chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Decreased appetite
Clinical narrative: Temperature at 101.5F or 101.2F; No appetite; Muscle weakness; Chills; Joint pain; Nausea; vomiting; Big Headache; A spontaneous report was received from a 56 year old, female, dietician who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, temperature of 101.5F or 101.2F, no appetite, muscle weakness, joint pain, nausea, vomiting and a big headache.   The patient's medical history, as provided by the reporter, included no comorbidities and no allergies. The patient reported taking no concomitant medications.   On 28 Dec 2020, approximately 4 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient reported side effects of chills, temperature of 101.5F or 101.2F, no appetite eating nothing for the last few days, muscle weakness, joint pain, nausea, vomiting and a big headache. The patient was surprised the vaccine hit her this way as she does not really get sick, has no comorbidity, takes no medications and has no allergies. She consented to follow up from safety and her HCP.   Treatment for the events included Tylenol (acetaminophen) and Motrin (ibuprofen) but the patient stated they were bothering her stomach. She mentioned that she also vomited some blood.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, chills, temperature of 101.5F or 101.2F, no appetite, muscle weakness, joint pain, nausea, vomiting and a big headache, were 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: Headache, Muscular weakness, Nausea, Vomiting
Clinical narrative: Temperature at 101.5F or 101.2F; No appetite; Muscle weakness; Chills; Joint pain; Nausea; vomiting; Big Headache; A spontaneous report was received from a 56 year old, female, dietician who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, temperature of 101.5F or 101.2F, no appetite, muscle weakness, joint pain, nausea, vomiting and a big headache.   The patient's medical history, as provided by the reporter, included no comorbidities and no allergies. The patient reported taking no concomitant medications.   On 28 Dec 2020, approximately 4 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient reported side effects of chills, temperature of 101.5F or 101.2F, no appetite eating nothing for the last few days, muscle weakness, joint pain, nausea, vomiting and a big headache. The patient was surprised the vaccine hit her this way as she does not really get sick, has no comorbidity, takes no medications and has no allergies. She consented to follow up from safety and her HCP.   Treatment for the events included Tylenol (acetaminophen) and Motrin (ibuprofen) but the patient stated they were bothering her stomach. She mentioned that she also vomited some blood.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, chills, temperature of 101.5F or 101.2F, no appetite, muscle weakness, joint pain, nausea, vomiting and a big headache, were 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: Heartbeat went to 125; Blood pressure increased; A spontaneous report was received from a physician concerning a 41-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heartbeat went to 125/heartbeats increased and blood pressure increased.  The patient's medical history was not provided. Concomitant medications reported included ascorbic acid and cholecalciferol.    On 04 Jan 2021, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient experienced heartbeat went to 125 and blood pressure increased.   Treatment for the events included oxygen and blood pressure medication.    Action taken with mRNA-1273 in response to the events heartbeat went to 125 and blood pressure increased was not reported.   The outcomes of the events heartbeat went to 125 and blood pressure increased 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 these  events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Headache, Heart rate increased
Clinical narrative: Vague headache; little chill (no fever); Vague dizziness; feeling unbalanced (walks to the left); Nervousness; Fast heartbeat; A spontaneous report was received from a 51 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experience vague dizziness, feeling unbalanced (walk deviated to the left), patient got nervous, her heart beats fast, vague headache and little chills.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient stated that she was experienced vague dizziness, when she stood up, feeling unbalanced, walk deviated to the left, patient got nervous and her heart beats fast.   On the morning of 01 Jan 2021, the patient mentioned that she feels better and ease off but vague headache and little chill (no fever) as evident, but she said that she could function normally. No treatment was information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of vague dizziness, feeling unbalanced (walk deviated to the left), patient got nervous and her heart beats fast, were resolving.   The outcome of events, vague headache and little chill, were unknown.; Reporter's Comments: This case concerns a 51-year-old female who experienced with NS events of unexpected dizziness, balance disorder, nervousness, heart rate increased and expected headache, chills.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. 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: Nervousness
Clinical narrative: Vague headache; little chill (no fever); Vague dizziness; feeling unbalanced (walks to the left); Nervousness; Fast heartbeat; A spontaneous report was received from a 51 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experience vague dizziness, feeling unbalanced (walk deviated to the left), patient got nervous, her heart beats fast, vague headache and little chills.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient stated that she was experienced vague dizziness, when she stood up, feeling unbalanced, walk deviated to the left, patient got nervous and her heart beats fast.   On the morning of 01 Jan 2021, the patient mentioned that she feels better and ease off but vague headache and little chill (no fever) as evident, but she said that she could function normally. No treatment was information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of vague dizziness, feeling unbalanced (walk deviated to the left), patient got nervous and her heart beats fast, were resolving.   The outcome of events, vague headache and little chill, were unknown.; Reporter's Comments: This case concerns a 51-year-old female who experienced with NS events of unexpected dizziness, balance disorder, nervousness, heart rate increased and expected headache, chills.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. 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: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Injection site pain; Fatigue; A spontaneous report was received from a Pharmacist, stating about multiple patients (no patient's valid identifiers) who received Moderna's COVID-19 vaccine and experienced injection site pain and fatigue.  Medical history was not provided. Concomitant medications were not reported.  On 28 Dec 2020, prior to the onset of the events, the patients received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.  On 29 Dec 2020, after receiving the vaccine, the patients experienced Pain at the injection site and fatigue. Treatment of the events were not reported. Pharmacist stated their employees were told to wait either until they were actually approved or 4-5 months to receive the 2nd dose of the vaccine.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events injection site pain and fatigue was not reported.; Reporter's Comments: This case concerns a patient with nonserious expected injection site pain and fatigue. Event onset Day 2 after first dose mRNA-1273. Treatment not reported.  Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Weakness; cough; headache; fatigue; chills; Arm felt heavy; A spontaneous report was received from a non-health professional concerning a 62-year-old ,patient who received Moderna's COVID-19 vaccine and developed chills at night, heaviness in her arm, cough, fatigue, diarrhea and weakness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 27 Dec 2020, the same day as the vaccination, the patient's arm felt heavy. On 28 Dec 2020, she developed chills at night. Then 3 days after the vaccination, on 30 Dec 2020, the patient experienced fatigue, headache, cough, diarrhea and weakness.   Treatment for the events included, acetaminophen for the headache. Mucinex and a cough syrup for the cough.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events were ongoing.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort
Clinical narrative: Diarrhea; Weakness; cough; headache; fatigue; chills; Arm felt heavy; A spontaneous report was received from a non-health professional concerning a 62-year-old ,patient who received Moderna's COVID-19 vaccine and developed chills at night, heaviness in her arm, cough, fatigue, diarrhea and weakness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 27 Dec 2020, the same day as the vaccination, the patient's arm felt heavy. On 28 Dec 2020, she developed chills at night. Then 3 days after the vaccination, on 30 Dec 2020, the patient experienced fatigue, headache, cough, diarrhea and weakness.   Treatment for the events included, acetaminophen for the headache. Mucinex and a cough syrup for the cough.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events were ongoing.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Flushing
Clinical narrative: Snotty; Sweatiness; Temperature 99.5 F; Feeling Cold with Bad Chills; Fatigue and Exhaustion; Achy; Feeling Cold; Red Hot Burning; Redness on the injection site (L deltoid), getting bigger now oval shaped; Dizzy; Flushed Face; Sick in the Stomach; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (Dizzy), FLUSHING (Flushed Face), PAIN (Achy), FEELING COLD (Feeling Cold) and RHINORRHOEA (Snotty) in a 59-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 medical reported history).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced DIZZINESS (Dizzy), FLUSHING (Flushed Face) and NAUSEA (Sick in the Stomach). On 26-Dec-2020, the patient experienced INJECTION SITE PAIN (Red Hot Burning) and INJECTION SITE ERYTHEMA (Redness on the injection site (L deltoid), getting bigger now oval shaped). On 28-Dec-2020, the patient experienced PAIN (Achy) and FEELING COLD (Feeling Cold). On 29-Dec-2020, the patient experienced RHINORRHOEA (Snotty), HYPERHIDROSIS (Sweatiness), PYREXIA (Temperature 99.5 F), CHILLS (Feeling Cold with Bad Chills) and FATIGUE (Fatigue and Exhaustion). On 23-Dec-2020, DIZZINESS (Dizzy), FLUSHING (Flushed Face) and NAUSEA (Sick in the Stomach) had resolved. At the time of the report, PAIN (Achy), FEELING COLD (Feeling Cold), RHINORRHOEA (Snotty), HYPERHIDROSIS (Sweatiness), PYREXIA (Temperature 99.5 F), CHILLS (Feeling Cold with Bad Chills), INJECTION SITE PAIN (Red Hot Burning), INJECTION SITE ERYTHEMA (Redness on the injection site (L deltoid), getting bigger now oval shaped) and FATIGUE (Fatigue and Exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive Positive.     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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: Snotty; Sweatiness; Temperature 99.5 F; Feeling Cold with Bad Chills; Fatigue and Exhaustion; Achy; Feeling Cold; Red Hot Burning; Redness on the injection site (L deltoid), getting bigger now oval shaped; Dizzy; Flushed Face; Sick in the Stomach; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (Dizzy), FLUSHING (Flushed Face), PAIN (Achy), FEELING COLD (Feeling Cold) and RHINORRHOEA (Snotty) in a 59-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 medical reported history).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced DIZZINESS (Dizzy), FLUSHING (Flushed Face) and NAUSEA (Sick in the Stomach). On 26-Dec-2020, the patient experienced INJECTION SITE PAIN (Red Hot Burning) and INJECTION SITE ERYTHEMA (Redness on the injection site (L deltoid), getting bigger now oval shaped). On 28-Dec-2020, the patient experienced PAIN (Achy) and FEELING COLD (Feeling Cold). On 29-Dec-2020, the patient experienced RHINORRHOEA (Snotty), HYPERHIDROSIS (Sweatiness), PYREXIA (Temperature 99.5 F), CHILLS (Feeling Cold with Bad Chills) and FATIGUE (Fatigue and Exhaustion). On 23-Dec-2020, DIZZINESS (Dizzy), FLUSHING (Flushed Face) and NAUSEA (Sick in the Stomach) had resolved. At the time of the report, PAIN (Achy), FEELING COLD (Feeling Cold), RHINORRHOEA (Snotty), HYPERHIDROSIS (Sweatiness), PYREXIA (Temperature 99.5 F), CHILLS (Feeling Cold with Bad Chills), INJECTION SITE PAIN (Red Hot Burning), INJECTION SITE ERYTHEMA (Redness on the injection site (L deltoid), getting bigger now oval shaped) and FATIGUE (Fatigue and Exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive Positive.     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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Snotty; Sweatiness; Temperature 99.5 F; Feeling Cold with Bad Chills; Fatigue and Exhaustion; Achy; Feeling Cold; Red Hot Burning; Redness on the injection site (L deltoid), getting bigger now oval shaped; Dizzy; Flushed Face; Sick in the Stomach; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (Dizzy), FLUSHING (Flushed Face), PAIN (Achy), FEELING COLD (Feeling Cold) and RHINORRHOEA (Snotty) in a 59-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 medical reported history).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced DIZZINESS (Dizzy), FLUSHING (Flushed Face) and NAUSEA (Sick in the Stomach). On 26-Dec-2020, the patient experienced INJECTION SITE PAIN (Red Hot Burning) and INJECTION SITE ERYTHEMA (Redness on the injection site (L deltoid), getting bigger now oval shaped). On 28-Dec-2020, the patient experienced PAIN (Achy) and FEELING COLD (Feeling Cold). On 29-Dec-2020, the patient experienced RHINORRHOEA (Snotty), HYPERHIDROSIS (Sweatiness), PYREXIA (Temperature 99.5 F), CHILLS (Feeling Cold with Bad Chills) and FATIGUE (Fatigue and Exhaustion). On 23-Dec-2020, DIZZINESS (Dizzy), FLUSHING (Flushed Face) and NAUSEA (Sick in the Stomach) had resolved. At the time of the report, PAIN (Achy), FEELING COLD (Feeling Cold), RHINORRHOEA (Snotty), HYPERHIDROSIS (Sweatiness), PYREXIA (Temperature 99.5 F), CHILLS (Feeling Cold with Bad Chills), INJECTION SITE PAIN (Red Hot Burning), INJECTION SITE ERYTHEMA (Redness on the injection site (L deltoid), getting bigger now oval shaped) and FATIGUE (Fatigue and Exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive Positive.     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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; A spontaneous report (United States) was received from a female consumer who received Moderna's COVID-19 vaccine and experienced side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date 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 an unknown date, after receiving the vaccine she stated she experienced some side effects. Treatment to the event was unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: positive COVID test; A spontaneous report was received from a physician concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID-19  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, after administration of the vaccine, the patient developed mild to low moderate symptoms of COVID-19 and tested positive for COVID-19 on 04-JAN-2021. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   Outcome of the event tested positive for COVID-19 was unknown.; Reporter's Comments: This case concerns a male of unknown age who experienced a NS unexpected event of COVID-19 with mild to low moderate symptoms of COVID-19. Event onset occurred 6 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Diagnosed with COVID; A spontaneous report was received from a female consumer of an unknown age concerning herself, She received Moderna's COVID-19 Vaccine and was diagnosed with COVID.  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 (Lot number not provided) on 24 Dec 2020 via unknown route at unknown anatomical region for prophylaxis of COVID-19 infection.   On 03 Jan 2021, after receiving the first dose of mRNA-1273, the patient was diagnosed with COVID. The patient would like to know if she can receive the second dose, which is scheduled for 21 Jan 2021.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the event of diagnosed with COVID was not reported.; Reporter's Comments: Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of Covid-19 diagnosis after vaccination, this event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Rash of small red dots on her arms and hips which by had spread to her legs and front torso; A spontaneous report was received from a healthcare facility staff member concerning a 25-year-old, female patient who was participating in the mRNA-1273 Program and who developed a rash of small red dots on my arms and hips which has spread to my legs and front torso.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Lot- unknown) on 29-Dec-2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   She stated that on 04-Jan-2020, she started developing a rash of small red dots on her arms and hips which continued to spread to her legs and anterior torso.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event, developed a rash of small red dots on my arms and hips which has spread to my legs and front torso, was not provided.   The outcome of the event, developed a rash of small red dots on my arms and hips which has spread to my legs and front torso, was not reported.; Reporter's Comments: This case concerns a 25-year-old female who experienced NS event of unexpected Rash erythematous.  Event onset occurred 7 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: A little bump; big red mark, area is red to the touch; Itchy at the site of injection; A spontaneous report was received from a health professional  concerning a 22-year-old, female patient who received Moderna's COVID-19 vaccine and developed itching, a big red mark and a little bump at the injection site.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037k20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.    On 01 Jan 2021, a few days after receiving the vaccine, the patient started to itchy at the injection site. On 05 Jan 2021, the patient developed a big red mark, the area was red to touch and a little bump at the injection site. Treatment information was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, itching, a red mark and a bump at the injection site, 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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site dysaesthesia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: vaccination site dysesthesia; arm was sore; vaccination site warmth; Injection site itching; Injection site lump; red and warm around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DYSAESTHESIA (vaccination site dysesthesia), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site lump) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-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 DYSAESTHESIA (vaccination site dysesthesia), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Injection site lump) and VACCINATION SITE ERYTHEMA (red and warm around injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth). At the time of the report, VACCINATION SITE DYSAESTHESIA (vaccination site dysesthesia), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Injection site lump) and VACCINATION SITE ERYTHEMA (red and warm around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided.  Case comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: vaccination site dysesthesia; arm was sore; vaccination site warmth; Injection site itching; Injection site lump; red and warm around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DYSAESTHESIA (vaccination site dysesthesia), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site lump) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-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 DYSAESTHESIA (vaccination site dysesthesia), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Injection site lump) and VACCINATION SITE ERYTHEMA (red and warm around injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth). At the time of the report, VACCINATION SITE DYSAESTHESIA (vaccination site dysesthesia), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Injection site lump) and VACCINATION SITE ERYTHEMA (red and warm around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided.  Case comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive after receiving the vaccine; A spontaneous report was received from a reporter, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive after receiving the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number unknown) for prophylaxis of COVID-19 infection.    On an unknown date, after administration, the patient tested positive and subsequently received mAb therapy. No additional information was provided. No treatment information was provided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of event, and tested positive after receiving the vaccine, was unknown.; Reporter's Comments: This case concerns a male of unknown age who experienced NS events of unexpected SARS-CoV-2 test positive and received mAb therapy for COVID-19.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Maternal exposure during pregnancy, Pain in extremity, Pyrexia
Clinical narrative: Super tired; Maternal exposure during pregnancy; Sore arm; Fever; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and FATIGUE (Super tired) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Liver disorder. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Jul-2020 and the estimated date of delivery was 04-Apr-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). On 05-Jan-2021, the patient experienced FATIGUE (Super tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 05-Jan-2021, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and FATIGUE (Super tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included prenatal multivitamin.   Company Comment: This is a case of product exposure during pregnancy with associated AEs for this 34-year-old female. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 34-year-old female. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Taste of metal (metallic taste) in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Taste of metal (metallic taste) in her mouth) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DYSGEUSIA (Taste of metal (metallic taste) in her mouth). On 11-Jan-2021, DYSGEUSIA (Taste of metal (metallic taste) in her mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Patient did not receive any treatment.  Company comment: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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Hives between his neck and waist, mostly around his upper chest area; Rash; Red; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives between his neck and waist, mostly around his upper chest area), RASH (Rash) and ERYTHEMA (Red) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 07-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 URTICARIA (Hives between his neck and waist, mostly around his upper chest area), RASH (Rash) and ERYTHEMA (Red). In January 2021, URTICARIA (Hives between his neck and waist, mostly around his upper chest area), RASH (Rash) and ERYTHEMA (Red) had resolved.        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.   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.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Redness on arm; Rash on arm; A spontaneous report was received from a Non-Health Professional, female, of unknown age who was administered Moderna COVID-19 vaccine on an unknown date.  The Non-Health Professional's medical history was not reported. No relevant concomitant medications were reported.  The Non-Health Professional received her first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection on an unknown date. The Non-Health Professional experienced redness and rash on her arm on an unknown date. The Non-Health Professional's treatment history was not reported.  The action taken for Moderna COVID-19 vaccine was unknown.  The outcome of the events, redness and rash on her arm was unknown.   The Non-Health Professional did not declared any relatedness between the events, redness and rash on her arm and the Moderna COVID-19 vaccine.; Reporter'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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Vaccination site pain, Vaccination site rash
Clinical narrative: Analgesic; Injection site flared up with a nasty rash; neck and jaw felt numb; A little bit of pain/ a reaction around the injection site, it was hurting again; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (neck and jaw felt numb), HYPOAESTHESIA ORAL (neck and jaw felt numb), INJECTION SITE PAIN (A little bit of pain/ a reaction around the injection site, it was hurting again) and INJECTION SITE RASH (Injection site flared up with a nasty rash) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced INJECTION SITE PAIN (A little bit of pain/ a reaction around the injection site, it was hurting again). On 08-Jan-2021, the patient experienced HYPOAESTHESIA (neck and jaw felt numb), HYPOAESTHESIA ORAL (neck and jaw felt numb) and INJECTION SITE RASH (Injection site flared up with a nasty rash). On 10-Jan-2021, HYPOAESTHESIA (neck and jaw felt numb) outcome was unknown, HYPOAESTHESIA ORAL (neck and jaw felt numb) and INJECTION SITE RASH (Injection site flared up with a nasty rash) had resolved. At the time of the report, INJECTION SITE PAIN (A little bit of pain/ a reaction around the injection site, it was hurting again) 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 products included birth control pill and seartic. Treatment included anesthetic and Benadryl.; 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, Body temperature abnormal, Heart rate, Heart rate abnormal, Hyperhidrosis
Clinical narrative: sweaty; temperature 85.7F; muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee); 100.4F fever; heart rate 115; muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee); A spontaneous report was received from a 45 years female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site ), sweaty, temperature 85.7F.   The patient's medical history included tested positive for COVID.   No relevant concomitant medications were reported.    On 30-Dec-2020, prior to the onset of the events nodule size of a quarter on the injection site red, injection site red and injection site warm to touch, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) via unknown route in left arm  for prophylaxis of COVID-19 infection.  On 12-Jan-2021, the patient experienced 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee) (LLT: muscle tightness and muscle tenderness any site), on 13-Jan-2021 experienced sweaty.  Laboratory details included 100.4 F, heart rate: 115 and temperature: 85.7 F.  Treatment details included Tylenol for 100.4 F fever throughout the night 12-Jan-2021. She used the CPAP machine all night 12-Jan-2021.  Action taken with mRNA-1273 in response to the events 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site), sweaty, temperature 85.7F was not provided.  The outcome of the events 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site ), sweaty, temperature 85.7F was not provided.  The reporter did not provide the assessment of the events 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site ), sweaty, temperature 85.7F to study drug.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Muscle tightness, Myalgia, Pyrexia
Clinical narrative: sweaty; temperature 85.7F; muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee); 100.4F fever; heart rate 115; muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee); A spontaneous report was received from a 45 years female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site ), sweaty, temperature 85.7F.   The patient's medical history included tested positive for COVID.   No relevant concomitant medications were reported.    On 30-Dec-2020, prior to the onset of the events nodule size of a quarter on the injection site red, injection site red and injection site warm to touch, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) via unknown route in left arm  for prophylaxis of COVID-19 infection.  On 12-Jan-2021, the patient experienced 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee) (LLT: muscle tightness and muscle tenderness any site), on 13-Jan-2021 experienced sweaty.  Laboratory details included 100.4 F, heart rate: 115 and temperature: 85.7 F.  Treatment details included Tylenol for 100.4 F fever throughout the night 12-Jan-2021. She used the CPAP machine all night 12-Jan-2021.  Action taken with mRNA-1273 in response to the events 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site), sweaty, temperature 85.7F was not provided.  The outcome of the events 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site ), sweaty, temperature 85.7F was not provided.  The reporter did not provide the assessment of the events 100.4F fever, heart rate 115, muscle was tight and tender (area is left mid-outer thigh going diagonally towards the knee)(LLT: muscle tightness and muscle tenderness any site ), sweaty, temperature 85.7F to study drug.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.