chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site warm to touch; Huge red circle at the injection site; A spontaneous report was received from an adult female patient who was participating in the mRNA-1273 Emergency Use Program and experienced huge red circle at the injection site and injection site warm to touch.    The patient's medical history was not provided.  Concomitant product use was not provided.  On an unspecified date the patient received the first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly, for prophylaxis of COVID-19 infection.  On an unspecified date, ten days after vaccination the patient experienced huge red circle at the injection site and injection site warm to touch. It was noted the circle was about the length of her index finger. There was no treatment information provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, huge red circle at the injection site and injection site warm to touch, was unknown 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 onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: Pain in arm; Red patch around the injection site; Soreness; A spontaneous report was received from a consumer who was also a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness, red patch around the injection site and difficulty moving her arm.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 07 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.    On 07 Jan 2021, after being given the mRNA-1273 vaccine, the patient experienced soreness. Treatment for this event was two Tylenol 325mg Capsules.  On 08 Jan 2021, she reports having a red patch around the injection site and having difficulty in moving her arm.  Treatment included was Motrin on this morning. It was also noted that an ice pack was applied, but time not specified.  Treatment for these symptoms were reported as the following: Ice pack applied, Motrin taken but not reported when   Action taken with mRNA-1273 was not reported.  The outcome of the events, experienced soreness, red patch around the injection site and difficulty moving  her arm, was not reported.; Reporter's Comments: Based on a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.  Injection site erythema and Injection site pain are consistent with the known safety profile of the vaccine
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: arm  felt tender and like she was being punched; Body aches in the elbows; arm  ached for days and she could hardly use the arm  because it hurt so bad, arm pain lasted much longer; Fever; This spontaneous case was reported by a nurse and describes the occurrence of TENDERNESS (arm  felt tender and like she was being punched), PAIN (Body aches in the elbows), PAIN IN EXTREMITY (arm  ached for days and she could hardly use the arm  because it hurt so bad, arm pain lasted much longer) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025220A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    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 TENDERNESS (arm  felt tender and like she was being punched), PAIN (Body aches in the elbows), PAIN IN EXTREMITY (arm  ached for days and she could hardly use the arm  because it hurt so bad, arm pain lasted much longer) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. On 31-Dec-2020, PAIN (Body aches in the elbows) and PYREXIA (Fever) had resolved. At the time of the report, TENDERNESS (arm  felt tender and like she was being punched) and PAIN IN EXTREMITY (arm  ached for days and she could hardly use the arm  because it hurt so bad, arm pain lasted much longer) 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.; 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: Anxiety
Clinical narrative: Anxiety attack; A spontaneous report was received from a consumer (patient's husband), concerning a female patient (age unspecified), who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Anxiety attack.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 09-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 09-JAN-2021, the patient experienced Anxiety attack. Treatment for the events was not reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event Anxiety attack was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Left arm swelling; Injection site redness; painful said that it is located an inch below the injection site; A spontaneous report was received from a Consumer concerning a herself, 42 years- old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, Left arm swelling, Injection site redness, and Injection site pain.  The patient's medical history was not provided.  The concomitant medications included fexofenadine hydrochloride, hydroxychloroquine sulfate, and spironolactone.  On 30 Dec 2021, approximately one day prior to the onset of the events, the patient received their unknown of the two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route on left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2021, the patient left arm swelling, Injection site redness, and Injection site pain.  The treatment information included Allegra and Ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.   At the time of this report, the outcome of the events, left arm swelling, Injection site redness, and Injection site pain was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Low energy; feeling really really tired, fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Low energy) and FATIGUE (feeling really really tired, fatigue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LEVOTHYROXINE and SERTRALINE HYDROCHLORIDE (ZOLOFT).    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 ASTHENIA (Low energy) and FATIGUE (feeling really really tired, fatigue). At the time of the report, ASTHENIA (Low energy) and FATIGUE (feeling really really tired, fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatments for the events is Unknown.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: tingling sensation on fingers; burning sensation; Injection site itching; Injection site soreness; Injection site swelling; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling sensation on fingers), VACCINATION SITE WARMTH (burning sensation), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE SWELLING (Injection site swelling) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included DOCOSAHEXAENOIC ACID (DHA), CYANOCOBALAMIN (VITAMIN B12 AAA) and VITAMIN D3.    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE SWELLING (Injection site swelling) and FATIGUE (Fatigue). On 07-Jan-2021, the patient experienced PARAESTHESIA (tingling sensation on fingers), VACCINATION SITE WARMTH (burning sensation) and VACCINATION SITE PRURITUS (Injection site itching). On 02-Jan-2021, VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE SWELLING (Injection site swelling) and FATIGUE (Fatigue) had resolved. At the time of the report, PARAESTHESIA (tingling sensation on fingers), VACCINATION SITE WARMTH (burning sensation) and VACCINATION SITE PRURITUS (Injection site itching) had not 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.   On or about 2 January 2021, approximately 36 hours after vaccine was given she felt better and improvement was evident.  Treatment included Benadryl, a topical steroid and antibiotic.   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.; 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: Vaccination site warmth
Clinical narrative: tingling sensation on fingers; burning sensation; Injection site itching; Injection site soreness; Injection site swelling; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling sensation on fingers), VACCINATION SITE WARMTH (burning sensation), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE SWELLING (Injection site swelling) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included DOCOSAHEXAENOIC ACID (DHA), CYANOCOBALAMIN (VITAMIN B12 AAA) and VITAMIN D3.    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE SWELLING (Injection site swelling) and FATIGUE (Fatigue). On 07-Jan-2021, the patient experienced PARAESTHESIA (tingling sensation on fingers), VACCINATION SITE WARMTH (burning sensation) and VACCINATION SITE PRURITUS (Injection site itching). On 02-Jan-2021, VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE SWELLING (Injection site swelling) and FATIGUE (Fatigue) had resolved. At the time of the report, PARAESTHESIA (tingling sensation on fingers), VACCINATION SITE WARMTH (burning sensation) and VACCINATION SITE PRURITUS (Injection site itching) had not 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.   On or about 2 January 2021, approximately 36 hours after vaccine was given she felt better and improvement was evident.  Treatment included Benadryl, a topical steroid and antibiotic.   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.; 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: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site streaking
Clinical narrative: red line that spread into her arm; Arm started to itch; Arm got swollen, circular, hardened; arm red; Arm got swollen, circular, hardened; Muscle pain; Itching in the arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE STREAKING (red line that spread into her arm), VACCINATION SITE PRURITUS (Itching in the arm), VACCINATION SITE PRURITUS (Arm started to itch), VACCINATION SITE INDURATION (Arm got swollen, circular, hardened) and VACCINATION SITE ERYTHEMA (arm red) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 30-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Itching in the arm) and MYALGIA (Muscle pain). On 05-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arm started to itch), VACCINATION SITE INDURATION (Arm got swollen, circular, hardened), VACCINATION SITE ERYTHEMA (arm red) and VACCINATION SITE SWELLING (Arm got swollen, circular, hardened). On 09-Jan-2021, the patient experienced VACCINATION SITE STREAKING (red line that spread into her arm). The patient was treated with IBUPROFEN on 09-Jan-2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL LOTION N) on 05-Jan-2021 for Adverse event, at an unspecified dose and frequency. On 31-Dec-2020, VACCINATION SITE PRURITUS (Itching in the arm) had resolved. On 01-Jan-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, VACCINATION SITE STREAKING (red line that spread into her arm), VACCINATION SITE INDURATION (Arm got swollen, circular, hardened), VACCINATION SITE ERYTHEMA (arm red) and VACCINATION SITE SWELLING (Arm got swollen, circular, hardened) was resolving and VACCINATION SITE PRURITUS (Arm started to itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: red line that spread into her arm; Arm started to itch; Arm got swollen, circular, hardened; arm red; Arm got swollen, circular, hardened; Muscle pain; Itching in the arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE STREAKING (red line that spread into her arm), VACCINATION SITE PRURITUS (Itching in the arm), VACCINATION SITE PRURITUS (Arm started to itch), VACCINATION SITE INDURATION (Arm got swollen, circular, hardened) and VACCINATION SITE ERYTHEMA (arm red) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 30-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Itching in the arm) and MYALGIA (Muscle pain). On 05-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arm started to itch), VACCINATION SITE INDURATION (Arm got swollen, circular, hardened), VACCINATION SITE ERYTHEMA (arm red) and VACCINATION SITE SWELLING (Arm got swollen, circular, hardened). On 09-Jan-2021, the patient experienced VACCINATION SITE STREAKING (red line that spread into her arm). The patient was treated with IBUPROFEN on 09-Jan-2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL LOTION N) on 05-Jan-2021 for Adverse event, at an unspecified dose and frequency. On 31-Dec-2020, VACCINATION SITE PRURITUS (Itching in the arm) had resolved. On 01-Jan-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, VACCINATION SITE STREAKING (red line that spread into her arm), VACCINATION SITE INDURATION (Arm got swollen, circular, hardened), VACCINATION SITE ERYTHEMA (arm red) and VACCINATION SITE SWELLING (Arm got swollen, circular, hardened) was resolving and VACCINATION SITE PRURITUS (Arm started to itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Gait disturbance, Headache
Clinical narrative: Feel weak; Can't walk; Feel like I have the flu; Headache; Chills; Feel dizzy; Really sick for 3 days; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feel dizzy), MALAISE (Really sick for 3 days), ASTHENIA (Feel weak), GAIT DISTURBANCE (Can't walk) and INFLUENZA LIKE ILLNESS (Feel like I have the flu) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Menopause.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (Feel dizzy), MALAISE (Really sick for 3 days) and NAUSEA (Nauseated). On 09-Jan-2021, the patient experienced ASTHENIA (Feel weak), GAIT DISTURBANCE (Can't walk), INFLUENZA LIKE ILLNESS (Feel like I have the flu), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, DIZZINESS (Feel dizzy), MALAISE (Really sick for 3 days), ASTHENIA (Feel weak), GAIT DISTURBANCE (Can't walk), INFLUENZA LIKE ILLNESS (Feel like I have the flu), HEADACHE (Headache), NAUSEA (Nauseated) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.; 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: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Nausea
Clinical narrative: Feel weak; Can't walk; Feel like I have the flu; Headache; Chills; Feel dizzy; Really sick for 3 days; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feel dizzy), MALAISE (Really sick for 3 days), ASTHENIA (Feel weak), GAIT DISTURBANCE (Can't walk) and INFLUENZA LIKE ILLNESS (Feel like I have the flu) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Menopause.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (Feel dizzy), MALAISE (Really sick for 3 days) and NAUSEA (Nauseated). On 09-Jan-2021, the patient experienced ASTHENIA (Feel weak), GAIT DISTURBANCE (Can't walk), INFLUENZA LIKE ILLNESS (Feel like I have the flu), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, DIZZINESS (Feel dizzy), MALAISE (Really sick for 3 days), ASTHENIA (Feel weak), GAIT DISTURBANCE (Can't walk), INFLUENZA LIKE ILLNESS (Feel like I have the flu), HEADACHE (Headache), NAUSEA (Nauseated) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vomiting
Clinical narrative: Threw up; A little sore at the injection site; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache), VOMITING (Threw up) and VACCINATION SITE PAIN (A little sore at the injection site) in a 58-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 medical history reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (Terrible headache). On 11-Jan-2021, the patient experienced VOMITING (Threw up) and VACCINATION SITE PAIN (A little sore at the injection site). At the time of the report, HEADACHE (Terrible headache) was resolving and VOMITING (Threw up) and VACCINATION SITE PAIN (A little sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided 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.; 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: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: A spontaneous report was received from a consumer (age and gender unknown) who received Moderna's COVID-19 vaccine first dose and experienced Covid-19 test positive.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021 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 06 Jan 2021, one day after receiving the vaccine, the patient was tested positive for Covid-19.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event is Recovering/resolving.; 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: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertension, Tachycardia
Clinical narrative: Hypertension (BP of 150/100); Tachycardia (HR of 130); This spontaneous case was reported by a physician and describes the occurrence of HYPERTENSION (Hypertension (BP of 150/100)) and TACHYCARDIA (Tachycardia (HR of 130)) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    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 HYPERTENSION (Hypertension (BP of 150/100)) and TACHYCARDIA (Tachycardia (HR of 130)). At the time of the report, HYPERTENSION (Hypertension (BP of 150/100)) and TACHYCARDIA (Tachycardia (HR of 130)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Blood pressure measurement: 150/100 (Inconclusive) 150/100. On 04-Jan-2021, Heart rate: 130 (Inconclusive) 130.     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.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; A spontaneous report was received from a consumer, concerning his wife, a female patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced loss of taste.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On 15-Jan-2021 (Friday), approximately one day prior to the onset of event, the patient received their first two planned doses of mRNA-1273 (lot number unknown) for the prophylaxis of COVID-19 infection.  On 16-Jan-2021 (the following day), after the first shot of vaccine, the patient experienced loss of taste. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, loss of taste was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced event of loss of taste. The event occurred the next day after the first and last dose of mRNA-1273 vaccine administration. 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 and the event is assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Influenza like illness, Malaise, Muscle spasms
Clinical narrative: spasms on her shoulder on the same side where she got the shot; Malaise; flu-like symptoms; severe pain in her shoulder on same side of arm where she got the vaccine; low grade fever of 99.3 - 99.7F; A spontaneous report was received from a consumer regarding his 30-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not being able to move her arm, spasms on her shoulder, severe pain on her shoulder, low grade fever 99.3  99.7 degrees Fahrenheit, Flu-like symptoms, and malaise.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 07 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 08 Jan 2021, after receiving the mRNA-1273 vaccine, the patient experienced not being able to move her arm, spasms on her shoulder, severe pain on her shoulder, low grade fever 99.3  99.7 degrees Fahrenheit, Flu-like symptoms, and malaise. Consent to contact obtained.  Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, not being able to move her arm, spasms on her shoulder, severe pain on her shoulder, low grade fever 99.3  99.7 degrees Fahrenheit, Flu-like symptoms, and malaise, 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: spasms on her shoulder on the same side where she got the shot; Malaise; flu-like symptoms; severe pain in her shoulder on same side of arm where she got the vaccine; low grade fever of 99.3 - 99.7F; A spontaneous report was received from a consumer regarding his 30-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not being able to move her arm, spasms on her shoulder, severe pain on her shoulder, low grade fever 99.3  99.7 degrees Fahrenheit, Flu-like symptoms, and malaise.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 07 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 08 Jan 2021, after receiving the mRNA-1273 vaccine, the patient experienced not being able to move her arm, spasms on her shoulder, severe pain on her shoulder, low grade fever 99.3  99.7 degrees Fahrenheit, Flu-like symptoms, and malaise. Consent to contact obtained.  Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, not being able to move her arm, spasms on her shoulder, severe pain on her shoulder, low grade fever 99.3  99.7 degrees Fahrenheit, Flu-like symptoms, and malaise, 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 event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Vaccination site pain
Clinical narrative: Headache; injection was very painful when injected; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection was very painful when injected), INJECTION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection was very painful when injected) and INJECTION SITE PAIN (Soreness at injection site). On 08-Jan-2021, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (injection was very painful when injected) and INJECTION SITE PAIN (Soreness at injection site) was resolving and HEADACHE (Headache) outcome was unknown. On 08 Jan 2021 pain is 20% less than previous day.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took one Advil (Ibuprofen) before an hour of injection did not get any treatment after the vaccine for any of these events.  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.; 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: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever in excess of 102 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever in excess of 102 degrees Fahrenheit) 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 from December 2020 to 28-Dec-2020.    On 10-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PYREXIA (fever in excess of 102 degrees Fahrenheit). At the time of the report, PYREXIA (fever in excess of 102 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive in early Dec-2020. On 28-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative. On 11-Jan-2021, Body temperature: 102 (High) 102 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not 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: Vaccination site reaction, Vaccination site swelling
Clinical narrative: >25cm injection site reaction; slightly swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (>25cm injection site reaction) and VACCINATION SITE SWELLING (slightly swollen) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Contact dermatitis (reaction to 'decyl glucoside').    On 24-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 VACCINATION SITE REACTION (>25cm injection site reaction) and VACCINATION SITE SWELLING (slightly swollen). At the time of the report, VACCINATION SITE REACTION (>25cm injection site reaction) and VACCINATION SITE SWELLING (slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment was reported for the events.; 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.; 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: M
Vaccine: COVID19
Symptoms: Erythema, Ocular hyperaemia
Clinical narrative: Left arm and left eye is bloodshot; Left arm and left eye is bloodshot; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Left arm and left eye is bloodshot) and ERYTHEMA (Left arm and left eye is bloodshot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced OCULAR HYPERAEMIA (Left arm and left eye is bloodshot) and ERYTHEMA (Left arm and left eye is bloodshot). At the time of the report, OCULAR HYPERAEMIA (Left arm and left eye is bloodshot) and ERYTHEMA (Left arm and left eye is bloodshot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: chills; head hurts; knee pain; very tired; nauseated; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired) and NAUSEA (nauseated) in a 32-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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE (very tired) and NAUSEA (nauseated). At the time of the report, FATIGUE (very tired) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.  Treatment for the event included, Tylenol.  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; 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: chills; head hurts; knee pain; very tired; nauseated; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired) and NAUSEA (nauseated) in a 32-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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE (very tired) and NAUSEA (nauseated). At the time of the report, FATIGUE (very tired) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.  Treatment for the event included, Tylenol.  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; 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: Blood glucose increased, Pain in extremity
Clinical narrative: My sugar was higher; Arm was sore for 2 days; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 Vaccine, and who experienced arm was sore for 2 days and sugar was higher.   The patient's medical history included diabetes. Concomitant product use was not provided by the reporter.   On 23-Dec-2020, approximately 1 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.   On 23-Dec-2020, patient had no side effects expect for sore arm and sugar was higher. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events arm was sore, and sugar was higher 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.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of maternal exposure during pregnancy (vaccine exposure during pregnancy) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Last menstrual period and estimated date of delivery not provided. On an unknown date, patient experienced maternal exposure during pregnancy (vaccine exposure during pregnancy). At the time of the report, maternal exposure during pregnancy (vaccine exposure during pregnancy) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported. Patient is about 37 weeks pregnant. Most recent follow-up information incorporated above includes: On Mar 27, 2021: Follow-up received as no new information. Sender's comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on her right arm, size of rash is 4 inches by 2 inches; Itchy rash; Bright red rash; A spontaneous report was received from a 46 year old female patient (dental hygienist) who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a rash on her right arm, size of rash is 4 inches by 2 inches/ rash, bright red/ Rash erythematous and itchy rash/ Rash pruritic.   The patient's medical history, as provided by the reporter, included a bee sting allergy. The patient had Epinephrine handy for that but does not take any other meds No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 9 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (039K20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient began to experience a bright red, itchy rash on her right arm. The size of the rash was about 4 inches by 2 inches. Treatment for the event included diphenhydramine hydrochloride, ibuprofen, and a cold compress.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, bright red, itchy rash, was considered recovering/resolving; Reporter's Comments: This case concerns a 46-year-old female who experienced NS events of unexpected rash pruritic and rash erythematous and expected rash.  Event onset occurred XX as / after the first dose of mRNA-1273. Treatment with diphenhydramine and ibuprofen. 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: Feeling hot, Insomnia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: keeping her up at night; heat sensation; her arm  became really red; injection site extended (Swollen); A spontaneous report was received from a consumer who was a 47-year-old, female patient who received Moderna's COVID -19 Vaccine, who experienced at the injection site her arm became really red and extended (swollen), heat sensation, and keeping her up at night.  The patient's medical history was not provided. Concomitant medications were not provided.  Prior to the events, the patient received her first of two planned doses of mRNA-1273 (Batch number 011L2OA) on 29-Dec-2020 intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 06-Jan-2021, the patient experienced at the injection site of her left arm was really red and was extended (swollen).  The patient also reported that there was a heat sensation coming from the her that had been bad and keeping her up at night.  The patient reported from 06-Jan-2021 (Wednesday) to today, the events had worsened.  Treatment for the events included ice pack to treat the symptoms, ibuprofen and Benadryl (diphenhydramine hydrochloride), which the patient complained that the medications have not worked.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events experienced at the injection site her arm became really red and extended (swollen), heat sensation, and keeping her up at night were considered not resolved at the time of the 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.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 102 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 102 F) in a  patient of an unknown age and gender 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PYREXIA (Fever 102 F). At the time of the report, PYREXIA (Fever 102 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, Body temperature: 102 f (Inconclusive) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the established safety profile and a temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Pyrexia is consistent with the known safety profile of the vaccine.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Pyrexia is consistent with the known safety profile of the vaccine.