chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid) 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 medical history reported).    On 22-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 COVID-19 (Diagnosed with Covid). At the time of the report, COVID-19 (Diagnosed with Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Reporter's Comments: This case concerns an adult female with nonserious unexpected event of COVID-19, and nonserious unexpected , and expected. Event onset 8 days after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warmness at injection site; Redness at injection site; Itchiness; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Itchiness), VACCINATION SITE WARMTH (Warmness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PRURITUS (Itchiness). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, PRURITUS (Itchiness), VACCINATION SITE WARMTH (Warmness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Lab tests were not provided.  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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Got first shot of the vaccine and tested positive for COVID-19 20 days after; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 18-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Got first shot of the vaccine and tested positive for COVID-19 20 days after) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011S20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Got first shot of the vaccine and tested positive for COVID-19 20 days after). At the time of the report, SARS-COV-2 TEST POSITIVE (Got first shot of the vaccine and tested positive for COVID-19 20 days after) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2020, SARS-CoV-2 test: Negative. On 16-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included antibiotics.  The patient was isolated and was awaiting for new laboratory results to consult doctor.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: local rash; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (local rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (local rash). At the time of the report, RASH (local rash) 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 information was not provided.  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.   Reporter did not allow further contact; 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: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red mark under injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (red mark under injection site) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (red mark under injection site). At the time of the report, INJECTION SITE ERYTHEMA (red mark under injection site) outcome was unknown.   Prior to receiving mRNA-1273, on 27-Dec-2020, the patient felt red marks under the injection site     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.   Reporter did not allow further contact; Sender's Comments: Based on 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: Pain
Clinical narrative: right and left side  body pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (right and left side  body pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN (right and left side  body pain). The patient was treated with CYCLOBENZAPRINE at an unspecified dose and frequency. At the time of the report, PAIN (right and left side  body pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: experiencing various degrees of itching and itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (experiencing various degrees of itching and itchiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (experiencing various degrees of itching and itchiness). At the time of the report, PRURITUS (experiencing various degrees of itching and itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Severe vertigo) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VERTIGO (Severe vertigo). At the time of the report, VERTIGO (Severe vertigo) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications were not reported.  Treatment for the event was not specified.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Feeling too weak; Had 2nd vaccine 7 weeks after getting the first; chills; FEVER; Covid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid), ASTHENIA (Feeling too weak), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd vaccine 7 weeks after getting the first), CHILLS (chills) and PYREXIA (FEVER) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (Covid), CHILLS (chills) and PYREXIA (FEVER). On an unknown date, the patient experienced ASTHENIA (Feeling too weak) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd vaccine 7 weeks after getting the first). At the time of the report, COVID-19 (Covid) had not resolved and ASTHENIA (Feeling too weak), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had 2nd vaccine 7 weeks after getting the first), CHILLS (chills) and PYREXIA (FEVER) had resolved.            No relevant concomitant medications were reported.    Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Report attached on 3-jun-2021, significant follow up, new events were added and patient declined further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: Muscle joint aches; Arm pain; Joint pain; Fever; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Muscle joint aches), VACCINATION SITE PAIN (Arm pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (Muscle joint aches), VACCINATION SITE PAIN (Arm pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, MYALGIA (Muscle joint aches), VACCINATION SITE PAIN (Arm pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: in the past in the Past.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Dry mouth, Eyelid disorder, Eyelid oedema
Clinical narrative: tingling-itching on his face; dry mouth; Dehydrated; Shaky legs; Lower eyelids really red; Lower eyelids really red and swollen; Tingling, itching on face, hands; Exhausted, depleted of energy; Chills; Feeling weird, feeling medicine moving in the arm, felt rushes; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling weird, feeling medicine moving in the arm, felt rushes), DRY MOUTH (dry mouth), DEHYDRATION (Dehydrated), TREMOR (Shaky legs) and EYELID DISORDER (Lower eyelids really red) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (Medical history reported as diabetes) and Asthma (Medical history reported as asthma) since January 2021. Concomitant products included PREDNISONE from 04-Jan-2021 to an unknown date for Asthma, METFORMIN for Diabetes.    On 17-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling weird, feeling medicine moving in the arm, felt rushes). On 18-Jan-2021, the patient experienced DRY MOUTH (dry mouth), DEHYDRATION (Dehydrated), TREMOR (Shaky legs), EYELID DISORDER (Lower eyelids really red), EYELID OEDEMA (Lower eyelids really red and swollen), PARAESTHESIA (Tingling, itching on face, hands), FATIGUE (Exhausted, depleted of energy) and CHILLS (Chills). On an unknown date, the patient experienced PRURITUS (tingling-itching on his face). At the time of the report, FEELING ABNORMAL (Feeling weird, feeling medicine moving in the arm, felt rushes), DRY MOUTH (dry mouth), DEHYDRATION (Dehydrated), TREMOR (Shaky legs), EYELID DISORDER (Lower eyelids really red), EYELID OEDEMA (Lower eyelids really red and swollen), PARAESTHESIA (Tingling, itching on face, hands), FATIGUE (Exhausted, depleted of energy), CHILLS (Chills) and PRURITUS (tingling-itching on his face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been 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.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Paraesthesia, Pruritus, Tremor
Clinical narrative: tingling-itching on his face; dry mouth; Dehydrated; Shaky legs; Lower eyelids really red; Lower eyelids really red and swollen; Tingling, itching on face, hands; Exhausted, depleted of energy; Chills; Feeling weird, feeling medicine moving in the arm, felt rushes; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling weird, feeling medicine moving in the arm, felt rushes), DRY MOUTH (dry mouth), DEHYDRATION (Dehydrated), TREMOR (Shaky legs) and EYELID DISORDER (Lower eyelids really red) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (Medical history reported as diabetes) and Asthma (Medical history reported as asthma) since January 2021. Concomitant products included PREDNISONE from 04-Jan-2021 to an unknown date for Asthma, METFORMIN for Diabetes.    On 17-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling weird, feeling medicine moving in the arm, felt rushes). On 18-Jan-2021, the patient experienced DRY MOUTH (dry mouth), DEHYDRATION (Dehydrated), TREMOR (Shaky legs), EYELID DISORDER (Lower eyelids really red), EYELID OEDEMA (Lower eyelids really red and swollen), PARAESTHESIA (Tingling, itching on face, hands), FATIGUE (Exhausted, depleted of energy) and CHILLS (Chills). On an unknown date, the patient experienced PRURITUS (tingling-itching on his face). At the time of the report, FEELING ABNORMAL (Feeling weird, feeling medicine moving in the arm, felt rushes), DRY MOUTH (dry mouth), DEHYDRATION (Dehydrated), TREMOR (Shaky legs), EYELID DISORDER (Lower eyelids really red), EYELID OEDEMA (Lower eyelids really red and swollen), PARAESTHESIA (Tingling, itching on face, hands), FATIGUE (Exhausted, depleted of energy), CHILLS (Chills) and PRURITUS (tingling-itching on his face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test, Vaccination complication
Clinical narrative: Most likely patient has gotten COVID from exposure; Side effects she experienced from vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Most likely patient has gotten COVID from exposure) and VACCINATION COMPLICATION (Side effects she experienced from vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION COMPLICATION (Side effects she experienced from vaccine). On 11-Jan-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Most likely patient has gotten COVID from exposure). At the time of the report, EXPOSURE TO SARS-COV-2 (Most likely patient has gotten COVID from exposure) and VACCINATION COMPLICATION (Side effects she experienced from vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: positive (Positive) Possible.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-JUN-2021 contains significant information: The patient took 2nd dose of vaccine on FEB-2021. The outcome of the events changed from unknown to resolved.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Heart rate increased, Nausea
Clinical narrative: arm soreness; Racing heartbeat; little bit dizzy; Fever; Chills; Nauseous; Fatigue; A spontaneous report was received from a physical therapist concerning a fifty-five-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fever, chills, heartbeats increased, arm soreness, nauseous, fatigue and dizzy.   The patient's medical history was not provided. Concomitant medications reported included Synthroid.  The patient received their first of two planned doses of mRNA-1273 (BATCH # 026L20A) on 12 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Reporter called and stated they were a physical therapist who received their first dose of Moderna COVID-19 vaccine in their left arm at her place of work on 12 Jan 2021 and experienced fevers, chills and racing heartbeat. She stated she was better now but that she wanted to know, if they should receive the second vaccine. She had arm soreness but stated it was expected. Twelve hours after reporter received the vaccine, she was nauseous and experienced fatigue, chills and elevated heartbeat. She also had a fever. As of the day of this report, fever was down but persisted, and heartbeat was down. She still felt a little bit dizzy. Reporter just stayed in bed and did not take any medicines to treat the symptoms. Reporter was currently on Synthroid  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events chills, arm soreness, nauseous and fatigue was unknown. Fever, heartbeats increased and dizzy were resolving.  The reporter did not provide an assessment for the events, fever, chills, heartbeats increased, arm soreness, nauseous, fatigue and dizzy.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm soreness; Racing heartbeat; little bit dizzy; Fever; Chills; Nauseous; Fatigue; A spontaneous report was received from a physical therapist concerning a fifty-five-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fever, chills, heartbeats increased, arm soreness, nauseous, fatigue and dizzy.   The patient's medical history was not provided. Concomitant medications reported included Synthroid.  The patient received their first of two planned doses of mRNA-1273 (BATCH # 026L20A) on 12 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Reporter called and stated they were a physical therapist who received their first dose of Moderna COVID-19 vaccine in their left arm at her place of work on 12 Jan 2021 and experienced fevers, chills and racing heartbeat. She stated she was better now but that she wanted to know, if they should receive the second vaccine. She had arm soreness but stated it was expected. Twelve hours after reporter received the vaccine, she was nauseous and experienced fatigue, chills and elevated heartbeat. She also had a fever. As of the day of this report, fever was down but persisted, and heartbeat was down. She still felt a little bit dizzy. Reporter just stayed in bed and did not take any medicines to treat the symptoms. Reporter was currently on Synthroid  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events chills, arm soreness, nauseous and fatigue was unknown. Fever, heartbeats increased and dizzy were resolving.  The reporter did not provide an assessment for the events, fever, chills, heartbeats increased, arm soreness, nauseous, fatigue and dizzy.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: Lump on the injection site; Red rash injection site 1/2 inch; Swollen injection site; A spontaneous report was received from a consumer concerning a 65-year old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, red rash about 1/2" on the injection site/injection site rash, it is swollen/injection site swelling and feels like there is a lump on the injection site/injection site mass.  The patient's medical history as provided by the reporter included cancer. No relevant concomitant medications were reported.  On 04 Jan 2021, approximately eight days prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received the vaccine and on 12 Jan 2021, the patient experienced red rash about 1/2" on the injection site, it is swollen and feels like there is a lump on the injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was not reported.  At the time of the report, the outcome of the events, red rash about 1/2" on the injection site, it is swollen and feels like there is a lump on the injection site were not resolved.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Hyperhidrosis, SARS-CoV-2 antibody test, Vaccination site lymphadenopathy
Clinical narrative: Excessive sweating; Swelling on lymph node (right side); Pain and Soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Excessive sweating), VACCINATION SITE LYMPHADENOPATHY (Swelling on lymph node (right side)) and AXILLARY PAIN (Pain and Soreness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 06-Apr-2020. Concomitant products included ZINC, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 09-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling on lymph node (right side)) and AXILLARY PAIN (Pain and Soreness). On 11-Jan-2021, the patient experienced HYPERHIDROSIS (Excessive sweating). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Jan-2021, AXILLARY PAIN (Pain and Soreness) had resolved. At the time of the report, HYPERHIDROSIS (Excessive sweating) and VACCINATION SITE LYMPHADENOPATHY (Swelling on lymph node (right side)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2020, SARS-CoV-2 antibody test: unknown (Positive) Unknown. In December 2020, SARS-CoV-2 antibody test: unknown (Positive) Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took her second dose on 06 Feb 2021.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03 Jun 2021 contains significant information such as added medical history, lab data and concomitant products .Updated reporter information and patient demographics.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dysgeusia, Vaccination site discomfort
Clinical narrative: stomach pain which was worsened by eating; diarrhea; burps that taste like something; a minor feeling near where I got shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain which was worsened by eating), DIARRHOEA (diarrhea), VACCINATION SITE DISCOMFORT (a minor feeling near where I got shot) and DYSGEUSIA (burps that taste like something) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was 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 VACCINATION SITE DISCOMFORT (a minor feeling near where I got shot). On 12-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain which was worsened by eating), DIARRHOEA (diarrhea) and DYSGEUSIA (burps that taste like something). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) on 12-Jan-2021 for Adverse event, at an unspecified dose and frequency. On 11-Jan-2021, VACCINATION SITE DISCOMFORT (a minor feeling near where I got shot) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain which was worsened by eating) and DIARRHOEA (diarrhea) had not resolved and DYSGEUSIA (burps that taste like something) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: No new information 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 rash
Clinical narrative: a delayed reaction, rash at injection site which looks like cellulitis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (a delayed reaction, rash at injection site which looks like cellulitis) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (a delayed reaction, rash at injection site which looks like cellulitis). The patient was treated with PREDNISONE for Vaccination site rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (a delayed reaction, rash at injection site which looks like cellulitis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Age of patient was corrected; 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.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: red blotchy knot at the injection site; red blotchy knot at the injection site; itchiness at the injection site; soreness and tenderness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of RASH MACULAR (red blotchy knot at the injection site), VACCINATION SITE PAIN (soreness and tenderness at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (red blotchy knot at the injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 05-Jan-2021, 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 PAIN (soreness and tenderness at the injection site). On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site). On 11-Jan-2021, the patient experienced RASH MACULAR (red blotchy knot at the injection site) and VACCINATION SITE ERYTHEMA (red blotchy knot at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 12.5 milligram. On 05-Jan-2021, VACCINATION SITE PAIN (soreness and tenderness at the injection site) had resolved. At the time of the report, RASH MACULAR (red blotchy knot at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (red blotchy knot at the injection site) 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.   Patient was treated with Tylenol and Benadryl 12.5 mg orally.; 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: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation
Clinical narrative: blood pressure has been going up and down; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (blood pressure has been going up and down) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure has been going up and down). At the time of the report, BLOOD PRESSURE FLUCTUATION (blood pressure has been going up and down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain in extremity, Vaccination site warmth
Clinical narrative: sore throat/throat felt very tender; arm felt a little warm to touch at the injection site; head ache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat/throat felt very tender), VACCINATION SITE WARMTH (arm felt a little warm to touch at the injection site) and HEADACHE (head ache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (arm felt a little warm to touch at the injection site) and HEADACHE (head ache). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat/throat felt very tender). At the time of the report, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat/throat felt very tender), VACCINATION SITE WARMTH (arm felt a little warm to touch at the injection site) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The arm felt a little warm to touch so the consumer used a heating pad on the injection site. That evening she started to get a headache and went to bed early. When she woke up on 14Jan2021 she started to have a sore throat. Her throat felt very tender.  Concomitant information not provided. Treatment medications were not 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Exposure during pregnancy, Ultrasound foetal
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M0A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included Pregnancy (Live full time birth, healthy baby.) on 18-Jan-2019. Concurrent medical conditions included Nickel sensitivity (allergy to Nickel( causes rash)). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Feb-2020 to an unknown date for Pregnancy.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Jun-2020 and the estimated date of delivery was 14-Feb-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy. The delivery occurred  on 19-Jan-2019, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. menstruation date is not an error: I had a full period during first month of pregnancy. Baby was born healthy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Ultrasound foetal: normal (normal) Normal. In October 2020, Ultrasound foetal: normal (normal) Normal. In November 2020, Blood glucose: normal (normal) Normal.         Prenatal care was established.  The patient's positive pregnancy test was on 30-Jun-2020 and estimated date of conception was 24-May-2020.  The patient had a full period during first month of pregnancy. The baby was born healthy.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter Details were Updated
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Aug-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient is pregnant and lactating. Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Reporter details, patient demographics and product information were updated
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm swelled; had a red circle.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Left arm swelled) and INJECTION SITE ERYTHEMA (had a red circle.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L208) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced INJECTION SITE SWELLING (Left arm swelled) and INJECTION SITE ERYTHEMA (had a red circle.). At the time of the report, INJECTION SITE SWELLING (Left arm swelled) and INJECTION SITE ERYTHEMA (had a red circle.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  Upon internal review on 04-AUG-2021, the age was corrected to 83 years.   Reporter did not allow further contact; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SL208) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE ERYTHEMA (redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
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 26-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2 drinks, 3 times a week.) on 25-Dec-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 25-Dec-2020 and the estimated date of delivery was 01-Oct-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Pregnancy test: positive (Positive) Positive. On 13-May-2021, Ultrasound scan: normal (normal) Normal 20 week anatomy ultrasound.         No treatment medications were provided by the reporter.  Action taken with mRNA-1273 in response to the events were Not Applicable.   Estimated date of conception was 08 Jan 2021.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added second dose information.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Fatigue, Lymphadenopathy, Myalgia, Oropharyngeal pain
Clinical narrative: my ear and eye got really hot; running low grade fever; body aches; very fatigued; really swollen lymph nodes; throat hurts; extreme pain in my arm, neck, ear, and eye; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (really swollen lymph nodes), OROPHARYNGEAL PAIN (throat hurts), PAIN (extreme pain in my arm, neck, ear, and eye), ABNORMAL SENSATION IN EYE (my ear and eye got really hot) and PYREXIA (running low grade fever) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN (extreme pain in my arm, neck, ear, and eye). On an unknown date, the patient experienced LYMPHADENOPATHY (really swollen lymph nodes), OROPHARYNGEAL PAIN (throat hurts), ABNORMAL SENSATION IN EYE (my ear and eye got really hot), PYREXIA (running low grade fever), MYALGIA (body aches) and FATIGUE (very fatigued). At the time of the report, LYMPHADENOPATHY (really swollen lymph nodes), OROPHARYNGEAL PAIN (throat hurts), PAIN (extreme pain in my arm, neck, ear, and eye), ABNORMAL SENSATION IN EYE (my ear and eye got really hot), PYREXIA (running low grade fever), MYALGIA (body aches) and FATIGUE (very fatigued) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The treatment reported was Tylenol which helped with the pain, sore throat, and fever.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.