chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; Soreness at injection site; Tenderness at the injection site; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, soreness at injection site, tenderness at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011L20A) Intramuscularly for prophylaxis of COVID-19 infection.   On 27 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 011M20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced fever, soreness at injection site, tenderness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disorientation, Fatigue, Pain
Clinical narrative: disorientation; Achiness; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientation), PAIN (Achiness), CHILLS (chills) and FATIGUE (tiredness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DISORIENTATION (disorientation), PAIN (Achiness), CHILLS (chills) and FATIGUE (tiredness). At the time of the report, DISORIENTATION (disorientation), PAIN (Achiness), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not reported. No treatment medication was not reported
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: Redness; Pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) and PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-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 ERYTHEMA (Redness) and PAIN (Pain). At the time of the report, ERYTHEMA (Redness) and PAIN (Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Vaccination site pain
Clinical narrative: Weakness; Chills; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, ASTHENIA (Weakness), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Really rapid heartbeat; A spontaneous report was received from a consumer concerning of an unknown age, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, really rapid heartbeat, progressed and became more frequent.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Mar 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 025A21A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, really rapid heartbeat, progressed and became more frequent.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, really rapid heartbeat, progressed and became more frequent was unknown.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Dyspnoea, Fatigue, Muscle spasms, Myalgia
Clinical narrative: Shortness of breath; cramps in legs; joint problems; Fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), MUSCLE SPASMS (cramps in legs), ARTHROPATHY (joint problems), FATIGUE (Fatigue) and MYALGIA (muscle pain) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 042L20A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM and ATORVASTATIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), MUSCLE SPASMS (cramps in legs), ARTHROPATHY (joint problems), FATIGUE (Fatigue) and MYALGIA (muscle pain). At the time of the report, DYSPNOEA (Shortness of breath), MUSCLE SPASMS (cramps in legs), ARTHROPATHY (joint problems), FATIGUE (Fatigue) and MYALGIA (muscle pain) had not resolved.            Additional concomitant medications included a blood thinner (not specified) and a potassium pill.  Patient initially reported that after the first dose of the vaccine, he experienced fatigue, muscle pain, joint "problems", cramps in legs and shortness of breath periodically which continued through the 2nd administration of the vaccine and were ongoing.  No treatment medication was reported.  On 06-Aug-2021, the patient denied having experienced any side effects from the use of the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Narrative updated per information in TCR.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Insomnia, Myalgia
Clinical narrative: felt woozy; within two days lost one and a half pounds; Muscles were aching and in pain; 102.3 temperature; Felt like a truck knocked her out; Rapid heartbeat; Caller stated she couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt woozy), WEIGHT DECREASED (within two days lost one and a half pounds), MYALGIA (Muscles were aching and in pain), PYREXIA (102.3 temperature) and FATIGUE (Felt like a truck knocked her out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression (The patient take anti depressant.). Concomitant products included ESCITALOPRAM OXALATE for Depression.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (felt woozy), WEIGHT DECREASED (within two days lost one and a half pounds), MYALGIA (Muscles were aching and in pain), PYREXIA (102.3 temperature), FATIGUE (Felt like a truck knocked her out), TACHYCARDIA (Rapid heartbeat) and INSOMNIA (Caller stated she couldn't sleep). On 10-Mar-2021, PYREXIA (102.3 temperature) had resolved. At the time of the report, DIZZINESS (felt woozy), WEIGHT DECREASED (within two days lost one and a half pounds), MYALGIA (Muscles were aching and in pain), FATIGUE (Felt like a truck knocked her out), TACHYCARDIA (Rapid heartbeat) and INSOMNIA (Caller stated she couldn't sleep) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 102.3 f High.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Weight decreased
Clinical narrative: felt woozy; within two days lost one and a half pounds; Muscles were aching and in pain; 102.3 temperature; Felt like a truck knocked her out; Rapid heartbeat; Caller stated she couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt woozy), WEIGHT DECREASED (within two days lost one and a half pounds), MYALGIA (Muscles were aching and in pain), PYREXIA (102.3 temperature) and FATIGUE (Felt like a truck knocked her out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression (The patient take anti depressant.). Concomitant products included ESCITALOPRAM OXALATE for Depression.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (felt woozy), WEIGHT DECREASED (within two days lost one and a half pounds), MYALGIA (Muscles were aching and in pain), PYREXIA (102.3 temperature), FATIGUE (Felt like a truck knocked her out), TACHYCARDIA (Rapid heartbeat) and INSOMNIA (Caller stated she couldn't sleep). On 10-Mar-2021, PYREXIA (102.3 temperature) had resolved. At the time of the report, DIZZINESS (felt woozy), WEIGHT DECREASED (within two days lost one and a half pounds), MYALGIA (Muscles were aching and in pain), FATIGUE (Felt like a truck knocked her out), TACHYCARDIA (Rapid heartbeat) and INSOMNIA (Caller stated she couldn't sleep) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 102.3 f High.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Lost sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost sense of taste) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced AGEUSIA (Lost sense of taste). At the time of the report, AGEUSIA (Lost sense of taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nasal congestion, Pain in extremity, Pruritus, Swelling
Clinical narrative: Right nostril blistered and closed/ hard to breathe; Right nostril blistered and closed/ hard to breathe; Swelling legs/itching; Swelling legs/itching; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SWELLING (Swelling legs/itching), PRURITUS (Swelling legs/itching), DYSPNOEA (Right nostril blistered and closed/ hard to breathe) and NASAL CONGESTION (Right nostril blistered and closed/ hard to breathe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced SWELLING (Swelling legs/itching) and PRURITUS (Swelling legs/itching). On 21-Feb-2021, the patient experienced DYSPNOEA (Right nostril blistered and closed/ hard to breathe) and NASAL CONGESTION (Right nostril blistered and closed/ hard to breathe). On 20-Feb-2021, SWELLING (Swelling legs/itching) and PRURITUS (Swelling legs/itching) had resolved. On 21-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 23-Feb-2021, DYSPNOEA (Right nostril blistered and closed/ hard to breathe) and NASAL CONGESTION (Right nostril blistered and closed/ hard to breathe) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Vaccination site erythema
Clinical narrative: 2 inch diameter patch at injection site; Reddish color at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (2 inch diameter patch at injection site) and VACCINATION SITE ERYTHEMA (Reddish color at site of injection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE HYPERSENSITIVITY (2 inch diameter patch at injection site) and VACCINATION SITE ERYTHEMA (Reddish color at site of injection). At the time of the report, INJECTION SITE HYPERSENSITIVITY (2 inch diameter patch at injection site) and VACCINATION SITE ERYTHEMA (Reddish color at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever of 102; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102), CHILLS (Chills) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (Fever of 102), CHILLS (Chills) and HEADACHE (Headache). On 08-Mar-2021, PYREXIA (Fever of 102), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   No treatment details were provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm; Little chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and CHILLS (Little chills) in an 83-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 reported medical history).   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and CHILLS (Little chills). On 12-Mar-2021, PAIN IN EXTREMITY (Sore arm) and CHILLS (Little chills) had resolved.            No concomitant medications were provided.  No treatment details were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Product dose omission issue
Clinical narrative: Neither agreed to take the 2nd vaccine; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and PRODUCT DOSE OMISSION ISSUE (Neither agreed to take the 2nd vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Neither agreed to take the 2nd vaccine). At the time of the report, DIARRHOEA (diarrhea) and PRODUCT DOSE OMISSION ISSUE (Neither agreed to take the 2nd vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Reportedly, the patient took medications the doctor gave her but it didn't work (doesn't know the name). It was reported that the diarrhea lasted for a month. The patient was not agree to take second dose of the vaccine.   This case was linked to MOD-2021-042913.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received included outcome of the Event.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Uncontrollable urine; Severe body aches; Headache; Muscle ache; Possible fever; Chills; Fatigue; Covid like symptoms; Arm pain; Sweats; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid like symptoms), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweats), URINE ABNORMALITY (Uncontrollable urine) and PAIN (Severe body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (8 months ago). Concomitant products included METFORMIN, LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN and ATORVASTATIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (Covid like symptoms), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweats), PAIN (Severe body aches), HEADACHE (Headache), MYALGIA (Muscle ache), PYREXIA (Possible fever), CHILLS (Chills) and FATIGUE (Fatigue). On 05-Mar-2021, the patient experienced URINE ABNORMALITY (Uncontrollable urine). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. On 05-Mar-2021, COVID-19 (Covid like symptoms), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweats), URINE ABNORMALITY (Uncontrollable urine), PAIN (Severe body aches), HEADACHE (Headache), MYALGIA (Muscle ache), PYREXIA (Possible fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Pyrexia, Urine abnormality
Clinical narrative: Uncontrollable urine; Severe body aches; Headache; Muscle ache; Possible fever; Chills; Fatigue; Covid like symptoms; Arm pain; Sweats; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid like symptoms), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweats), URINE ABNORMALITY (Uncontrollable urine) and PAIN (Severe body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (8 months ago). Concomitant products included METFORMIN, LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN and ATORVASTATIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (Covid like symptoms), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweats), PAIN (Severe body aches), HEADACHE (Headache), MYALGIA (Muscle ache), PYREXIA (Possible fever), CHILLS (Chills) and FATIGUE (Fatigue). On 05-Mar-2021, the patient experienced URINE ABNORMALITY (Uncontrollable urine). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. On 05-Mar-2021, COVID-19 (Covid like symptoms), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweats), URINE ABNORMALITY (Uncontrollable urine), PAIN (Severe body aches), HEADACHE (Headache), MYALGIA (Muscle ache), PYREXIA (Possible fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Itchiness ongoing; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness ongoing) and PAIN IN EXTREMITY (Arm pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (Itchiness ongoing) and PAIN IN EXTREMITY (Arm pain). On 01-Mar-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, PRURITUS (Itchiness ongoing) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient felt itchy off-and-on on a daily basis.  Concomitant product used was not provided by the reporter.  Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received  contains non-significant information
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site black in color; itchy; her injection site is swollen; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (injection site black in color), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (her injection site is swollen) and VACCINATION SITE ERYTHEMA (injection site red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 04UA21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 10:00 AM, the patient experienced VACCINATION SITE DISCOLOURATION (injection site black in color), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (her injection site is swollen) and VACCINATION SITE ERYTHEMA (injection site red). On 12-Mar-2021, VACCINATION SITE DISCOLOURATION (injection site black in color), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (her injection site is swollen) and VACCINATION SITE ERYTHEMA (injection site red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported.  Patient reported that she did not take any medication to treat the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up was received on 05-MAY-2021. Second dose batch number was added.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Chills; Muscle aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Muscle aches) and HEADACHE (Headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills), MYALGIA (Muscle aches) and HEADACHE (Headache). At the time of the report, CHILLS (Chills), MYALGIA (Muscle aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Muscular weakness, Vaccination complication, Vaccination site pain
Clinical narrative: legs feeling weak; weak, lethargic, out of it; Headache; Chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (weak, lethargic, out of it), MUSCULAR WEAKNESS (legs feeling weak), CHILLS (Chills), VACCINATION SITE PAIN (sore arm) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and INSULIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 10-Mar-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On 11-Mar-2021, the patient experienced VACCINATION COMPLICATION (weak, lethargic, out of it). On 12-Mar-2021, the patient experienced MUSCULAR WEAKNESS (legs feeling weak). At the time of the report, VACCINATION COMPLICATION (weak, lethargic, out of it), MUSCULAR WEAKNESS (legs feeling weak), CHILLS (Chills), VACCINATION SITE PAIN (sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Treatment of events was not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site induration, Vaccination site swelling
Clinical narrative: Hardness; A little bit swelling; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (A little bit swelling) and MYALGIA (Muscle pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (A little bit swelling) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (A little bit swelling) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (arm is swollen from elbow to shoulder) and VACCINATION SITE RASH (raised red rash at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. Co-suspect product included non-company product CEPHALEXIN [CEFALEXIN] for an unknown indication. No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ATORVASTATIN, GABAPENTIN, ABALOPARATIDE (TYMLOS), LAMOTRIGINE, HYDROXYZINE, VITAMINS NOS, ZOLPIDEM and AMPHETAMINE for an unknown indication. On 02-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 started CEPHALEXIN [CEFALEXIN] (unknown route) 500 milligram three times a day. On an unknown date, the patient experienced VACCINATION SITE SWELLING (arm is swollen from elbow to shoulder) and VACCINATION SITE RASH (raised red rash at the injection site). At the time of the report, VACCINATION SITE SWELLING (arm is swollen from elbow to shoulder) and VACCINATION SITE RASH (raised red rash at the injection site) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: arm is still sore; can barely move it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still sore) and MOBILITY DECREASED (can barely move it) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is still sore) and MOBILITY DECREASED (can barely move it). At the time of the report, PAIN IN EXTREMITY (arm is still sore) and MOBILITY DECREASED (can barely move it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not reported. No treatment medication was not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-042502 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-042502:Same reporter/Husband
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site induration
Clinical narrative: diarrhoea; Hardness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness at the injection site) and DIARRHOEA (diarrhoea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at the injection site). On 12-Mar-2021, the patient experienced DIARRHOEA (diarrhoea). At the time of the report, VACCINATION SITE INDURATION (Hardness at the injection site) and DIARRHOEA (diarrhoea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported.   No treatment information was reported.   Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Poor quality sleep, Pyrexia
Clinical narrative: Fever of 102F; Sleep was uncomfortable; Aches and pains which felt like muscle tension; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Sleep was uncomfortable), MYALGIA (Aches and pains which felt like muscle tension) and PYREXIA (Fever of 102F) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A2A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced POOR QUALITY SLEEP (Sleep was uncomfortable) and MYALGIA (Aches and pains which felt like muscle tension). On 11-Mar-2021, the patient experienced PYREXIA (Fever of 102F). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 at a dose of UNK dosage form. At the time of the report, POOR QUALITY SLEEP (Sleep was uncomfortable), MYALGIA (Aches and pains which felt like muscle tension) and PYREXIA (Fever of 102F) outcome was unknown.            No relevant concomitant medications were reported.  The patient reported that later that same evening of vaccination, his sleep was uncomfortable due to aches and pains. On the day of reporting the patient was feeling better.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Alopecia
Clinical narrative: mild symptoms; Loosing hairs of head; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (mild symptoms) and ALOPECIA (Loosing hairs of head) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ALOPECIA (Loosing hairs of head). On an unknown date, the patient experienced ADVERSE EVENT (mild symptoms). At the time of the report, ADVERSE EVENT (mild symptoms) and ALOPECIA (Loosing hairs of head) outcome was unknown.            Concomitant medications include thyroid, blood pressure and blood thinner medicine. Reporter did not provide any treatment medications.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Hypersomnia
Clinical narrative: brain fogginess is still persisting following the 1st shot; tiredness/no energy at all; Difficulty Breathing; Can't Seem to Wake-Up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty Breathing), HYPERSOMNIA (Can't Seem to Wake-Up), FEELING ABNORMAL (brain fogginess is still persisting following the 1st shot) and FATIGUE (tiredness/no energy at all) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event, Breast cancer, Heparin-induced thrombosis (Patient developed clot in one kidney.) and Splenic thrombosis. Concurrent medical conditions included Single functional kidney. Concomitant products included RIVAROXABAN (XARELTO) and LOSARTAN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DYSPNOEA (Difficulty Breathing) and HYPERSOMNIA (Can't Seem to Wake-Up). On an unknown date, the patient experienced FEELING ABNORMAL (brain fogginess is still persisting following the 1st shot) and FATIGUE (tiredness/no energy at all). At the time of the report, DYSPNOEA (Difficulty Breathing), FEELING ABNORMAL (brain fogginess is still persisting following the 1st shot) and FATIGUE (tiredness/no energy at all) had not resolved and HYPERSOMNIA (Can't Seem to Wake-Up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided. Concomitant medication include Serota.       Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up was received Added events, patient relevant history, concomitant medication, events,Updated reporters contact information, event outcome.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Hypersensitivity reaction; Very painful; Rash appeared at the injection site; Arm itched at injection site; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Very painful), VACCINATION SITE RASH (Rash appeared at the injection site), VACCINATION SITE PRURITUS (Arm itched at injection site) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis (wasp sting), Hay fever, Wasp sting (stung 15 times; whole body rash; itching lasted for over a week) in September 2019 and Hives. Concurrent medical conditions included Asthma.    On 26-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Very painful), VACCINATION SITE PRURITUS (Arm itched at injection site) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). 06-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash appeared at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 06-Mar-2021 to 20-Mar-2021 at an unspecified dose and frequency. On 20-Mar-2021, HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Very painful), VACCINATION SITE RASH (Rash appeared at the injection site), VACCINATION SITE PRURITUS (Arm itched at injection site) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported.   .   This case was linked to MOD-2021-231140 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18JUN2021, updated 2nd dose details and events. On 21-Jun-2021: Follow up received on 21JUN2021, contains reporter's Email address On 29-Jul-2021: Significant follow up included new events, updated  outcome, narrative, relevant history, batch #'s.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: Extremely cold hands; Extremely cold feet; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Extremely cold hands) and PERIPHERAL COLDNESS (Extremely cold feet) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PERIPHERAL COLDNESS (Extremely cold hands) and PERIPHERAL COLDNESS (Extremely cold feet). At the time of the report, PERIPHERAL COLDNESS (Extremely cold hands) and PERIPHERAL COLDNESS (Extremely cold feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: circle of redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (circle of redness around the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (circle of redness around the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (circle of redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: increase in blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (increase in blood pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 BLOOD PRESSURE INCREASED (increase in blood pressure). At the time of the report, BLOOD PRESSURE INCREASED (increase in blood pressure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Oropharyngeal pain, Pyrexia
Clinical narrative: pretty dizzy; sore throat; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (pretty dizzy), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included WARFARIN, LISINOPRIL, ROSUVASTATIN CALCIUM (CRESTOR) and METOPROLOL for an unknown indication.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever). On 12-Mar-2021, the patient experienced DIZZINESS (pretty dizzy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (pretty dizzy) had not resolved and OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) outcome was unknown.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy bumps on tops of forearms and some bumps on chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy bumps on tops of forearms and some bumps on chest) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH PRURITIC (Itchy bumps on tops of forearms and some bumps on chest). At the time of the report, RASH PRURITIC (Itchy bumps on tops of forearms and some bumps on chest) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment medication included "cream". It had been going on for 3 days and was not bad as the put cream on it and he felt great.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Nasal congestion, Rash
Clinical narrative: Vaccine exposure via breast milk; Rash all over the neck; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk), NASAL CONGESTION (Congestion) and RASH (Rash all over the neck) in a 29-day-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): No medical history was reported.     On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced NASAL CONGESTION (Congestion). On 10-Mar-2021, the patient experienced RASH (Rash all over the neck). On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk), NASAL CONGESTION (Congestion) and RASH (Rash all over the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Breastfeeding mom called on behalf of her son. She reported that she received her first dose Moderna Vaccine on 19 Feb 2021.On 5March 2021 her baby developed congestion. On 10 March the baby developed rashes all over his neck. No treatment taken so far
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: FEVER; CHILLS; HEADACHE; MUSCLE PAIN; JOINT PAIN; NAUSEA; roof of mouth raw; left side throat swollen; This spontaneous case was reported by a consumer and describes the occurrence of PALATAL SWELLING (roof of mouth raw), PHARYNGEAL SWELLING (left side throat swollen), PYREXIA (FEVER), CHILLS (CHILLS) and HEADACHE (HEADACHE) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PALATAL SWELLING (roof of mouth raw) and PHARYNGEAL SWELLING (left side throat swollen). On an unknown date, the patient experienced PYREXIA (FEVER), CHILLS (CHILLS), HEADACHE (HEADACHE), MYALGIA (MUSCLE PAIN), ARTHRALGIA (JOINT PAIN) and NAUSEA (NAUSEA). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (FEVER), CHILLS (CHILLS), MYALGIA (MUSCLE PAIN), ARTHRALGIA (JOINT PAIN) and NAUSEA (NAUSEA) had resolved. At the time of the report, PALATAL SWELLING (roof of mouth raw), PHARYNGEAL SWELLING (left side throat swollen) and HEADACHE (HEADACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.