chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: disorientated; brain was foggy; totally crashed and had to go to sleep; severe diarrhea,like never before. Still not having normal bowel movements; sore arm; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements) and PAIN IN EXTREMITY (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and CHILLS (chills). On 10-Feb-2021, DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), FATIGUE (fatigue) and CHILLS (chills) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Imodium. No concomitant medications were provided by reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Feeling of body temperature change, Pain
Clinical narrative: Arm is very hot, like you can fry an egg on it; Chills for 15-20 minutes and then go supper hot; Sore arm went down to elbowand into my shoulder; Arm is really sore, started to boom boom; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm is very hot, like you can fry an egg on it), FEELING OF BODY TEMPERATURE CHANGE (Chills for 15-20 minutes and then go supper hot), ARTHRALGIA (Sore arm went down to elbowand into my shoulder) and PAIN (Arm is really sore, started to boom boom) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid disorder NOS.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FEELING HOT (Arm is very hot, like you can fry an egg on it), FEELING OF BODY TEMPERATURE CHANGE (Chills for 15-20 minutes and then go supper hot), ARTHRALGIA (Sore arm went down to elbowand into my shoulder) and PAIN (Arm is really sore, started to boom boom). At the time of the report, FEELING HOT (Arm is very hot, like you can fry an egg on it), FEELING OF BODY TEMPERATURE CHANGE (Chills for 15-20 minutes and then go supper hot), ARTHRALGIA (Sore arm went down to elbowand into my shoulder) and PAIN (Arm is really sore, started to boom boom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Nightmare
Clinical narrative: nightmares; foggy head; headaches; chills on and off; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmares), FEELING ABNORMAL (foggy head), HEADACHE (headaches) and CHILLS (chills on and off) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced NIGHTMARE (nightmares), FEELING ABNORMAL (foggy head), HEADACHE (headaches) and CHILLS (chills on and off). On 15-Feb-2021, NIGHTMARE (nightmares) and FEELING ABNORMAL (foggy head) had resolved. At the time of the report, HEADACHE (headaches) and CHILLS (chills on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red spots on her right arm where she got the the injection; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red spots on her right arm where she got the injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received the first planned dose of mRNA-1273 (lot/batch: unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event red spots on her right arm where she got the injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event red spots was unknown.; 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.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site rash, Pain in extremity, Rash
Clinical narrative: the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy; woke up with the rash today /It's not as severe but it's larger, it covers a bigger area; a little bit sore; got what people are calling a COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit sore), HYPERSENSITIVITY (got what people are calling a COVID arm), INJECTION SITE RASH (the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy) and RASH (woke up with the rash today /It's not as severe but it's larger, it covers a bigger area) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DOMZOA) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, ATORVASTATIN and METHAQUALONE (TOQUILONE) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (a little bit sore) and HYPERSENSITIVITY (got what people are calling a COVID arm). On 19-Feb-2021, the patient experienced INJECTION SITE RASH (the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy) and RASH (woke up with the rash today /It's not as severe but it's larger, it covers a bigger area). At the time of the report, PAIN IN EXTREMITY (a little bit sore), HYPERSENSITIVITY (got what people are calling a COVID arm), INJECTION SITE RASH (the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy) and RASH (woke up with the rash today /It's not as severe but it's larger, it covers a bigger area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: High blood sugar 279 and 197; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (High blood sugar 279 and 197) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 016M20A) for COVID-19 immunisation.     Concurrent medical conditions included Type 2 diabetes mellitus, Diverticulitis since 1988, Hypertension, Obesity and Mercury sensitivity.   On 17-Feb-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (High blood sugar 279 and 197). At the time of the report, BLOOD GLUCOSE INCREASED (High blood sugar 279 and 197) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Blood glucose: 279 (High) complete. On 18-Feb-2021, Blood glucose: 197 (High) complete.         Treatment medication included glimepiride.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: 2nd dose vaccination date and batch number added, race,height, weight, medical condition of hypertension and obese, diverticulitus since 1988 as chronic condition added, allergy to mercury added; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen gland on opposite arm after the 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen gland on opposite arm after the 1st vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0266208 and 01SM20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen gland on opposite arm after the 1st vaccine). At the time of the report, LYMPHADENOPATHY (Swollen gland on opposite arm after the 1st vaccine) outcome was unknown.            No treatment information was provided by Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: TCR received.Nobody received the call. Left voicemail with call back number and Argus case number.; Reporter's Comments: Based on the current available information which includes a g temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Arm became numb; Tingling; Achy sensation; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm became numb), PARAESTHESIA (Tingling) and PAIN (Achy sensation) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023H0A) for an unknown indication.     The patient's past medical history included No adverse event (The patient's medical history was not provided.  ). Concomitant products included PITAVASTATIN CALCIUM (LIVALO) for Cholesterol, WARFARIN.    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 HYPOAESTHESIA (Arm became numb), PARAESTHESIA (Tingling) and PAIN (Achy sensation). On 17-Feb-2021, HYPOAESTHESIA (Arm became numb), PARAESTHESIA (Tingling) and PAIN (Achy sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Feeling hot, Pain, Pyrexia
Clinical narrative: Clammy; Hot; In pain; Feverish; Fatigue; Red/Erythema at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-1900, the patient experienced VACCINATION SITE ERYTHEMA (Red/Erythema at injection site). On 27-Jan-2021, the patient experienced COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish) and FATIGUE (Fatigue). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red/Erythema at injection site) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Clammy; Hot; In pain; Feverish; Fatigue; Red/Erythema at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-1900, the patient experienced VACCINATION SITE ERYTHEMA (Red/Erythema at injection site). On 27-Jan-2021, the patient experienced COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish) and FATIGUE (Fatigue). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red/Erythema at injection site) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Insomnia, Vaccination site pain
Clinical narrative: A spontaneous report was received from a consumer concerning an 86-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  woke up on the middle of the night extremely dizzy/dizziness, interrupted her sleep/insomnia and sore arm/vaccination site pain. The patient's medical history was not provided. No relevant concomitant medications on use were reported. On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025120A) intramuscularly for prophylaxis of COVID-19 infection. On 9 Feb 2021, the patient experienced the event sore arm. On 16 Feb 2021, the patient experienced the events woke up on the middle of the night extremely dizzy and this interrupted her sleep. No laboratory data was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event sore arm was resolved on 11 Feb 2021. The events  woke up on the middle of the night extremely dizzy and  this interrupted her sleep were recovered on 17 Feb. 2021.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain, Vomiting
Clinical narrative: Vomiting; Sore arm; Bad headache; Fatigued/Tired; A spontaneous report was received from a consumer (patient) concerning a 73 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like a sore arm, a bad headache, fatigued/tired, and vomiting.  The patient's medical history was not provided. Relevant concomitant medications were reported. The patient is taking blood pressure medicines.  On 13-JAN-2021, the patient received their first of two planned doses of mRNA-1273(Batch number 012L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 09-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273( Batch Number 010M20A ) intramuscularly for prophylaxis of COVID-19 infection.  On  09-FEB-2021, the patient experienced a sore arm, a bad headache and was fatigued/tired.   On 18-FEB-2021, the patient experienced the event vomiting.  Treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, a sore arm, a bad headache and was fatigued/tired were considered resolved on 12 Feb 2021. The outcome of the event, vomiting was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Although temporality cannot be established due to the known safety profile of the vaccine, a causal relationship with the event cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow up information was received on 31 Mar 2021: added reporter E mail ID
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal
Clinical narrative: uncontrolled blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE ABNORMAL (uncontrolled blood pressure) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included METOPROLOL, HYDRALAZINE and LOSARTAN 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 an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (uncontrolled blood pressure). At the time of the report, BLOOD PRESSURE ABNORMAL (uncontrolled blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy; Hard; Very painful; Redness/big red; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness/big red), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PAIN (Very painful) and VACCINATION SITE INDURATION (Hard) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included LITHIUM, CITALOPRAM and FREMANEZUMAB (AJOVY [FREMANEZUMAB]) 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 VACCINATION SITE ERYTHEMA (Redness/big red) and VACCINATION SITE SWELLING (Swelling). On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Very painful). On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE INDURATION (Hard). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness/big red), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PAIN (Very painful) and VACCINATION SITE INDURATION (Hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included unspecified lotion.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site infection, Vaccination site lymphadenopathy, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: was told that it was infected; Started itching below the injection site; lymph node under her arm that is sore and swollen; arm was red and swollen below the injection site; arm was red and swollen below the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFECTION (was told that it was infected), VACCINATION SITE PRURITUS (Started itching below the injection site), VACCINATION SITE LYMPHADENOPATHY (lymph node under her arm that is sore and swollen), VACCINATION SITE SWELLING (arm was red and swollen below the injection site) and VACCINATION SITE ERYTHEMA (arm was red and swollen below the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Prozac allergy) and Drug allergy (Wellburtin allergy). Concomitant products included LORATADINE for Allergy, LISINOPRIL for Blood pressure high, ESTRADIOL and MEDROXYPROGESTERONE for Hormone therapy, CLONAZEPAM for Nerve pain.    On 30-Jan-2021, 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 INFECTION (was told that it was infected), VACCINATION SITE PRURITUS (Started itching below the injection site), VACCINATION SITE LYMPHADENOPATHY (lymph node under her arm that is sore and swollen), VACCINATION SITE SWELLING (arm was red and swollen below the injection site) and VACCINATION SITE ERYTHEMA (arm was red and swollen below the injection site). At the time of the report, VACCINATION SITE INFECTION (was told that it was infected), VACCINATION SITE PRURITUS (Started itching below the injection site), VACCINATION SITE LYMPHADENOPATHY (lymph node under her arm that is sore and swollen), VACCINATION SITE SWELLING (arm was red and swollen below the injection site) and VACCINATION SITE ERYTHEMA (arm was red and swollen below the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was prescribed Cephalexin 500mg, Atarax 10mg , Diflucan (Fluconazole)150mg, but she has not taken any of these yet.   This case was linked to MOD-2021-017024 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up document was received. Patient's demography, relevant medical history and concomitant medications were updated. It contains significant information.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Right arm became swollen; Red rash; Itchy in the area where he got injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Right arm became swollen), VACCINATION SITE RASH (Red rash) and VACCINATION SITE PRURITUS (Itchy in the area where he got injected) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE SWELLING (Right arm became swollen), VACCINATION SITE RASH (Red rash) and VACCINATION SITE PRURITUS (Itchy in the area where he got injected). At the time of the report, VACCINATION SITE SWELLING (Right arm became swollen), VACCINATION SITE RASH (Red rash) and VACCINATION SITE PRURITUS (Itchy in the area where he got injected) outcome was unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Sometimes sweats; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sometimes sweats) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sometimes sweats) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sometimes sweats) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Hypertension
Clinical narrative: Bloody nose bleed; Elevated BP; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bloody nose bleed) and HYPERTENSION (Elevated BP) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced EPISTAXIS (Bloody nose bleed) and HYPERTENSION (Elevated BP). At the time of the report, EPISTAXIS (Bloody nose bleed) and HYPERTENSION (Elevated BP) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Came down with a cold; On-going cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Came down with a cold) and COUGH (On-going cough) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced NASOPHARYNGITIS (Came down with a cold) and COUGH (On-going cough). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Came down with a cold) and COUGH (On-going cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure medicine.    Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: Body ache; headache; Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Body ache), HEADACHE (headache) and DIZZINESS (Dizziness) in a 53-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 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) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (Body ache), HEADACHE (headache) and DIZZINESS (Dizziness). At the time of the report, MYALGIA (Body ache), HEADACHE (headache) and DIZZINESS (Dizziness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up information received on 28may2021 contains updated contact details (email id)
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Hyperhidrosis, Middle insomnia, Muscle spasms
Clinical narrative: Tingly feeling on face, hands; White patches on entire both hands,nose; Woke up through night; Chills; Left hand cramping; Left arm hurt; Sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt), HYPERHIDROSIS (Sweats), PARAESTHESIA (Tingly feeling on face, hands) and SKIN DISCOLOURATION (White patches on entire both hands,nose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (since then she has mucus in her throat.) in May 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Thick nasal mucus.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt) and HYPERHIDROSIS (Sweats). 02-Feb-2021, the patient experienced MIDDLE INSOMNIA (Woke up through night) and CHILLS (Chills). On 03-Feb-2021, the patient experienced PARAESTHESIA (Tingly feeling on face, hands) and SKIN DISCOLOURATION (White patches on entire both hands,nose). The patient was treated with FLURBIPROFEN (ANSAID) at an unspecified dose and frequency and LORATADINE at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt), HYPERHIDROSIS (Sweats), PARAESTHESIA (Tingly feeling on face, hands), SKIN DISCOLOURATION (White patches on entire both hands,nose), MIDDLE INSOMNIA (Woke up through night) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, COVID-19: positive (Inconclusive) positive.         No information regarding corrective treatment was reported by the patient.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received and reporter information was updated, patient demographics, Dose 1 added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Skin discolouration
Clinical narrative: Tingly feeling on face, hands; White patches on entire both hands,nose; Woke up through night; Chills; Left hand cramping; Left arm hurt; Sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt), HYPERHIDROSIS (Sweats), PARAESTHESIA (Tingly feeling on face, hands) and SKIN DISCOLOURATION (White patches on entire both hands,nose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (since then she has mucus in her throat.) in May 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Thick nasal mucus.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt) and HYPERHIDROSIS (Sweats). 02-Feb-2021, the patient experienced MIDDLE INSOMNIA (Woke up through night) and CHILLS (Chills). On 03-Feb-2021, the patient experienced PARAESTHESIA (Tingly feeling on face, hands) and SKIN DISCOLOURATION (White patches on entire both hands,nose). The patient was treated with FLURBIPROFEN (ANSAID) at an unspecified dose and frequency and LORATADINE at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Left hand cramping), PAIN IN EXTREMITY (Left arm hurt), HYPERHIDROSIS (Sweats), PARAESTHESIA (Tingly feeling on face, hands), SKIN DISCOLOURATION (White patches on entire both hands,nose), MIDDLE INSOMNIA (Woke up through night) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, COVID-19: positive (Inconclusive) positive.         No information regarding corrective treatment was reported by the patient.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received and reporter information was updated, patient demographics, Dose 1 added.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pain, Tenderness
Clinical narrative: Pain; Redness; Tenderness; Redness widespread from from site of injection to her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), ERYTHEMA (Redness), TENDERNESS (Tenderness) and CONDITION AGGRAVATED (Redness widespread from from site of injection to her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), ERYTHEMA (Redness), TENDERNESS (Tenderness) and CONDITION AGGRAVATED (Redness widespread from from site of injection to her arm). At the time of the report, PAIN (Pain), ERYTHEMA (Redness), TENDERNESS (Tenderness) and CONDITION AGGRAVATED (Redness widespread from from site of injection to her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little sore arm at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm at the injection site.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On 11-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 VACCINATION SITE PAIN (Little sore arm at the injection site.). At the time of the report, VACCINATION SITE PAIN (Little sore arm at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported event is consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Feeling abnormal, Headache
Clinical narrative: she feels foggy; diarrhea; sore arm; dizziness; weakness; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness) and HEADACHE (headache) 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.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: she feels foggy; diarrhea; sore arm; dizziness; weakness; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness) and HEADACHE (headache) 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.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, FEELING ABNORMAL (she feels foggy), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Chills, Decreased appetite, Fatigue
Clinical narrative: In bed all day; Didnt have an appetite; few chills; Fatigue; Moderate headache enough to bother me; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), HEADACHE (Moderate headache enough to bother me), CHILLS (few chills) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Moderate headache enough to bother me). On 13-Feb-2021, the patient experienced BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), CHILLS (few chills) and FATIGUE (Fatigue). At the time of the report, BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), HEADACHE (Moderate headache enough to bother me), CHILLS (few chills) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 100.2 (High) fever-100.2. On 18-Feb-2021, Body temperature: 98 (High) fever-98.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported  Treatment was not specified
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: In bed all day; Didnt have an appetite; few chills; Fatigue; Moderate headache enough to bother me; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), HEADACHE (Moderate headache enough to bother me), CHILLS (few chills) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Moderate headache enough to bother me). On 13-Feb-2021, the patient experienced BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), CHILLS (few chills) and FATIGUE (Fatigue). At the time of the report, BEDRIDDEN (In bed all day), DECREASED APPETITE (Didnt have an appetite), HEADACHE (Moderate headache enough to bother me), CHILLS (few chills) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 100.2 (High) fever-100.2. On 18-Feb-2021, Body temperature: 98 (High) fever-98.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported  Treatment was not specified
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: mild pain; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild pain) and VACCINATION SITE SWELLING (swelling) 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 (mild pain) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE PAIN (mild pain) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Myalgia
Clinical narrative: shingles; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), FATIGUE (fatigue) and HERPES ZOSTER (shingles) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Cholesterol, Diabetes, Enlarged prostate and Hypertension. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, TAMSULOSIN for Enlarged prostate, VALSARTAN for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) and OMEPRAZOLE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Feb-2021, the patient experienced HERPES ZOSTER (shingles). In February 2021, the patient experienced MYALGIA (body aches) and FATIGUE (fatigue). At the time of the report, MYALGIA (body aches), FATIGUE (fatigue) and HERPES ZOSTER (shingles) outcome was unknown.            No treatment details were provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: hot; tchy; red spot, size 2 coins; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (tchy) and VACCINATION SITE ERYTHEMA (red spot, size 2 coins) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U31620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 09-Feb-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) Dose 2. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (tchy) and VACCINATION SITE ERYTHEMA (red spot, size 2 coins). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (tchy) and VACCINATION SITE ERYTHEMA (red spot, size 2 coins) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.