chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Skin reaction, Vaccination site erythema, Vaccination site induration
Clinical narrative: Delayed injection site reaction; Injection site hard/Injection site induration; Injection site itchy; Injection site hivethe size of a miniature orange; Injection site swelled; Joint aches; Muscle aches/Myalgias; Injection site redness; A spontaneous report was received from a physician concerning a 45 years old, female patient who experienced delayed injection site reaction/delayed skin reaction, injection site hard, injection site induration/vaccination site induration, injection site itchy/vaccination site pruritus, injection site hive the size of a miniature orange/vaccination site urticaria, injection site swelled/vaccination site swelling, joint pain/arthralgia, muscle aches, myalgias/myalgia and injection site redness/vaccination site erythema.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 24 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:39K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient experienced delayed injection site reaction, injection site hard, injection site induration, injection site itchy, joint pain, muscle aches, myalgias.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The events, injection site hard, injection site induration, injection site itchy, injection site swelled, joint pain, muscle aches and myalgias were resolved o 03 Jan 2021.  The outcome of the events delayed injection site reaction, injection site hives the size of a miniature orange, injection site swelled, and injection site redness were unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Delayed injection site reaction; Injection site hard/Injection site induration; Injection site itchy; Injection site hivethe size of a miniature orange; Injection site swelled; Joint aches; Muscle aches/Myalgias; Injection site redness; A spontaneous report was received from a physician concerning a 45 years old, female patient who experienced delayed injection site reaction/delayed skin reaction, injection site hard, injection site induration/vaccination site induration, injection site itchy/vaccination site pruritus, injection site hive the size of a miniature orange/vaccination site urticaria, injection site swelled/vaccination site swelling, joint pain/arthralgia, muscle aches, myalgias/myalgia and injection site redness/vaccination site erythema.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 24 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:39K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient experienced delayed injection site reaction, injection site hard, injection site induration, injection site itchy, joint pain, muscle aches, myalgias.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The events, injection site hard, injection site induration, injection site itchy, injection site swelled, joint pain, muscle aches and myalgias were resolved o 03 Jan 2021.  The outcome of the events delayed injection site reaction, injection site hives the size of a miniature orange, injection site swelled, and injection site redness were unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Nausea; Chills; A spontaneous report was received from a nurse concerning a 83-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea and chills.   The patient's medical history was not provided. The Concomitant medications reported included atorvastatin, losartan, sertraline hydrochloride.  On 23 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011V201A) via intramuscularly in an unknown location for prophylaxis of COVID-19 infection.After three days on 26 Jan 2021, patient developed nausea and chills.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, nausea and chills were considered as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site induration, Pain, Pruritus, Rash
Clinical narrative: Rash; itchiness; Redness; pain; Tightness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), INJECTION SITE INDURATION (Tightness), RASH (Rash), PRURITUS (itchiness) and ERYTHEMA (Redness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported history). Concomitant products included BENAZEPRIL, AMLODIPINE and PEGINTERFERON BETA-1A (PLEGRIDY) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN (pain) and INJECTION SITE INDURATION (Tightness). On 21-Feb-2021, the patient experienced RASH (Rash), PRURITUS (itchiness) and ERYTHEMA (Redness). The patient was treated with Benadryl cream at an unspecified dose and frequency. At the time of the report, PAIN (pain), INJECTION SITE INDURATION (Tightness), RASH (Rash), PRURITUS (itchiness) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Benadryl Cream.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 01-Feb-2021, PAIN IN EXTREMITY (Arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2021: NNI added.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: headache; muscle and joint ache; nausea; chills; fever; fatigue; A spontaneous report was received from a consumer concerning a unknown patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who experienced effects and till today fever, fatigue, headache, muscle and joint ache, nausea, chills.   The patient's medical history,is not provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 24/Jan/2021. Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: unknown) for prophylaxis of COVID-19 infection.    Experienced fever, fatigue, headache, muscle and joint ache, nausea, chills.   No lab data I reported by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, fever, fatigue, headache, muscle and joint ache, nausea, chills, were unknown.   The reporter did not provide an assessment for the events, fever, fatigue, headache, muscle and joint ache, nausea, chills.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; muscle and joint ache; nausea; chills; fever; fatigue; A spontaneous report was received from a consumer concerning a unknown patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who experienced effects and till today fever, fatigue, headache, muscle and joint ache, nausea, chills.   The patient's medical history,is not provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 24/Jan/2021. Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: unknown) for prophylaxis of COVID-19 infection.    Experienced fever, fatigue, headache, muscle and joint ache, nausea, chills.   No lab data I reported by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, fever, fatigue, headache, muscle and joint ache, nausea, chills, were unknown.   The reporter did not provide an assessment for the events, fever, fatigue, headache, muscle and joint ache, nausea, chills.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Peripheral swelling, Tremor
Clinical narrative: shaking; unable to write; A tingling sensation in my fingers, in both hands, and my palms; swelling in hands and foot; Throbbing in hands and foot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (A tingling sensation in my fingers, in both hands, and my palms), PERIPHERAL SWELLING (swelling in hands and foot), PAIN (Throbbing in hands and foot) and TREMOR (shaking; unable to write) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2DA) for COVID-19 vaccination.     Concurrent medical conditions included Carpal tunnel syndrome. Concomitant products included VITAMIN A NOS for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PARAESTHESIA (A tingling sensation in my fingers, in both hands, and my palms), PERIPHERAL SWELLING (swelling in hands and foot) and PAIN (Throbbing in hands and foot). On an unknown date, the patient experienced TREMOR (shaking; unable to write). At the time of the report, PARAESTHESIA (A tingling sensation in my fingers, in both hands, and my palms), PERIPHERAL SWELLING (swelling in hands and foot), PAIN (Throbbing in hands and foot) and TREMOR (shaking; unable to write) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Patient mention the swelling/tingling in my hands and feet were unrelated to the vaccine.  Patient was diagnosed with carpal tunnel syndrome in his hands and inflammation in the arches of my feet.  Now Patient  feel fine and have recovered. It was not side effects from the vaccine. he was mistaken   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2021: No specific follow-up information recorded. On 13-Jun-2021: Follow up received include Reporters Email, Patients DOB and included some event also like stronger throb in the arch of my left foot and subtle shake in both hands.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Erythema, Flushing, Oropharyngeal discomfort
Clinical narrative: hives on her arm that started 2cm below the vaccination site- hives on face and forehead; arm as burning hot; throat felt weird; right upper arm started itching like crazy; Chest was kind of red; Rash on her arm spread a little more; flushing; fever; chills; A spontaneous report was received from a consumer concerning a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  events of flushing, ears were hot,  had  fever, chills, typical reactions, right upper arm started itching like crazy, had hives on her arm that started 2cm below the vaccination site and her arm was burning hot, chest was kind of red,  throat felt weird ,  had some hives on her face and forehead and the rash on her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On   09-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch no: unknown) in the right upper arm for prophylaxis of COVID-19 infection.  On 09-JAN-2021, the patient experienced flushing, ears was hot, had fever, chills, typical reaction and these was completely fine by the next day. On 17-JAN-2021, the patient experienced her right arm itching like crazy, had hives on the arm started below the vaccination site, arm was burning hot, chest was kind of red, and her throat felt weird. Later at the night, the patient had hives on face and forehead, rash on the arm spread a little more.  The patient was tested COVID-19 negative. The patient had taken Benadryl for the throat irritation.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events flushing, ears was hot, had fever, chills, typical reaction was recovered by the next day. The outcome of the events right arm itching like crazy, hives on the arm below the vaccination site, arm  burning hot, chest  kind of red, and  throat felt weird,  hives on face and forehead, rash on the arm was not recovered/resolved.  Recoded events (Vaccination site warmth and Vaccination site pruritus)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: hives on her arm that started 2cm below the vaccination site- hives on face and forehead; arm as burning hot; throat felt weird; right upper arm started itching like crazy; Chest was kind of red; Rash on her arm spread a little more; flushing; fever; chills; A spontaneous report was received from a consumer concerning a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  events of flushing, ears were hot,  had  fever, chills, typical reactions, right upper arm started itching like crazy, had hives on her arm that started 2cm below the vaccination site and her arm was burning hot, chest was kind of red,  throat felt weird ,  had some hives on her face and forehead and the rash on her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On   09-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch no: unknown) in the right upper arm for prophylaxis of COVID-19 infection.  On 09-JAN-2021, the patient experienced flushing, ears was hot, had fever, chills, typical reaction and these was completely fine by the next day. On 17-JAN-2021, the patient experienced her right arm itching like crazy, had hives on the arm started below the vaccination site, arm was burning hot, chest was kind of red, and her throat felt weird. Later at the night, the patient had hives on face and forehead, rash on the arm spread a little more.  The patient was tested COVID-19 negative. The patient had taken Benadryl for the throat irritation.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events flushing, ears was hot, had fever, chills, typical reaction was recovered by the next day. The outcome of the events right arm itching like crazy, hives on the arm below the vaccination site, arm  burning hot, chest  kind of red, and  throat felt weird,  hives on face and forehead, rash on the arm was not recovered/resolved.  Recoded events (Vaccination site warmth and Vaccination site pruritus)
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported.   No treatment information was provided.     Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: the follow up were received on 15-apr-2021 and contains following updated information :Patientconfirmed he had sore throat and fatigue after the vaccine, but he feels fine now. He does not want to fill the AE follow-up format and denies further follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: aching; chills; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching), CHILLS (chills), HEADACHE (headache) and FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (aching), CHILLS (chills), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, PAIN (aching), CHILLS (chills), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.            No treatment information was provided
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Pubic pain, Pyrexia
Clinical narrative: pain in her pubic area; wobbly on her legs; body temperature of 100.4 deg. F; A spontaneous report was received from a consumer concerning a 89-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain on her pubic area, body temp. of 100.4 deg. f, wobbly on her legs.  The patient's medical history was not provided. Concomitant medications reported were Pravastatin for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 20 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 041L20A) via unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) pain on her pubic area, body temp. of 100.4 deg. f, wobbly on her legs.  Treatment details included No  taken, but patient plans to see HCP tomorrow.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain on her pubic area, body temp, of 100, 4 deg, f, wobbly on her legs was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Sweating all night; tired; Fever of 103.2; Splitting headache; unstoppable chills; Muscles aches, muscle pain; Nausea; Exhausted; Shot hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating all night), FATIGUE (tired), PYREXIA (Fever of 103.2), HEADACHE (Splitting headache) and CHILLS (unstoppable chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (Shot hurt). On 17-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating all night), FATIGUE (tired), PYREXIA (Fever of 103.2), HEADACHE (Splitting headache), CHILLS (unstoppable chills), MYALGIA (Muscles aches, muscle pain), NAUSEA (Nausea) and FATIGUE (Exhausted). At the time of the report, HYPERHIDROSIS (Sweating all night), FATIGUE (tired), PYREXIA (Fever of 103.2), HEADACHE (Splitting headache), CHILLS (unstoppable chills), MYALGIA (Muscles aches, muscle pain), NAUSEA (Nausea), VACCINATION SITE PAIN (Shot hurt) and FATIGUE (Exhausted) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Sweating all night; tired; Fever of 103.2; Splitting headache; unstoppable chills; Muscles aches, muscle pain; Nausea; Exhausted; Shot hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating all night), FATIGUE (tired), PYREXIA (Fever of 103.2), HEADACHE (Splitting headache) and CHILLS (unstoppable chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (Shot hurt). On 17-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating all night), FATIGUE (tired), PYREXIA (Fever of 103.2), HEADACHE (Splitting headache), CHILLS (unstoppable chills), MYALGIA (Muscles aches, muscle pain), NAUSEA (Nausea) and FATIGUE (Exhausted). At the time of the report, HYPERHIDROSIS (Sweating all night), FATIGUE (tired), PYREXIA (Fever of 103.2), HEADACHE (Splitting headache), CHILLS (unstoppable chills), MYALGIA (Muscles aches, muscle pain), NAUSEA (Nausea), VACCINATION SITE PAIN (Shot hurt) and FATIGUE (Exhausted) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: might have had a low grade fever night 1; Soreness; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events might have had a low grade fever night 1, soreness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) might have had a low grade fever night 1, soreness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), might have had a low grade fever night 1, soreness was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Sputum discoloured, Vaccination complication
Clinical narrative: Cough up green phlegm; Chills for 10 hours; Fever of up to 101.7 F; Body aches; Uable to lift her head; A spontaneous report ( was received from a consumer concerning, herself a 35-years-old  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, chills, fever of up to 101.7 F, body aches, unable to lift her head and cough up green phlegm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 004M20A) by unknown route, in the right arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, approximately nine hours later, the patient experienced chills which lasted for ten hours, fever of up to 101.7 F, body aches, unable to lift her head, which lasted for twenty-four hours. On 21 Feb 2021, patient coughed up green phlegm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The event, chills was resolved on 19 Feb 2021. The events, fever of up to 101.7 F, body aches, unable to lift her head, were resolved on 20 Feb 2021. The event coughed up green phlegm, was resolved on 21 Feb 2021.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: 99.7 fever; chills; diarrhea; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 99.7f fever, chills, diarrhea.  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 first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) 99.7F Fever, chills, diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), 99, 7f fever, chills, diarrhea was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Muscular weakness, Vaccination site pain
Clinical narrative: Injection site arm tender; Bruised; Injection site arm is weak; A spontaneous report was received from a consumer concerning an 80-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site arm tender/vaccination site pain, bruised/contusion and injection site arm is weak/muscular weakness.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 10 Feb 2021, prior to the onset of the events, the patient received their unknown of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 10 Feb 2021, patient experienced injection site arm tender, bruised and injection site arm is weak.  Lab details were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, injection site arm tender, bruised and injection site arm is weak were unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Vaccination site erythema, Vaccination site mass
Clinical narrative: A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, muscle pain / myalgia, fatigability, been lying on bed the whole afternoon / fatigue, lump / vaccination site mass and redness / vaccination site erythema. The patient's medical history was not provided. Concomitant medications reported were Levothyroxine sodium 0.112mg and Liothyronine sodium 5mcg for drug use for unknown indication. On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 20 Feb 2021, the patient had chills, muscle pain, fatiguability and had been lying on bed the whole afternoon. She also had a lump and redness on her right arm which was 2 inches long and 1 and a half inches wide. Treatment details included Tylenol 500mg 2 tabs. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, chills, muscle pain, fatiguability, been lying on bed the whole afternoon, lump and redness was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain, Vaccination site rash
Clinical narrative: Rash (about 2 inches) on the injection site; Fatigue; Upper left arm was little sore; Little nausea; A spontaneous report was received from consumer, concerning herself, a 76-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and noticed a rash (about 2 inches) on the injection site, she also felt fatigue, upper left arm was a little sore and had little nausea.  The patient's medical history and concomitant medication were not reported.  On 13-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly on the upper left arm for prophylaxis of COVID-19 infection.   On 26-Jan-2021, 14 days after administration of vaccine, patient accidently noticed a rash (about 2 inches) at the injection site and she also felt fatigue. The upper left arm was a little sore and she had a little nausea.  Action taken with the mRNA-1273 in response to the event was not provided.   The outcome of event rash (about 2 inches) on the injection site, she also felt fatigue, upper left arm was a little sore and had little nausea was considered unknown at the time of this report.; Reporter's Comments: This case concerns a 76-year-old female who experienced nonserious expected events of vaccination site pain, vaccination site rash, fatigue, and nausea.  The events occurred 14 days 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Hypoaesthesia, Muscle spasms, Muscle twitching
Clinical narrative: Legs stiff; Difficult to walk; Face numb; Face tingly and legs tingling; Face started twitching; Arm weak; Legs weak; Fatigue; Leg cramping/ leg cramp; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramping/ leg cramp), HYPOAESTHESIA (Face numb), PARAESTHESIA (Face tingly and legs tingling), MUSCLE TWITCHING (Face started twitching) and MUSCULAR WEAKNESS (Arm weak) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Flu vaccination: Flu vaccine. Past adverse reactions to the above products included Guillain Barre syndrome with Flu vaccine. Concurrent medical conditions included Lupus syndrome. Concomitant products included TOPIRAMATE (TOPAMAX) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MUSCLE SPASMS (Leg cramping/ leg cramp) and FATIGUE (Fatigue). On 20-Feb-2021, the patient experienced HYPOAESTHESIA (Face numb), PARAESTHESIA (Face tingly and legs tingling), MUSCLE TWITCHING (Face started twitching), MUSCULAR WEAKNESS (Arm weak), MUSCULAR WEAKNESS (Legs weak) and GAIT DISTURBANCE (Difficult to walk). On 21-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Legs stiff). On 20-Feb-2021, MUSCLE TWITCHING (Face started twitching) and FATIGUE (Fatigue) had resolved. On 21-Feb-2021, MUSCULAR WEAKNESS (Arm weak) had resolved. At the time of the report, MUSCLE SPASMS (Leg cramping/ leg cramp), HYPOAESTHESIA (Face numb), PARAESTHESIA (Face tingly and legs tingling), MUSCULOSKELETAL STIFFNESS (Legs stiff) and GAIT DISTURBANCE (Difficult to walk) had not resolved and MUSCULAR WEAKNESS (Legs weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Initial additional information received on 28-Apr-2021: Reporter email address added
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Legs stiff; Difficult to walk; Face numb; Face tingly and legs tingling; Face started twitching; Arm weak; Legs weak; Fatigue; Leg cramping/ leg cramp; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramping/ leg cramp), HYPOAESTHESIA (Face numb), PARAESTHESIA (Face tingly and legs tingling), MUSCLE TWITCHING (Face started twitching) and MUSCULAR WEAKNESS (Arm weak) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Flu vaccination: Flu vaccine. Past adverse reactions to the above products included Guillain Barre syndrome with Flu vaccine. Concurrent medical conditions included Lupus syndrome. Concomitant products included TOPIRAMATE (TOPAMAX) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MUSCLE SPASMS (Leg cramping/ leg cramp) and FATIGUE (Fatigue). On 20-Feb-2021, the patient experienced HYPOAESTHESIA (Face numb), PARAESTHESIA (Face tingly and legs tingling), MUSCLE TWITCHING (Face started twitching), MUSCULAR WEAKNESS (Arm weak), MUSCULAR WEAKNESS (Legs weak) and GAIT DISTURBANCE (Difficult to walk). On 21-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Legs stiff). On 20-Feb-2021, MUSCLE TWITCHING (Face started twitching) and FATIGUE (Fatigue) had resolved. On 21-Feb-2021, MUSCULAR WEAKNESS (Arm weak) had resolved. At the time of the report, MUSCLE SPASMS (Leg cramping/ leg cramp), HYPOAESTHESIA (Face numb), PARAESTHESIA (Face tingly and legs tingling), MUSCULOSKELETAL STIFFNESS (Legs stiff) and GAIT DISTURBANCE (Difficult to walk) had not resolved and MUSCULAR WEAKNESS (Legs weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Initial additional information received on 28-Apr-2021: Reporter email address added
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever 100.5 F, fatigued, pinching/shooting pain type headache, very sore left arm.  All of these symptoms lasted about 24 hours.  I took Tylenol for pain 2 times in this period.  However, the pinching/shooting pain type headache persisted on and off for two weeks.  I did not take anything for treatment of the headaches.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Received Moderna Covid vaccine at outside facility (walmart) 4/25/2021, 5/24/2021.  tested COVID positive 8/11/2021. vaccine failure.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: SYNCOPE FOR A COUPLE OF SECONDS
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: injection site has itched every day; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site has itched every day) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE PRURITUS (injection site has itched every day). At the time of the report, INJECTION SITE PRURITUS (injection site has itched every day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Product administered at inappropriate site, Pyrexia
Clinical narrative: Patient got shingles vaccine on 8/3/2021 and appears the vaccine was injected into the subcutaneous tissu e, not the left deltoid muscle.  The area below the deltoid is now hot and red and patient reports she feels feverish. In addition, the vaccine was stored in the freezer upon its arrival to our clinic site on 7/20/21 until 8/10/21 when we learned that the vaccine should have been stored in the refrigerator at temperatures between 36-46 degrees farenheit.  Therefore, the vaccine has no efficacy.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Tinnitus/high-pitched ear ringing (both ears) intermittently several times per day (all hours, no pattern, not co-occurring with other symptoms), even waking me in the middle of the night.  I've NEVER had this issue.  It begun the following evening after initially getting vaccinated.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Drug screen, Immediate post-injection reaction, Laboratory test
Clinical narrative: dizziness immediately following vaccination, followed by syncopal episode
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Urine analysis
Clinical narrative: dizziness immediately following vaccination, followed by syncopal episode
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Tinnitus, Wheezing
Clinical narrative: I hear loud ?Crickets ? all the time. My hearing seems deminished. Toes hurt. I have wheezing. I have dizziness.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Adnexa uteri mass, Computerised tomogram liver abnormal, Condition aggravated, Hepatic neoplasm
Clinical narrative: I'm not sure if my experience is a result of the 2nd Pfizer vaccine, but several women in my colon cancer support group (online) shared similar stories after their 2nd Pfizer vaccine, so I thought I would send this in  in case it was important.  I have Stage 4 colon cancer, with a small adnexal mass (3x2 cm) and 4 liver lesions which had remained stable for months.  Because I was doing so well and my disease had remained stable, I was scheduled for surgery to remove the small mass, along with fallopian tubes and other ovary, as well as surgery to remove the liver lesions.  However,  within two weeks of the Pfizer vaccine, I started having major abdominal discomfort.  A CT scan showed that the liver tumors had all increased in size, and the adnexal mass which had been 3x2 cm ballooned up to 8x8 cm, and two weeks later to 10x12 cm, by which time I was in excruciating pain.  They had to move my surgery date up because the mass was starting to block other organs and was eroding the fat plane and the vaginal cuff.  The only thing that had changed from my long period of stable disease status was the Pfizer vaccine.  Again, I don't know if my experience is related, but several other women reported similar occurrences.... small adnexal masses that hyper-progressed within weeks of the Pfizer vaccine.  I was surprised that anyone else had had the same experience, and my doctor doesn't think it could be related.  But the stories from other women, including one who had been NED for a year, with a clear CT in March (before she got the vaccine), and by mid-April, she had DEVELOPED a huge adnexal mass which had not even been there.... with a clear CT just weeks before.  Anyway, I don't know if this information is useful, but if it can help someone, I'm glad to share my story.  I am very scared to get the booster that is being discussed currently because I am terrified it will cause another hyper-progression of my cancer (which now is just in my liver).  I'm not sure what to do because I don't want to die of Covid, but I'm scared of the vaccine causing another incident like the one I experience in April after my 2nd Pfizer vaccine (March 30).  Thank you.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I'm not sure if my experience is a result of the 2nd Pfizer vaccine, but several women in my colon cancer support group (online) shared similar stories after their 2nd Pfizer vaccine, so I thought I would send this in  in case it was important.  I have Stage 4 colon cancer, with a small adnexal mass (3x2 cm) and 4 liver lesions which had remained stable for months.  Because I was doing so well and my disease had remained stable, I was scheduled for surgery to remove the small mass, along with fallopian tubes and other ovary, as well as surgery to remove the liver lesions.  However,  within two weeks of the Pfizer vaccine, I started having major abdominal discomfort.  A CT scan showed that the liver tumors had all increased in size, and the adnexal mass which had been 3x2 cm ballooned up to 8x8 cm, and two weeks later to 10x12 cm, by which time I was in excruciating pain.  They had to move my surgery date up because the mass was starting to block other organs and was eroding the fat plane and the vaginal cuff.  The only thing that had changed from my long period of stable disease status was the Pfizer vaccine.  Again, I don't know if my experience is related, but several other women reported similar occurrences.... small adnexal masses that hyper-progressed within weeks of the Pfizer vaccine.  I was surprised that anyone else had had the same experience, and my doctor doesn't think it could be related.  But the stories from other women, including one who had been NED for a year, with a clear CT in March (before she got the vaccine), and by mid-April, she had DEVELOPED a huge adnexal mass which had not even been there.... with a clear CT just weeks before.  Anyway, I don't know if this information is useful, but if it can help someone, I'm glad to share my story.  I am very scared to get the booster that is being discussed currently because I am terrified it will cause another hyper-progression of my cancer (which now is just in my liver).  I'm not sure what to do because I don't want to die of Covid, but I'm scared of the vaccine causing another incident like the one I experience in April after my 2nd Pfizer vaccine (March 30).  Thank you.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Allergic respiratory symptom, Arthralgia, Chills, Cough, Exposure during pregnancy
Clinical narrative: 31weeks and 2 days pregnant at time of shot, expected due date 10/09/2021.  Within 24 hours of shot had expected reaction to shot, fever/chills, muscle/joint pain, headache. 48 hours after, developed allergy like symptoms of cough, stuffy nose, mucus build up. 72 hours after, still cough, still stuffy nose.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection related reaction, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: 31weeks and 2 days pregnant at time of shot, expected due date 10/09/2021.  Within 24 hours of shot had expected reaction to shot, fever/chills, muscle/joint pain, headache. 48 hours after, developed allergy like symptoms of cough, stuffy nose, mucus build up. 72 hours after, still cough, still stuffy nose.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: 31weeks and 2 days pregnant at time of shot, expected due date 10/09/2021.  Within 24 hours of shot had expected reaction to shot, fever/chills, muscle/joint pain, headache. 48 hours after, developed allergy like symptoms of cough, stuffy nose, mucus build up. 72 hours after, still cough, still stuffy nose.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test abnormal, Irritability, Liver injury, Menstrual disorder
Clinical narrative: 1.5 days after vaccination I became irritated and on edge. I began to feel a squeezing pain in my ribs and upper abdomen then vomited 3 times over the course of a few hours. The pain in my ribs was increasing so I went to the emergency room. I had ultrasounds and fluid, I showed higher than normal levels that show potential blood clots and the ultrasound came back as having liver damage which I have had no inclination of in the past.  The pain did not subside and I ended up back in the er the following day. Was given pain medication, nausea meds and more tests. Ultimately the ruling was unknown but with 25 years of having fibromyalgia I know my body very well and that was a very abnormal experience. As well, seeing the studies done regarding liver damage and vaccines I am extremely scared to attempt the second out of fear of liver failure. I then began my period over a week early, following a two week break. Another, and then a 6 week span. It was about 3 months before my cycle was normal.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: 1.5 days after vaccination I became irritated and on edge. I began to feel a squeezing pain in my ribs and upper abdomen then vomited 3 times over the course of a few hours. The pain in my ribs was increasing so I went to the emergency room. I had ultrasounds and fluid, I showed higher than normal levels that show potential blood clots and the ultrasound came back as having liver damage which I have had no inclination of in the past.  The pain did not subside and I ended up back in the er the following day. Was given pain medication, nausea meds and more tests. Ultimately the ruling was unknown but with 25 years of having fibromyalgia I know my body very well and that was a very abnormal experience. As well, seeing the studies done regarding liver damage and vaccines I am extremely scared to attempt the second out of fear of liver failure. I then began my period over a week early, following a two week break. Another, and then a 6 week span. It was about 3 months before my cycle was normal.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Blood test normal, Computerised tomogram normal, Dyspnoea
Clinical narrative: Was fine initially, a few weeks later started to have more pain in my legs and back.  Had to take more pain meds. Started to get tired more and legs swelled more. Now, 8/12/21 I have extreme back pain that I have to be on pain killer every 5 hrs to be able to move. My knees have swelling and have  developed cysts on both knees now.  My arthritis in my hands are worse to where I have shooting pain. I have trouble sleeping, restless leg has increases.  Have had shortness of breath for past 3 mo.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Joint swelling, Pain, Pain in extremity
Clinical narrative: Was fine initially, a few weeks later started to have more pain in my legs and back.  Had to take more pain meds. Started to get tired more and legs swelled more. Now, 8/12/21 I have extreme back pain that I have to be on pain killer every 5 hrs to be able to move. My knees have swelling and have  developed cysts on both knees now.  My arthritis in my hands are worse to where I have shooting pain. I have trouble sleeping, restless leg has increases.  Have had shortness of breath for past 3 mo.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Restless legs syndrome, Synovial cyst, Ultrasound scan abnormal
Clinical narrative: Was fine initially, a few weeks later started to have more pain in my legs and back.  Had to take more pain meds. Started to get tired more and legs swelled more. Now, 8/12/21 I have extreme back pain that I have to be on pain killer every 5 hrs to be able to move. My knees have swelling and have  developed cysts on both knees now.  My arthritis in my hands are worse to where I have shooting pain. I have trouble sleeping, restless leg has increases.  Have had shortness of breath for past 3 mo.