chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Influenza, Nasopharyngitis, Pyrexia
Clinical narrative: Got the flu; Diarrhea; Running temperature; Freezing cold; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Got the flu), DIARRHOEA (Diarrhea), PYREXIA (Running temperature), NASOPHARYNGITIS (Freezing cold) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA (Got the flu), DIARRHOEA (Diarrhea), PYREXIA (Running temperature), NASOPHARYNGITIS (Freezing cold) and FATIGUE (Fatigue). At the time of the report, INFLUENZA (Got the flu), DIARRHOEA (Diarrhea), PYREXIA (Running temperature), NASOPHARYNGITIS (Freezing cold) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No treatment information was provided.    Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; really bad fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and FATIGUE (really bad fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included evunatol for anti-inflammatories, LOSARTAN, ACETYLSALICYLIC ACID (BABY ASPIRIN), OMEPRAZOLE and propenarol for an unknown indication.  On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (really bad fatigue). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) and FATIGUE (really bad fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Irritability, Myalgia
Clinical narrative: extreme fatigue; muscle aches; severe headaches; irritable; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue), MYALGIA (muscle aches), HEADACHE (severe headaches) and IRRITABILITY (irritable) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE SOLUTION TABLETS) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (extreme fatigue), MYALGIA (muscle aches), HEADACHE (severe headaches) and IRRITABILITY (irritable). At the time of the report, FATIGUE (extreme fatigue), MYALGIA (muscle aches), HEADACHE (severe headaches) and IRRITABILITY (irritable) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details included ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: queasiness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (queasiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced NAUSEA (queasiness). At the time of the report, NAUSEA (queasiness) 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.   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site joint swelling, Pain in extremity, Swelling
Clinical narrative: Sore Arm; swelling; injection site has a bump the size of a hard boiled egg.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), SWELLING (swelling) and INJECTION SITE JOINT SWELLING (injection site has a bump the size of a hard boiled egg.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), SWELLING (swelling) and INJECTION SITE JOINT SWELLING (injection site has a bump the size of a hard boiled egg.). At the time of the report, PAIN IN EXTREMITY (Sore Arm), SWELLING (swelling) and INJECTION SITE JOINT SWELLING (injection site has a bump the size of a hard boiled egg.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19 and started having symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Positive for COVID-19 and started having symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (Positive for COVID-19 and started having symptoms). The patient was treated with BAMLANIVIMAB for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Positive for COVID-19 and started having symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: large red painful rash on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (large red painful rash on the injection arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included METHOTREXATE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE RASH (large red painful rash on the injection arm). At the time of the report, INJECTION SITE RASH (large red painful rash on the injection arm) outcome was unknown. Not Provided      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.   No treatment information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: Swelling arm; Vaccination site pain; A spontaneous report was received from a consumer concerning a 85-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed pain in her arm and soreness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the event(s) pain in her arm. soreness.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain in her arm, soreness was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain around the injection site; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain around the injection site.  The patient's medical history included that he had mild case of COVID injection in October to November 2020, he also has a current condition of arthritis. Concomitant medications reported were Tylenol for drug use for unknown indication.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced pain around the injection site (injection site pain).  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site erythema, Injection site pruritus, Superficial vein prominence, Tenderness
Clinical narrative: itchy rash; reddish; superficial vein in leg; tender to touch; bruise; A spontaneous report was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced superficial vein in leg, tender to touch, bruise, itchy rash, reddish.  The patient's medical history was not provided. Concomitant medications reported were Advil for drug use for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced superficial vein in leg, tender to touch (tenderness), bruise (contusion). and On 12 Feb 2021, the patient experienced itchy rash (injection site pruritus) and was reddish (injection site erythema).  Treatment details included that patient had applied a compress many times a day in the leg and applied a cream in the injection site.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: tender arm but was still able to do her daily activities with no issues.; A spontaneous report was received from a consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tender arm but was still able to do her daily activities with no issue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  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: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced tender arm (tenderness) but was still able to do her daily activities with no issues.  Treatment details was not included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Muscle pain and pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Muscle pain and pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (Muscle pain and pain at the injection site). At the time of the report, INJECTION SITE PAIN (Muscle pain and pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported.   Reporter did not allow further contact
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site discharge
Clinical narrative: I took the bandage off and saw black and blue bruise; saw little blood on the bandage; A spontaneous report was received from a consumer concerning a 87-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events i took the bandage off and saw black and blue bruise, saw little blood on the bandage.  The patient's medical history was not provided. Concomitant medications reported were Lovastatin, Baby Aspirin for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient took the bandage off and saw black and blue bruise (contusion) and saw little blood on the bandage (vaccination site discharge).  Treatment details included, mRNA-1273 mRNA-1273 Adverse Event Not Applicable.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; A spontaneous  report (United States) was received from a  consumer concerning an   female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and    experienced chills.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications was  not reported.  on unknown date prior to the onset of the symptoms, the patient received their first  of two planned doses of mRNA-1273 (Batch number Unknown)  for prophylaxis of COVID-19 infection   On 11 Feb  2021, patient reported  the event chills for  about 36 hours.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided.   The outcome of the event chills is unknown
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Sore arm; Rash; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, 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 17 Feb 2021, the patient experienced sore arm(pain in extremity) and rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Headache, Myalgia
Clinical narrative: weak; out of breath; aches; chills; headaches; pain; A spontaneous report was received on 8 Feb 2021, from a consumer concerning a 87-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events aches, chills, headaches, pain, weak, out of breath.  The patient's medical history was not provided. Concomitant medications reported were amlodipine for drug use for unknown indication.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 103K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the event(s) aches, chills, headaches, pain. On 8 Feb 2021, the patient experienced the event(s) weak, out of breath.  Treatment details included Tylenol, YSayegh8Feb2021.  Action taken with mRNA-1273 in response to the events was not reported.  On 1 Feb 2021 the outcome of event(s), aches, chills, headaches was resolved. The outcome of event(s), pain, weak, out of breath was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: weak; out of breath; aches; chills; headaches; pain; A spontaneous report was received on 8 Feb 2021, from a consumer concerning a 87-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events aches, chills, headaches, pain, weak, out of breath.  The patient's medical history was not provided. Concomitant medications reported were amlodipine for drug use for unknown indication.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 103K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the event(s) aches, chills, headaches, pain. On 8 Feb 2021, the patient experienced the event(s) weak, out of breath.  Treatment details included Tylenol, YSayegh8Feb2021.  Action taken with mRNA-1273 in response to the events was not reported.  On 1 Feb 2021 the outcome of event(s), aches, chills, headaches was resolved. The outcome of event(s), pain, weak, out of breath was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects after the vaccine; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events as side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, 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.   Side effects after the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown  The outcome of event(s), side effects after the vaccine,  was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site mass
Clinical narrative: Small lump at the injection site; Redness at the injection site; Bruising at the injection site; A spontaneous report  was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at the injection site, bruising at the injection site and small lump at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced redness at the injection site (injection site erythema), bruising at the injection site (injection site bruise). On 15 Feb 2021, the patient experienced  small lump at the injection site (injection site mass).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Nausea, Pyrexia
Clinical narrative: fever; chills; nausea; reemergent fatigue; pain at injection site; fatigue; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at injection site, fatigue, fever, chills, nausea and the reemergence of fatigue.  The patient's medical history was not provided. Concomitant medications reported were Allergia pill, Prolia injection, Crestor pill for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011L20A) intramuscularly for prophylaxis of COVID-19 infection and on unknown date, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 8 Jan 2021, the patient experienced pain at injection site (injection site pain) and fatigue. On 5 Feb 2021, the patient experienced fever (pyrexia), chills, nausea, reemergent fatigue (fatigue).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Headache
Clinical narrative: joint pain; headache; dizziness; Patient is weak; lost appetite; A spontaneous report was received from a consumer concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events joint pain, headache, dizziness, patient is weak and lost appetite.  The patient's medical history was not provided. Concomitant medications reported were Tylenol for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced joint pain (Arthralgia), headache, dizziness, patient is weak (Asthenia), lost appetite (decreased appetite).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event  was unknown.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: CHILLS; FEVER; BODY ACHES; A spontaneous report was received from a consumer concerning a 47-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, fever, body aches and back aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 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 for prophylaxis of COVID-19 infection and On 15 Feb 2021,  the patient received their second of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced chills. fever(pyrexia), body aches.it was reported that patient took Tylenol to treat the body ache but that did not help. After contacting doctor, patient was asked to alternate Tylenol with Mortin. it was reported that fever was getting better but body ache was still same.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Skin burning sensation
Clinical narrative: strong chemical taste; burning feeling in her eyes and scalp; A spontaneous report was received from a healthcare professional concerning a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events strong chemical taste (dsgeusia), burning feeling in her eyes and scalp (skin burning sensation).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Jan 2021, approximately one day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A)(route unknown) in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the event(s) strong chemical taste and burning feeling in her eyes and scalp.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s) strong chemical taste and burning feeling in her eyes and scalp was considered resolved on 31 Jan 2021. .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Motion sickness, Peripheral swelling
Clinical narrative: Swelling arm; hurting arm; range of motion; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), LIMB DISCOMFORT (hurting arm) and MOTION SICKNESS (range of motion) in a 73-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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm), LIMB DISCOMFORT (hurting arm) and MOTION SICKNESS (range of motion). At the time of the report, PERIPHERAL SWELLING (Swelling arm), LIMB DISCOMFORT (hurting arm) and MOTION SICKNESS (range of motion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Neck pain
Clinical narrative: weakness; fatigue; neck aches; A spontaneous report was received from a consumer concerning a 77-years-old male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events weakness, fatigue, neck aches.  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) for prophylaxis of COVID-19 infection.   After 2 weeks, the patient experienced weakness, fatigue, and severe neck aches.  Treatment details included Diclofenac, Lidocaine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), weakness was unknown.The outcome of event(s), fatigue was unknown.The outcome of event(s), neck aches was unknown..
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Tiredness; Joint pain; A spontaneous report was received from a consumer concerning a 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue and arthralgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 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 for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events tiredness and joint pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report,the outcome of events, tiredness, joint pain was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Swelling
Clinical narrative: njection site started to itch; Swelling of lymph nodes under left arm; 5 inch red, round circle around injection site; A spontaneous report was received from a consumer concerning a 76-years-old ,female patient ,who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  5 inch red, round circle around injection site(injection site erythema), injection site started to itch(injection site pruritus), swelling of lymph nodes under left arm(swelling).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced  5 inch red,round circle around injection site. On 8 Feb 2021, the patient experienced itching in the injection site and  swelling of lymph nodes under left arm.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, 5 inch red, round circle around injection site,injection site started to itch, swelling of lymph nodes under left arm,  were considered as resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site got red, hot and itchy; Injection site got red, hot and itchy; Injection site got red, hot and itchy; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, Injection site erythema, injection site warmth and injection site pruritus.  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: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection. On 9 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events, injection site got red, hot and itchy.  Treatment details included Antibiotic, antihistamine, cortisone cream.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, injection site got red, hot and itchy was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Could not lift up her head; Little fever; A spontaneous report was received from a Consumer concerning a 70-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, pain in extremity, headache and pyrexia.     The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events, totally wiped her out. sore arm, could not lift up her head, little fever.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   A t the time of this report, the outcome of events, totally wiped her out, sore arm,could not lift up her head,little fever was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Immune enhancement therapy
Clinical narrative: In spite of everything, I was able to amount a very good immune response; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events in spite of everything, i was able to amount a very good immune response, it is a very favorable reaction.  The patient's medical history was not provided. Concomitant medications reported were Ninlaro, Darzalex, IVIg for drug use for unknown indication.  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 events, In spite of everything, I was able to amount a very good immune response, It is a VERY favorable reaction.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, in spite of everything, i was able to amount a very good immune response,it is a very favorable reaction was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Lethargy, Somnolence
Clinical narrative: Severe headaches; Fatigue; Sleepy; Weak; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headaches), FATIGUE (Fatigue), SOMNOLENCE (Sleepy), ASTHENIA (Weak) and LETHARGY (Lethargic) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced HEADACHE (Severe headaches), FATIGUE (Fatigue), SOMNOLENCE (Sleepy), ASTHENIA (Weak) and LETHARGY (Lethargic). At the time of the report, HEADACHE (Severe headaches), FATIGUE (Fatigue), SOMNOLENCE (Sleepy), ASTHENIA (Weak) and LETHARGY (Lethargic) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was provided as acetaminophen and ibuprofen.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Back pain, Chills, Headache, Illness
Clinical narrative: Flu-ish; Sick-ish; Back ache; Burning in the pelvic area; Bloated; Feeling shaky; Headache; Chills; Nausea; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu-ish/ influenza like illness, sick-ish/ sickness, headache, nausea, back ache/back pain, chills, burning in the pelvic area/ pelvic pain, bloated/ abdominal distension, feeling shaky/ nervousness  The patient's medical history included chronic UTI, interstitial cystitis. Allergies included antibiotic allergy No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events flu-ish, sick-ish, headache, nausea, back ache, chills, burning in the pelvic area, Bloated, feeling shaky. No lab data were provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events flu-ish, sick-ish, headache, nausea, back ache, chills, burning in the pelvic area, Bloated, feeling shaky was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Nervousness, Pelvic pain
Clinical narrative: Flu-ish; Sick-ish; Back ache; Burning in the pelvic area; Bloated; Feeling shaky; Headache; Chills; Nausea; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu-ish/ influenza like illness, sick-ish/ sickness, headache, nausea, back ache/back pain, chills, burning in the pelvic area/ pelvic pain, bloated/ abdominal distension, feeling shaky/ nervousness  The patient's medical history included chronic UTI, interstitial cystitis. Allergies included antibiotic allergy No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events flu-ish, sick-ish, headache, nausea, back ache, chills, burning in the pelvic area, Bloated, feeling shaky. No lab data were provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events flu-ish, sick-ish, headache, nausea, back ache, chills, burning in the pelvic area, Bloated, feeling shaky was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Minor injection site pain; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events minor injection site pain.  The patient's medical history was provided as Sinus infection as current condition. Relevant concomitant medications were not reported.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event minor injection site pain.  Treatment information was provided as antibiotic.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event's, minor injection site pain,  was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: Common Variable Immune Deficiency and received the vaccine anyway; A spontaneous report was received from a consumer concerning a 56-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events common variable immune deficiency 9immune system disorder) and received the vaccine anyway.  The patient's medical history was not provided.Concomitant medications  reported include immunoglobulin human normal, hydroxychloroquine sulfate, tamoxifen, denosumab, guaifenesin, diclofenac diethylamine, famotidine, pantoprazole, QVAR inhaler, antibiotics, asthma inhaler.   On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.  On an unknown date patient experienced, common Variable Immune Deficiency and received the vaccine anyway.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), common variable immune deficiency and received the vaccine anyway,  was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching, swelling, redness, and warmth near the injection site; Itching, swelling, redness, and warmth near the injection site; Itching, swelling, redness, and warmth near the injection site; vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Itching, swelling, redness, and warmth near the injection site), VACCINATION SITE PRURITUS (Itching, swelling, redness, and warmth near the injection site), VACCINATION SITE SWELLING (Itching, swelling, redness, and warmth near the injection site) and INJECTION SITE ERYTHEMA (vaccination site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE WARMTH (Itching, swelling, redness, and warmth near the injection site), VACCINATION SITE PRURITUS (Itching, swelling, redness, and warmth near the injection site), VACCINATION SITE SWELLING (Itching, swelling, redness, and warmth near the injection site) and INJECTION SITE ERYTHEMA (vaccination site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INJECTION SITE WARMTH (Itching, swelling, redness, and warmth near the injection site), VACCINATION SITE PRURITUS (Itching, swelling, redness, and warmth near the injection site), VACCINATION SITE SWELLING (Itching, swelling, redness, and warmth near the injection site) and INJECTION SITE ERYTHEMA (vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. Treatment medication also include ice on the area for symptom relief.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had COVID after 1st dose; A spontaneous report was received from a Consumer concerning a 48-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, had covid after 1st dose.  The patient's medical history was not provided. Concomitant medications reported were Lisinopril, Rosuvastatin for drug use for unknown indication.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch : unknown) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, had COVID after 1st dose.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, had covid after 1st dose, was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Body aches; Muscle ache; Chills; Extreme fatigue; High less fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), MYALGIA (Muscle ache), CHILLS (Chills), FATIGUE (Extreme fatigue) and PYREXIA (High less fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for Depression, VITAMINS NOS for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 13-Jan-2021, the patient experienced PAIN (Body aches), MYALGIA (Muscle ache), CHILLS (Chills), FATIGUE (Extreme fatigue) and PYREXIA (High less fever). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL (TYLENOL PM, EXTRA STRENGTH) at an unspecified dose and frequency. On 14-Jan-2021, PAIN (Body aches), MYALGIA (Muscle ache), CHILLS (Chills), FATIGUE (Extreme fatigue) and PYREXIA (High less fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Myalgia
Clinical narrative: weak; heavy breathing; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), DYSPNOEA (heavy breathing) and MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     no specified medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ASTHENIA (weak), DYSPNOEA (heavy breathing) and MYALGIA (sore arm). At the time of the report, ASTHENIA (weak), DYSPNOEA (heavy breathing) and MYALGIA (sore arm) outcome was unknown. Not Provided          Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse reactions; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Adverse 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ADVERSE EVENT (Adverse reactions). At the time of the report, ADVERSE EVENT (Adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test
Clinical narrative: Tested Covid-19 positive; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested Covid-19 positive) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested Covid-19 positive). At the time of the report, COVID-19 (Tested Covid-19 positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coronavirus test: (Positive) Covid-19 tested positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pyrexia, Rash
Clinical narrative: severe allergic reaction; fever; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), PYREXIA (fever), RASH (rash) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Multiple allergies.    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 HYPERSENSITIVITY (severe allergic reaction), PYREXIA (fever), RASH (rash) and FATIGUE (fatigue). At the time of the report, HYPERSENSITIVITY (severe allergic reaction), PYREXIA (fever), RASH (rash) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter.  No treatment was reported   Reporter did not allow further contact