chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 January 2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Chest pain so bad thought I was having a heart attack; Pain in the arm; Headache; Nausea; Vomiting; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain so bad thought I was having a heart attack), PAIN IN EXTREMITY (Pain in the arm), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057620A) for COVID-19 vaccination.     Concurrent medical conditions included Endometriosis. Concomitant products included OXYBUTYNIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced CHEST PAIN (Chest pain so bad thought I was having a heart attack), PAIN IN EXTREMITY (Pain in the arm), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, CHEST PAIN (Chest pain so bad thought I was having a heart attack), PAIN IN EXTREMITY (Pain in the arm), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: A spontaneous report was received from a Consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore right arm and achy, felt pretty bad, had a small fatigue, right arm was swollen, right arm was hard, hardly move the arm because of the ache, the fatigue increased, felt dizzy or kind of disorientated, caller can't tell which one it was, she sweated, had chills, could not sleep, she had head pressure, and right arm has like a bruises. The patient's medical history was not provided. Concomitant medications reported were Blood pressure medication, Pepsin medication for drug use for unknown indication. On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the right arm for  prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced the events sore right arm and achy, felt pretty bad, had a small fatigue. On 29 Jan 2021, the patient experienced the events right arm was swollen, right arm was hard, hardly move the arm because of the ache, the fatigue increased, felt dizzy or kind of disorientated, caller can't tell which one it was, she sweated, had chills. On 30 Jan 2021, the patient experienced the events could not sleep. she had head pressure. On 31 Jan 2021, the patient experienced the events symptoms went milder almost went away. On 01 Feb 2021, the patient experienced the events right arm has like a bruise and patient reported that  her  husband and she was a bit scared, because she heard the second dose can give stronger side effects.  Treatment details included,  Decongestive and antiallergic medication on 30Jan2021.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include sore right arm and achy, felt pretty bad, had a small fatigue, right arm was swollen, right arm was hard, hardly move the arm because of the ache, the fatigue increased, felt dizzy or kind of disorientated, caller can't tell which one it was, she sweated, had chills, could not sleep, she had head pressure, symptoms went milder almost went away, recovering/resolving, and right arm has like a bruise, a bit scared, because i heard the second dose can give stronger side effects was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hyperhidrosis, Induration, Insomnia, Pain in extremity
Clinical narrative: A spontaneous report was received from a Consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore right arm and achy, felt pretty bad, had a small fatigue, right arm was swollen, right arm was hard, hardly move the arm because of the ache, the fatigue increased, felt dizzy or kind of disorientated, caller can't tell which one it was, she sweated, had chills, could not sleep, she had head pressure, and right arm has like a bruises. The patient's medical history was not provided. Concomitant medications reported were Blood pressure medication, Pepsin medication for drug use for unknown indication. On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the right arm for  prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced the events sore right arm and achy, felt pretty bad, had a small fatigue. On 29 Jan 2021, the patient experienced the events right arm was swollen, right arm was hard, hardly move the arm because of the ache, the fatigue increased, felt dizzy or kind of disorientated, caller can't tell which one it was, she sweated, had chills. On 30 Jan 2021, the patient experienced the events could not sleep. she had head pressure. On 31 Jan 2021, the patient experienced the events symptoms went milder almost went away. On 01 Feb 2021, the patient experienced the events right arm has like a bruise and patient reported that  her  husband and she was a bit scared, because she heard the second dose can give stronger side effects.  Treatment details included,  Decongestive and antiallergic medication on 30Jan2021.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include sore right arm and achy, felt pretty bad, had a small fatigue, right arm was swollen, right arm was hard, hardly move the arm because of the ache, the fatigue increased, felt dizzy or kind of disorientated, caller can't tell which one it was, she sweated, had chills, could not sleep, she had head pressure, symptoms went milder almost went away, recovering/resolving, and right arm has like a bruise, a bit scared, because i heard the second dose can give stronger side effects was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: A spontaneous report was received from a Consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore right arm and achy, felt pretty bad, had a small fatigue, right arm was swollen, right arm was hard, hardly move the arm because of the ache, the fatigue increased, felt dizzy or kind of disorientated, caller can't tell which one it was, she sweated, had chills, could not sleep, she had head pressure, and right arm has like a bruises. The patient's medical history was not provided. Concomitant medications reported were Blood pressure medication, Pepsin medication for drug use for unknown indication. On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the right arm for  prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced the events sore right arm and achy, felt pretty bad, had a small fatigue. On 29 Jan 2021, the patient experienced the events right arm was swollen, right arm was hard, hardly move the arm because of the ache, the fatigue increased, felt dizzy or kind of disorientated, caller can't tell which one it was, she sweated, had chills. On 30 Jan 2021, the patient experienced the events could not sleep. she had head pressure. On 31 Jan 2021, the patient experienced the events symptoms went milder almost went away. On 01 Feb 2021, the patient experienced the events right arm has like a bruise and patient reported that  her  husband and she was a bit scared, because she heard the second dose can give stronger side effects.  Treatment details included,  Decongestive and antiallergic medication on 30Jan2021.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include sore right arm and achy, felt pretty bad, had a small fatigue, right arm was swollen, right arm was hard, hardly move the arm because of the ache, the fatigue increased, felt dizzy or kind of disorientated, caller can't tell which one it was, she sweated, had chills, could not sleep, she had head pressure, symptoms went milder almost went away, recovering/resolving, and right arm has like a bruise, a bit scared, because i heard the second dose can give stronger side effects was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: body aches; pain in the arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), INJECTION SITE PAIN (pain in the arm) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 28-Jan-2021, the patient experienced PAIN (body aches), INJECTION SITE PAIN (pain in the arm) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   At the time of the report, PAIN (body aches), INJECTION SITE PAIN (pain in the arm) and CHILLS (chills) 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 product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Patient's contact information updated; 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: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: has an adverse event to report; A spontaneous report was received on 26 Jan 2021, from a Healthcare Professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the event has an adverse event to report.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, has an adverse event to report was not reported.; Reporter's Comments: Very limited (NO) information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Having reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having reactions) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Having reactions). At the time of the report, VACCINATION COMPLICATION (Having reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Delayed rash; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delayed rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, approximately 13 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced delayed rash. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event delayed rash was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breathe, he said he cannot breathe which lasted for 2 minutes; A spontaneous report was received on 3Feb 2021,  from a Consumer concerning a 50-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shortness of breathe, he said he cannot breathe which lasted for 2 minutes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the events shortness of breathe. he said he cannot breathe which lasted for 2 minutes.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 13 Jan 2021 the outcome of events shortness of breathe was resolved.On 13 Jan 2021 the outcome of events he said he cannot breathe which lasted for 2 minutes was recovered/ resolved. .
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular, Vaccination site erythema, Vaccination site inflammation, Vaccination site mass
Clinical narrative: my arm was big and inflamed; red maculopapular rash; redness; small lump; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (small lump), VACCINATION SITE INFLAMMATION (my arm was big and inflamed), RASH MACULO-PAPULAR (red maculopapular rash) and VACCINATION SITE ERYTHEMA (redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 MASS (small lump) and VACCINATION SITE ERYTHEMA (redness). On 15-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (my arm was big and inflamed) and RASH MACULO-PAPULAR (red maculopapular rash). At the time of the report, VACCINATION SITE MASS (small lump), VACCINATION SITE INFLAMMATION (my arm was big and inflamed), RASH MACULO-PAPULAR (red maculopapular rash) and VACCINATION SITE ERYTHEMA (redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. The patient reported that red maculopapular rash was completely gone on day 14.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cognitive disorder, Headache, Myalgia
Clinical narrative: cognitive problems; loss of sense of smell and taste temporarily; loss of sense of smell and taste temporarily; Bodyaches; slight fever; heavier headaches; This spontaneous case was reported by a consumer and describes the occurrence of COGNITIVE DISORDER (cognitive problems), ANOSMIA (loss of sense of smell and taste temporarily), AGEUSIA (loss of sense of smell and taste temporarily), HEADACHE (heavier headaches) and MYALGIA (Bodyaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Headache.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (heavier headaches). On an unknown date, the patient experienced COGNITIVE DISORDER (cognitive problems), ANOSMIA (loss of sense of smell and taste temporarily), AGEUSIA (loss of sense of smell and taste temporarily), MYALGIA (Bodyaches) and PYREXIA (slight fever). On 24-Jan-2021, HEADACHE (heavier headaches) had resolved. At the time of the report, COGNITIVE DISORDER (cognitive problems), ANOSMIA (loss of sense of smell and taste temporarily), AGEUSIA (loss of sense of smell and taste temporarily), MYALGIA (Bodyaches) and PYREXIA (slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: Positive. On 20-Jan-2021, SARS-CoV-2 test: Positive. On 24-Jan-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Added new events.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: cognitive problems; loss of sense of smell and taste temporarily; loss of sense of smell and taste temporarily; Bodyaches; slight fever; heavier headaches; This spontaneous case was reported by a consumer and describes the occurrence of COGNITIVE DISORDER (cognitive problems), ANOSMIA (loss of sense of smell and taste temporarily), AGEUSIA (loss of sense of smell and taste temporarily), HEADACHE (heavier headaches) and MYALGIA (Bodyaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Headache.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (heavier headaches). On an unknown date, the patient experienced COGNITIVE DISORDER (cognitive problems), ANOSMIA (loss of sense of smell and taste temporarily), AGEUSIA (loss of sense of smell and taste temporarily), MYALGIA (Bodyaches) and PYREXIA (slight fever). On 24-Jan-2021, HEADACHE (heavier headaches) had resolved. At the time of the report, COGNITIVE DISORDER (cognitive problems), ANOSMIA (loss of sense of smell and taste temporarily), AGEUSIA (loss of sense of smell and taste temporarily), MYALGIA (Bodyaches) and PYREXIA (slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: Positive. On 20-Jan-2021, SARS-CoV-2 test: Positive. On 24-Jan-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Added new events.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This spontaneous case was reported by a pharmacist and describes the occurrence of ARTHRALGIA (Sore shoulder) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (COZAAR) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRALGIA (Sore shoulder). The patient was treated with IBUPROFEN (IBUPROFEN ACTAVIS) at a dose of 400 mg. At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; 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: Arthralgia
Clinical narrative: Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced ARTHRALGIA (Knee pain). At the time of the report, ARTHRALGIA (Knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.; 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Mild sore arm), HEADACHE (Mild headache) and NAUSEA (Mild nausea) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Mild sore arm). 06-Jan-2021, the patient experienced HEADACHE (Mild headache) and NAUSEA (Mild nausea). At the time of the report, PAIN IN EXTREMITY (Mild sore arm), HEADACHE (Mild headache) and NAUSEA (Mild nausea) 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 product use was not provided by the reporter. No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm; warm and itchy; red spot; vaccination site pain; vaccination site erythema; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (warm and itchy), VACCINATION SITE RASH (red spot), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (warm and itchy), VACCINATION SITE RASH (red spot), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (warm and itchy), VACCINATION SITE RASH (red spot), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site erythema) outcome 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 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: Muscle tightness, Vaccination site pain, Vaccination site reaction
Clinical narrative: the muscle has really tight feeling; have muscle spasm at the injection site; arm is painful; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (the muscle has really tight feeling), VACCINATION SITE REACTION (have muscle spasm at the injection site) and VACCINATION SITE PAIN (arm is painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A201A) for COVID-19 vaccination.     The patient's past medical history included Spinal cord injury.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (the muscle has really tight feeling), VACCINATION SITE REACTION (have muscle spasm at the injection site) and VACCINATION SITE PAIN (arm is painful). At the time of the report, MUSCLE TIGHTNESS (the muscle has really tight feeling), VACCINATION SITE REACTION (have muscle spasm at the injection site) and VACCINATION SITE PAIN (arm is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included ibuprofen and muscle relaxer.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: rash; hives; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (pin size pimples (hives) on top of feets and legs bilaterally/Hives started on wrist and cheek), PRURITUS (itchiness) and RASH (rash) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Patient takes allegra as needed for seasonal allergies), Sulfonamide allergy, Dust allergy, Asthma and GERD.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced URTICARIA (pin size pimples (hives) on top of feets and legs bilaterally/Hives started on wrist and cheek) and PRURITUS (itchiness). On an unknown date, the patient experienced RASH (rash). At the time of the report, URTICARIA (pin size pimples (hives) on top of feets and legs bilaterally/Hives started on wrist and cheek), PRURITUS (itchiness) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Benadryl for hives, allegra for hives started on wrist and cheek and prednisone. The dermatologist thought that the patient's immune system was ramping up in response to vaccine. No concomitant medication was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, SARS-CoV-2 test
Clinical narrative: now its in my palms and different parts of my body; itching sensation; tingling in my fingers like pins and needles; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my fingers like pins and needles), PARAESTHESIA (now its in my palms and different parts of my body) and PRURITUS (itching sensation) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy and Allergy.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PARAESTHESIA (tingling in my fingers like pins and needles) and PRURITUS (itching sensation). On an unknown date, the patient experienced PARAESTHESIA (now its in my palms and different parts of my body). At the time of the report, PARAESTHESIA (tingling in my fingers like pins and needles) and PARAESTHESIA (now its in my palms and different parts of my body) had not resolved and PRURITUS (itching sensation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter 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: Body temperature, Chills, Erythema, Gingival pain, Gingival swelling
Clinical narrative: bumps on roof of mouth; Tender swollen gums; Tender swollen gums; heart was racing; tender bumps at the roof of the mouth behind her front teeth; itchy and tender 2 inch circle at the injection site; 2 inch circle at the injection site; chills; fever; hands, arms, face and eyes were red; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth), ERYTHEMA (hands, arms, face and eyes were red), GINGIVAL PAIN (Tender swollen gums) and GINGIVAL SWELLING (Tender swollen gums) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive on 18-Dec-2020.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Jan-2021, the patient experienced ERYTHEMA (hands, arms, face and eyes were red), CHILLS (chills) and PYREXIA (fever). On 17-Jan-2021, the patient experienced PALPITATIONS (heart was racing), ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth) and VACCINATION SITE PRURITUS (itchy and tender 2 inch circle at the injection site). On an unknown date, the patient experienced GINGIVAL PAIN (Tender swollen gums), GINGIVAL SWELLING (Tender swollen gums), ORAL DISORDER (bumps on roof of mouth) and VACCINATION SITE RASH (2 inch circle at the injection site). On 15-Jan-2021, ERYTHEMA (hands, arms, face and eyes were red), CHILLS (chills) and PYREXIA (fever) had resolved. On 17-Jan-2021, PALPITATIONS (heart was racing) had resolved. On 20-Jan-2021, ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth) and VACCINATION SITE PRURITUS (itchy and tender 2 inch circle at the injection site) had resolved. At the time of the report, GINGIVAL PAIN (Tender swollen gums), GINGIVAL SWELLING (Tender swollen gums) and VACCINATION SITE RASH (2 inch circle at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.2-102 degree F.     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.; 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: Oral disorder, Oral pain, Palpitations, Pyrexia, Vaccination site pruritus
Clinical narrative: bumps on roof of mouth; Tender swollen gums; Tender swollen gums; heart was racing; tender bumps at the roof of the mouth behind her front teeth; itchy and tender 2 inch circle at the injection site; 2 inch circle at the injection site; chills; fever; hands, arms, face and eyes were red; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth), ERYTHEMA (hands, arms, face and eyes were red), GINGIVAL PAIN (Tender swollen gums) and GINGIVAL SWELLING (Tender swollen gums) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive on 18-Dec-2020.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Jan-2021, the patient experienced ERYTHEMA (hands, arms, face and eyes were red), CHILLS (chills) and PYREXIA (fever). On 17-Jan-2021, the patient experienced PALPITATIONS (heart was racing), ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth) and VACCINATION SITE PRURITUS (itchy and tender 2 inch circle at the injection site). On an unknown date, the patient experienced GINGIVAL PAIN (Tender swollen gums), GINGIVAL SWELLING (Tender swollen gums), ORAL DISORDER (bumps on roof of mouth) and VACCINATION SITE RASH (2 inch circle at the injection site). On 15-Jan-2021, ERYTHEMA (hands, arms, face and eyes were red), CHILLS (chills) and PYREXIA (fever) had resolved. On 17-Jan-2021, PALPITATIONS (heart was racing) had resolved. On 20-Jan-2021, ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth) and VACCINATION SITE PRURITUS (itchy and tender 2 inch circle at the injection site) had resolved. At the time of the report, GINGIVAL PAIN (Tender swollen gums), GINGIVAL SWELLING (Tender swollen gums) and VACCINATION SITE RASH (2 inch circle at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.2-102 degree F.     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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: bumps on roof of mouth; Tender swollen gums; Tender swollen gums; heart was racing; tender bumps at the roof of the mouth behind her front teeth; itchy and tender 2 inch circle at the injection site; 2 inch circle at the injection site; chills; fever; hands, arms, face and eyes were red; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth), ERYTHEMA (hands, arms, face and eyes were red), GINGIVAL PAIN (Tender swollen gums) and GINGIVAL SWELLING (Tender swollen gums) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive on 18-Dec-2020.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Jan-2021, the patient experienced ERYTHEMA (hands, arms, face and eyes were red), CHILLS (chills) and PYREXIA (fever). On 17-Jan-2021, the patient experienced PALPITATIONS (heart was racing), ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth) and VACCINATION SITE PRURITUS (itchy and tender 2 inch circle at the injection site). On an unknown date, the patient experienced GINGIVAL PAIN (Tender swollen gums), GINGIVAL SWELLING (Tender swollen gums), ORAL DISORDER (bumps on roof of mouth) and VACCINATION SITE RASH (2 inch circle at the injection site). On 15-Jan-2021, ERYTHEMA (hands, arms, face and eyes were red), CHILLS (chills) and PYREXIA (fever) had resolved. On 17-Jan-2021, PALPITATIONS (heart was racing) had resolved. On 20-Jan-2021, ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth) and VACCINATION SITE PRURITUS (itchy and tender 2 inch circle at the injection site) had resolved. At the time of the report, GINGIVAL PAIN (Tender swollen gums), GINGIVAL SWELLING (Tender swollen gums) and VACCINATION SITE RASH (2 inch circle at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.2-102 degree F.     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.; 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccination site pruritus; Vaccination site swelling; Pain in extremity; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in extremity). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling). On 03-Feb-2021, VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in extremity) outcome was unknown.            No concomitant medications were provided by the reporter Treatment medicines include Some Allergy medication (not specified)   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received , updated second dose information and event outcome was updated from unknown to recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Nausea
Clinical narrative: Flush; Felt a tiny bit nauseous; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flush), NAUSEA (Felt a tiny bit nauseous) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FLUSHING (Flush), NAUSEA (Felt a tiny bit nauseous) and FATIGUE (Fatigue). At the time of the report, FLUSHING (Flush), NAUSEA (Felt a tiny bit nauseous) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: 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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Fatigue, Nausea, Oxygen saturation
Clinical narrative: On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and DYSPNOEA (difficulty of breathing/his difficulty of breathing got worse). On 02-Feb-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced NAUSEA (nauseous). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), DYSPNOEA (difficulty of breathing/his difficulty of breathing got worse) and FATIGUE (fatigue) outcome was unknown and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Oxygen saturation: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysgeusia, Pyrexia
Clinical narrative: Metallic taste in mouth; Cough; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth), COUGH (Cough) and PYREXIA (Low grade fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth), COUGH (Cough) and PYREXIA (Low grade fever). At the time of the report, DYSGEUSIA (Metallic taste in mouth), COUGH (Cough) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site erythema, Vaccination site mass
Clinical narrative: Both her legs hurt, it was very painful, and it got progressively worse; muscle aches and could not walk around; still has a red mark on her arm; arm was sore; red bump/lump; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021. The most recent information was received on 11-Jul-2021 and was forwarded to Moderna on 11-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (red bump/lump), PAIN IN EXTREMITY (Both her legs hurt, it was very painful, and it got progressively worse), VACCINATION SITE ERYTHEMA (still has a red mark on her arm) and MYALGIA (muscle aches and could not walk around) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (red bump/lump) and VACCINATION SITE ERYTHEMA (still has a red mark on her arm). On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Both her legs hurt, it was very painful, and it got progressively worse) and MYALGIA (muscle aches and could not walk around). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE MASS (red bump/lump), PAIN IN EXTREMITY (Both her legs hurt, it was very painful, and it got progressively worse), VACCINATION SITE ERYTHEMA (still has a red mark on her arm) and MYALGIA (muscle aches and could not walk around) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For the second dose, the patient reported they did not have any reaction.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: follow up received on 11-jul-2021 is Significant Follow up  and  outcome of event updated