chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Itchy; feels warm to the touch; swollen from site of injection to elbow; soreness/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE WARMTH (feels warm to the touch), VACCINATION SITE SWELLING (swollen from site of injection to elbow) and PAIN (soreness/sore arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20a and 013L20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MELOXICAM (MOBIC), PARACETAMOL (TYLENOL), METFORMIN, AMLODIPINE and NABUMETONE for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE WARMTH (feels warm to the touch), VACCINATION SITE SWELLING (swollen from site of injection to elbow) and PAIN (soreness/sore arm). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE WARMTH (feels warm to the touch), VACCINATION SITE SWELLING (swollen from site of injection to elbow) and PAIN (soreness/sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Benadryl cream.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: He received the first dose of the vaccine on 05Jan2021 and the second dose on 29Jan2021.; Rash on body; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received the first dose of the vaccine on 05Jan2021 and the second dose on 29Jan2021.) and RASH (Rash on body) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced RASH (Rash on body). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received the first dose of the vaccine on 05Jan2021 and the second dose on 29Jan2021.). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received the first dose of the vaccine on 05Jan2021 and the second dose on 29Jan2021.) outcome was unknown and RASH (Rash on body) had not resolved.            Concomitant product use was not provided by the reporter. Treatment details included Steroid Shot. Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Headache
Clinical narrative: Not a clear focus; Headache; No energy; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (Not a clear focus), HEADACHE (Headache) and FATIGUE (No energy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DISTURBANCE IN ATTENTION (Not a clear focus), HEADACHE (Headache) and FATIGUE (No energy). At the time of the report, DISTURBANCE IN ATTENTION (Not a clear focus), HEADACHE (Headache) and FATIGUE (No energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lacrimation increased, Ocular discomfort, Vertigo, Vision blurred
Clinical narrative: eye pressure; watery eyes; blurred vision; vertigo; headaches; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eye pressure), LACRIMATION INCREASED (watery eyes), VISION BLURRED (blurred vision), VERTIGO (vertigo) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    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 OCULAR DISCOMFORT (eye pressure), LACRIMATION INCREASED (watery eyes), VISION BLURRED (blurred vision), VERTIGO (vertigo) and HEADACHE (headaches). At the time of the report, OCULAR DISCOMFORT (eye pressure) and LACRIMATION INCREASED (watery eyes) outcome was unknown and VISION BLURRED (blurred vision), VERTIGO (vertigo) and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported. No concomitant medicine  was reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Having fever; Having chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Having fever) and CHILLS (Having chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Having fever) and CHILLS (Having chills). At the time of the report, PYREXIA (Having fever) and CHILLS (Having chills) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Blood pressure decreased, Chills, Headache, Hyperhidrosis
Clinical narrative: Drop in blood sugar; Chills; Fever; SWEATING; headache; body aches; nauseas; Drop in Blood Pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (SWEATING), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nauseas) and BLOOD PRESSURE DECREASED (Drop in Blood Pressure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus syndrome, Diabetes, Sciatica, Arthritis and Drug allergy (BACTRIM).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced HYPERHIDROSIS (SWEATING), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nauseas) and BLOOD PRESSURE DECREASED (Drop in Blood Pressure). On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (Drop in blood sugar), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, HYPERHIDROSIS (SWEATING), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nauseas), BLOOD PRESSURE DECREASED (Drop in Blood Pressure), BLOOD GLUCOSE DECREASED (Drop in blood sugar), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional info
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Drop in blood sugar; Chills; Fever; SWEATING; headache; body aches; nauseas; Drop in Blood Pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (SWEATING), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nauseas) and BLOOD PRESSURE DECREASED (Drop in Blood Pressure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus syndrome, Diabetes, Sciatica, Arthritis and Drug allergy (BACTRIM).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced HYPERHIDROSIS (SWEATING), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nauseas) and BLOOD PRESSURE DECREASED (Drop in Blood Pressure). On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (Drop in blood sugar), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, HYPERHIDROSIS (SWEATING), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nauseas), BLOOD PRESSURE DECREASED (Drop in Blood Pressure), BLOOD GLUCOSE DECREASED (Drop in blood sugar), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional info
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PAIN (Pain and tenderness arm) and the second episode of VACCINATION SITE PAIN (Pain and tenderness arm) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced the first episode of VACCINATION SITE PAIN (Pain and tenderness arm) and the second episode of VACCINATION SITE PAIN (Pain and tenderness arm). At the time of the report, last episode of VACCINATION SITE PAIN (Pain and tenderness arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-033892 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: 20 doses that were administered after the temperature excursion; A spontaneous report was received from a pharmacist concerning 20 patients, who received Moderna's COVID-19 vaccine (mRNA-1273)  after the temperature excursion.  The patients medical history, was not reported. Concomitant medications was not reported.   On unknown date, prior to the onset of the events, the patients received their planned doses of mRNA-1273 (Lot number: 025A21A) for prophylaxis of COVID-19 infection.   On 02/25/21 at 12:35pm Thursday, 10 vials were delivered in a frozen container, moved to Ultra Cold -66.5°F at 12:40pm. 1 vial moved from ultra-cold storage to room temp 70°F on 02/28/21 at 9:43am to use for patient administration. 1 more vial moved from ultra-cold storage to refrigerator on 02/28/21 6pm to be used for patient administration on 3/1/21.Interim disposition of vials: returned to the freezer/refrigerator, or maintained at room temperature: Vial 1 Maintained at room temp 70°F 02/28/21 at 9:43am for administration. Vial 2 Maintained at room temp 70°F 03/01/21 At 9:05am. The other 8 vials were moved from ultra-cold storage to room temperature with the purpose of salvaging on 3/1 at 11:40 am.Visual inspection noting any vaccine state change (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all): Vial 1: Frozen vial thawed at room temp to liquid state from 9.43am to 11:30am 02/28/21. Vial 2 thawed in refrigerator 6pm 02/28/21 and liquid when opened at 9am 03/01/21.Proposed Use by Date (date of vaccination clinic, patient appointments, etc) Vial 1: Used for patient appointments starting at 11:30 am and completing at 3 pm on 2/28. Vial 2 used for patient appointments starting at 9:15 am until 11:40 am on 3/1/21.Number of vials/doses impacted: 20doses (2vials) Pertinent details: whether the vial(s) were punctured, any previous excursions with the impacted vial(s) Vial 1 punctured 1130am Sunday 02/28/21 . Vial 2 punctured 09.05am Monday 03/01/21.They thawed the vial from Sunday 02/28 943am at room temp and administered to 11 patients.The vial thawed from Sunday 02/28 at 6pm was placed in the refrigerator and we began to administer at 9.15am Monday. 9 patients received this vaccine.  No laboratory details was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report,the outcome of the event expired vaccine used was resolved.; Reporter's Comments: This case concerns a patient who was administered mRNA-1273 (Lot number: 025A21A)  after the temperature excursion (Out of specification product use.  There was no associated adverse event reported for the event of out of specification product use.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after shot). At the time of the report, PAIN IN EXTREMITY (Sore arm after shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment details was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site movement impairment
Clinical narrative: Arm pain; Pain is mostly with movement; Pain is through the upper left arm and into the shoulder; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Pain is mostly with movement) and ARTHRALGIA (Pain is through the upper left arm and into the shoulder) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029l20a and 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Pain is mostly with movement) and ARTHRALGIA (Pain is through the upper left arm and into the shoulder). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Pain is mostly with movement) and ARTHRALGIA (Pain is through the upper left arm and into the shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-033893 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administered to someone at the age of under 18; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered to someone at the age of under 18) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered to someone at the age of under 18). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered to someone at the age of under 18) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (under 18 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (When I get up to walk, the pain gets to the back of my legs), NECK PAIN (Pain from the injection site up to the neck) and VACCINATION SITE PAIN (Pain from the injection site up to the neck) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (When I get up to walk, the pain gets to the back of my legs), NECK PAIN (Pain from the injection site up to the neck) and VACCINATION SITE PAIN (Pain from the injection site up to the neck). At the time of the report, PAIN IN EXTREMITY (When I get up to walk, the pain gets to the back of my legs), NECK PAIN (Pain from the injection site up to the neck) and VACCINATION SITE PAIN (Pain from the injection site up to the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse reaction to their arm a week after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction to their arm a week after the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 COMPLICATION (adverse reaction to their arm a week after the shot). At the time of the report, VACCINATION COMPLICATION (adverse reaction to their arm a week after the shot) 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Muscle spasms
Clinical narrative: tinglining from knee to ankles; Foot cramps; Sore arm; Uncontrolled shaking; Roots of her hair were sore to touch; Severe chills; elevated pulse rate; Leg cramps; exhaustion; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Severe chills), HEART RATE INCREASED (elevated pulse rate), MUSCLE SPASMS (Leg cramps), FATIGUE (exhaustion) and HEADACHE (severe headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Severe chills), HEART RATE INCREASED (elevated pulse rate), MUSCLE SPASMS (Leg cramps), FATIGUE (exhaustion), HEADACHE (severe headache), MUSCLE SPASMS (Foot cramps), PAIN IN EXTREMITY (Sore arm), TREMOR (Uncontrolled shaking) and PAIN (Roots of her hair were sore to touch). On an unknown date, the patient experienced PARAESTHESIA (tinglining from knee to ankles). At the time of the report, CHILLS (Severe chills), HEART RATE INCREASED (elevated pulse rate), MUSCLE SPASMS (Leg cramps), FATIGUE (exhaustion), HEADACHE (severe headache), MUSCLE SPASMS (Foot cramps), PAIN IN EXTREMITY (Sore arm), TREMOR (Uncontrolled shaking) and PAIN (Roots of her hair were sore to touch) outcome was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Tremor
Clinical narrative: tinglining from knee to ankles; Foot cramps; Sore arm; Uncontrolled shaking; Roots of her hair were sore to touch; Severe chills; elevated pulse rate; Leg cramps; exhaustion; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Severe chills), HEART RATE INCREASED (elevated pulse rate), MUSCLE SPASMS (Leg cramps), FATIGUE (exhaustion) and HEADACHE (severe headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Severe chills), HEART RATE INCREASED (elevated pulse rate), MUSCLE SPASMS (Leg cramps), FATIGUE (exhaustion), HEADACHE (severe headache), MUSCLE SPASMS (Foot cramps), PAIN IN EXTREMITY (Sore arm), TREMOR (Uncontrolled shaking) and PAIN (Roots of her hair were sore to touch). On an unknown date, the patient experienced PARAESTHESIA (tinglining from knee to ankles). At the time of the report, CHILLS (Severe chills), HEART RATE INCREASED (elevated pulse rate), MUSCLE SPASMS (Leg cramps), FATIGUE (exhaustion), HEADACHE (severe headache), MUSCLE SPASMS (Foot cramps), PAIN IN EXTREMITY (Sore arm), TREMOR (Uncontrolled shaking) and PAIN (Roots of her hair were sore to touch) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and CHILLS (Chills). At the time of the report, HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A little bit of pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A little bit of pain at the injection site) in a male 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. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), CLOPIDOGREL BISULFATE (PLAVIX), GLIPIZIDE, METFORMIN and AMLODIPINE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (A little bit of pain at the injection site). At the time of the report, VACCINATION SITE PAIN (A little bit of pain at the injection site) had resolved.            No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20 Jul 2021 contains no new information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate irregular, Hypotension, Oxygen saturation
Clinical narrative: Blood pressure was low 98/62; Checked oxygen levels and it was at 84; Heart was racing; Pulse was irregular; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure was low 98/62), OXYGEN SATURATION DECREASED (Checked oxygen levels and it was at 84), PALPITATIONS (Heart was racing) and HEART RATE IRREGULAR (Pulse was irregular) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESTRADIOL (IMVEXXY), LEVOTHYROXINE, MONTELUKAST, METOPROLOL and ATORVASTATIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced HYPOTENSION (Blood pressure was low 98/62), OXYGEN SATURATION DECREASED (Checked oxygen levels and it was at 84), PALPITATIONS (Heart was racing) and HEART RATE IRREGULAR (Pulse was irregular). On 24-Feb-2021, HYPOTENSION (Blood pressure was low 98/62), OXYGEN SATURATION DECREASED (Checked oxygen levels and it was at 84) and HEART RATE IRREGULAR (Pulse was irregular) had resolved. At the time of the report, PALPITATIONS (Heart was racing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Blood pressure measurement: 98/62 mmHg Low. On 24-Feb-2021, Heart rate: 85. On 24-Feb-2021, Oxygen saturation: 84 After an hour it increased to 94.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Palpitations
Clinical narrative: Blood pressure was low 98/62; Checked oxygen levels and it was at 84; Heart was racing; Pulse was irregular; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure was low 98/62), OXYGEN SATURATION DECREASED (Checked oxygen levels and it was at 84), PALPITATIONS (Heart was racing) and HEART RATE IRREGULAR (Pulse was irregular) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESTRADIOL (IMVEXXY), LEVOTHYROXINE, MONTELUKAST, METOPROLOL and ATORVASTATIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced HYPOTENSION (Blood pressure was low 98/62), OXYGEN SATURATION DECREASED (Checked oxygen levels and it was at 84), PALPITATIONS (Heart was racing) and HEART RATE IRREGULAR (Pulse was irregular). On 24-Feb-2021, HYPOTENSION (Blood pressure was low 98/62), OXYGEN SATURATION DECREASED (Checked oxygen levels and it was at 84) and HEART RATE IRREGULAR (Pulse was irregular) had resolved. At the time of the report, PALPITATIONS (Heart was racing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Blood pressure measurement: 98/62 mmHg Low. On 24-Feb-2021, Heart rate: 85. On 24-Feb-2021, Oxygen saturation: 84 After an hour it increased to 94.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   No concomitant product was reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Ectopic pregnancy in April 2019.   On 25-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 01-Nov-2021. On 20-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Ultrasound scan: inconclusive (Inconclusive) Inconclusive. On 27-Feb-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027620A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) had resolved. Not Provided          Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Reporter confirmed that reaction was not due to Moderna Vaccine; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swollen; red; itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 SWELLING (swollen), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches). At the time of the report, VACCINATION SITE SWELLING (swollen), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: Horrible time breathing; Sleeping all the time; Arm was Red; Arm was very hurt; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was Red), PAIN IN EXTREMITY (Arm was very hurt), PERIPHERAL SWELLING (Arm was swollen), DYSPNOEA (Horrible time breathing) and SOMNOLENCE (Sleeping all the time) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Lung infection in 2015, Adverse reaction to antibiotics and Pleural effusion. Concurrent medical conditions included Oxygen supplementation. Concomitant products included OXYGEN for an unknown indication.    On 11-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 ERYTHEMA (Arm was Red), PAIN IN EXTREMITY (Arm was very hurt) and PERIPHERAL SWELLING (Arm was swollen). On 18-Feb-2021, the patient experienced DYSPNOEA (Horrible time breathing) and SOMNOLENCE (Sleeping all the time). On 22-Feb-2021, ERYTHEMA (Arm was Red), PAIN IN EXTREMITY (Arm was very hurt) and PERIPHERAL SWELLING (Arm was swollen) had resolved. At the time of the report, DYSPNOEA (Horrible time breathing) and SOMNOLENCE (Sleeping all the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included oxygen during the day and night.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029l20a and 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-033873 (Patient Link).
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-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 IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Constipation
Clinical narrative: Constipated; "Usual stuff"; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipated) and ADVERSE REACTION ("Usual stuff") in a 67-year-old male 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.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ADVERSE REACTION ("Usual stuff"). On 11-Feb-2021, the patient experienced CONSTIPATION (Constipated). At the time of the report, CONSTIPATION (Constipated) and ADVERSE REACTION ("Usual stuff") outcome was unknown. Not Provided          Concomitant medications reported were unknown hypertension medication, unknown cholesterol medication, unknown anxiety medication for drug use for unknown indication. No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Tenderness, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: redness is increased to 3 inch x 5 inch; Rash area is increased; arm is now very tender; Arm very sore; redness at the injecton site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness is increased to 3 inch x 5 inch), VACCINATION SITE PAIN (Arm very sore), TENDERNESS (arm is now very tender), VACCINATION SITE RASH (Rash area is increased) and VACCINATION SITE ERYTHEMA (redness at the injecton site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), CLOPIDOGREL BISULFATE (PLAVIX), VALSARTAN, ATORVASTATIN CALCIUM (LIPITOR), LANSOPRAZOLE (PREVACID), PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injecton site). On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm very sore). On 02-Mar-2021, the patient experienced TENDERNESS (arm is now very tender). On 03-Mar-2021, the patient experienced ERYTHEMA (redness is increased to 3 inch x 5 inch) and VACCINATION SITE RASH (Rash area is increased). At the time of the report, ERYTHEMA (redness is increased to 3 inch x 5 inch), VACCINATION SITE PAIN (Arm very sore), TENDERNESS (arm is now very tender), VACCINATION SITE RASH (Rash area is increased) and VACCINATION SITE ERYTHEMA (redness at the injecton site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Illness, Insomnia
Clinical narrative: Sick; Very hard weakness; Very hard to sleep even with the pill; He cant walk because of weakness; A spontaneous report was received from a consumer concerning a 77-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events both are sick/illness, very hard weakness/asthenia, he could not walk because of the weakness/gait disturbance, very hard to sleep even with the pill/insomnia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the events both are sick, very hard weakness, he could not walk because of the weakness,he could not walk because of the weakness,very hard to sleep even with the pill.  Treatment details included trazadone.  Action taken with mRNA-1273 in response to the events was not reported.   On 11 Feb 2021 the outcome of events, both are sick, very hard weakness, he could not walk because of the weakness,very hard to sleep even with the pill was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Feeling cold, Influenza
Clinical narrative: itching and swelling at the injection site; weak; 100.7 F very low; literally couldn't get warm; like a flu; Her body is trying to keep that out of her body; itching and swelling at the injection site; cold; absolutely frozen; shaking; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (absolutely frozen), TREMOR (shaking), FATIGUE (fatigue), ASTHENIA (weak) and PYREXIA (100.7 F very low) in a 73-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 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (fatigue). On 21-Feb-2021, the patient experienced FEELING COLD (absolutely frozen), TREMOR (shaking) and NASOPHARYNGITIS (cold). On 23-Feb-2021, the patient experienced ASTHENIA (weak), PYREXIA (100.7 F very low), FEELING COLD (literally couldn't get warm), INFLUENZA (like a flu), FEELING ABNORMAL (Her body is trying to keep that out of her body) and PRURITUS (itching and swelling at the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (itching and swelling at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING COLD (absolutely frozen), TREMOR (shaking), FATIGUE (fatigue), ASTHENIA (weak), PYREXIA (100.7 F very low), NASOPHARYNGITIS (cold), FEELING COLD (literally couldn't get warm), INFLUENZA (like a flu), FEELING ABNORMAL (Her body is trying to keep that out of her body), PRURITUS (itching and swelling at the injection site) and VACCINATION SITE SWELLING (itching and swelling at the injection site) outcome was unknown.            This case was linked to MOD-2021-033813 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pruritus, Pyrexia, Tremor, Vaccination site swelling
Clinical narrative: itching and swelling at the injection site; weak; 100.7 F very low; literally couldn't get warm; like a flu; Her body is trying to keep that out of her body; itching and swelling at the injection site; cold; absolutely frozen; shaking; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (absolutely frozen), TREMOR (shaking), FATIGUE (fatigue), ASTHENIA (weak) and PYREXIA (100.7 F very low) in a 73-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 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (fatigue). On 21-Feb-2021, the patient experienced FEELING COLD (absolutely frozen), TREMOR (shaking) and NASOPHARYNGITIS (cold). On 23-Feb-2021, the patient experienced ASTHENIA (weak), PYREXIA (100.7 F very low), FEELING COLD (literally couldn't get warm), INFLUENZA (like a flu), FEELING ABNORMAL (Her body is trying to keep that out of her body) and PRURITUS (itching and swelling at the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (itching and swelling at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING COLD (absolutely frozen), TREMOR (shaking), FATIGUE (fatigue), ASTHENIA (weak), PYREXIA (100.7 F very low), NASOPHARYNGITIS (cold), FEELING COLD (literally couldn't get warm), INFLUENZA (like a flu), FEELING ABNORMAL (Her body is trying to keep that out of her body), PRURITUS (itching and swelling at the injection site) and VACCINATION SITE SWELLING (itching and swelling at the injection site) outcome was unknown.            This case was linked to MOD-2021-033813 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Paraesthesia, Vaccination site pain
Clinical narrative: Coolness in her chest during the shot; tingling; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Coolness in her chest during the shot), PARAESTHESIA (tingling) and VACCINATION SITE PAIN (arm was sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 011120A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHEST DISCOMFORT (Coolness in her chest during the shot), PARAESTHESIA (tingling) and VACCINATION SITE PAIN (arm was sore). On 10-Feb-2021, CHEST DISCOMFORT (Coolness in her chest during the shot) and PARAESTHESIA (tingling) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was sore) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.; 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.