chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, White blood cell count
Clinical narrative: Weakness; Fever; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weakness) and PYREXIA (Fever) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Coronary artery disease since 01-Apr-2004, Sulfonamide allergy (Sulfa) and Allergy to antibiotic (Levaquin). Concomitant products included CLOPIDOGREL and ACETYLSALICYLIC ACID (ECOTRIN) for Coronary artery disease, LISINOPRIL and AMLODIPINE for Hypertension, ROSUVASTATIN for an unknown indication.   On 30-Dec-2020 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (Weakness) and PYREXIA (Fever). On 05-Feb-2021, PYREXIA (Fever) had resolved. On 28-Feb-2021, ASTHENIA (Weakness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, AST/ALT ratio: (High) Mild elevation. On an unknown date, Body temperature: 100 and 100.2. On an unknown date, C-reactive protein increased: (High) elevated. On an unknown date, Red blood cell sedimentation rate increased: (High) Elevated. On an unknown date, White blood cell count: 12000 (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include Tylenol. Action taken with mRNA-1273 in response to the events was  not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Updated patient demographics and medical history. New concomitant medication added. The outcome of the event changed from unknown to recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: sore arm; itchy red path where they had the first shot; itchy red path where they had the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itchy red path where they had the first shot) and VACCINATION SITE ERYTHEMA (itchy red path where they had the first shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itchy red path where they had the first shot) and VACCINATION SITE ERYTHEMA (itchy red path where they had the first shot). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itchy red path where they had the first shot) and VACCINATION SITE ERYTHEMA (itchy red path where they had the first shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided.  Action taken with mRNA-123 is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional information received
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: difficult to walk; left leg started to hurt; knee burning; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (left leg started to hurt) and ARTHRALGIA (knee burning) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included MELOXICAM for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (left leg started to hurt) and ARTHRALGIA (knee burning). The patient was treated with PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (left leg started to hurt) and ARTHRALGIA (knee burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included took tylenol for arthritis.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: very itchy; vaccination site redness; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (vaccination site redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (vaccination site redness). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE ERYTHEMA (vaccination site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like having the flu), HYPERHIDROSIS (The sweats) and MYALGIA (Body aches) in a 48-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 Historical condition reported.).   On 29-Jan-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like having the flu), HYPERHIDROSIS (The sweats) and MYALGIA (Body aches). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like having the flu), HYPERHIDROSIS (The sweats) and MYALGIA (Body aches) outcome was unknown.            No treatment information was provided.No relevant concomitant medications were reported.  Action taken with mRNA -123 is not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Hypertension, Palpitations, Tachycardia
Clinical narrative: Possible adverse reaction to the Moderna vacccine; Episodic recurrent tachycardia; Hypertension; Palpitations; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Possible adverse reaction to the Moderna vacccine), TACHYCARDIA (Episodic recurrent tachycardia), HYPERTENSION (Hypertension) and PALPITATIONS (Palpitations) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccine.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ADVERSE EVENT (Possible adverse reaction to the Moderna vacccine). On an unknown date, the patient experienced TACHYCARDIA (Episodic recurrent tachycardia), HYPERTENSION (Hypertension) and PALPITATIONS (Palpitations). At the time of the report, ADVERSE EVENT (Possible adverse reaction to the Moderna vacccine), TACHYCARDIA (Episodic recurrent tachycardia), HYPERTENSION (Hypertension) and PALPITATIONS (Palpitations) had not 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.   No treatment information and concomitant medications were reported.   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Neuropathy peripheral, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Feet and legs felt like she was walking in a muddy land; Difficult to move because lower legs felt like it was 30 or 40 pounds each; It was warmer than the rest of my arm; It was itching; Arms started to swell; It was reddish pink; A spontaneous report, was received from a consumer (patient), an 85 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced feet and legs felt like she was walking in a muddy land (peripheral neuropathy), difficult to move because lower legs felt like it was 30 or 40 pounds each (bradykinesia), it was warmer than the rest of my arm (vaccination site warmth), it was itching (vaccination site pruritus), arms started to swell (vaccination site swelling), and it was reddish pink (vaccination site erythema).  The patient's medical history was not provided. Concomitant medications were not provided.  On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A), intramuscularly in the left arm for the prophylaxis of COVID-19 infection.   On 21 Jan 2021, right away after the vaccine was administered, the patient had nothing. After taking a nap, that day while the patient wanted to get up, but feet and legs felt like she was walking in a muddy land and shoes would pick up mud and become heavier. It was difficult to move because her lower legs felt like it was 30 or 40 pounds each, which went away. About a week later, the patient felt nothing. On 27 Jan 2021, the patient's arm started to swell, just at the area, as big as a kiwi. It was warmer than the rest of her arm, reddish pink and was itching, but did not want to scratch her arm. That lasted about two days. The patient had no fever, and no chills. No treatment details were provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, feet and legs felt like she was walking in a muddy land, difficult to move because lower legs felt like it was 30 or 40 pounds each was recovered on an unknown date in Jan 2021, that of event it was itching was recovered on 27 Jan 2021, and that of events it was warmer than the rest of my arm, arms started to swell, and it was reddish pink were recovered on 29 Jan 2021.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event and excluding any other etiology,  a causal relationship with the events cannot be excluded. Vaccination site pruritus, Vaccination site swelling, and Vaccination site erythema are consistent with the vaccine profile.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Feet and legs felt like she was walking in a muddy land; Difficult to move because lower legs felt like it was 30 or 40 pounds each; It was warmer than the rest of my arm; It was itching; Arms started to swell; It was reddish pink; A spontaneous report, was received from a consumer (patient), an 85 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced feet and legs felt like she was walking in a muddy land (peripheral neuropathy), difficult to move because lower legs felt like it was 30 or 40 pounds each (bradykinesia), it was warmer than the rest of my arm (vaccination site warmth), it was itching (vaccination site pruritus), arms started to swell (vaccination site swelling), and it was reddish pink (vaccination site erythema).  The patient's medical history was not provided. Concomitant medications were not provided.  On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A), intramuscularly in the left arm for the prophylaxis of COVID-19 infection.   On 21 Jan 2021, right away after the vaccine was administered, the patient had nothing. After taking a nap, that day while the patient wanted to get up, but feet and legs felt like she was walking in a muddy land and shoes would pick up mud and become heavier. It was difficult to move because her lower legs felt like it was 30 or 40 pounds each, which went away. About a week later, the patient felt nothing. On 27 Jan 2021, the patient's arm started to swell, just at the area, as big as a kiwi. It was warmer than the rest of her arm, reddish pink and was itching, but did not want to scratch her arm. That lasted about two days. The patient had no fever, and no chills. No treatment details were provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, feet and legs felt like she was walking in a muddy land, difficult to move because lower legs felt like it was 30 or 40 pounds each was recovered on an unknown date in Jan 2021, that of event it was itching was recovered on 27 Jan 2021, and that of events it was warmer than the rest of my arm, arms started to swell, and it was reddish pink were recovered on 29 Jan 2021.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event and excluding any other etiology,  a causal relationship with the events cannot be excluded. Vaccination site pruritus, Vaccination site swelling, and Vaccination site erythema are consistent with the vaccine profile.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Petechiae, Rash, Rash pruritic
Clinical narrative: a petechiae type rash; it was a little bit itchy; bright red color overall; a small rash on both legs; like 2 bands around the top of her lower legs down by the ankle; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (a petechiae type rash), RASH PRURITIC (it was a little bit itchy), ERYTHEMA (bright red color overall), RASH (a small rash on both legs) and RASH (like 2 bands around the top of her lower legs down by the ankle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PETECHIAE (a petechiae type rash), RASH PRURITIC (it was a little bit itchy), ERYTHEMA (bright red color overall), RASH (a small rash on both legs) and RASH (like 2 bands around the top of her lower legs down by the ankle). On 02-Feb-2021, PETECHIAE (a petechiae type rash), RASH PRURITIC (it was a little bit itchy), ERYTHEMA (bright red color overall), RASH (a small rash on both legs) and RASH (like 2 bands around the top of her lower legs down by the ankle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure medication, vitamins, acetylsalicylic acid for drug use for unknown indication.  Treatment details included Moisturizer.     Reporter did not allow further contact
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm is sore) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (Arm is sore). At the time of the report, MYALGIA (Arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication,cholesterol medication,urinary control medication and blood thinners (Unspecified).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, Pre-existing condition improved, Skin disorder
Clinical narrative: had sore left arm for a couple of days; she has a little thing under the skin of the left arm ,said she used to have it when she was younger , and now it appeared again,; had done the rapid test , it was negative for Covid, had no symptoms; she spent the weekend with her brother in law, and on Monday he tested positive for Covid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (she spent the weekend with her brother in law, and on Monday he tested positive for Covid), PRE-EXISTING CONDITION IMPROVED (had done the rapid test , it was negative for Covid, had no symptoms), PAIN IN EXTREMITY (had sore left arm for a couple of days) and SKIN DISORDER (she has a little thing under the skin of the left arm ,said she used to have it when she was younger , and now it appeared again,) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032LL20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (she spent the weekend with her brother in law, and on Monday he tested positive for Covid). On 23-Feb-2021, the patient experienced PRE-EXISTING CONDITION IMPROVED (had done the rapid test , it was negative for Covid, had no symptoms) and SKIN DISORDER (she has a little thing under the skin of the left arm ,said she used to have it when she was younger , and now it appeared again,). On an unknown date, the patient experienced PAIN IN EXTREMITY (had sore left arm for a couple of days). On 21-Feb-2021, COVID-19 (she spent the weekend with her brother in law, and on Monday he tested positive for Covid) had resolved. At the time of the report, PRE-EXISTING CONDITION IMPROVED (had done the rapid test , it was negative for Covid, had no symptoms), PAIN IN EXTREMITY (had sore left arm for a couple of days) and SKIN DISORDER (she has a little thing under the skin of the left arm ,said she used to have it when she was younger , and now it appeared again,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: warm to the touch; little itchy; "A lump about the size of a softball"; little red ring around the IS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), PRURITUS (little itchy), VACCINATION SITE MASS ("A lump about the size of a softball") and VACCINATION SITE ERYTHEMA (little red ring around the IS) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (little red ring around the IS). On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), PRURITUS (little itchy) and VACCINATION SITE MASS ("A lump about the size of a softball"). On 14-Feb-2021, VACCINATION SITE ERYTHEMA (little red ring around the IS) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to the touch), PRURITUS (little itchy) and VACCINATION SITE MASS ("A lump about the size of a softball") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 69.0
Sex: U
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 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. 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.        No relevant concomitant medications were reported.  Treatment for the event included Tylenol and Benadryl.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: On the 04FEB2021 the same thing happen. The redness was smaller about 1.5 inch to 2.5 inches; Itchy and then it went away; Red about 2 inches wide 3 inches long; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy and then it went away), VACCINATION SITE RASH (Red about 2 inches wide 3 inches long) and VACCINATION SITE RASH (On the 04FEB2021 the same thing happen. The redness was smaller about 1.5 inch to 2.5 inches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy and then it went away) and VACCINATION SITE RASH (Red about 2 inches wide 3 inches long). On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (On the 04FEB2021 the same thing happen. The redness was smaller about 1.5 inch to 2.5 inches). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy and then it went away), VACCINATION SITE RASH (Red about 2 inches wide 3 inches long) and VACCINATION SITE RASH (On the 04FEB2021 the same thing happen. The redness was smaller about 1.5 inch to 2.5 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Claritin.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vaccination site swelling
Clinical narrative: swelling on the injection site; chills; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on the injection site), CHILLS (chills), PYREXIA (fever) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling on the injection site), CHILLS (chills), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, VACCINATION SITE SWELLING (swelling on the injection site), CHILLS (chills), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Migraine, Vomiting
Clinical narrative: Strong headaches which turned into migraine; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Strong headaches which turned into migraine) and VOMITING (Vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MIGRAINE (Strong headaches which turned into migraine) and VOMITING (Vomiting). At the time of the report, MIGRAINE (Strong headaches which turned into migraine) outcome was unknown and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Heart rate
Clinical narrative: headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (patient is reported to be a heart patient).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: real low blood pressure in morning, but it had stabilized. On 05-Feb-2021, Heart rate: rapid heart beat of around 122ppm, then it was at around 98ppm.     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 products included heart medication and sinus infection medication. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Astronomical pain; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events astronomical pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025J202A) via unknown route for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030L20A) via unknown route for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the events astronomical pain.  Treatment details included the doctors give her steroids but it's don't caring of it.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, astronomical pain was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Gland Under Jaw; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph Gland Under Jaw) in an 82-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.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph Gland Under Jaw). At the time of the report, LYMPHADENOPATHY (Swollen Lymph Gland Under Jaw) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (patient is on blood pressure medications) and Cholesterol (patient is on cholesterol medications). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided. Concomitant medications also include   Blood pressure and cholesterol medications.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Nausea, Pain
Clinical narrative: Body aches; Fever of 102.9 (degree Fahrenheit); Joint pain; Chills; Nausea; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever of 102.9 (degree Fahrenheit)), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) 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 prior medical history was reported).    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), PYREXIA (Fever of 102.9 (degree Fahrenheit)), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Extreme fatigue). At the time of the report, PAIN (Body aches), PYREXIA (Fever of 102.9 (degree Fahrenheit)), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Extreme fatigue) had resolved.            concomitant medications were not provided by the reporter.  Treatment medication include anti-nausea medication.  Action taken with m-RNA-123 is not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches; Fever of 102.9 (degree Fahrenheit); Joint pain; Chills; Nausea; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever of 102.9 (degree Fahrenheit)), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) 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 prior medical history was reported).    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), PYREXIA (Fever of 102.9 (degree Fahrenheit)), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Extreme fatigue). At the time of the report, PAIN (Body aches), PYREXIA (Fever of 102.9 (degree Fahrenheit)), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Extreme fatigue) had resolved.            concomitant medications were not provided by the reporter.  Treatment medication include anti-nausea medication.  Action taken with m-RNA-123 is not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriosclerosis, Dyspnoea, Electrocardiogram, Tachycardia
Clinical narrative: A moderate amount of LDA arteriosclerosis around the heart; shortness of breath; Fast heart rate, rapid heart beat related to drop in sugar levels; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast heart rate, rapid heart beat related to drop in sugar levels), ARTERIOSCLEROSIS (A moderate amount of LDA arteriosclerosis around the heart) and DYSPNOEA (shortness of breath) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced TACHYCARDIA (Fast heart rate, rapid heart beat related to drop in sugar levels). On an unknown date, the patient experienced ARTERIOSCLEROSIS (A moderate amount of LDA arteriosclerosis around the heart) and DYSPNOEA (shortness of breath). On 19-Feb-2021, TACHYCARDIA (Fast heart rate, rapid heart beat related to drop in sugar levels) had resolved. At the time of the report, ARTERIOSCLEROSIS (A moderate amount of LDA arteriosclerosis around the heart) and DYSPNOEA (shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient needs to have an operation for their rotator cuff, but is not able until they get clearance from their cardiologist..  No relevant concomitant medications were reported. Treatment information for the event was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: New events added.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Pain, Vaccination site lymphadenopathy
Clinical narrative: pain under armpit; hurts a little; pain in breast and nipple area; Axillary node inflamed; This spontaneous case was reported by a health care professional and describes the occurrence of AXILLARY PAIN (pain under armpit), PAIN (hurts a little), BREAST PAIN (pain in breast and nipple area) and VACCINATION SITE LYMPHADENOPATHY (Axillary node inflamed) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MELATONIN for an unknown indication.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced AXILLARY PAIN (pain under armpit), PAIN (hurts a little), BREAST PAIN (pain in breast and nipple area) and VACCINATION SITE LYMPHADENOPATHY (Axillary node inflamed). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (MOTRIN COLD & FLU) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, AXILLARY PAIN (pain under armpit), PAIN (hurts a little), BREAST PAIN (pain in breast and nipple area) and VACCINATION SITE LYMPHADENOPATHY (Axillary node inflamed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment activities for the event included Motrin, Ibuprofen.  Action taken with mRNA-1273 in response to the events was not applicable.    Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Functional gastrointestinal disorder, Headache
Clinical narrative: Stomach issues because bowels were swollen; Stomach issues because bowels were swollen; Allergic reaction; Itching; Hard lump; Swelling; Lymph node pain; Headache; Fatigue; Chills; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching) and MASS (Hard lump) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphadenectomy (lymph nodes removed on side of injection (left arm) 5 years ago). Concomitant products included TOPIRAMATE (TOPAMAX) and OMEPRAZOLE for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching), MASS (Hard lump), SWELLING (Swelling), LYMPH NODE PAIN (Lymph node pain), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching), MASS (Hard lump), SWELLING (Swelling), LYMPH NODE PAIN (Lymph node pain), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines included centroid.; Sender's Comments: There is not enough information to assess stomach issue without an exact description and the patient's concomitant medication include omeprazolesuggestive of a digestive issue.  Additional information will be requested.  Based on temporal association, a causal association between the product use and the other events cannot be excluded. headache, fatigue, chills, nausea, fever, and lymph node pain are consistent with the known safety profile of the vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lymph node pain, Mass, Nausea, Pruritus
Clinical narrative: Stomach issues because bowels were swollen; Stomach issues because bowels were swollen; Allergic reaction; Itching; Hard lump; Swelling; Lymph node pain; Headache; Fatigue; Chills; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching) and MASS (Hard lump) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphadenectomy (lymph nodes removed on side of injection (left arm) 5 years ago). Concomitant products included TOPIRAMATE (TOPAMAX) and OMEPRAZOLE for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching), MASS (Hard lump), SWELLING (Swelling), LYMPH NODE PAIN (Lymph node pain), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching), MASS (Hard lump), SWELLING (Swelling), LYMPH NODE PAIN (Lymph node pain), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines included centroid.; Sender's Comments: There is not enough information to assess stomach issue without an exact description and the patient's concomitant medication include omeprazolesuggestive of a digestive issue.  Additional information will be requested.  Based on temporal association, a causal association between the product use and the other events cannot be excluded. headache, fatigue, chills, nausea, fever, and lymph node pain are consistent with the known safety profile of the vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Stomach issues because bowels were swollen; Stomach issues because bowels were swollen; Allergic reaction; Itching; Hard lump; Swelling; Lymph node pain; Headache; Fatigue; Chills; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching) and MASS (Hard lump) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphadenectomy (lymph nodes removed on side of injection (left arm) 5 years ago). Concomitant products included TOPIRAMATE (TOPAMAX) and OMEPRAZOLE for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching), MASS (Hard lump), SWELLING (Swelling), LYMPH NODE PAIN (Lymph node pain), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues because bowels were swollen), FUNCTIONAL GASTROINTESTINAL DISORDER (Stomach issues because bowels were swollen), HYPERSENSITIVITY (Allergic reaction), PRURITUS (Itching), MASS (Hard lump), SWELLING (Swelling), LYMPH NODE PAIN (Lymph node pain), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines included centroid.; Sender's Comments: There is not enough information to assess stomach issue without an exact description and the patient's concomitant medication include omeprazolesuggestive of a digestive issue.  Additional information will be requested.  Based on temporal association, a causal association between the product use and the other events cannot be excluded. headache, fatigue, chills, nausea, fever, and lymph node pain are consistent with the known safety profile of the vaccine.