chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Myalgia, Pyrexia
Clinical narrative: odd side effect started, which I didn't know was a side effect at the time; then become numb; then up my face, about halfway up my face became numb; the arm at the injection site has 3 big round red lumps; hard to the touch; very sensitive; body aches; diarrhea; you just feel tired; wiped out; headache; fever of 101-102F; normal side effects with the chills and everything; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (odd side effect started, which I didn't know was a side effect at the time), HYPOAESTHESIA ORAL (then become numb), HYPOAESTHESIA (then up my face, about halfway up my face became numb), VACCINATION SITE MASS (the arm at the injection site has 3 big round red lumps) and VACCINATION SITE INDURATION (hard to the touch) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0209L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 06-Feb-2021, the patient experienced ADVERSE REACTION (odd side effect started, which I didn't know was a side effect at the time), HYPOAESTHESIA ORAL (then become numb), HYPOAESTHESIA (then up my face, about halfway up my face became numb), VACCINATION SITE MASS (the arm at the injection site has 3 big round red lumps), VACCINATION SITE INDURATION (hard to the touch), SENSITIVE SKIN (very sensitive), MYALGIA (body aches), DIARRHOEA (diarrhea), FATIGUE (you just feel tired), FEELING ABNORMAL (wiped out), HEADACHE (headache), PYREXIA (fever of 101-102F) and CHILLS (normal side effects with the chills and everything). The patient was treated with PARACETAMOL (TYLENOL) on 06-Feb-2021 for Fever, at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (odd side effect started, which I didn't know was a side effect at the time), HYPOAESTHESIA ORAL (then become numb), HYPOAESTHESIA (then up my face, about halfway up my face became numb), VACCINATION SITE MASS (the arm at the injection site has 3 big round red lumps), VACCINATION SITE INDURATION (hard to the touch), SENSITIVE SKIN (very sensitive), MYALGIA (body aches), DIARRHOEA (diarrhea), FATIGUE (you just feel tired), FEELING ABNORMAL (wiped out), HEADACHE (headache), PYREXIA (fever of 101-102F) and CHILLS (normal side effects with the chills and everything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Pyrexia: unknown (High) 101-102 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medications were Tylenol.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Vaccination site induration, Vaccination site mass
Clinical narrative: odd side effect started, which I didn't know was a side effect at the time; then become numb; then up my face, about halfway up my face became numb; the arm at the injection site has 3 big round red lumps; hard to the touch; very sensitive; body aches; diarrhea; you just feel tired; wiped out; headache; fever of 101-102F; normal side effects with the chills and everything; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (odd side effect started, which I didn't know was a side effect at the time), HYPOAESTHESIA ORAL (then become numb), HYPOAESTHESIA (then up my face, about halfway up my face became numb), VACCINATION SITE MASS (the arm at the injection site has 3 big round red lumps) and VACCINATION SITE INDURATION (hard to the touch) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0209L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 06-Feb-2021, the patient experienced ADVERSE REACTION (odd side effect started, which I didn't know was a side effect at the time), HYPOAESTHESIA ORAL (then become numb), HYPOAESTHESIA (then up my face, about halfway up my face became numb), VACCINATION SITE MASS (the arm at the injection site has 3 big round red lumps), VACCINATION SITE INDURATION (hard to the touch), SENSITIVE SKIN (very sensitive), MYALGIA (body aches), DIARRHOEA (diarrhea), FATIGUE (you just feel tired), FEELING ABNORMAL (wiped out), HEADACHE (headache), PYREXIA (fever of 101-102F) and CHILLS (normal side effects with the chills and everything). The patient was treated with PARACETAMOL (TYLENOL) on 06-Feb-2021 for Fever, at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (odd side effect started, which I didn't know was a side effect at the time), HYPOAESTHESIA ORAL (then become numb), HYPOAESTHESIA (then up my face, about halfway up my face became numb), VACCINATION SITE MASS (the arm at the injection site has 3 big round red lumps), VACCINATION SITE INDURATION (hard to the touch), SENSITIVE SKIN (very sensitive), MYALGIA (body aches), DIARRHOEA (diarrhea), FATIGUE (you just feel tired), FEELING ABNORMAL (wiped out), HEADACHE (headache), PYREXIA (fever of 101-102F) and CHILLS (normal side effects with the chills and everything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Pyrexia: unknown (High) 101-102 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medications were Tylenol.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, Nasal congestion
Clinical narrative: Body Ache; Congestion; tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), MYALGIA (Body Ache) and NASAL CONGESTION (Congestion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced COVID-19 (tested positive for covid). On an unknown date, the patient experienced MYALGIA (Body Ache) and NASAL CONGESTION (Congestion). At the time of the report, COVID-19 (tested positive for covid), MYALGIA (Body Ache) and NASAL CONGESTION (Congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: Body aches; Chills; Soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at the site of injection) in a 45-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 24-Feb-2021, the patient experienced PAIN (Body aches), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at the site of injection). At the time of the report, PAIN (Body aches), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided No  Concomitant medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Malaise, Pyrexia
Clinical narrative: Feels like flu or COVID; Fever; Chills; Bad headache; Didn't feel good on Saturday; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like flu or COVID), MALAISE (Didn't feel good on Saturday), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Bad headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]), LEVOTHYROXINE, MONTELUKAST, METFORMIN and AMLODIPINE for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced MALAISE (Didn't feel good on Saturday). On 23-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like flu or COVID), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Feb-2021, MALAISE (Didn't feel good on Saturday) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Feels like flu or COVID) outcome was unknown and PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: headache; a little diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and DIARRHOEA (a little diarrhea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and DIARRHOEA (a little diarrhea). At the time of the report, HEADACHE (headache) and DIARRHOEA (a little diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Advil   This case was linked to MOD-2021-026067, MOD-2021-026020 (Linked Report).; Sender's Comments:  MOD-2021-026020:same reporter, different patient and event MOD-2021-026067:same reporter, different patient and event
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oral pain, Tongue discolouration
Clinical narrative: mouth very sore; tongue discolored; headache; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (mouth very sore), TONGUE DISCOLOURATION (tongue discolored) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced ORAL PAIN (mouth very sore) and TONGUE DISCOLOURATION (tongue discolored). On 25-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, ORAL PAIN (mouth very sore) and TONGUE DISCOLOURATION (tongue discolored) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Pruritus, Pyrexia, Vaccination site erythema
Clinical narrative: Itching; Huge, red spot reappeared at the injection site/red blotches on her arm; Left armpit hurt; Fever; Felt a little chilly; Huge, red rash injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), AXILLARY PAIN (Left armpit hurt), PYREXIA (Fever), CHILLS (Felt a little chilly) and VACCINATION SITE RASH (Huge, red rash injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives. Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Allergic to Cipro and neomycin.) since 2011. Concomitant products included VITAMIN D3, CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE RASH (Huge, red rash injection site). On 17-Feb-2021, the patient experienced AXILLARY PAIN (Left armpit hurt), PYREXIA (Fever) and CHILLS (Felt a little chilly). On 23-Feb-2021, the patient experienced PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Huge, red spot reappeared at the injection site/red blotches on her arm). The patient was treated with TRIAMCINOLONE ACETONIDE at a dose of unknown. On 23-Feb-2021, VACCINATION SITE RASH (Huge, red rash injection site) had resolved. At the time of the report, PRURITUS (Itching), PYREXIA (Fever) and CHILLS (Felt a little chilly) outcome was unknown, AXILLARY PAIN (Left armpit hurt) had resolved and VACCINATION SITE ERYTHEMA (Huge, red spot reappeared at the injection site/red blotches on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: ADR added
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Itching; Huge, red spot reappeared at the injection site/red blotches on her arm; Left armpit hurt; Fever; Felt a little chilly; Huge, red rash injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), AXILLARY PAIN (Left armpit hurt), PYREXIA (Fever), CHILLS (Felt a little chilly) and VACCINATION SITE RASH (Huge, red rash injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives. Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Allergic to Cipro and neomycin.) since 2011. Concomitant products included VITAMIN D3, CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE RASH (Huge, red rash injection site). On 17-Feb-2021, the patient experienced AXILLARY PAIN (Left armpit hurt), PYREXIA (Fever) and CHILLS (Felt a little chilly). On 23-Feb-2021, the patient experienced PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Huge, red spot reappeared at the injection site/red blotches on her arm). The patient was treated with TRIAMCINOLONE ACETONIDE at a dose of unknown. On 23-Feb-2021, VACCINATION SITE RASH (Huge, red rash injection site) had resolved. At the time of the report, PRURITUS (Itching), PYREXIA (Fever) and CHILLS (Felt a little chilly) outcome was unknown, AXILLARY PAIN (Left armpit hurt) had resolved and VACCINATION SITE ERYTHEMA (Huge, red spot reappeared at the injection site/red blotches on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: ADR added
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 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 (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: chills; fever; joint ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint ache). At the time of the report, CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (joint ache) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Headache
Clinical narrative: severe weakness; chills; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (severe weakness), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) in an 83-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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ASTHENIA (severe weakness), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache). At the time of the report, ASTHENIA (severe weakness), CHILLS (chills) and ARTHRALGIA (joint pain) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: achy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (achy arm). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (achy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included blood pressure medications and cholesterol medication.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: injection site is very painful; body aches and other pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site is very painful) and PAIN (body aches and other pains) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site is very painful) and PAIN (body aches and other pains). At the time of the report, VACCINATION SITE PAIN (injection site is very painful) and PAIN (body aches and other pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash pruritic, Swollen tongue
Clinical narrative: Rash - Near Injection Site; Swelling - Near Injection Site; Swelling - Under Tongue; Arm Pain; A spontaneous report was received from a consumer, concerning a male patient of 82 years old age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Arm Pain, Rash - Near Injection Site,  Swelling - Near Injection Site, Itchy Sensation - Near Injection Site, Swelling - Under Tongue .  The patient medical history was not provided. concomitant product use was not provided by the reporter.  On 22Feb2021 , prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number:031M20A ) via intramuscular route for the prophylaxis of COVID-19 infection.  On 22Feb2021, the patient experienced Arm Pain.  On 25Feb2021, the patient experienced  Rash - Near Injection Site,  Swelling - Near Injection Site, Itchy Sensation - Near Injection Site, Swelling - Under Tongue .The treatment medication was not provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, Arm Pain, Rash - Near Injection Site,  Swelling - Near Injection Site, Itchy Sensation - Near Injection Site, Swelling - Under Tongue . were considered to be unknown at the time of this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: generally not feeling well; fever close to 101.0 degrees; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (generally not feeling well) and PYREXIA (fever close to 101.0 degrees) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, VENLAFAXINE and LEVOTHYROXINE for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Feb-2021, the patient experienced MALAISE (generally not feeling well) and PYREXIA (fever close to 101.0 degrees). At the time of the report, MALAISE (generally not feeling well) and PYREXIA (fever close to 101.0 degrees) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included advil with acetaminophen (ibuprofen/acetaminophen combo) - unknown dose as needed for elevated body temperature (one dose taken as of time of call).Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report received from a consumer, concerning a patient who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced sore arm, a fever that night and  body did not hurt as badly as it hurt when had COVID. The patient's medical history not provided. No relevant concomitant medications reported. On Jan 13, 2021, prior to the onset of the events, patient received the first of two planned doses of mRNA-1273 (lot/batch# unknown), intramuscularly, for prophylaxis of COVID-19 infection. On Jan 13, 2021, patient experienced sore arm and a fever that night. On an unknown date, patient experienced: body did not hurt as badly as it hurt when had COVID. No treatment information provided. Action taken with mRNA-1273 in response to the events not reported. The outcome of sore arm, a fever that night and body did not hurt as badly as it hurt when had COVID not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Nausea, Pain in extremity, Pregnancy test
Clinical narrative: Received 2nd dose of the vaccine while pregnant; arm was sore; nausea; Fatigue; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received 2nd dose of the vaccine while pregnant), PAIN IN EXTREMITY (arm was sore), NAUSEA (nausea) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Jun-2020 and the estimated date of delivery was 02-Apr-2021. On 14-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received 2nd dose of the vaccine while pregnant), PAIN IN EXTREMITY (arm was sore), NAUSEA (nausea) and FATIGUE (Fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  On 14-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received 2nd dose of the vaccine while pregnant) and PAIN IN EXTREMITY (arm was sore) had resolved. On 15-Feb-2021, NAUSEA (nausea) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound foetal: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication included certax. Treatment information was not reported.   This case was linked to MOD-2021-026240 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound foetal
Clinical narrative: Received 2nd dose of the vaccine while pregnant; arm was sore; nausea; Fatigue; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received 2nd dose of the vaccine while pregnant), PAIN IN EXTREMITY (arm was sore), NAUSEA (nausea) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Jun-2020 and the estimated date of delivery was 02-Apr-2021. On 14-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received 2nd dose of the vaccine while pregnant), PAIN IN EXTREMITY (arm was sore), NAUSEA (nausea) and FATIGUE (Fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  On 14-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received 2nd dose of the vaccine while pregnant) and PAIN IN EXTREMITY (arm was sore) had resolved. On 15-Feb-2021, NAUSEA (nausea) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound foetal: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication included certax. Treatment information was not reported.   This case was linked to MOD-2021-026240 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Vomiting
Clinical narrative: He threw up all over bed that night; He did not want to eat dinner; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (He did not want to eat dinner) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia, Dementia and Prostate cancer. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), ATENOLOL, MEMANTINE and VITAMINS NOS for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DECREASED APPETITE (He did not want to eat dinner). At the time of the report, DECREASED APPETITE (He did not want to eat dinner) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment medications.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, White blood cell count
Clinical narrative: small red circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (small red circle at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20a) for COVID-19 vaccination.     The patient's past medical history included Cellulitis (Cellulitis with mosquito bites) and Swelling (Swelling with mosquito bites).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced VACCINATION SITE ERYTHEMA (small red circle at injection site). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency and VANCOMYCIN at an unspecified dose and frequency. In January 2021, VACCINATION SITE ERYTHEMA (small red circle at injection site) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, White blood cell count: inconclusive (Inconclusive) count was 35,000.         No concomitant drug information provided.   This case was linked to MOD-2021-026113 (Patient Link).   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash, Rash pruritic, Vertigo
Clinical narrative: travel rash; itched/hurt; bad vertigo; lip swelled; A spontaneous report was received from a (Consumer) concerning a  79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced travel Rash, itched, hurt, lip swelling and bad vertigo.  The patient's medical history included that patient had slight case of COVID-19. No relevant concomitant medications were reported.    On 14 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route and in left upper arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced travel Rash, itched, hurt, lip swelling and bad vertigo. Laboratory details not provided. Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date, the outcome of the event Lip swelling and Vertigo were Recovered. At the time of this report, the outcome of the events travel rash, itched, hurt were unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Rash
Clinical narrative: numb hands and feet and numbness in the lower legs; covid toes; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numb hands and feet and numbness in the lower legs) and RASH (covid toes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numb hands and feet and numbness in the lower legs) and RASH (covid toes). At the time of the report, HYPOAESTHESIA (numb hands and feet and numbness in the lower legs) and RASH (covid toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: severe itching on left toe; Rash on left toe; excessive Swatting; swelling of arm; Pain in arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (severe itching on left toe), RASH (Rash on left toe), HYPERHIDROSIS (excessive Swatting), PERIPHERAL SWELLING (swelling of arm) and PAIN IN EXTREMITY (Pain in arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PRURITUS (severe itching on left toe), RASH (Rash on left toe), HYPERHIDROSIS (excessive Swatting), PERIPHERAL SWELLING (swelling of arm) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, PRURITUS (severe itching on left toe), RASH (Rash on left toe), HYPERHIDROSIS (excessive Swatting), PERIPHERAL SWELLING (swelling of arm) and PAIN IN EXTREMITY (Pain in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.    Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sensitive skin
Clinical narrative: itching head, face, and body itching; I am a little bit sensitive; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching head, face, and body itching) and SENSITIVE SKIN (I am a little bit sensitive) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (itching head, face, and body itching) and SENSITIVE SKIN (I am a little bit sensitive). At the time of the report, PRURITUS (itching head, face, and body itching) and SENSITIVE SKIN (I am a little bit sensitive) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient take blood pressure pill in Concomitant medication. No Treatment Medication was provided by Reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Pain in extremity, Pregnancy test
Clinical narrative: Fatigue; Vaccine exposure during pregnancy; Sore arm after 1 dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN IN EXTREMITY (Sore arm after 1 dose) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     Medical history not provided.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 26-Jun-2020 and the estimated date of delivery was 02-Apr-2021. On 19-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN IN EXTREMITY (Sore arm after 1 dose). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 19-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm after 1 dose) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medications are CERTAX.   This case was linked to MOD-2021-026199 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus, Rash, Urticaria
Clinical narrative: itching on both arms; whelps on both arms; red circle at injection site; rash on both arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on both arms), URTICARIA (whelps on both arms), INJECTION SITE ERYTHEMA (red circle at injection site) and RASH (rash on both arms) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Medical history not provided.  The patient's past medical history included No adverse event (no medical records).    On 12-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 PRURITUS (itching on both arms), URTICARIA (whelps on both arms), INJECTION SITE ERYTHEMA (red circle at injection site) and RASH (rash on both arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 25-Feb-2021, PRURITUS (itching on both arms), URTICARIA (whelps on both arms), INJECTION SITE ERYTHEMA (red circle at injection site) and RASH (rash on both arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient used steroid cream for rash and itching.
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: Delayed site reaction (reasonably mild); This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Delayed site reaction (reasonably mild)) 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 Radical mastectomy.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced SKIN REACTION (Delayed site reaction (reasonably mild)). At the time of the report, SKIN REACTION (Delayed site reaction (reasonably mild)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021 at 1:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Mar-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment details were provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Whole arm aching; Pain in left shoulder blade/Pain in shoulder joints/pain moved to shoulder joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Whole arm aching) and ARTHRALGIA (Pain in left shoulder blade/Pain in shoulder joints/pain moved to shoulder joints) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Hip arthritis). Concomitant products included CELECOXIB (CELEBREX) from 12-Feb-2021 to an unknown date for Hips osteoarthritis, AMLODIPINE, SIMVASTATIN and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Whole arm aching) and ARTHRALGIA (Pain in left shoulder blade/Pain in shoulder joints/pain moved to shoulder joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Whole arm aching) and ARTHRALGIA (Pain in left shoulder blade/Pain in shoulder joints/pain moved to shoulder joints) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Indication added for Suspect vaccine. Treatment drug added. Outcome updated to resolved.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Insomnia, Lethargy, Night sweats
Clinical narrative: felt lethargic; hot flashes; night sweats; not able to sleep; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic), HOT FLUSH (hot flashes), NIGHT SWEATS (night sweats), INSOMNIA (not able to sleep) and CHILLS (chills) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced LETHARGY (felt lethargic), HOT FLUSH (hot flashes), NIGHT SWEATS (night sweats), INSOMNIA (not able to sleep) and CHILLS (chills). At the time of the report, LETHARGY (felt lethargic), HOT FLUSH (hot flashes), NIGHT SWEATS (night sweats), INSOMNIA (not able to sleep) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .No concomitant medications was provided.  Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Urticaria
Clinical narrative: Eczema around the mouth and hands; Hives around the mouth and hands; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema around the mouth and hands) and URTICARIA (Hives around the mouth and hands) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ECZEMA (Eczema around the mouth and hands) and URTICARIA (Hives around the mouth and hands). At the time of the report, ECZEMA (Eczema around the mouth and hands) and URTICARIA (Hives around the mouth and hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information included mometasone 0.1% ointment and triple antibiotic.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Penile rash
Clinical narrative: Rash on penis; This spontaneous case was reported by a consumer and describes the occurrence of PENILE RASH (Rash on penis) in an 89-year-old male patient 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 provided.). Concomitant products included TRAVOPROST (TRAVATAN) for an unknown indication.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced PENILE RASH (Rash on penis). At the time of the report, PENILE RASH (Rash on penis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Vaccination site pain
Clinical narrative: Pressure in her chest; Headache; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of   in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was reported.    Reporter did not allow further contact