her throat/Itchy sensation on throat/burning sensation on throat; Pin point dime sized headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), THROAT IRRITATION (noticed odd sensation in her throat/Itchy sensation on throat/burning sensation on throat) and HEADACHE (Pin point dime sized headache) 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 PAIN IN EXTREMITY (Sore arm), THROAT IRRITATION (noticed odd sensation in her throat/Itchy sensation on throat/burning sensation on throat) and HEADACHE (Pin point dime sized headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and THROAT IRRITATION (noticed odd sensation in her throat/Itchy sensation on throat/burning sensation on throat) and HEADACHE (Pin point dime sized headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She does not remember the exact date of receiving the first dose. Concomitant product information was not provided. Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted, Product availability issue
Clinical narrative: Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days; Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days) and PRODUCT AVAILABILITY ISSUE (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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. In April 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days) and PRODUCT AVAILABILITY ISSUE (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days) and PRODUCT AVAILABILITY ISSUE (Second dose is scheduled on 44th day/beyond the recommended dosing window of 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not information. Treatment information was not product. Care giver is looking for places to reschedule for second shot
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia
Clinical narrative: Numbness in skin and face; Bouts of heat on whole body; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in skin and face) and FEELING HOT (Bouts of heat on whole body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN, OMEPRAZOLE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in skin and face) and FEELING HOT (Bouts of heat on whole body). At the time of the report, HYPOAESTHESIA (Numbness in skin and face) and FEELING HOT (Bouts of heat on whole body) had resolved.            Other concomitant mediations included: Hormone replacement. No treatment information was provided. Action taken with respect to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Additional information received and Outcome of the events Numbness in skin and face,Bouts of heat on whole body were changed from Unknown to recovered
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: No new information is present in source document.