chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Muscle spasms; Twitching on her left side of her face, near her left eyelid.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasms) and MUSCLE TWITCHING (Twitching on her left side of her face, near her left eyelid.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided) on 15-Jan-2021.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced MUSCLE SPASMS (Muscle spasms) and MUSCLE TWITCHING (Twitching on her left side of her face, near her left eyelid.). At the time of the report, MUSCLE SPASMS (Muscle spasms) and MUSCLE TWITCHING (Twitching on her left side of her face, near her left eyelid.) outcome was unknown.            no concomitant medication provided no treatment taken
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Vaccination site sore; Ache; Itchy, tender to touch "giant circle-oblong" rash on the injection site; Tender to touch "giant circle-oblong" rash on the injection site; Very, very tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy, tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE RASH (Tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE PAIN (Vaccination site sore), HEADACHE (Headache) and FATIGUE (Very, very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polymyalgia rheumatica on 26-Aug-2016, Hay fever and Anaphylaxis. Concurrent medical conditions included Asthma, Penicillin allergy (reaction hives) since 1950, Drug allergy (Aspirin/Ibuprofen) since 1988, Allergy (nonsteroidal anti-inflammatory drug NSAIDS) since 1986 and Drug allergy (ALLERGY TO LIPITOR) in 2019. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, ALIROCUMAB for High cholesterol, CELECOXIB (CELEXA [CELECOXIB]) from 12-Sep-2000 to an unknown date and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 13-Jan-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache). On 11-Feb-2021, the patient experienced FATIGUE (Very, very tired). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy, tender to touch "giant circle-oblong" rash on the injection site) and VACCINATION SITE RASH (Tender to touch "giant circle-oblong" rash on the injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site sore) and MYALGIA (Ache). On 11-Feb-2021, HEADACHE (Headache) and FATIGUE (Very, very tired) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy, tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE RASH (Tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE PAIN (Vaccination site sore) and MYALGIA (Ache) outcome was unknown.            No treatment medication was reported by patient.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Significant Follow-up received on 10-6-201 contains significant information - Height , weigh and race of the patient was updated as white. Medical history and allergies was updated. Concomitant medicine was also  updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Vaccination site sore; Ache; Itchy, tender to touch "giant circle-oblong" rash on the injection site; Tender to touch "giant circle-oblong" rash on the injection site; Very, very tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy, tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE RASH (Tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE PAIN (Vaccination site sore), HEADACHE (Headache) and FATIGUE (Very, very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polymyalgia rheumatica on 26-Aug-2016, Hay fever and Anaphylaxis. Concurrent medical conditions included Asthma, Penicillin allergy (reaction hives) since 1950, Drug allergy (Aspirin/Ibuprofen) since 1988, Allergy (nonsteroidal anti-inflammatory drug NSAIDS) since 1986 and Drug allergy (ALLERGY TO LIPITOR) in 2019. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, ALIROCUMAB for High cholesterol, CELECOXIB (CELEXA [CELECOXIB]) from 12-Sep-2000 to an unknown date and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 13-Jan-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache). On 11-Feb-2021, the patient experienced FATIGUE (Very, very tired). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy, tender to touch "giant circle-oblong" rash on the injection site) and VACCINATION SITE RASH (Tender to touch "giant circle-oblong" rash on the injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site sore) and MYALGIA (Ache). On 11-Feb-2021, HEADACHE (Headache) and FATIGUE (Very, very tired) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy, tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE RASH (Tender to touch "giant circle-oblong" rash on the injection site), VACCINATION SITE PAIN (Vaccination site sore) and MYALGIA (Ache) outcome was unknown.            No treatment medication was reported by patient.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Significant Follow-up received on 10-6-201 contains significant information - Height , weigh and race of the patient was updated as white. Medical history and allergies was updated. Concomitant medicine was also  updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness). At the time of the report, VACCINATION SITE PAIN (Arm soreness) outcome was unknown.            No concomitant medication provided No treatment taken
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Bad itching; Hardness; Aching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Bad itching), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE PAIN (Aching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported).    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 VACCINATION SITE PRURITUS (Bad itching), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE PAIN (Aching). At the time of the report, VACCINATION SITE PRURITUS (Bad itching), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE PAIN (Aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided no treatment given
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; A spontaneous report was received from a healthcare professional concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headaches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Feb 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced headaches.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of headaches was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of headache, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure during breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding) outcome was unknown. Not Provided      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 concomitant medication information was provided. No treatment medication information was provided.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Swollen lymph node along my right clavicle of my arm that was injected/swollen on right side of her neck; Body aches; Extremely high temperature, a fever over 102; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), PYREXIA (Extremely high temperature, a fever over 102) and LYMPHADENOPATHY (Swollen lymph node along my right clavicle of my arm that was injected/swollen on right side of her neck) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (Extremely high temperature, a fever over 102). On 12-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node along my right clavicle of my arm that was injected/swollen on right side of her neck). At the time of the report, MYALGIA (Body aches), PYREXIA (Extremely high temperature, a fever over 102) and LYMPHADENOPATHY (Swollen lymph node along my right clavicle of my arm that was injected/swollen on right side of her neck) outcome was unknown.            no concomitant medication provided. no treatment taken
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: his arm is little swollen; His arm is hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (his arm is little swollen) and VACCINATION SITE WARMTH (His arm is hot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE SWELLING (his arm is little swollen) and VACCINATION SITE WARMTH (His arm is hot). At the time of the report, VACCINATION SITE SWELLING (his arm is little swollen) and VACCINATION SITE WARMTH (His arm is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided no treatment taken
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema
Clinical narrative: Chills; Redness at the injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at the injection site (right arm)) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-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 CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at the injection site (right arm)). At the time of the report, CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at the injection site (right arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site pain
Clinical narrative: Sore arm; Felt heavy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and DISCOMFORT (Felt heavy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and DISCOMFORT (Felt heavy). At the time of the report, VACCINATION SITE PAIN (Sore arm) and DISCOMFORT (Felt heavy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at Injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at Injection site). At the time of the report, VACCINATION SITE PAIN (Pain at Injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itchy; tenderness; swelling; rash at the injection site; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling ), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (redness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and CANNABIDIOL (CBD OIL) for an unknown indication.    On 04-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 VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling ), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling ), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.            Treatment information not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Shortness of breath; chills; Pain at injection site; Redness at injection site; Itching at injection site; Swelling at injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), CHILLS (chills), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PRURITUS (Itching at injection site) in a 42-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.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 10-Feb-2021, the patient experienced CHILLS (chills), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site). On 11-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), CHILLS (chills), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Shortness of breath; chills; Pain at injection site; Redness at injection site; Itching at injection site; Swelling at injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), CHILLS (chills), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PRURITUS (Itching at injection site) in a 42-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.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 10-Feb-2021, the patient experienced CHILLS (chills), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site). On 11-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), CHILLS (chills), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (arm soreness), headache, fatigue (intense fatigue) and pyrexia (fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025L20A and 031M20A) for COVID-19 immunization. The patient's past medical history included cardiopulmonary arrest (2 years ago). On Jan 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 10, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dosage form. On Jan 11, 2021, patient experienced vaccination site pain (arm soreness) and fatigue (intense fatigue). On Feb 11, 2021, patient experienced headache and pyrexia (fever). At the time of the report, vaccination site pain (arm soreness), headache, fatigue (intense fatigue) and pyrexia (fever) outcome: unknown/not provided. Treatment details included Tylenol yesterday twice. No concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Fever; soreness; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), VACCINATION SITE PAIN (soreness) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No reported adverse event).  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (soreness) and CHILLS (chills). At the time of the report, PYREXIA (fever), VACCINATION SITE PAIN (soreness) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Freezing phenomenon, Illness, Pain
Clinical narrative: I was freezing I couldn't get warm; body ache; hands shaking so bad; got very sick; stomach distress;  chattering of my teeth/severe chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach distress), FREEZING PHENOMENON (I was freezing I couldn't get warm), ILLNESS (got very sick), TREMOR (hands shaking so bad) and CHILLS (chattering of my teeth/severe chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and LORAZEPAM for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FREEZING PHENOMENON (I was freezing I couldn't get warm), ILLNESS (got very sick), TREMOR (hands shaking so bad), CHILLS (chattering of my teeth/severe chills) and PAIN (body ache). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach distress). At the time of the report, ABDOMINAL DISCOMFORT (stomach distress), FREEZING PHENOMENON (I was freezing I couldn't get warm), ILLNESS (got very sick), TREMOR (hands shaking so bad), CHILLS (chattering of my teeth/severe chills) and PAIN (body ache) outcome was unknown.            Treatment information was not provided.    Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I was freezing I couldn't get warm; body ache; hands shaking so bad; got very sick; stomach distress;  chattering of my teeth/severe chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach distress), FREEZING PHENOMENON (I was freezing I couldn't get warm), ILLNESS (got very sick), TREMOR (hands shaking so bad) and CHILLS (chattering of my teeth/severe chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and LORAZEPAM for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FREEZING PHENOMENON (I was freezing I couldn't get warm), ILLNESS (got very sick), TREMOR (hands shaking so bad), CHILLS (chattering of my teeth/severe chills) and PAIN (body ache). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach distress). At the time of the report, ABDOMINAL DISCOMFORT (stomach distress), FREEZING PHENOMENON (I was freezing I couldn't get warm), ILLNESS (got very sick), TREMOR (hands shaking so bad), CHILLS (chattering of my teeth/severe chills) and PAIN (body ache) outcome was unknown.            Treatment information was not provided.    Reporter did not allow further contact
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Rash, Vaccination site pain
Clinical narrative: soreness arm; itchiness; a rash surround his belly bottom and his; headache; intense fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness arm), VACCINATION SITE PRURITUS (itchiness), RASH (a rash surround his belly bottom and his), HEADACHE (headache) and FATIGUE (intense fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031m20a and 025I20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiopulmonary arrest (2years  ago).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness arm), VACCINATION SITE PRURITUS (itchiness), RASH (a rash surround his belly bottom and his), HEADACHE (headache), FATIGUE (intense fatigue) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness arm), VACCINATION SITE PRURITUS (itchiness), RASH (a rash surround his belly bottom and his), HEADACHE (headache), FATIGUE (intense fatigue) and PYREXIA (fever) outcome was unknown. Not Provided          Concomitant medication was not provided.  Treatment information reported include Tylenol yesterday twice.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: soreness arm; itchiness; a rash surround his belly bottom and his; headache; intense fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness arm), VACCINATION SITE PRURITUS (itchiness), RASH (a rash surround his belly bottom and his), HEADACHE (headache) and FATIGUE (intense fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031m20a and 025I20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiopulmonary arrest (2years  ago).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness arm), VACCINATION SITE PRURITUS (itchiness), RASH (a rash surround his belly bottom and his), HEADACHE (headache), FATIGUE (intense fatigue) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness arm), VACCINATION SITE PRURITUS (itchiness), RASH (a rash surround his belly bottom and his), HEADACHE (headache), FATIGUE (intense fatigue) and PYREXIA (fever) outcome was unknown. Not Provided          Concomitant medication was not provided.  Treatment information reported include Tylenol yesterday twice.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain
Clinical narrative: Fatigue; Headache; Muscle ache/ muscle pain; Nausea; Vomiting; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache/ muscle pain), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-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 reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache/ muscle pain), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced PAIN (body aches). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache/ muscle pain), NAUSEA (Nausea), VOMITING (Vomiting) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fatigue; Headache; Muscle ache/ muscle pain; Nausea; Vomiting; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache/ muscle pain), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-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 reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache/ muscle pain), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced PAIN (body aches). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache/ muscle pain), NAUSEA (Nausea), VOMITING (Vomiting) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site induration, Injection site swelling, Insomnia
Clinical narrative: woke up in middle of night; injection site hurt; injection site hard; injection site swelling; A spontaneous report was received from a Consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events woke up in the middle of the night, hurting injection site, hard injection site, swollen injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the events woke up in the middle of the night. hurting injection site, hard injection site, swollen injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable  On an unknown date the outcome of events, woke up in the middle of the night, On an unknown date the outcome of events, hurting injection site, On an unknown date the outcome of events, hard injection site, On an unknown date the outcome of events, swollen injection site was not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Red rash around left, right ankle and on lower arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Red rash around left, right ankle and on lower arms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021 at 6:00 AM, the patient experienced RASH (Red rash around left, right ankle and on lower arms). At the time of the report, RASH (Red rash around left, right ankle and on lower arms) had resolved. Not Provided          Concomitant medications were not provided. Treatment details were not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: A spontaneous report (United states) was received from other health care professional on 11Feb2021, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced   Headache, stiffness and arm sore  The patient's medical history not provided by reporter. Concomitant medications reported include vitamins, coq10 supplements and garlic.  On 09Feb2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number:  031L209 - 0311209 not sure) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date, she experienced Headache, stiffness and arm sore Laboratory details were not provided  Treatment information not reported. Action taken with mRNA-1273 in response to the events were not applicable. The outcome of the events, Headache, stiffness and arm sore were not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Heart rate irregular, Nausea
Clinical narrative: rapid heartbeat; temperature; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), HEART RATE IRREGULAR (rapid heartbeat) and BODY TEMPERATURE INCREASED (temperature) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 11-Feb-2021, the patient experienced CHILLS (chills), NAUSEA (nausea) and BODY TEMPERATURE INCREASED (temperature). On 12-Feb-2021, the patient experienced HEART RATE IRREGULAR (rapid heartbeat). At the time of the report, CHILLS (chills), NAUSEA (nausea), HEART RATE IRREGULAR (rapid heartbeat) and BODY TEMPERATURE INCREASED (temperature) outcome was unknown.            Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: sharp pain in arm; soreness in arm about hour or 2 later after injection; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events got soreness in arm about hour or 2 later after injection, i am having sharp pain in arm other arm (right arm), right in the middle of forearm like somebody.  The patient's medical history was not provided. Concomitant medications reported were amiloride, liptor, allopurinol, levothyroxine, quinApril, Norvasc for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) got soreness in arm about hour or 2 later after injection . On 13 Feb 2021, the patient experienced the event(s) i am having sharp pain in arm other arm (right arm). right in the middle of forearm like somebody.  Treatment details included applied ice and helped.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), got soreness in arm about hour or 2 later after injection, i am having sharp pain in arm other arm (right arm),right in the middle of forearm like somebody was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Headache, Hot flush, Pain
Clinical narrative: fast heartbeat; head ache; achiness; runny nose; sore arm; weakness in legs; hot flash; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness in legs), HOT FLUSH (hot flash) and DYSPNOEA (shortness of breath) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, METOPROLOL, EZETIMIBE, DRONEDARONE HYDROCHLORIDE (MULTAQ), ATORVASTATIN, RIVAROXABAN (XARELTO) and VITAMIN D3 for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness in legs), HOT FLUSH (hot flash), DYSPNOEA (shortness of breath) and PAIN (achiness). On 03-Mar-2021, the patient experienced TACHYCARDIA (fast heartbeat) and HEADACHE (head ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021, RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness in legs), HOT FLUSH (hot flash) and PAIN (achiness) had resolved. At the time of the report, DYSPNOEA (shortness of breath), TACHYCARDIA (fast heartbeat) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea, Tachycardia
Clinical narrative: fast heartbeat; head ache; achiness; runny nose; sore arm; weakness in legs; hot flash; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness in legs), HOT FLUSH (hot flash) and DYSPNOEA (shortness of breath) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, METOPROLOL, EZETIMIBE, DRONEDARONE HYDROCHLORIDE (MULTAQ), ATORVASTATIN, RIVAROXABAN (XARELTO) and VITAMIN D3 for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness in legs), HOT FLUSH (hot flash), DYSPNOEA (shortness of breath) and PAIN (achiness). On 03-Mar-2021, the patient experienced TACHYCARDIA (fast heartbeat) and HEADACHE (head ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021, RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness in legs), HOT FLUSH (hot flash) and PAIN (achiness) had resolved. At the time of the report, DYSPNOEA (shortness of breath), TACHYCARDIA (fast heartbeat) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Warmness at the injection site; Redness at the injection site, three inches in diameter; Itchiness at the injection site; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness at the injection site, three inches in diameter, warmness at the injection site, itchiness at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.   Redness at the injection site, three inches in diameter, Warmness at the injection site, Itchiness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), redness at the injection site, three inches in diameter,warmness at the injection site,itchiness at the injection site was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Headache, Malaise, Ocular hyperaemia, Pain in extremity
Clinical narrative: eye felt irritated and burned; eye puffed up and was red; eye was red; felt a little cruddy; arm hurts; headache; A spontaneous report was received from a consumer concerning a 69-years-old male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, arm hurts, felt a little cruddy, normal side effects, puffed up and was red.  The patient's medical history was not provided. Concomitant medications reported were  for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) headache. arm hurts, felt a little cruddy, normal side effects. On 11 Feb 2021, the patient experienced the events, eye puffed up and was red.  Treatment details included Didn't take anything.  Action taken with mRNA-1273 in response to the events were not applicable. The outcome of event,felt a little cruddy was considered resolved on 9 Feb 2021.The outcome of events ,normal side effects was considered resolved on 11 Feb 2021.The outcome of events,puffed up eye  was considered resolved on 11 Feb 2021. The outcome of events, headache, arm hurts, eye felt irritated and burned and red eyes were unknown.