chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (bad cough this morning), HYPERHIDROSIS (sweat), FATIGUE (Felt tired,fatigue), MYALGIA (Woke up with aches) and CHILLS (chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN POTASSIUM (LOSARTAN POTASSSIUM) and OMEPRAZOLE (OMEPRAZOLE ABBOTT) for an unknown indication.    On 11-Jan-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FATIGUE (Felt tired,fatigue), MYALGIA (Woke up with aches), CHILLS (chills) and PYREXIA (fever). On 13-Jan-2021, the patient experienced COUGH (bad cough this morning). On an unknown date, the patient experienced HYPERHIDROSIS (sweat). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form. At the time of the report, COUGH (bad cough this morning) outcome was unknown and HYPERHIDROSIS (sweat), FATIGUE (Felt tired,fatigue), MYALGIA (Woke up with aches), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: 101.4 (High) high.         The patient reported taking an unspecified nasal spray concomitantly.  In the afternoon of 11JAN2021, the patient felt tired and took a nap. He woke up with aches, chills , fever and fatigue. (which lasted for about 48 hours).  The patient self-treated with ibuprofen, which helped the fever. On 13JAN2021, the patient developed a "bad cough" which was concerning. The patient experienced fatigue for 4 or 5 days.   This case was linked to MOD-2021-075444 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: Reporter address and Lot # provided, additional events and event details reported On 12-Apr-2021: Completed ADR Form: includes patient demographic information and medical history, event outcomes updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: muscle aches; chills; fever (about 101.5 temp); body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches), CHILLS (chills), PYREXIA (fever (about 101.5 temp)) and PAIN (body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle aches), CHILLS (chills), PYREXIA (fever (about 101.5 temp)) and PAIN (body aches). At the time of the report, MYALGIA (muscle aches), CHILLS (chills), PYREXIA (fever (about 101.5 temp)) and PAIN (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 °F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Company Comment  This case concerns a patient of unknown age and gender, with PMH of COVID-19, who experienced nonserious expected events of pain, fever, chills, and myalgia.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: felt dizzy; dizzy and lightheaded when she woke up; Sore arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (felt dizzy; dizzy and lightheaded when she woke up) and VACCINATION SITE PAIN (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included HYDROCHLOROTHIAZIDE, CALCIUM, VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE], BIOTIN and FISH OIL for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 06-Jan-2021, the patient experienced DIZZINESS (felt dizzy; dizzy and lightheaded when she woke up). In January 2021, VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, DIZZINESS (felt dizzy; dizzy and lightheaded when she woke up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dyspepsia, Feeling abnormal, Headache
Clinical narrative: extreme migraine; inflamed nodules in neck; can't bend fingers; heartburn; Left arm - can't even move it (injection site); bad sweating; I feel like I have been poisoned; Couldn't go to work; stomach issues; body aches; vomiting; bad chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (extreme migraine), LYMPH NODE PAIN (inflamed nodules in neck), JOINT STIFFNESS (can't bend fingers), DYSPEPSIA (heartburn) and VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm - can't even move it (injection site)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEADACHE (headache). On 08-Jan-2021, the patient experienced MIGRAINE (extreme migraine), LYMPH NODE PAIN (inflamed nodules in neck), JOINT STIFFNESS (can't bend fingers), DYSPEPSIA (heartburn), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm - can't even move it (injection site)), HYPERHIDROSIS (bad sweating), FEELING ABNORMAL (I feel like I have been poisoned), IMPAIRED WORK ABILITY (Couldn't go to work), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches), VOMITING (vomiting) and CHILLS (bad chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, tid; Physical therapy (ice) for Migraine and Physical therapy (ice) for Headache. At the time of the report, MIGRAINE (extreme migraine), LYMPH NODE PAIN (inflamed nodules in neck), JOINT STIFFNESS (can't bend fingers), DYSPEPSIA (heartburn), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm - can't even move it (injection site)), HYPERHIDROSIS (bad sweating), FEELING ABNORMAL (I feel like I have been poisoned), IMPAIRED WORK ABILITY (Couldn't go to work), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches), VOMITING (vomiting), CHILLS (bad chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment reported was homeopathic previously.; 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, Impaired work ability, Joint stiffness, Lymph node pain, Migraine
Clinical narrative: extreme migraine; inflamed nodules in neck; can't bend fingers; heartburn; Left arm - can't even move it (injection site); bad sweating; I feel like I have been poisoned; Couldn't go to work; stomach issues; body aches; vomiting; bad chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (extreme migraine), LYMPH NODE PAIN (inflamed nodules in neck), JOINT STIFFNESS (can't bend fingers), DYSPEPSIA (heartburn) and VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm - can't even move it (injection site)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEADACHE (headache). On 08-Jan-2021, the patient experienced MIGRAINE (extreme migraine), LYMPH NODE PAIN (inflamed nodules in neck), JOINT STIFFNESS (can't bend fingers), DYSPEPSIA (heartburn), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm - can't even move it (injection site)), HYPERHIDROSIS (bad sweating), FEELING ABNORMAL (I feel like I have been poisoned), IMPAIRED WORK ABILITY (Couldn't go to work), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches), VOMITING (vomiting) and CHILLS (bad chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, tid; Physical therapy (ice) for Migraine and Physical therapy (ice) for Headache. At the time of the report, MIGRAINE (extreme migraine), LYMPH NODE PAIN (inflamed nodules in neck), JOINT STIFFNESS (can't bend fingers), DYSPEPSIA (heartburn), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm - can't even move it (injection site)), HYPERHIDROSIS (bad sweating), FEELING ABNORMAL (I feel like I have been poisoned), IMPAIRED WORK ABILITY (Couldn't go to work), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches), VOMITING (vomiting), CHILLS (bad chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment reported was homeopathic previously.; 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: Myalgia, Vaccination site movement impairment, Vomiting
Clinical narrative: extreme migraine; inflamed nodules in neck; can't bend fingers; heartburn; Left arm - can't even move it (injection site); bad sweating; I feel like I have been poisoned; Couldn't go to work; stomach issues; body aches; vomiting; bad chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (extreme migraine), LYMPH NODE PAIN (inflamed nodules in neck), JOINT STIFFNESS (can't bend fingers), DYSPEPSIA (heartburn) and VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm - can't even move it (injection site)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEADACHE (headache). On 08-Jan-2021, the patient experienced MIGRAINE (extreme migraine), LYMPH NODE PAIN (inflamed nodules in neck), JOINT STIFFNESS (can't bend fingers), DYSPEPSIA (heartburn), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm - can't even move it (injection site)), HYPERHIDROSIS (bad sweating), FEELING ABNORMAL (I feel like I have been poisoned), IMPAIRED WORK ABILITY (Couldn't go to work), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches), VOMITING (vomiting) and CHILLS (bad chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, tid; Physical therapy (ice) for Migraine and Physical therapy (ice) for Headache. At the time of the report, MIGRAINE (extreme migraine), LYMPH NODE PAIN (inflamed nodules in neck), JOINT STIFFNESS (can't bend fingers), DYSPEPSIA (heartburn), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm - can't even move it (injection site)), HYPERHIDROSIS (bad sweating), FEELING ABNORMAL (I feel like I have been poisoned), IMPAIRED WORK ABILITY (Couldn't go to work), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches), VOMITING (vomiting), CHILLS (bad chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment reported was homeopathic previously.; 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: Ageusia, Anosmia
Clinical narrative: Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Chills; Fever; Soreness in my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (Soreness in my shoulder) and CHILLS (Chills) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (Fever) and ARTHRALGIA (Soreness in my shoulder). On 13-Jan-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Shoulder pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and ARTHRALGIA (Soreness in my shoulder) had resolved and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site mass
Clinical narrative: bump at the injection site; rash at the injection site; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed rash at injection site and bump at injection site.  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) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed a rash and bump at the injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events of rash at injection site and bump at injection site was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced NS events of unexpected Vaccination site mass and expected Injection site rash.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Paraesthesia oral, Pyrexia
Clinical narrative: low grade fever; swollen lymph node on collar bone; pain in arm; tingling in lips and tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in lips and tongue), PAIN IN EXTREMITY (pain in arm), PYREXIA (low grade fever) and LYMPHADENOPATHY (swollen lymph node on collar bone) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced PARAESTHESIA ORAL (tingling in lips and tongue). On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 11-Jan-2021, the patient experienced PYREXIA (low grade fever) and LYMPHADENOPATHY (swollen lymph node on collar bone). On 07-Jan-2021, PARAESTHESIA ORAL (tingling in lips and tongue) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) outcome was unknown and PYREXIA (low grade fever) and LYMPHADENOPATHY (swollen lymph node on collar bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Throbbing in my arm after the injection; A spontaneous report was received from a physician concerning a 65-years-old, female patient who experienced throbbing in arm after injection.   The patient's medical history included diabetes, borderline high cholesterol levels, high blood pressure and migraines. Concomitant products were Metformin for diabetes, Rosuvastatin for cholesterol levels, Propranolol for migraines and an unknown medication to control blood pressure.   On 02 JAN 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient reported throbbing in arm after the injection. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, throbbing in arm after the injection was considered recovered on 03 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy site of injection; Swollen site of injection; Redness site of injection; bad headache; Pain at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Pain at the site of injection), INJECTION SITE PRURITUS (Itchy site of injection), INJECTION SITE SWELLING (Swollen site of injection), INJECTION SITE ERYTHEMA (Redness site of injection) and HEADACHE (bad headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   The patient's past medical history included No adverse event (No medical history provided).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at the site of injection). On 11-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy site of injection), INJECTION SITE SWELLING (Swollen site of injection), INJECTION SITE ERYTHEMA (Redness site of injection) and HEADACHE (bad headache). At the time of the report, INJECTION SITE PAIN (Pain at the site of injection), INJECTION SITE PRURITUS (Itchy site of injection), INJECTION SITE SWELLING (Swollen site of injection), INJECTION SITE ERYTHEMA (Redness site of injection) and HEADACHE (bad headache) had not resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Vaccination site pain
Clinical narrative: A kind of strange feeling; The whole body was tied all over; Slight nausea; Soreness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (A kind of strange feeling), VACCINATION SITE PAIN (Soreness), FATIGUE (The whole body was tied all over) and NAUSEA (Slight nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027DOA) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness). On 10-Jan-2021, the patient experienced FEELING ABNORMAL (A kind of strange feeling), FATIGUE (The whole body was tied all over) and NAUSEA (Slight nausea). At the time of the report, FEELING ABNORMAL (A kind of strange feeling) and NAUSEA (Slight nausea) had not resolved, VACCINATION SITE PAIN (Soreness) outcome was unknown and FATIGUE (The whole body was tied all over) 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 did not receive any treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: Grew to a rash; Injection site became swollen; Itchy; arm was sore to touch; A spontaneous report was received from a consumer who was an 68-year-old, female patient who experienced sore to touch, injection site became swollen, itchy and grew to a rash.  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient experienced sore to touch. No treatment information was included.   On 07 Jan 2021, the patient reported that the injection site became swollen and itchy.   On 08 Jan 2021, the patient developed a rash. The treatment for the event included caladryl.  Action taken with mRNA-1273 in response to the events was not provided.  The event, sore to touch, was considered resolved on 02 Jan 2021.  The outcome for the events, injection site became swollen and itchy was unknown.  The outcome for the event, grew to a rash was not resolved.; Reporter's Comments: This case concerns a 68-year-old female who experienced nonserious expected events of pain in extremity, injection site swelling, injection site pruritus, injection site rash.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment included caladryl. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, Chills, Fatigue
Clinical narrative: Blood pressure of 171/87; heartbeat increases to 85 bpm; Fatigue; Headache; Muscle pain; Joint pain; Chills; Fever; Nausea; A spontaneous report was received from a consumer concerning a 67 year old male patient who experienced elevated BP/Hypertension, heartbeat increased/Elevated heart rate, fatigue/Fatigue,headache/Headache, muscle pain/Myalgia, joint pain/Arthralgia, chills/Chills, fever/Pyrexia, and nausea/Nausea.  The patient's medical history was not provided. Concomitant product use was not provided.  On 04-Jan-2021, prior to the onset of events,  the patient received the first of two planned doses of mRNA-1273 (Batch number 037K20A) (route and site not provided) for prophylaxis of Covid 19 infection.  The reporter (wife of the patient), stated that her husband was vaccinated with Moderna Covid-19 vaccine on 04-Jan-2021 at his place of employment, where he works as a nurse. Since 08-Jan-2021 the patient has been experiencing fatigue, headache, muscle pain, joint pain, chills, and nausea. She reported a fever of 100.9 degrees F. and a blood pressure of 171/87. She stated," if he is being stressed his heartbeat increases to 85 bpm when his usual is 60bpm". She further reported that on 09-Jan-2021, "they" (not defined)  recorded the patient's blood pressure at 184/104, a heartbeat of 87 bpm, and a body temperature of 99.2 degrees F.  Treatment was reported as Motrin 600mg for fever and Nyquil cold and flu. Regimen for these medications was not provided.  The reporter stated that the patient's symptoms continue to persist and they worsen at night time.  Action taken with mRNA-1273 in response to the events was not provided  The outcome of the events, fatigue, headache, muscle pain, joint pain, chills, nausea, fever, elevated blood pressure, and heartbeat increased were Not recovered/Not resolved.  Company comment:  The reported events, Hypertension, Elevated Heart Rate, Fatigue, Headache, Myalgia, Arthralgia, Chills, Pyrexia, and Nausea were considered possibly related to mRNA-1273.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the headache, fatigue, myalgia, arthralgia, chills, pyrexia and nausea, a causal relationship cannot be excluded. Very limited information regarding the cardiovascular events has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Myalgia, Nausea
Clinical narrative: Blood pressure of 171/87; heartbeat increases to 85 bpm; Fatigue; Headache; Muscle pain; Joint pain; Chills; Fever; Nausea; A spontaneous report was received from a consumer concerning a 67 year old male patient who experienced elevated BP/Hypertension, heartbeat increased/Elevated heart rate, fatigue/Fatigue,headache/Headache, muscle pain/Myalgia, joint pain/Arthralgia, chills/Chills, fever/Pyrexia, and nausea/Nausea.  The patient's medical history was not provided. Concomitant product use was not provided.  On 04-Jan-2021, prior to the onset of events,  the patient received the first of two planned doses of mRNA-1273 (Batch number 037K20A) (route and site not provided) for prophylaxis of Covid 19 infection.  The reporter (wife of the patient), stated that her husband was vaccinated with Moderna Covid-19 vaccine on 04-Jan-2021 at his place of employment, where he works as a nurse. Since 08-Jan-2021 the patient has been experiencing fatigue, headache, muscle pain, joint pain, chills, and nausea. She reported a fever of 100.9 degrees F. and a blood pressure of 171/87. She stated," if he is being stressed his heartbeat increases to 85 bpm when his usual is 60bpm". She further reported that on 09-Jan-2021, "they" (not defined)  recorded the patient's blood pressure at 184/104, a heartbeat of 87 bpm, and a body temperature of 99.2 degrees F.  Treatment was reported as Motrin 600mg for fever and Nyquil cold and flu. Regimen for these medications was not provided.  The reporter stated that the patient's symptoms continue to persist and they worsen at night time.  Action taken with mRNA-1273 in response to the events was not provided  The outcome of the events, fatigue, headache, muscle pain, joint pain, chills, nausea, fever, elevated blood pressure, and heartbeat increased were Not recovered/Not resolved.  Company comment:  The reported events, Hypertension, Elevated Heart Rate, Fatigue, Headache, Myalgia, Arthralgia, Chills, Pyrexia, and Nausea were considered possibly related to mRNA-1273.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the headache, fatigue, myalgia, arthralgia, chills, pyrexia and nausea, a causal relationship cannot be excluded. Very limited information regarding the cardiovascular events has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Blood pressure of 171/87; heartbeat increases to 85 bpm; Fatigue; Headache; Muscle pain; Joint pain; Chills; Fever; Nausea; A spontaneous report was received from a consumer concerning a 67 year old male patient who experienced elevated BP/Hypertension, heartbeat increased/Elevated heart rate, fatigue/Fatigue,headache/Headache, muscle pain/Myalgia, joint pain/Arthralgia, chills/Chills, fever/Pyrexia, and nausea/Nausea.  The patient's medical history was not provided. Concomitant product use was not provided.  On 04-Jan-2021, prior to the onset of events,  the patient received the first of two planned doses of mRNA-1273 (Batch number 037K20A) (route and site not provided) for prophylaxis of Covid 19 infection.  The reporter (wife of the patient), stated that her husband was vaccinated with Moderna Covid-19 vaccine on 04-Jan-2021 at his place of employment, where he works as a nurse. Since 08-Jan-2021 the patient has been experiencing fatigue, headache, muscle pain, joint pain, chills, and nausea. She reported a fever of 100.9 degrees F. and a blood pressure of 171/87. She stated," if he is being stressed his heartbeat increases to 85 bpm when his usual is 60bpm". She further reported that on 09-Jan-2021, "they" (not defined)  recorded the patient's blood pressure at 184/104, a heartbeat of 87 bpm, and a body temperature of 99.2 degrees F.  Treatment was reported as Motrin 600mg for fever and Nyquil cold and flu. Regimen for these medications was not provided.  The reporter stated that the patient's symptoms continue to persist and they worsen at night time.  Action taken with mRNA-1273 in response to the events was not provided  The outcome of the events, fatigue, headache, muscle pain, joint pain, chills, nausea, fever, elevated blood pressure, and heartbeat increased were Not recovered/Not resolved.  Company comment:  The reported events, Hypertension, Elevated Heart Rate, Fatigue, Headache, Myalgia, Arthralgia, Chills, Pyrexia, and Nausea were considered possibly related to mRNA-1273.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the headache, fatigue, myalgia, arthralgia, chills, pyrexia and nausea, a causal relationship cannot be excluded. Very limited information regarding the cardiovascular events has been provided at this time. Further information has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site hot to touch; Injection site itching; Left arm a little swollen; Left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Left arm a little swollen) and VACCINATION SITE PAIN (Left arm was sore) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.) since an unknown date.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Left arm a little swollen) and VACCINATION SITE PAIN (Left arm was sore). On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE PRURITUS (Injection site itching). On 31-Dec-2020, VACCINATION SITE PAIN (Left arm was sore) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site hot to touch), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Left arm a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Flushing, Pruritus, Vaccination site pain
Clinical narrative: Face was red and blushy; face was warm to the touch; Itchiness all over body; Pain at injection site; Felt coldness/chills; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face was red and blushy), FEELING HOT (face was warm to the touch), PRURITUS (Itchiness all over body), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Felt coldness/chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Sulfur), Type 2 diabetes mellitus and Drug allergy (allergic to Macrobid). Concomitant products included METFORMIN for Type 2 diabetes mellitus, LEVOTHYROXINE SODIUM (SYNTHROID), POTASSIUM CITRATE, ALLOPURINOL, HYDROCHLOROTHIAZIDE and METHENAMINE HIPPURATE for an unknown indication, METOPROLOL SUCCINATE.    On 08-Jan-2021 at 7:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced FLUSHING (Face was red and blushy), FEELING HOT (face was warm to the touch), PRURITUS (Itchiness all over body), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Felt coldness/chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 08-Jan-2021, FLUSHING (Face was red and blushy), FEELING HOT (face was warm to the touch), PRURITUS (Itchiness all over body), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Felt coldness/chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: Hives at the injection site; Rush at the injection site; Little pain at the injection site; A spontaneous report was received from a consumer concerning a 43-years-old, female patient who experienced a little pain at the injection site, hives at the injection site, and rush at the injection site.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Dec 2020, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 025G20) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, patient had a little pain at the injection site for a couple of days but yesterday on 07 Jan 2021 started experiencing significantly flowing, hives, rush and pain in the same area of her left arm. Treatment for the event included ibuprofen since 08 Jan 2021 but symptoms still ongoing.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events little pain at the injection site, hives at the injection site, and rush 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 onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: ringing in the ears; soreness at the injection site; headache; nausea; chills; fever; general fatigue; This spontaneous case was reported by a dentist and describes the occurrence of TINNITUS (ringing in the ears), VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included COVID-19 in September 2020.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced TINNITUS (ringing in the ears), VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (general fatigue). On 10-Jan-2021, VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (general fatigue) had resolved. At the time of the report, TINNITUS (ringing in the ears) 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.   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   This case was linked to MOD-2021-004639 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: ringing in the ears; soreness at the injection site; headache; nausea; chills; fever; general fatigue; This spontaneous case was reported by a dentist and describes the occurrence of TINNITUS (ringing in the ears), VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included COVID-19 in September 2020.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced TINNITUS (ringing in the ears), VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (general fatigue). On 10-Jan-2021, VACCINATION SITE PAIN (soreness at the injection site), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (general fatigue) had resolved. At the time of the report, TINNITUS (ringing in the ears) 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.   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   This case was linked to MOD-2021-004639 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness on the injection site; Swelling on the injection site; A report was received from a healthcare professional concerning a 44 year old female patient who was participating in a mRNA-1273 Program and developed redness and swelling at the injection site.   The patient's medical history and relevant concomitant medications were not reported.   On 31 Dec 2020, approximately eight days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the [left arm] for prophylaxis of COVID-19 infection.   The patient experienced redness and swelling at the injection site on the morning of 08 Jan 2021.  The patient treated the event with acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported .   The outcome of the events redness and swelling at the injection site were not reported.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Rash
Clinical narrative: Face rash all over; Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Face rash all over), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced RASH (Face rash all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 08-Jan-2021, HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, RASH (Face rash all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were 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: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: headache; muscle pain; joint pain; chills; will throw up any second; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (will throw up any second) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (will throw up any second). At the time of the report, HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (will throw up any second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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 events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Rash, Vaccination site discharge, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm has liquid on it; Arm is hot; Arm is swollen, puffy, swelling is getting bigger; Arm is tender; Rash in my chest; Metal taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal taste in mouth), VACCINATION SITE DISCHARGE (Arm has liquid on it), VACCINATION SITE WARMTH (Arm is hot), RASH (Rash in my chest) and VACCINATION SITE SWELLING (Arm is swollen, puffy, swelling is getting bigger) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Attention deficit hyperactivity disorder.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE DISCHARGE (Arm has liquid on it), VACCINATION SITE WARMTH (Arm is hot), VACCINATION SITE SWELLING (Arm is swollen, puffy, swelling is getting bigger) and VACCINATION SITE PAIN (Arm is tender). In January 2021, the patient experienced DYSGEUSIA (Metal taste in mouth) and RASH (Rash in my chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In January 2021, DYSGEUSIA (Metal taste in mouth) and RASH (Rash in my chest) had resolved. At the time of the report, VACCINATION SITE DISCHARGE (Arm has liquid on it), VACCINATION SITE WARMTH (Arm is hot), VACCINATION SITE SWELLING (Arm is swollen, puffy, swelling is getting bigger) and VACCINATION SITE PAIN (Arm is tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking medications for depression and ADHT.; Reporter's Comments: This case concerns a 44-year-old female with a nonserious unexpected event of dysgeusia, vaccination site warmth, vaccination site discharge, and expected rash, vaccination site swelling, and vaccination site pain. Event onset the same day as first dose mRNA-1273. 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.