chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate increased, Hypertension, Palpitations
Clinical narrative: Heart palpitations; Blood pressure was high 192/110; Increased pulse rate; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), HYPERTENSION (Blood pressure was high 192/110) and HEART RATE INCREASED (Increased pulse rate) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PALPITATIONS (Heart palpitations), HYPERTENSION (Blood pressure was high 192/110) and HEART RATE INCREASED (Increased pulse rate). At the time of the report, PALPITATIONS (Heart palpitations), HYPERTENSION (Blood pressure was high 192/110) and HEART RATE INCREASED (Increased pulse rate) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Blood pressure measurement: 192/110 mmHg was high 192/110.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.; Reporter'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: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: arm itchiness; arm pain on the injection site; arm was swollen; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site arm pain, increasing swelling and itchiness.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 6 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly (batch unknown) in the arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, after the vaccine was administered, the patient reports experiencing arm pain at the injection site (not too painful) and swelling.   On 7 Jan 2021, the patient reports increasing swelling and arm itchiness. The patient noticed that it was swollen and started getting bigger, she drew a circle around it and it was as big as her index finger. No treatment information was provided.    Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events of injection site arm pain, increasing swelling and itchiness was not recovered.; Reporter'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. Further information has been requested
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Chills, Headache, Pyrexia
Clinical narrative: Receiving half the dose; Horrible chills; High fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Receiving half the dose), CHILLS (Horrible chills), PYREXIA (High fever) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 since July 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced ACCIDENTAL OVERDOSE (Receiving half the dose), CHILLS (Horrible chills), PYREXIA (High fever) and HEADACHE (Headache). On 04-Jan-2021, ACCIDENTAL OVERDOSE (Receiving half the dose) had resolved. At the time of the report, CHILLS (Horrible chills), PYREXIA (High fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch just below the injection site; Arm was little swollen; Arm was red; Arm sore; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch just below the injection site), VACCINATION SITE PAIN (Arm sore), VACCINATION SITE SWELLING (Arm was little swollen) and VACCINATION SITE ERYTHEMA (Arm was red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (Arm sore). On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch just below the injection site), VACCINATION SITE SWELLING (Arm was little swollen) and VACCINATION SITE ERYTHEMA (Arm was red). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch just below the injection site), VACCINATION SITE PAIN (Arm sore), VACCINATION SITE SWELLING (Arm was little swollen) and VACCINATION SITE ERYTHEMA (Arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.; Reporter'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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain, Pruritus, Skin swelling
Clinical narrative: Headache; Itchy arm; Swelling underneath skin; Swelling; Soreness; Redness; A spontaneous report  was received from a consumer concerning a 44-year-old female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced swelling, soreness and redness in her arm, itchy arm, redness, swelling underneath and on the skin and headache.  The patient's medical history included migraines. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: was not provided) on 28 Dec 2020 in the left arm for prophylaxis of COVID-19 infection.   She experienced swelling, soreness and redness in the left arm in which she received her injection that lasted three days. On 04 Jan 2021, she reported experiencing an itchy arm, redness and swelling underneath and on the skin.   On 06 Jan 2021, she reported having a headache that resolved the same day. She stated she went to urgent care for her symptoms.  Treatment for the event included a steroid and antibiotic.  Action taken with mRNA-1273 in response to the events was not provided.   The events swelling, soreness and redness in the arm were considered resolved on 31 Dec 2021.   The itchy arm, redness and swelling underneath and on the skin was considered unknown. The headache, was considered resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 44-year-old female who experienced NS events of unexpected erythema, pruritus, pain, swelling, skin swelling and expected headache.  Event onset Day 1 after the first dose of mRNA-1273, followed by skin swelling and pruritus on Day 8. Treated with steroid and antibiotic. Events resolved. Based on 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Headache; Itchy arm; Swelling underneath skin; Swelling; Soreness; Redness; A spontaneous report  was received from a consumer concerning a 44-year-old female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced swelling, soreness and redness in her arm, itchy arm, redness, swelling underneath and on the skin and headache.  The patient's medical history included migraines. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: was not provided) on 28 Dec 2020 in the left arm for prophylaxis of COVID-19 infection.   She experienced swelling, soreness and redness in the left arm in which she received her injection that lasted three days. On 04 Jan 2021, she reported experiencing an itchy arm, redness and swelling underneath and on the skin.   On 06 Jan 2021, she reported having a headache that resolved the same day. She stated she went to urgent care for her symptoms.  Treatment for the event included a steroid and antibiotic.  Action taken with mRNA-1273 in response to the events was not provided.   The events swelling, soreness and redness in the arm were considered resolved on 31 Dec 2021.   The itchy arm, redness and swelling underneath and on the skin was considered unknown. The headache, was considered resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 44-year-old female who experienced NS events of unexpected erythema, pruritus, pain, swelling, skin swelling and expected headache.  Event onset Day 1 after the first dose of mRNA-1273, followed by skin swelling and pruritus on Day 8. Treated with steroid and antibiotic. Events resolved. Based on 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site cellulitis, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: arm was all red and tender and swollen/clinic said it was cellulitis; Red arm; Tender arm; Swollen arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE CELLULITIS (arm was all red and tender and swollen/clinic said it was cellulitis), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PAIN (Tender arm) and VACCINATION SITE SWELLING (Swollen arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Asthma. Concomitant products included LOSARTAN for an unknown indication, SECNIDAZOLE (SENEX).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (arm was all red and tender and swollen/clinic said it was cellulitis), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PAIN (Tender arm) and VACCINATION SITE SWELLING (Swollen arm). The patient was treated with CEFATRIZINE PROPYLENEGLYCOLATE (CEFTIN [CEFATRIZINE PROPYLENEGLYCOLATE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CELLULITIS (arm was all red and tender and swollen/clinic said it was cellulitis) had not resolved and VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PAIN (Tender arm) and VACCINATION SITE SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, C-reactive protein increased, Chills, Injection site pain, Pneumocystis jirovecii pneumonia
Clinical narrative: Soreness in her underarm/started having pain under her arm; Soreness at the injection site/arm was so sore that she could not move it; Fever; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of AXILLARY PAIN (Soreness in her underarm/started having pain under her arm), INJECTION SITE PAIN (Soreness at the injection site/arm was so sore that she could not move it), PYREXIA (Fever) and CHILLS (Chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039420A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced INJECTION SITE PAIN (Soreness at the injection site/arm was so sore that she could not move it), PYREXIA (Fever) and CHILLS (Chills). On 29-Dec-2020, the patient experienced AXILLARY PAIN (Soreness in her underarm/started having pain under her arm). The patient was treated with ACETAMINOPHEN 500 mg BID-TID and IBUPROFEN 200 mg at an unspecified frequency. On 26-Dec-2020, INJECTION SITE PAIN (Soreness at the injection site/arm was so sore that she could not move it), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, AXILLARY PAIN (Soreness in her underarm/started having pain under her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein increased: ELEVATED. On an unknown date, Pneumocystis jirovecii pneumonia: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2021: Injection site, new events of fever and chills; 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Soreness in her underarm/started having pain under her arm; Soreness at the injection site/arm was so sore that she could not move it; Fever; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of AXILLARY PAIN (Soreness in her underarm/started having pain under her arm), INJECTION SITE PAIN (Soreness at the injection site/arm was so sore that she could not move it), PYREXIA (Fever) and CHILLS (Chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039420A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced INJECTION SITE PAIN (Soreness at the injection site/arm was so sore that she could not move it), PYREXIA (Fever) and CHILLS (Chills). On 29-Dec-2020, the patient experienced AXILLARY PAIN (Soreness in her underarm/started having pain under her arm). The patient was treated with ACETAMINOPHEN 500 mg BID-TID and IBUPROFEN 200 mg at an unspecified frequency. On 26-Dec-2020, INJECTION SITE PAIN (Soreness at the injection site/arm was so sore that she could not move it), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, AXILLARY PAIN (Soreness in her underarm/started having pain under her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein increased: ELEVATED. On an unknown date, Pneumocystis jirovecii pneumonia: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2021: Injection site, new events of fever and chills; 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: Injection site pain, Tenderness, Vaccination site pain
Clinical narrative: Tenderness; Pain at the injection site; A spontaneous report  was received from a physician concerning his wife, a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tenderness (Tenderness) and pain at the injection site (Vaccination site pain).     The patient's medical history was not provided. No relevant concomitant medications were provided.     On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 039K20A) via unknown route for prophylaxis of COVID-19.  On 30 Dec 2020, the patient experienced tenderness and pain at the injection site. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the events, tenderness and pain at the injection site, were resolved on 01 Jan 2021.; Reporter'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: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warmth at the injection site; Hardness at the injection site; Itchiness at the injection site; Redness at the injection site; Soreness; A spontaneous report was received from a nurse (patient), concerning herself, a female patient of unknow age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced soreness (pain in extremity), warmth at the injection site (injection site warmth), itchiness at the injection site (injection site pruritus), hardness at the injection site (injection site induration), and redness at the injection site (injection site erythema).  The patient's medical history was not provided. Concomitant product use was not provided.  On 29 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  A nurse who is the patient called to report that she received the Moderna COVID-19 vaccine on 29 Dec 2020. She stated that she had the typical soreness after receiving the vaccine. On 06 Jan 2021, the patient reported and experienced redness, itchiness, hardness and warmth at the injection site. Treatment information was not provided.   Action taken with second dose of mRNA-1273 in response to the events was not provided.   The outcome of the events, soreness, warmth at the injection site, itchiness at the injection site, hardness at the injection site, and redness at the injection site was considered not reported.; Reporter'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: Chills, Headache, Pyrexia
Clinical narrative: Severe effects of chills; Fever; Headache; This spontaneous case was reported by a physician and describes the occurrence of   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 COVID-19 (Patient reported having COVID-19 in March 2020.) in March 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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 medications were not reported.  Reportedly, patient did not report symptoms to the physician since patient was a physician and assumed by reaction was vaccine related. The symptoms were not unusual, fever, chills, severe headache which resolved in 72 hours after the first vaccine.   This case was linked to MOD-2021-071783 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Information added to the narrative.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination complication, Vaccination site pain
Clinical narrative: Swollen lymph nodes on face and ears; Doesn't feel well/started feeling weird; Sore muscle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes on face and ears), VACCINATION COMPLICATION (Doesn't feel well/started feeling weird) and VACCINATION SITE PAIN (Sore muscle around injection site) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN and METFORMIN (GLUCOPHAGE [METFORMIN]) for Diabetes mellitus.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on face and ears), VACCINATION COMPLICATION (Doesn't feel well/started feeling weird) and VACCINATION SITE PAIN (Sore muscle around injection site). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes on face and ears) and VACCINATION SITE PAIN (Sore muscle around injection site) outcome was unknown and VACCINATION COMPLICATION (Doesn't feel well/started feeling weird) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events,a causal relationship cannot be excluded.; Reporter'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: Vaccination complication
Clinical narrative: Some side effects; A spontaneous report was received from a consumer, concerning herself, a female patient of an unspecified age, who received Moderna's Covid-19 Vaccine (mRNA-1273) and experienced some side effects.  The patient's medical history was not reported. Concomitant medications were not reported.   On 06 Jan 2021 at 09:00 AM, the patient received their one of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unspecified date in 2021, after vaccination, the patient experienced some side effects. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event some side effects were considered unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025120A and 025120A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High blood pressure) since 07-Jul-2016 and Hypothyroidism (Low Thyroid) since 11-Mar-2014. Concomitant products included AMLODIPINE BESILATE (NORVAS) from 07-Jul-2016 to an unknown date for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) from 11-Mar-2014 to an unknown date for Hypothyroidism, FISH OIL from 06-Oct-2019 to an unknown date, ACETYLSALICYLIC ACID (ASPIRIN LOW) from 07-Jul-2016 to an unknown date, ASCORBIC ACID (VITAMIN C75) from 07-Jul-2014 to an unknown date and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE (MULTIVITAMIN 6) from 06-Nov-2010 to an unknown date for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Shingles, at a dose of 1 dosage form and GABAPENTIN for Pain, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Shingles) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.  It was reported that patient had medical history of CLH from 08-JUN-2018.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up was received on 08-JUL-2021 and contain significant information updated patient demographics, medical history was added,concomitant medication were added and treatment medication was added.; 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Arm is swollen; Redness is spreading like cellulitis; Painful; Hot to the touch; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness is spreading like cellulitis), PAIN IN EXTREMITY (Painful) and INJECTION SITE WARMTH (Hot to the touch) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history Information was reported.     On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness is spreading like cellulitis), PAIN IN EXTREMITY (Painful) and INJECTION SITE WARMTH (Hot to the touch). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness is spreading like cellulitis), PAIN IN EXTREMITY (Painful) and INJECTION SITE WARMTH (Hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.; 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Miliaria, Nervousness, Pain in extremity
Clinical narrative: Her arm got red on shoulder; Her arm also got hot and have very noticable heated; A very noticeable heated, raised red rash on her arm; Tender to touch,pain from the rash and arm; Nervous; Deltoid has been sore like a bruise; Pain under her armpit; Arm was a little sore; A spontaneous report was received from 23 year old, female patient concerning herself who received Moderna's covid-19 vaccine(mRNA-1273) and experienced sore arm( pain in extremity), pain under the armpit (axillary pain), red arm at shoulder part(erythema), heated ,raised red rash on the arm(miliaria), nervousness, pain from the rash and arm, deltoid has been sore all day like a bruise(injection site bruising).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 30 Dec 2020, after the vaccination, the patient stated that her arm was a little sore and  On the next day (31 Dec 2021), the patient had pain under the armpit, her arm got red on the shoulder part, her arm also got hot, had a very noticeable heated, raised red ash on her arm. The patient stated that the area is tender to the touch and experienced pain from the rash and arm. Additionally, she stated that her deltoid has been sore all day like a bruise. The patient was nervous. Treatment medication included Benadryl 25 mg.  Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the events, sore arm, pain under the armpit, red arm at shoulder part, heated ,raised red rash on the arm, nervousness, pain from the rash and arm, deltoid has been sore all day like a bruise, were considered as not reported.; Reporter's Comments: This case concerns a 23-year-old female who experienced NS unexpected events of pain in extremity, axillary pain, skin warm, miliaria, pain of skin, nervousness, injection site bruising and NS expected events of erythema. Event onset occurred the same day as the first dose of mRNA-1273. Treated with Benadryl. Event outcomes unknown. Based on 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Skin warm, Vaccination site bruising
Clinical narrative: Her arm got red on shoulder; Her arm also got hot and have very noticable heated; A very noticeable heated, raised red rash on her arm; Tender to touch,pain from the rash and arm; Nervous; Deltoid has been sore like a bruise; Pain under her armpit; Arm was a little sore; A spontaneous report was received from 23 year old, female patient concerning herself who received Moderna's covid-19 vaccine(mRNA-1273) and experienced sore arm( pain in extremity), pain under the armpit (axillary pain), red arm at shoulder part(erythema), heated ,raised red rash on the arm(miliaria), nervousness, pain from the rash and arm, deltoid has been sore all day like a bruise(injection site bruising).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 30 Dec 2020, after the vaccination, the patient stated that her arm was a little sore and  On the next day (31 Dec 2021), the patient had pain under the armpit, her arm got red on the shoulder part, her arm also got hot, had a very noticeable heated, raised red ash on her arm. The patient stated that the area is tender to the touch and experienced pain from the rash and arm. Additionally, she stated that her deltoid has been sore all day like a bruise. The patient was nervous. Treatment medication included Benadryl 25 mg.  Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the events, sore arm, pain under the armpit, red arm at shoulder part, heated ,raised red rash on the arm, nervousness, pain from the rash and arm, deltoid has been sore all day like a bruise, were considered as not reported.; Reporter's Comments: This case concerns a 23-year-old female who experienced NS unexpected events of pain in extremity, axillary pain, skin warm, miliaria, pain of skin, nervousness, injection site bruising and NS expected events of erythema. Event onset occurred the same day as the first dose of mRNA-1273. Treated with Benadryl. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: 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 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided by the reporter.   No treatment information was provided.  Company comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011G20 7 or 8) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Apr-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This is a case of vaccine exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.  No Treatment medications was provided by the reporter.; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Extreme dizziness; A spontaneous report was received from a consumer concerning herself, a 74-year-old female patient. She reports that she was fine at time of vaccination and even stayed for 15 minutes to be sure there were no side effects. Approximately two hours later, she began to experience extreme dizziness. Patient reported being fine at the time of the phone call. She was questioning whether the extreme dizziness could be from her blood pressure being high at time of injection.   The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included Ibandronate 150mg, Atenol (dosage not reported,) hydrochlorothiazide (dosage not reported) and Ezetimibe (dosage not reported.)  The patient received their first of two planned doses of mRNA-1273 batch number 0256200 on 6-Jan-2021. On 6-Jan-2021, approximately two hours after dose was given in the left arm, for prophylaxis of COVID-19 infection, patient experienced extreme dizziness. She reported that the symptoms got better after taking her after-lunch medication for her blood pressure and was feeling fine at the time of the phone call. Patient denies taking any medication to treat her dizziness.  Action taken with mRNA-1273 in response to event is unknown. Outcome of event appears to have resolved per the patient.; 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Occasionally itches; red blotch around where they gave it; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Occasionally itches) and INJECTION SITE ERYTHEMA (red blotch around where they gave it) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Occasionally itches) and INJECTION SITE ERYTHEMA (red blotch around where they gave it). At the time of the report, INJECTION SITE PRURITUS (Occasionally itches) and INJECTION SITE ERYTHEMA (red blotch around where they gave it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-Jun-2021 and does not contain any new information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received and does not contain any new information.; 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 of fever, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye pain, Head discomfort, Sinus pain
Clinical narrative: Head pressure; Ears hurting; Eyes were hurting; Sinus infection; A spontaneous report was received from a nurse, who is a 58-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced head pressure, eyes and ears hurting and feeling like sinus infection.  The patient's medical history included sinus infection. Concomitant medications were not reported.  On 04 Jan 2021, the patient received their first dose of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient experienced head pressure, eyes and ears hurting and feeling like sinus infection.  Treatment for the events included azithromycin.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, head pressure, eyes and ears hurting and feeling like sinus infection 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 these events, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: A spontaneous report was received from a 30-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea and fatigue.   The patient's medical history was COVID-19 and autoimmune disease. Concomitant medications were antidepressants and alprazolam.  On 06 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient experienced nausea and fatigue. Treatment for the events was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events of nausea and fatigue was 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 reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Muscle fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site papule
Clinical narrative: Muscle hot to the touch; Injection site bumpy; Injection site swollen; Injection site itchy; Muscle fatigue; Lymph node pain; Pain at injection site; Redness at injection site; A spontaneous report was received from a 38-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness and pain at injection site, muscle fatigue and lymph node pain, injection site bumpy, swollen, red and itchy and muscle hot to the touch.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 026L20A) intramuscularly in her left deltoid for prophylaxis of COVID-19.  On 30 Dec 2020, the patient experienced redness and pain at the injection site.  On 03 Jan 2021, the patient stated she started to experience muscle fatigue and lymph node pain on left arm.   On 06 Jan 2021, the patient noticed her arm became bumpy, swollen, red and itchy.   On 07 Jan 2021, the patient woke up to her arm being big, swollen, firm, rem bump and her muscle hot to the touch. Patient still fatigued and still has lymph node pain in her arm. Treatment included ibuprofen and cetirizine hydrochloride.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the events, muscle fatigue, lymph node pain, redness and pain at injection site, injection site bumpy, swollen, red and itchy and muscle hot to the touch were unknown.; Reporter's Comments: This case concerns a 38 Y/O M who had NS events of unexpected injection site warmth, injection site papule, muscle fatigue and expected injection site pain, injection site swelling, injection site erythema, injection site pruritus, lymph node pain. Event onset the same day as first dose mRNA-1273. Treatment ibuprofen and cetirizine. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Muscle hot to the touch; Injection site bumpy; Injection site swollen; Injection site itchy; Muscle fatigue; Lymph node pain; Pain at injection site; Redness at injection site; A spontaneous report was received from a 38-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness and pain at injection site, muscle fatigue and lymph node pain, injection site bumpy, swollen, red and itchy and muscle hot to the touch.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 026L20A) intramuscularly in her left deltoid for prophylaxis of COVID-19.  On 30 Dec 2020, the patient experienced redness and pain at the injection site.  On 03 Jan 2021, the patient stated she started to experience muscle fatigue and lymph node pain on left arm.   On 06 Jan 2021, the patient noticed her arm became bumpy, swollen, red and itchy.   On 07 Jan 2021, the patient woke up to her arm being big, swollen, firm, rem bump and her muscle hot to the touch. Patient still fatigued and still has lymph node pain in her arm. Treatment included ibuprofen and cetirizine hydrochloride.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the events, muscle fatigue, lymph node pain, redness and pain at injection site, injection site bumpy, swollen, red and itchy and muscle hot to the touch were unknown.; Reporter's Comments: This case concerns a 38 Y/O M who had NS events of unexpected injection site warmth, injection site papule, muscle fatigue and expected injection site pain, injection site swelling, injection site erythema, injection site pruritus, lymph node pain. Event onset the same day as first dose mRNA-1273. Treatment ibuprofen and cetirizine. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Chills; Fever; Throwing up everything; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, fever and throwing up everything.  The patient's medical history was not provided.  No concomitant medications were reported.  On 30 Dec 2020, approximately three days prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On 01 Jan 2021, the patient experienced chills, fever and throwing everything up. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events chills, fever and throwing up everything was not reported.; Reporter'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.