chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Slightly itchy; Arm was enlarged the next day; headache; nausea; Arm got red; Arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE PRURITUS (Slightly itchy), VACCINATION SITE ERYTHEMA (Arm got red), VACCINATION SITE SWELLING (Arm was enlarged the next day) and HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to statins), Hyperlipidemia and Drug allergy (Allergic to sulfa drugs). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), EZETIMIBE, AZITHROMYCIN (AZO) and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm) and VACCINATION SITE ERYTHEMA (Arm got red). On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Slightly itchy), VACCINATION SITE SWELLING (Arm was enlarged the next day), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE PRURITUS (Slightly itchy), VACCINATION SITE ERYTHEMA (Arm got red), VACCINATION SITE SWELLING (Arm was enlarged the next day), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Feeling hot, Headache
Clinical narrative: pain (body ache); Feels like need sleep; Hard at the touch; Swelling and hard at the touch; Very hot at the touch; Arm pain/ Soreness in the arm/ Arm hurt so bad like surgery; Overall tiredness; Headache; Arm pain and rash and very hot at the touch; Chilling and shaking; Severe nausea; Cold; Chilling and shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain (body ache)), SOMNOLENCE (Feels like need sleep), INDURATION (Hard at the touch), SWELLING (Swelling and hard at the touch) and FEELING COLD (Cold) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PYREXIA (Fever). On 14-Feb-2021, the patient experienced FEELING COLD (Cold), TREMOR (Chilling and shaking), CHILLS (Chilling and shaking) and NAUSEA (Severe nausea). On an unknown date, the patient experienced PAIN (pain (body ache)), SOMNOLENCE (Feels like need sleep), INDURATION (Hard at the touch), SWELLING (Swelling and hard at the touch), FEELING HOT (Very hot at the touch), PAIN IN EXTREMITY (Arm pain/ Soreness in the arm/ Arm hurt so bad like surgery), FATIGUE (Overall tiredness), HEADACHE (Headache) and RASH (Arm pain and rash and very hot at the touch). On 14-Feb-2021, CHILLS (Chilling and shaking) outcome was unknown. At the time of the report, PAIN (pain (body ache)), SOMNOLENCE (Feels like need sleep), INDURATION (Hard at the touch), SWELLING (Swelling and hard at the touch), FEELING COLD (Cold), TREMOR (Chilling and shaking), FEELING HOT (Very hot at the touch), PAIN IN EXTREMITY (Arm pain/ Soreness in the arm/ Arm hurt so bad like surgery), FATIGUE (Overall tiredness), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Severe nausea) and RASH (Arm pain and rash and very hot at the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The Patient was given Medications for body aches and acetaminophen for fever. Concomitant medications were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash, chills, headache, fever,  fatigue and nausea are consistent with the product safety profile
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: pain (body ache); Feels like need sleep; Hard at the touch; Swelling and hard at the touch; Very hot at the touch; Arm pain/ Soreness in the arm/ Arm hurt so bad like surgery; Overall tiredness; Headache; Arm pain and rash and very hot at the touch; Chilling and shaking; Severe nausea; Cold; Chilling and shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain (body ache)), SOMNOLENCE (Feels like need sleep), INDURATION (Hard at the touch), SWELLING (Swelling and hard at the touch) and FEELING COLD (Cold) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PYREXIA (Fever). On 14-Feb-2021, the patient experienced FEELING COLD (Cold), TREMOR (Chilling and shaking), CHILLS (Chilling and shaking) and NAUSEA (Severe nausea). On an unknown date, the patient experienced PAIN (pain (body ache)), SOMNOLENCE (Feels like need sleep), INDURATION (Hard at the touch), SWELLING (Swelling and hard at the touch), FEELING HOT (Very hot at the touch), PAIN IN EXTREMITY (Arm pain/ Soreness in the arm/ Arm hurt so bad like surgery), FATIGUE (Overall tiredness), HEADACHE (Headache) and RASH (Arm pain and rash and very hot at the touch). On 14-Feb-2021, CHILLS (Chilling and shaking) outcome was unknown. At the time of the report, PAIN (pain (body ache)), SOMNOLENCE (Feels like need sleep), INDURATION (Hard at the touch), SWELLING (Swelling and hard at the touch), FEELING COLD (Cold), TREMOR (Chilling and shaking), FEELING HOT (Very hot at the touch), PAIN IN EXTREMITY (Arm pain/ Soreness in the arm/ Arm hurt so bad like surgery), FATIGUE (Overall tiredness), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Severe nausea) and RASH (Arm pain and rash and very hot at the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The Patient was given Medications for body aches and acetaminophen for fever. Concomitant medications were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash, chills, headache, fever,  fatigue and nausea are consistent with the product safety profile
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Somnolence, Swelling, Tremor
Clinical narrative: pain (body ache); Feels like need sleep; Hard at the touch; Swelling and hard at the touch; Very hot at the touch; Arm pain/ Soreness in the arm/ Arm hurt so bad like surgery; Overall tiredness; Headache; Arm pain and rash and very hot at the touch; Chilling and shaking; Severe nausea; Cold; Chilling and shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain (body ache)), SOMNOLENCE (Feels like need sleep), INDURATION (Hard at the touch), SWELLING (Swelling and hard at the touch) and FEELING COLD (Cold) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PYREXIA (Fever). On 14-Feb-2021, the patient experienced FEELING COLD (Cold), TREMOR (Chilling and shaking), CHILLS (Chilling and shaking) and NAUSEA (Severe nausea). On an unknown date, the patient experienced PAIN (pain (body ache)), SOMNOLENCE (Feels like need sleep), INDURATION (Hard at the touch), SWELLING (Swelling and hard at the touch), FEELING HOT (Very hot at the touch), PAIN IN EXTREMITY (Arm pain/ Soreness in the arm/ Arm hurt so bad like surgery), FATIGUE (Overall tiredness), HEADACHE (Headache) and RASH (Arm pain and rash and very hot at the touch). On 14-Feb-2021, CHILLS (Chilling and shaking) outcome was unknown. At the time of the report, PAIN (pain (body ache)), SOMNOLENCE (Feels like need sleep), INDURATION (Hard at the touch), SWELLING (Swelling and hard at the touch), FEELING COLD (Cold), TREMOR (Chilling and shaking), FEELING HOT (Very hot at the touch), PAIN IN EXTREMITY (Arm pain/ Soreness in the arm/ Arm hurt so bad like surgery), FATIGUE (Overall tiredness), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Severe nausea) and RASH (Arm pain and rash and very hot at the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The Patient was given Medications for body aches and acetaminophen for fever. Concomitant medications were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash, chills, headache, fever,  fatigue and nausea are consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Swollen 2x2 inch red warm area around the injection site). On 15-Feb-2021, the patient experienced PYREXIA (Low grade fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (Low grade fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Swollen 2x2 inch red warm area around the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) 2 days post vaccine and (Negative) 9 days post vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other relevant medication history included Multivitamin. Patient had a bad reaction with the second moderna vaccine which lasted 10 day. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: outcome updated and diagnostic testing provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) and HEADACHE (Headache) 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 15-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 ARTHRALGIA (Joint pain) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Joint pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: redness on the injection arm; soreness on the injection arm; itchiness on the injection arm; swelling on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on the injection arm), PAIN IN EXTREMITY (soreness on the injection arm), PRURITUS (itchiness on the injection arm) and PERIPHERAL SWELLING (swelling on the injection arm) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (redness on the injection arm), PAIN IN EXTREMITY (soreness on the injection arm), PRURITUS (itchiness on the injection arm) and PERIPHERAL SWELLING (swelling on the injection arm). At the time of the report, ERYTHEMA (redness on the injection arm), PAIN IN EXTREMITY (soreness on the injection arm), PRURITUS (itchiness on the injection arm) and PERIPHERAL SWELLING (swelling on the injection arm) had not resolved.            No relevant Concomitant medications were reported.  Treatment includes Cold wash cloth, Ice Pack   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Painful urination; Aches all over; Headache; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Painful urination), MYALGIA (Aches all over), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (He had Covid last October and has had a slight but constant headache) in October 2020. Concomitant products included BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DYSURIA (Painful urination), MYALGIA (Aches all over), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, DYSURIA (Painful urination), MYALGIA (Aches all over), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: No new information.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Tremor
Clinical narrative: Ache; Trembles; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), TREMOR (Trembles) and FATIGUE (Fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Feb-2021, the patient experienced PAIN (Ache), TREMOR (Trembles) and FATIGUE (Fatigue). On 15-Feb-2021, PAIN (Ache) outcome was unknown and TREMOR (Trembles) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information and concomitant medications are not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Insomnia, Muscular weakness, Urticaria
Clinical narrative: weakness in arms and legs; patient can not sleep at all, patient hasn't been able to sleep for more than an hour or two at a time; shortness of breath; Hives; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in arms and legs), INSOMNIA (patient can not sleep at all, patient hasn't been able to sleep for more than an hour or two at a time), DYSPNOEA (shortness of breath), URTICARIA (Hives) and FATIGUE (extreme fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Feb-2021, the patient experienced MUSCULAR WEAKNESS (weakness in arms and legs), INSOMNIA (patient can not sleep at all, patient hasn't been able to sleep for more than an hour or two at a time), DYSPNOEA (shortness of breath), URTICARIA (Hives) and FATIGUE (extreme fatigue). At the time of the report, MUSCULAR WEAKNESS (weakness in arms and legs), INSOMNIA (patient can not sleep at all, patient hasn't been able to sleep for more than an hour or two at a time), DYSPNOEA (shortness of breath), URTICARIA (Hives) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information and concomitant medications were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness, Myalgia
Clinical narrative: joint pain; muscle pain; chills; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and CHILLS (chills) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 04-Feb-2021, the patient experienced ARTHRALGIA (joint pain), MYALGIA (muscle pain) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Patient email and address was added
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and Swollen at Injection site; Redness and Swollen at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and Swollen at Injection site) and VACCINATION SITE SWELLING (Redness and Swollen at Injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and Swollen at Injection site) and VACCINATION SITE SWELLING (Redness and Swollen at Injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and Swollen at Injection site) had resolved and VACCINATION SITE SWELLING (Redness and Swollen at Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchy; red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information and concomitant medications are not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Rash
Clinical narrative: Body rash on stomach and legs; Allergic reaction to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Body rash on stomach and legs) and DRUG HYPERSENSITIVITY (Allergic reaction to vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 103L20A) for COVID-19.     no medical history reported by the reporter.  The patient's past medical history included No adverse event. Concomitant products included METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR) and TOCOPHERYL ACETATE (VITAMIN E-400) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH (Body rash on stomach and legs) and DRUG HYPERSENSITIVITY (Allergic reaction to vaccine). At the time of the report, RASH (Body rash on stomach and legs) was resolving and DRUG HYPERSENSITIVITY (Allergic reaction to vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the events included prednisone.    Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: process with initial; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) in an 84-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications and treatment  were reported by the reporter.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Critical details is lacking in this case repot to include, the specific event or signs and symptoms, mRNA-1273 vaccination, onset dates of the event, patient's underlying medical history and concomitant medication. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Oral mucosal blistering, Vaccination site erythema
Clinical narrative: blisters in legs; Some redness at injection site; blisters in the roof of mouth; A spontaneous report was received from a consumer concerning a 68-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness, blisters in the roof of mouth and blisters in legs.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving the first dose of the Moderna COVID19 vaccine, the patient had some redness at injection site and developed blisters in the roof of the mouth 48 hours after vaccination and also in the leg, not sure when these started, but are still there. The reporter was not very sure about onset or lasting of any of the adverse reactions   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), redness was unknown.  The outcome of event(s), blisters in the roof of mouth, blisters in legs was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant patient received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine) in a 25-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 11-Feb-2021 at 6:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Oct-2020 and the estimated date of delivery was 20-Jul-2021. On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2020, Pregnancy test: positive (Positive) Positive. On 08-Dec-2020, Ultrasound scan: normal (normal) Ultrasound was also done on 03-FEB-2021, result was normal.. On 13-Jan-2021, Blood test: normal (normal) Blood test was also done on 03-FEB-2021, result was normal.. On 03-Feb-2021, Blood test: normal (normal) normal. On 03-Feb-2021, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include pre-natal vitamins.Treatment information was not provided.  Estimated date of conception reported was 15-Oct-2020. Patient was diagnosed with COVID-19 during pregnancy.; Sender's Comments: This case concerns a 25-Year-old female, Para1 gravida 2, who received mRNA-1273 while pregnant (vaccine exposure during pregnancy).  Positive pregnancy test was 10-NOV-2020, last menstrual period was 08-OCT-2020, a, estimated date of conception was 15-Oct-2020 and estimated due date is 20-JUN-2021. the event of vaccine exposure during pregnancy is assessed as not applicable
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Only little tenderness with second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Only little tenderness with second shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Only little tenderness with second shot). At the time of the report, VACCINATION SITE PAIN (Only little tenderness with second shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication was not provided.  The patient was concerned as she didn't had any side effects and wants to know if the vaccine was working in her body or not.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; headache; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache) and MYALGIA (myalgia) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     no medical history reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache) and MYALGIA (myalgia). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications  reported include ibuprofen and blood pressure medication.  Treatment medication include ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Some pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some pain in the arm) 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 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Some pain in the arm). At the time of the report, PAIN IN EXTREMITY (Some pain in the arm) outcome was unknown.            No treatment information was provided.     No relevant concomitant medications were reported. Action taken with mRNA -123 is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Body aches; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    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 PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) 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.   No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fever are chills are consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness at the injection site worsened; Hot at the injection site; Swelling at the injection site; Painful at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Painful at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site worsened) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Painful at the injection site). On 12-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site worsened). On 13-Jan-2021, VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Painful at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site worsened) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information and concomitant product were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. vaccination site pain, vaccination site swelling and vaccination site erythema are consistent with the product safety profile
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: feeling cold; body aches; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), PAIN (body aches), HEADACHE (headache) and PYREXIA (fever) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M020A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (feeling cold), PAIN (body aches), HEADACHE (headache) and PYREXIA (fever). At the time of the report, FEELING COLD (feeling cold), PAIN (body aches), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information, temporal association cannot be established between the use of mRNA-1273 and the onset of the events. Hence, causal association cannot be established.  However, fever and headache are consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Injection site pain, Lethargy, Pain in extremity
Clinical narrative: higher than normal blood pressure; pain in arm; no energy/slept for 12 hours; headache; pain at injection site; This spontaneous case was reported by a physician and describes the occurrence of BLOOD PRESSURE INCREASED (higher than normal blood pressure), PAIN IN EXTREMITY (pain in arm), LETHARGY (no energy/slept for 12 hours), HEADACHE (headache) and INJECTION SITE PAIN (pain at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (higher than normal blood pressure), PAIN IN EXTREMITY (pain in arm), LETHARGY (no energy/slept for 12 hours), HEADACHE (headache) and INJECTION SITE PAIN (pain at injection site). At the time of the report, BLOOD PRESSURE INCREASED (higher than normal blood pressure), PAIN IN EXTREMITY (pain in arm), LETHARGY (no energy/slept for 12 hours), HEADACHE (headache) and INJECTION SITE PAIN (pain at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The action taken with the drug was Not applicable.   This case was linked to MOD-2021-089937 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore). At the time of the report, VACCINATION SITE PAIN (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature fluctuation, Chills, Dyspnoea
Clinical narrative: Difficulty breathing for 2 mins; temperature has been fluctuating from 98.7 to 100.1; Chills "cold and shaking"; mild pain from the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing for 2 mins), BODY TEMPERATURE FLUCTUATION (temperature has been fluctuating from 98.7 to 100.1), CHILLS (Chills "cold and shaking") and ARTHRALGIA (mild pain from the shoulder) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 16-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing for 2 mins), BODY TEMPERATURE FLUCTUATION (temperature has been fluctuating from 98.7 to 100.1), CHILLS (Chills "cold and shaking") and ARTHRALGIA (mild pain from the shoulder). At the time of the report, DYSPNOEA (Difficulty breathing for 2 mins), BODY TEMPERATURE FLUCTUATION (temperature has been fluctuating from 98.7 to 100.1), CHILLS (Chills "cold and shaking") and ARTHRALGIA (mild pain from the shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: fluctuating from 98.7 to 100.1.         No treatment or concomitant medications reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Feeling hot
Clinical narrative: Feels different than normal; labored breathing, also while sleeping; Forehead feels warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels different than normal), DYSPNOEA (labored breathing, also while sleeping) and FEELING HOT (Forehead feels warm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Smoker (quit 25 years ago).    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 FEELING ABNORMAL (Feels different than normal), DYSPNOEA (labored breathing, also while sleeping) and FEELING HOT (Forehead feels warm). At the time of the report, FEELING ABNORMAL (Feels different than normal), DYSPNOEA (labored breathing, also while sleeping) and FEELING HOT (Forehead feels warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medication was reported. Patient mentioned that he has stent.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Followup received and contains non-significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: \\\ Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Jun-2021. On 13-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Patient was 22 weeks pregnant at the time of vaccination.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Muscle twitching at injection site; Red warm spot at injection site; Red warm spot at injection site about 4 x 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Muscle twitching at injection site), VACCINATION SITE WARMTH (Red warm spot at injection site) and VACCINATION SITE ERYTHEMA (Red warm spot at injection site about 4 x 3 inches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis since 2000, Peripheral neuropathy since 2006, Drug allergy (morphine) and Allergy to antibiotic. Concomitant products included ROMOSOZUMAB AQQG (EVENITY [ROMOSOZUMAB AQQG]) for Osteoporosis, GABAPENTIN (NEURONTIN) for Peripheral neuropathy.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Red warm spot at injection site) and VACCINATION SITE ERYTHEMA (Red warm spot at injection site about 4 x 3 inches). On 09-Feb-2021, the patient experienced MUSCLE TWITCHING (Muscle twitching at injection site). On 09-Feb-2021, VACCINATION SITE WARMTH (Red warm spot at injection site) and VACCINATION SITE ERYTHEMA (Red warm spot at injection site about 4 x 3 inches) had resolved. On 14-Feb-2021, MUSCLE TWITCHING (Muscle twitching at injection site) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received on 28-APR-2021 Contains medical history, concomitant medication details, patient demographics updated and end date provided.