chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: tiredness; Redness at the injection site; itching at the injection site; warm to touch at the site of the injection; swelling at the site of the injection; pain at the site of the injection; feel hard at the site of the injection; swollen lymph nodes right neck; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to touch at the site of the injection), INJECTION SITE SWELLING (swelling at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection), INJECTION SITE INDURATION (feel hard at the site of the injection) and LYMPHADENOPATHY (swollen lymph nodes right neck) in a 71-year-old female patient 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 provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm to touch at the site of the injection), INJECTION SITE SWELLING (swelling at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection), INJECTION SITE INDURATION (feel hard at the site of the injection), LYMPHADENOPATHY (swollen lymph nodes right neck), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PRURITUS (itching at the injection site). On an unknown date, the patient experienced FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, INJECTION SITE WARMTH (warm to touch at the site of the injection), INJECTION SITE SWELLING (swelling at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection), INJECTION SITE INDURATION (feel hard at the site of the injection), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PRURITUS (itching at the injection site) had not resolved, LYMPHADENOPATHY (swollen lymph nodes right neck) had resolved and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient symptoms started on 12MAR2021 & gradually worsened. She took  Advil & Tylenol along with applying some ice pack which was helpful. Symptoms  are unchanged since taking the medication.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) 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 product used was not provided by the reporter.  The reporting physician states the vial was needle punctured at 10:45 AM and expired at 4:45 pm. This patient was administered the vaccine from this vial at 5:20 pm. No additional details were provided.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: patient has rash on stomach; vaccine was given to 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash on his stomach/rash and vaccine was given to 17 year old/inappropriate age at vaccine administration.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (Batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  Someone had followed up prior to the patient receiving the vaccine and due to the patient being close to 18 years of age, the okay was given. On an unknown date, a vaccine was given to 17 year old patient. Patient had a rash on the stomach. Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not reported.  The event, vaccine was given to 17 year old, was considered resolved. The outcome of rash on his stomach was not reported.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age with associated adverse event. Based on the current available information and temporal association between the use of the product and the onset date of the rash, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: rash on torso; fatigue; headache; muscle pain; Joint pain; nausea; fever; A spontaneous report  was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, headache, muscle pain, joint pain, nausea, fever, rash on torso. Patient's has no historical conditions. No relevant concomitant medications were reported.  On an 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 12 Mar 2021, 1 day prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 048A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, the patient experienced the events fatigue, headache, muscle pain, joint pain, nausea, fever. On 14 Mar 2021, the patient experienced the events rash on torso.  Treatment details included as patient has taken ibuprofen for necessary events.  Action taken with mRNA-1273 in response to the events was not applicable. On 14 Mar 2021 the outcome of events such as fatigue, headache, muscle pain, joint pain, nausea, fever was resolved.  On an unknown date the outcome of events rash on torso was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: rash on torso; fatigue; headache; muscle pain; Joint pain; nausea; fever; A spontaneous report  was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, headache, muscle pain, joint pain, nausea, fever, rash on torso. Patient's has no historical conditions. No relevant concomitant medications were reported.  On an 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 12 Mar 2021, 1 day prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 048A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, the patient experienced the events fatigue, headache, muscle pain, joint pain, nausea, fever. On 14 Mar 2021, the patient experienced the events rash on torso.  Treatment details included as patient has taken ibuprofen for necessary events.  Action taken with mRNA-1273 in response to the events was not applicable. On 14 Mar 2021 the outcome of events such as fatigue, headache, muscle pain, joint pain, nausea, fever was resolved.  On an unknown date the outcome of events rash on torso was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Diarrhoea, Nausea
Clinical narrative: sensitive stomach; wiped out; spend 3 hours through the night going back and forth to the bathroom. didn't throw up; terrible terrible pain/valve movement; Diarrhea; sore arm; most severe stomach pain/stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (most severe stomach pain/stomach cramps), PAIN (terrible terrible pain/valve movement), ABDOMINAL DISCOMFORT (sensitive stomach) and DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical information was provided by the reporter .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and ABDOMINAL PAIN UPPER (most severe stomach pain/stomach cramps). On 21-Feb-2021, the patient experienced PAIN (terrible terrible pain/valve movement), DIARRHOEA (Diarrhea) and NAUSEA (spend 3 hours through the night going back and forth to the bathroom. didn't throw up). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (sensitive stomach) and ASTHENIA (wiped out). At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (most severe stomach pain/stomach cramps), PAIN (terrible terrible pain/valve movement), ABDOMINAL DISCOMFORT (sensitive stomach), DIARRHOEA (Diarrhea), ASTHENIA (wiped out) and NAUSEA (spend 3 hours through the night going back and forth to the bathroom. didn't throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient spent about 3 hours going back and forth to the bathroom but didn't throw up.  Concomitant medication also included blood pressure pill.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sensitive stomach; wiped out; spend 3 hours through the night going back and forth to the bathroom. didn't throw up; terrible terrible pain/valve movement; Diarrhea; sore arm; most severe stomach pain/stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (most severe stomach pain/stomach cramps), PAIN (terrible terrible pain/valve movement), ABDOMINAL DISCOMFORT (sensitive stomach) and DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical information was provided by the reporter .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and ABDOMINAL PAIN UPPER (most severe stomach pain/stomach cramps). On 21-Feb-2021, the patient experienced PAIN (terrible terrible pain/valve movement), DIARRHOEA (Diarrhea) and NAUSEA (spend 3 hours through the night going back and forth to the bathroom. didn't throw up). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (sensitive stomach) and ASTHENIA (wiped out). At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (most severe stomach pain/stomach cramps), PAIN (terrible terrible pain/valve movement), ABDOMINAL DISCOMFORT (sensitive stomach), DIARRHOEA (Diarrhea), ASTHENIA (wiped out) and NAUSEA (spend 3 hours through the night going back and forth to the bathroom. didn't throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient spent about 3 hours going back and forth to the bathroom but didn't throw up.  Concomitant medication also included blood pressure pill.  No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Pain in extremity, Swelling
Clinical narrative: Arm was warm to touch; Swelling; Pain in arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Arm was warm to touch), SWELLING (Swelling) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 000A21A and 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 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills). On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 14-Mar-2021, the patient experienced FEELING HOT (Arm was warm to touch) and SWELLING (Swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Arm was warm to touch) and SWELLING (Swelling) outcome was unknown.            No concomitant medication information not provided.  Treatment also includes ice.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VOMITING (vomiting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (chills) and VOMITING (vomiting). On 14-Mar-2021, CHILLS (chills) and VOMITING (vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Pyrexia: 101f (High) 101F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided.  No treatment information given.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea began 3 days later and has been on and off; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea began 3 days later and has been on and off) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 12-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Diarrhea began 3 days later and has been on and off). The patient was treated with ELECTROLYTES NOS for Diarrhea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea began 3 days later and has been on and off) had not resolved.            The reporter stated that diarrhea was like pouring out a bucket of water.  Additional treatment information included yogurt and lots of water.   This case was linked to MOD-2021-047783 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: fatigue; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills). At the time of the report, FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information is not provided.  No treatment medication information given.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), headache and chills in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever), headache and chills. At the time of the report, pyrexia (fever), headache and chills outcome: unknown/not provided. Concomitant medication and treatment information not reported. It was reported the patient's daughter experienced fever, headache and chills after receiving the second dose of the vaccine. Action taken with mRNA-1273 in response to the event not applicable. Reporter did not allow further contact.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Gait disturbance, Limb discomfort, Rash
Clinical narrative: She has never experienced anything like this before and is very scared; Heavier legs; equilibrium is off; She could barely walk; broke out with hives; Rash; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heavier legs), BALANCE DISORDER (equilibrium is off), GAIT DISTURBANCE (She could barely walk), FEELING ABNORMAL (She has never experienced anything like this before and is very scared) and URTICARIA (broke out with hives) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced URTICARIA (broke out with hives) and RASH (Rash). On 14-Mar-2021, the patient experienced LIMB DISCOMFORT (Heavier legs), BALANCE DISORDER (equilibrium is off) and GAIT DISTURBANCE (She could barely walk). On 16-Mar-2021, the patient experienced FEELING ABNORMAL (She has never experienced anything like this before and is very scared). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Rash, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Heavier legs) and FEELING ABNORMAL (She has never experienced anything like this before and is very scared) outcome was unknown, BALANCE DISORDER (equilibrium is off) had not resolved, GAIT DISTURBANCE (She could barely walk) was resolving and URTICARIA (broke out with hives) and RASH (Rash) had resolved.            Action taken with mRNA-1273 in response to the event was Not Applicable
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: She has never experienced anything like this before and is very scared; Heavier legs; equilibrium is off; She could barely walk; broke out with hives; Rash; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heavier legs), BALANCE DISORDER (equilibrium is off), GAIT DISTURBANCE (She could barely walk), FEELING ABNORMAL (She has never experienced anything like this before and is very scared) and URTICARIA (broke out with hives) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced URTICARIA (broke out with hives) and RASH (Rash). On 14-Mar-2021, the patient experienced LIMB DISCOMFORT (Heavier legs), BALANCE DISORDER (equilibrium is off) and GAIT DISTURBANCE (She could barely walk). On 16-Mar-2021, the patient experienced FEELING ABNORMAL (She has never experienced anything like this before and is very scared). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Rash, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Heavier legs) and FEELING ABNORMAL (She has never experienced anything like this before and is very scared) outcome was unknown, BALANCE DISORDER (equilibrium is off) had not resolved, GAIT DISTURBANCE (She could barely walk) was resolving and URTICARIA (broke out with hives) and RASH (Rash) had resolved.            Action taken with mRNA-1273 in response to the event was Not Applicable
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Gout.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurts). At the time of the report, PAIN IN EXTREMITY (arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included unspecified high blood pressure medicines and gout treatment medicines. The patient's dentist had prescribed antibiotic for tooth. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (patient is taking treatment for hear attack suffered in 1996.) in 1996. Concurrent medical conditions included Osteoporosis (patient taking treatment every 6 months.). Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Neck pain, Nodule, Peripheral swelling
Clinical narrative: under the arm is a knot; Pain in neck; Ear ache; Arm swollen; joint pain; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NODULE (under the arm is a knot), NECK PAIN (Pain in neck), EAR PAIN (Ear ache), PERIPHERAL SWELLING (Arm swollen) and PYREXIA (Fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021 at 10:25 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 10:00 PM, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced NODULE (under the arm is a knot), NECK PAIN (Pain in neck), EAR PAIN (Ear ache), PERIPHERAL SWELLING (Arm swollen) and ARTHRALGIA (joint pain). The patient was treated with TYLENOL at a dose of 1 dosage form. At the time of the report, NODULE (under the arm is a knot), NECK PAIN (Pain in neck), EAR PAIN (Ear ache) and PERIPHERAL SWELLING (Arm swollen) had not resolved, PYREXIA (Fever) had resolved and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant medications reported were blood pressure medication. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Action taken with the drug in response to the events was not applicable
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: under the arm is a knot; Pain in neck; Ear ache; Arm swollen; joint pain; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NODULE (under the arm is a knot), NECK PAIN (Pain in neck), EAR PAIN (Ear ache), PERIPHERAL SWELLING (Arm swollen) and PYREXIA (Fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021 at 10:25 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 10:00 PM, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced NODULE (under the arm is a knot), NECK PAIN (Pain in neck), EAR PAIN (Ear ache), PERIPHERAL SWELLING (Arm swollen) and ARTHRALGIA (joint pain). The patient was treated with TYLENOL at a dose of 1 dosage form. At the time of the report, NODULE (under the arm is a knot), NECK PAIN (Pain in neck), EAR PAIN (Ear ache) and PERIPHERAL SWELLING (Arm swollen) had not resolved, PYREXIA (Fever) had resolved and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant medications reported were blood pressure medication. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Action taken with the drug in response to the events was not applicable
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Discomfort, Dizziness, Fatigue
Clinical narrative: "I have to watch my balance on the stairs; I fall asleep more easily; my ability to work has been effected; lightheadedness; mild flu-like symptoms; more difficulty focusing kind of spacy feeling; symptoms mainly similar to the ones he experienced before during last stages of Pneumonia; found difficulty working; Moderate soreness in the arm; Foggy feeling in head; Fatigue/kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working) and PAIN IN EXTREMITY (Moderate soreness in the arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy feeling in head) and FATIGUE (Fatigue/kind of tired). On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working), PAIN IN EXTREMITY (Moderate soreness in the arm) and DIZZINESS (lightheadedness). On an unknown date, the patient experienced BALANCE DISORDER ("I have to watch my balance on the stairs), SOMNOLENCE (I fall asleep more easily) and IMPAIRED WORK ABILITY (my ability to work has been effected). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working), PAIN IN EXTREMITY (Moderate soreness in the arm), FEELING ABNORMAL (Foggy feeling in head), BALANCE DISORDER ("I have to watch my balance on the stairs), SOMNOLENCE (I fall asleep more easily) and IMPAIRED WORK ABILITY (my ability to work has been effected) outcome was unknown and DIZZINESS (lightheadedness) and FATIGUE (Fatigue/kind of tired) had not resolved.            Treatment included Acupuncture and vestibular therapy.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Signifcant Follow-up received provided additional events, event outcome update and reporter details.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Impaired work ability, Influenza like illness, Pain in extremity
Clinical narrative: "I have to watch my balance on the stairs; I fall asleep more easily; my ability to work has been effected; lightheadedness; mild flu-like symptoms; more difficulty focusing kind of spacy feeling; symptoms mainly similar to the ones he experienced before during last stages of Pneumonia; found difficulty working; Moderate soreness in the arm; Foggy feeling in head; Fatigue/kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working) and PAIN IN EXTREMITY (Moderate soreness in the arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy feeling in head) and FATIGUE (Fatigue/kind of tired). On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working), PAIN IN EXTREMITY (Moderate soreness in the arm) and DIZZINESS (lightheadedness). On an unknown date, the patient experienced BALANCE DISORDER ("I have to watch my balance on the stairs), SOMNOLENCE (I fall asleep more easily) and IMPAIRED WORK ABILITY (my ability to work has been effected). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working), PAIN IN EXTREMITY (Moderate soreness in the arm), FEELING ABNORMAL (Foggy feeling in head), BALANCE DISORDER ("I have to watch my balance on the stairs), SOMNOLENCE (I fall asleep more easily) and IMPAIRED WORK ABILITY (my ability to work has been effected) outcome was unknown and DIZZINESS (lightheadedness) and FATIGUE (Fatigue/kind of tired) had not resolved.            Treatment included Acupuncture and vestibular therapy.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Signifcant Follow-up received provided additional events, event outcome update and reporter details.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: "I have to watch my balance on the stairs; I fall asleep more easily; my ability to work has been effected; lightheadedness; mild flu-like symptoms; more difficulty focusing kind of spacy feeling; symptoms mainly similar to the ones he experienced before during last stages of Pneumonia; found difficulty working; Moderate soreness in the arm; Foggy feeling in head; Fatigue/kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working) and PAIN IN EXTREMITY (Moderate soreness in the arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy feeling in head) and FATIGUE (Fatigue/kind of tired). On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working), PAIN IN EXTREMITY (Moderate soreness in the arm) and DIZZINESS (lightheadedness). On an unknown date, the patient experienced BALANCE DISORDER ("I have to watch my balance on the stairs), SOMNOLENCE (I fall asleep more easily) and IMPAIRED WORK ABILITY (my ability to work has been effected). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working), PAIN IN EXTREMITY (Moderate soreness in the arm), FEELING ABNORMAL (Foggy feeling in head), BALANCE DISORDER ("I have to watch my balance on the stairs), SOMNOLENCE (I fall asleep more easily) and IMPAIRED WORK ABILITY (my ability to work has been effected) outcome was unknown and DIZZINESS (lightheadedness) and FATIGUE (Fatigue/kind of tired) had not resolved.            Treatment included Acupuncture and vestibular therapy.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Signifcant Follow-up received provided additional events, event outcome update and reporter details.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling cold, Pyrexia
Clinical narrative: could not get warm; hard time breathing; severe body chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (could not get warm), DYSPNOEA (hard time breathing) and CHILLS (severe body chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING COLD (could not get warm), DYSPNOEA (hard time breathing) and CHILLS (severe body chills). On 06-Mar-2021, FEELING COLD (could not get warm), DYSPNOEA (hard time breathing) and CHILLS (severe body chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Pyrexia: 102.2 (High) 102.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was having hard time breathing so he hooked up to his cpap machine & it helped him.  Patient is having heart issues& spoke with his cardiologist.  No concomitant medication information provided.  No treatment medication information given.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hyperhidrosis, Pyrexia, Vaccination site pruritus
Clinical narrative: Sweating; Weakness; Chills; Fever; a persisting and uncomfortable itching at the left arm , where the vaccine was injected; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PRURITUS (a persisting and uncomfortable itching at the left arm , where the vaccine was injected) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0880853) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PRURITUS (a persisting and uncomfortable itching at the left arm , where the vaccine was injected). At the time of the report, HYPERHIDROSIS (Sweating), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PRURITUS (a persisting and uncomfortable itching at the left arm , where the vaccine was injected) had resolved.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: TCR: Updated all events Outcome from Unknown to Recovered/ Resolved
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caught Covid after first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Caught Covid after first dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (Caught Covid after first dose). The patient was treated with STEROIDS at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency. At the time of the report, COVID-19 (Caught Covid after first dose) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient said doctor gave him a steriod, vitamin C, zinc, and cough medicine
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Illness
Clinical narrative: got very very sick; had a hard time with the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very very sick) and DISCOMFORT (had a hard time with the second dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced ILLNESS (got very very sick) and DISCOMFORT (had a hard time with the second dose). At the time of the report, ILLNESS (got very very sick) and DISCOMFORT (had a hard time with the second dose) outcome was unknown. Not Provided          No concomitant medication information provided.  NO treatment information provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity
Clinical narrative: taste of metal in their mouth; soreness and pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (taste of metal in their mouth) and PAIN IN EXTREMITY (soreness and pain in the arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced DYSGEUSIA (taste of metal in their mouth) and PAIN IN EXTREMITY (soreness and pain in the arm). On 13-Mar-2021, DYSGEUSIA (taste of metal in their mouth) and PAIN IN EXTREMITY (soreness and pain in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided.   Treatment medication was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching/pruritus; Rash on back/Rash spread to arm & legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching/pruritus) and RASH (Rash on back/Rash spread to arm & legs) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), AMLODIPINE BESYLATE, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 04-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced RASH (Rash on back/Rash spread to arm & legs). On an unknown date, the patient experienced PRURITUS (Itching/pruritus). The patient was treated with METHYLPREDNISOLONE (oral) at a dose of 4 milligram. At the time of the report, PRURITUS (Itching/pruritus) and RASH (Rash on back/Rash spread to arm & legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Methyl prednisone dose pack , Antihistamine and over the counter hydrating lotion. Rash started on his back on 12Mar2021& the patent went to urgent care on 13Mar2021. But they did not tell the cause but prescribed him medication which he took it on 14Mar2021.By this time, the rash spread to arm and legs & the patient suspected that rash is related to the swimming pool he was in and being out in the sun.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Reporter requested mailing address for form return On 15-Jul-2021: Followup document received on 15-JUL-2021 .Updated concomitant medications .Updated treatment Methyl prednisolone.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: slight muscle ache at the injection; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (slight muscle ache at the injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Skin tightness (Fibroblast Plasma pen surgery for her face to get rid of wrinkles) on 05-Mar-2021 and Skin tightness (second dose of the plasma pen) on 15-Mar-2021.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (slight muscle ache at the injection). At the time of the report, MYALGIA (slight muscle ache at the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinners.  No treatment information was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; A spontaneous report was received from a consumer concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt/ Pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Mar 2021, approximately one day 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 10 Mar 2021, the patient experienced the event arm hurt.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 12 Mar 2021 the outcome of event, arm hurt was resolved.