chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: injection site soreness; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (injection site soreness) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Abscess drainage on 05-Jan-2021.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (injection site soreness) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Vaccination site pain, at an unspecified dose and frequency. On 30-Dec-2020, VACCINATION SITE PAIN (injection site soreness) and FATIGUE (fatigue) 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.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea
Clinical narrative: Dizziness; Nauseous; head hurts really bad; Chills; The spontaneous report was received from a health technician (reporting on self), concerning a 57-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, head hurts really bad (headache), dizziness and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020 morning the patient received their first of two planned doses of mRNA-1273 (batch number: 039K20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.  On the night of 30 Dec 2020 or 31 Dec 2020 in the morning, she felt nauseas, her head hurt really bad, feels dizzy and she had chills, but she did not have fever. The patient was treated with ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, nausea, head hurts really bad, dizziness and chills 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 events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Itchiness in the arm; Arm was red; Arm was hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot), VACCINATION SITE PRURITUS (Itchiness in the arm) and VACCINATION SITE ERYTHEMA (Arm was red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE WARMTH (Arm was hot) and VACCINATION SITE ERYTHEMA (Arm was red). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness in the arm). At the time of the report, VACCINATION SITE WARMTH (Arm was hot), VACCINATION SITE PRURITUS (Itchiness in the arm) and VACCINATION SITE ERYTHEMA (Arm was red) 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.   Company Comment: 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.; 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: Back pain, Diarrhoea, Fatigue, Injection site pain, Muscular weakness
Clinical narrative: Diarrhea; Weakness in the legs; Back pain; Injection site soreness; Fatigue; A Spontaneous report was received from a healthcare professional concerning a 70 year old female patient who was participating in the mRNA-1273 Emergency Use Program and developed diarrhea, injection site soreness, back pain, weakness in her legs, and fatigue.   The patient's medical history included elevated cholesterol, hypertension, and an unspecified thyroid disorder. Concomitant medications reported included atorvastatin, olmesartan, and levothyroxine.    On 30 Dec 2020, approximately two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021,the patient experienced diarrhea, injection site soreness, back pain, weakness in her legs, and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events diarrhea, injection site soreness, back pain, weakness in her legs, and fatigue was not reported.  Reporter causality for the events was not provided.; 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Lymphadenopathy, Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site redness; Swelling of the lymph nodes in her armpit,  half an inch in size; Extremely itchy; Rash around vaccination site; Painful lymph nodes in armpit; Hurts to lower arm, sore; Feel sore and tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Extremely itchy), FATIGUE (Feel sore and tired), VACCINATION SITE RASH (Rash around vaccination site), AXILLARY PAIN (Painful lymph nodes in armpit) and VACCINATION SITE PAIN (Hurts to lower arm, sore) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 9:30 AM, 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 FATIGUE (Feel sore and tired) and VACCINATION SITE PAIN (Hurts to lower arm, sore). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Extremely itchy), VACCINATION SITE RASH (Rash around vaccination site) and AXILLARY PAIN (Painful lymph nodes in armpit). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. On 09-Jan-2021, AXILLARY PAIN (Painful lymph nodes in armpit) and VACCINATION SITE PAIN (Hurts to lower arm, sore) had resolved. On 10-Jan-2021, VACCINATION SITE PRURITUS (Extremely itchy) and VACCINATION SITE RASH (Rash around vaccination site) had resolved. At the time of the report, FATIGUE (Feel sore and tired) and VACCINATION SITE ERYTHEMA (Injection site redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up information was added on 16 April 2021. Second dose information and a new events (injection site erythema, injection site rash and injection site pruritis), race, ethnicity, event treatment, event outcome was added.; 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Injection site redness; Swelling of the lymph nodes in her armpit,  half an inch in size; Extremely itchy; Rash around vaccination site; Painful lymph nodes in armpit; Hurts to lower arm, sore; Feel sore and tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Extremely itchy), FATIGUE (Feel sore and tired), VACCINATION SITE RASH (Rash around vaccination site), AXILLARY PAIN (Painful lymph nodes in armpit) and VACCINATION SITE PAIN (Hurts to lower arm, sore) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 9:30 AM, 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 FATIGUE (Feel sore and tired) and VACCINATION SITE PAIN (Hurts to lower arm, sore). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Extremely itchy), VACCINATION SITE RASH (Rash around vaccination site) and AXILLARY PAIN (Painful lymph nodes in armpit). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. On 09-Jan-2021, AXILLARY PAIN (Painful lymph nodes in armpit) and VACCINATION SITE PAIN (Hurts to lower arm, sore) had resolved. On 10-Jan-2021, VACCINATION SITE PRURITUS (Extremely itchy) and VACCINATION SITE RASH (Rash around vaccination site) had resolved. At the time of the report, FATIGUE (Feel sore and tired) and VACCINATION SITE ERYTHEMA (Injection site redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up information was added on 16 April 2021. Second dose information and a new events (injection site erythema, injection site rash and injection site pruritis), race, ethnicity, event treatment, event outcome was added.; 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: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema
Clinical narrative: redness over the injection site; feeling tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (feeling tired) and INJECTION SITE ERYTHEMA (redness over the injection site) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Benadryl).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced FATIGUE (feeling tired). On 07-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness over the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (topical) for Injection site redness, at an unspecified dose and frequency. At the time of the report, FATIGUE (feeling tired) had resolved and INJECTION SITE ERYTHEMA (redness over the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient treatment includes topical cream/ gel Benadryl as a treatment. The treatment was topical as the patient is allergic to Benadryl. Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2021: No specific follow-up information recorded.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Burning feeling at injection site; Swelling; Burning Feeling at injection site; redness; warm to touch at injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch at injection site), VACCINATION SITE PAIN (Burning feeling at injection site), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Burning Feeling at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch at injection site), VACCINATION SITE PAIN (Burning feeling at injection site), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Burning Feeling at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch at injection site), VACCINATION SITE PAIN (Burning feeling at injection site), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Burning Feeling at injection site) 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.   Treatment medication included Antibiotic. No concomitant medications were 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 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.     The patient's past medical history included No adverse event (No reported medical history).    In December 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. In December 2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). In December 2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this Female with an unknown age. 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 for this female with unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 103F; A spontaneous report was received from a pharmacist, concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 103F.  The patient's medical history was not provided. Concomitant medications were not reported.  On 05 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (batch unknown) for prophylaxis of COVID-19 infection.  On 05 JAN 2021, the patient received the vaccine and two days later, on 07 JAN 2021, she experienced fever of 103F. The reporter hung up and declined to provide any additional information upon outbound of the call.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, fever of 103F, was considered unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced a NS expected event of fever.  Event onset occurred 3 days after the first dose of mRNA-1273. Treatment not reported. Event outcome 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: M
Vaccine: COVID19
Symptoms: Blood disorder, Headache
Clinical narrative: slight issue with some blood issues; Slight headache; A spontaneous report was received from a consumer concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight issue with some blood issues and slight headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient felt slight issues with some blood issues which lasted part of one evening and subsided and that he had no further problems other than a slight headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events, slight issue with some blood issues was recovered and slight headache 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.  Further information has been requested for details about the blood issue the patient experienced.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Body aches; Loss of appetite; Headache; fever of 101.8F; Nausea; fatigue; Chills; A spontaneous report was received from a nurse concerning a 60-year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced headache, fever, nausea, body aches, fatigue, chills and loss of appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the morning of 31 Dec 2020, the patient experienced headache, fever of 101.8F, nausea, body aches, fatigue, chills, and loss of appetite. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of headache, fever, nausea, body aches, fatigue, chills and loss of appetite, were recovered.; Reporter's Comments: This case concerns a 66-year-old female who experienced NS events of unexpected pain and decreased appetite and expected headache, fever, chills, fatigue, nausea.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment with paracetamol. 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.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Body aches; Loss of appetite; Headache; fever of 101.8F; Nausea; fatigue; Chills; A spontaneous report was received from a nurse concerning a 60-year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced headache, fever, nausea, body aches, fatigue, chills and loss of appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the morning of 31 Dec 2020, the patient experienced headache, fever of 101.8F, nausea, body aches, fatigue, chills, and loss of appetite. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of headache, fever, nausea, body aches, fatigue, chills and loss of appetite, were recovered.; Reporter's Comments: This case concerns a 66-year-old female who experienced NS events of unexpected pain and decreased appetite and expected headache, fever, chills, fatigue, nausea.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment with paracetamol. 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.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Rash pustular
Clinical narrative: pustules multiple it's painful; Pustules between her brows and multiples on face; A spontaneous report was received from a 44 year old female healthcare facility staff member who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed painful pustules in between brows, spreading down to the upper corner of the mouth and chin, and multiple on her face.  The patient's medical history was not provided. Concomitant medications reported included vitamin E, vitamin C, vitamin D3, fish oil, biotin and collagen.   On 31 Dec 2020, approximately two hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot# 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 31 Dec 2020, approximately two hours after the vaccine, patient developed pustules in between her brows. On 1 Jan 2021, she noticed multiples on her face, painful and spreading down the upper corner of the mouth going to the chin.   Treatment for the event included hydroxyzine hydrochloride on 1 Jan 2021 and diphenhydramine on 2 Jan 2021.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, developed painful pustules in between brows, spreading down to the upper corner of the mouth and chin, and multiple on her face, was considered Not Resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: injection site got swollen and growing; injection site red; injection site hot; injection site itchy; A spontaneous report was received from a 33 year old female healthcare facility staff member who was participating in the mRNA-1273 Emergency Use Program and developed red, hot, itchy, swollen injection site that is expanding.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Dec 2020, approximately 7 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot# 025J20-2A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 2 Jan 2021, the patient noted that the injection site became swollen, red, hot and itchy and was expanding with time. Treatment for the event included diphenhydramine every six hours and ibuprofen.   Action taken with mRNA-1273 in response to the event is not provided.   The outcome of the events, developed red, hot, itchy, swollen injection site that is expanding, were considered not  resolved.; 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: chills; fever; joint pain; soreness to the injection site; A spontaneous report was received from a health care professional concerning a 30-years-old, female patient, who received Moderna's COVID-19 Vaccine and who experienced soreness to the injection site, chills, fever 101 Fahrenheit (F) and joint pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 JAN 2021 at 11:40 AM, the patient received the first of two planned doses of mRNA-1273 (batch number: 025L20A) intramuscularly left deltoid for prophylaxis of COVID-19 infection.  On 01 JAN 2021, the patient experienced soreness to the injection site. On the same day at 11PM the patient reported chills, fever of 101 F and joint pain. On 03 JAN 2021, she still had low grade fever of 100.4 F, joint pain and woke up with chills. The patient stated that fever, chills, joint pain were resolved after taking acetaminophen, but the injection site was still painful.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, chills, fever 101 F and joint pain was resolved on the 03 JAN 2021. The event soreness to the injection site was not resolved.; 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 of chills, pyrexia, arthralgia and vaccination site pain, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash, Vaccination site nodule
Clinical narrative: Rash; Node in the injection site; Arm is swollen; Arm is swollen and sore; A spontaneous report  was received from a nurse concerning a 46-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed injection site nodule, peripheral swelling, pain in extremity and a rash.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 037KQ00) on 31 Dec 2020 in the left arm for prophylaxis of COVID-19 infection.   A nurse who is the patient called to report she received the Moderna COVID-19 vaccine on 31 Dec 2020. The next day, she noted a "node" at the injection site. The left arm was swollen and sore with rash.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   Outcome of the events, injection site nodule, peripheral swelling, pain in extremity and a rash, were considered 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.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache; A spontaneous report was received from a non-health professional concerning a male consumer who received Moderna's COVID-19 vaccine and developed a slight headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:  unknown) for prophylaxis of COVID-19 infection.     The patient received the vaccine and developed a slight headache for the remainder of the day. He reported no further adverse reactions and felt fine overall. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, a slight headache, was not provided.; Reporter's Comments: This case concerns a male of unknown age who experienced NS expected event of headache.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome known. 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: lump on the injection site; injection site warmth; injection site itching; injection site redness; soreness on the injection site; A report was received from a consumer who was a 74 year old, patient who was participating in the mRNA-1273 Emergency Use Program and experienced soreness on the injection site, a lump on the injection site, and itchiness and warmth at the injection site.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 039R2019- patient unsure of number as the vaccination card was illegible) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The patient reported that she received the Moderna Covid-19 vaccine on 29 Dec 2020 and 12-24 hours later had experienced soreness on the injection site, which spontaneously resolved. On 05 Jan 2021, 7 days after the vaccination, she felt a lump on the injection site which was less than 2 inches in size, itchy, and warm to the touch. The patient took her own temperature, 98.9F. On 07 Jan 2021, she stated that there is no more lump felt, but now the site is blotchy, pink in color and irregularly shaped. Treatment for the events included paracetamol and diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the events was not reported.   The event, soreness on injection site was considered resolved on 05 Jan 2021. The events lump on the injection site, and itchiness and warmth at the injection site were considered resolved on 08 Jan 2021.; Reporter's Comments: This case concerns a 74-year-old female who had NS events of unexpected injection site warmth, injection site mass and expected injection site pain, injection site erythema, injection site pruritus. Event onset Day 1 after first dose mRNA-1273, with later events on Day 8. Treatment paracetamol and diphenhydramine. Events resolved. 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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Lymphadenopathy
Clinical narrative: The injection site became very sensitive; lymph node swelling/lymph node inflammation; Injection site red; Injection site scratchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (The injection site became very sensitive), LYMPHADENOPATHY (lymph node swelling/lymph node inflammation), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PRURITUS (Injection site scratchy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced INJECTION SITE HYPERSENSITIVITY (The injection site became very sensitive), LYMPHADENOPATHY (lymph node swelling/lymph node inflammation), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PRURITUS (Injection site scratchy). At the time of the report, INJECTION SITE HYPERSENSITIVITY (The injection site became very sensitive), LYMPHADENOPATHY (lymph node swelling/lymph node inflammation), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PRURITUS (Injection site scratchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient has a medical history was not provided. No relevant concomitant medication was reported.  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 did not allow further contact; 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: Adverse event, Malaise
Clinical narrative: Have not felt good since having this vaccine; having a reaction to it; A spontaneous report  was received from a female consumer who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced not feeling good since receiving vaccine and having a reaction to it.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 1 Jan 2020, patient reports not feeling good since receiving vaccine and having a reaction to it.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, not feeling good since receiving vaccine and having a reaction to it was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced NS unexpected events of malaise and an unspecified adverse event (having a reaction to it). Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. 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: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Has temperature; Itch a lot; Red spot appear on the injection site; A spontaneous report was received from a caregiver concerning a 58-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a red spot at the vaccine injection site, has a temperature, and itches a lot.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26-Dec-2020, approximately 8 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J208) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02-Jan-2021, the caregiver called to report that the patient developed a red spot on the vaccine injection site of her left arm. The red spot was a half dollar in diameter, no bump, almost flat, and very red like a rose. The vaccine site also has temperature and itched a lot. Consent was given for HCP follow up.  Treatment for the events included hydrocortisone ointment, applied daily that was started on 02-Jan-2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events 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 events, a causal relationship cannot be excluded.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Wheezy; A spontaneous report was received from a consumer who was a 93-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed wheezing.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Jan 2021, approximately two days prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient felt that her breathing was wheezy which worsened at night.    On 04 Jan 2021, the patient's condition improved.   No treatment was received by the patient for wheezing.  Action taken with mRNA-1273 in response to the events was not reported.   The event, wheezing was considered recovering.; Reporter's Comments: This case concerns a 93-year-old male patient, who experienced a non-serious unexpected event of Wheezing. The event occurred approximately 2 days after first dose of mRNA-1273, lot # unknown. No treatment was received by the patient for wheezing. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm; A spontaneous report was received from healthcare facility staff member, concerning a female patient who was participating in the mRNA-1273 Emergency Program and who experienced soreness in the arm.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 on an undisclosed date intramuscularly for prophylaxis of COVID-19 infection.  Patient received the Moderna vaccine on an undisclosed date as did her husband. Her husband reported that they both experienced arm soreness following vaccine administration.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event, soreness in arm, was not provided.   The outcome of the events, soreness in arm,  was not reported.  The reporter did not provide a causality assessment for the events, soreness in the arm.; Reporter's Comments: This case concerns a female of unknown age who had a nonserious expected event of pain in extremity. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lymph node pain, Pain in extremity
Clinical narrative: Sensitivity to light; Tenderness in lymph nodes in neck and groin; Dizziness; Soreness in arm; Fatigue; Mild headache; A spontaneous report, was received from a nurse practitioner (patient), concerning herself, a 61-years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, sensitivity to light (photophobia), soreness in arm (pain in extremity), fatigue, mild headache (headache), and tenderness in lymph nodes in neck and groin (lymph node pain).   The patient's medical history was not provided. Concomitant medication reported included venlafaxine hydrochloride and sertraline for depression.  On 30 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number: 039K20A), intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient experienced soreness in her arm, dizziness, fatigue and a mild headache. These symptoms improved over the next two days. Then on day four after the vaccine, on 03 Jan 2021, the patient experienced a bad headache, sensitivity to light and tenderness in lymph nodes in neck and groin. Treatment for the events included acetaminophen, plenty of water and rest. As of 04 Jan 2021, the patient reported that she was feeling better and has less headache, lingering fatigue and no longer in need of pain-relieving medicine.   Action taken with second dose of mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, dizziness, sensitivity to light, soreness in arm, fatigue, mild headache, and tenderness in lymph nodes in neck and groin were resolving at the time of this report.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Sensitivity to light; Tenderness in lymph nodes in neck and groin; Dizziness; Soreness in arm; Fatigue; Mild headache; A spontaneous report, was received from a nurse practitioner (patient), concerning herself, a 61-years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, sensitivity to light (photophobia), soreness in arm (pain in extremity), fatigue, mild headache (headache), and tenderness in lymph nodes in neck and groin (lymph node pain).   The patient's medical history was not provided. Concomitant medication reported included venlafaxine hydrochloride and sertraline for depression.  On 30 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number: 039K20A), intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient experienced soreness in her arm, dizziness, fatigue and a mild headache. These symptoms improved over the next two days. Then on day four after the vaccine, on 03 Jan 2021, the patient experienced a bad headache, sensitivity to light and tenderness in lymph nodes in neck and groin. Treatment for the events included acetaminophen, plenty of water and rest. As of 04 Jan 2021, the patient reported that she was feeling better and has less headache, lingering fatigue and no longer in need of pain-relieving medicine.   Action taken with second dose of mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, dizziness, sensitivity to light, soreness in arm, fatigue, mild headache, and tenderness in lymph nodes in neck and groin were resolving at the time of this report.; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Pyrexia
Clinical narrative: fever; headache; Chills; feeling foggy; Tired; A report was received from nurse concerning a 53-year-old, a female patient who developed a foggy feeling, fatigue, headache, fever and chills after receiving the Moderna COVID-19 vaccine.  The patient's medical history was not provided. Concomitant medication reported include vedolizumab and rosuvastatin.   The dosing descriptions were not provided.  The patient received her first of two planned doses of mRNA-1273 vaccine 30 DEC 2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 DEC 2020 and 01 JAN 2021, the patient reported to have experienced fogginess and a feeling of tiredness.   On the night of 02 JAN 2021, she suddenly developed a fever, headache and chills. The intensity and duration of the headache, fever, and chills were not provided. There was no complaint of any localized discomfort or weakness in the patient's left arm.  On that same night, the patient reported that she took acetaminophen.   However, the outcome of the events was not reported. Any action taken regarding the completion of the second dosing of the vaccine was not communicated.; 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: Dizziness, Heart rate increased
Clinical narrative: fast heartbeat; kind of dizzy; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heartbeat and was kind of dizzy earlier.  The patient's medical history was not provided. Concomitant medications reported included tamoxifen.  On 04 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: not reported) for prophylaxis of COVID-19 infection.  On the same day, the patient experienced a fast heartbeat and was kind of dizzy earlier. The patient mentioned that she has been taking tamoxifen for 4.5 years and enquired if this concomitant medication was causing the side effects.    No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, fast heartbeat and kind of dizzy was not reported.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced non-serious unexpected events of Heart rate increased and Dizziness. The events occurred on the same date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided.  Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Tender at injection site; Redness at injection site; Swollen arm; Sore arm; Flu-like symptoms; A spontaneous report was received from a dentist concerning a 63 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, flu-like symptoms, tender at injection site, redness at injection site and a swollen arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch no: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 27 Dec 2020, the patient developed a sore arm. On 02 Jan 2021, she experienced flu-like symptoms. Additionally patient also developed tenderness, redness and swollen arm, which was getting bigger, 4 inch long by 3 inches wide at the injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm and flu-like symptoms was unknown. The outcome of the events, tender at injection site, redness at injection site and a swollen arm was considered as not resolved.; 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.