chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Oropharyngeal pain
Clinical narrative: chills; Nausea; bad sore throat; a little soreness on her arm; Headaches; Fever(103.4°F); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (bad sore throat), PAIN IN EXTREMITY (a little soreness on her arm), HEADACHE (Headaches), PYREXIA (Fever(103.4°F)) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062l70a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (bad sore throat), PAIN IN EXTREMITY (a little soreness on her arm), HEADACHE (Headaches) and PYREXIA (Fever(103.4°F)). On an unknown date, the patient experienced CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of every 4hs. At the time of the report, OROPHARYNGEAL PAIN (bad sore throat), PAIN IN EXTREMITY (a little soreness on her arm), HEADACHE (Headaches), PYREXIA (Fever(103.4°F)), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 103.4 (Inconclusive) 103.4.         She also had "a bad time" with the 1st dose as she had a relapse of her rheumatoid arthritis   This case was linked to MOD-2021-036146, MOD21-044393 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: chills; Nausea; bad sore throat; a little soreness on her arm; Headaches; Fever(103.4°F); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (bad sore throat), PAIN IN EXTREMITY (a little soreness on her arm), HEADACHE (Headaches), PYREXIA (Fever(103.4°F)) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062l70a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (bad sore throat), PAIN IN EXTREMITY (a little soreness on her arm), HEADACHE (Headaches) and PYREXIA (Fever(103.4°F)). On an unknown date, the patient experienced CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of every 4hs. At the time of the report, OROPHARYNGEAL PAIN (bad sore throat), PAIN IN EXTREMITY (a little soreness on her arm), HEADACHE (Headaches), PYREXIA (Fever(103.4°F)), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 103.4 (Inconclusive) 103.4.         She also had "a bad time" with the 1st dose as she had a relapse of her rheumatoid arthritis   This case was linked to MOD-2021-036146, MOD21-044393 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Heart rate, Nausea, Oxygen saturation
Clinical narrative: anxious; nausea came and went; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (anxious) and NAUSEA (nausea came and went) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Heart rate abnormal (has history of taking flax seed daily to lower heart rate, which often ran high.). Concurrent medical conditions included Prostate examination (Prostate issues). Concomitant products included FLAXSEED for Heart rate abnormal.    On 11-Feb-2021 at 5:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 5:21 PM, the patient experienced ANXIETY (anxious) and NAUSEA (nausea came and went). The patient was treated with WATER (oral) on 11-Feb-2021 for Nausea, at an unspecified dose and frequency. At the time of the report, ANXIETY (anxious) and NAUSEA (nausea came and went) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood pressure measurement: 135/92 (Inconclusive) at 5:25 pm, 126/90 (Inconclusive) at 5:30 pm, 128/83 (Inconclusive) at 5:35 pm, 129/89 (Inconclusive) at 5:40pm and 134/89 (Inconclusive) at 5:45 pm. On 11-Feb-2021, Heart rate: 103 (abnormal) at 5:25 pm, 112 (abnormal) at 5:30 pm, 100 (abnormal) at 5:35 pm, 101 (abnormal) at 5:40 pm and 98 (abnormal) at 5:45 pm. On 11-Feb-2021, Oxygen saturation: 97% (normal) at 5:25 pm, 96% (normal) at 5:30 pm, 96% (normal) at 5:35 pm, 97% (normal) at 5:40 pm and 97% (normal) at 5:45 pm.     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.   By 5:45 pm patient reported feeling better and was released with instructions to call MD or go to ER if symptoms recur.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: body was shaking uncontrollably; feels horrible; Really bad chills; bad headache; fever of 101°F.; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TREMOR (body was shaking uncontrollably), FEELING ABNORMAL (feels horrible), CHILLS (Really bad chills), HEADACHE (bad headache) and PYREXIA (fever of 101°F.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN DEGLUDEC (TRESIBA) and INSULIN LISPRO (HUMALOG) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced TREMOR (body was shaking uncontrollably), FEELING ABNORMAL (feels horrible), CHILLS (Really bad chills), HEADACHE (bad headache) and PYREXIA (fever of 101°F.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TREMOR (body was shaking uncontrollably), FEELING ABNORMAL (feels horrible) and CHILLS (Really bad chills) outcome was unknown and HEADACHE (bad headache) and PYREXIA (fever of 101°F.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 101 (Inconclusive) 101.     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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: body was shaking uncontrollably; feels horrible; Really bad chills; bad headache; fever of 101°F.; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TREMOR (body was shaking uncontrollably), FEELING ABNORMAL (feels horrible), CHILLS (Really bad chills), HEADACHE (bad headache) and PYREXIA (fever of 101°F.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN DEGLUDEC (TRESIBA) and INSULIN LISPRO (HUMALOG) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced TREMOR (body was shaking uncontrollably), FEELING ABNORMAL (feels horrible), CHILLS (Really bad chills), HEADACHE (bad headache) and PYREXIA (fever of 101°F.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TREMOR (body was shaking uncontrollably), FEELING ABNORMAL (feels horrible) and CHILLS (Really bad chills) outcome was unknown and HEADACHE (bad headache) and PYREXIA (fever of 101°F.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 101 (Inconclusive) 101.     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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scratch
Clinical narrative: Arm is itching; made it worse by scratching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm is itching) and SCRATCH (made it worse by scratching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0020L0A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (Arm is itching) and SCRATCH (made it worse by scratching). At the time of the report, PRURITUS (Arm is itching) and SCRATCH (made it worse by scratching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness
Clinical narrative: Arm stiffness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm stiffness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) capsule for Endometrial cancer.    Concurrent medical conditions included Hypertension (HCP has also increased her Amlodipine from 5mg to 10mg to control her blood pressure.) and Thyroid disorder (Patient advised her Thyroid levels are rising). Concomitant products included AMLODIPINE for Blood pressure, PEMBROLIZUMAB (KEYTRUDA) for Endometrial cancer.   On 16-Jan-2021, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 20 milligram. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On 03-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm stiffness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment medications were not reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Felt nauseous the day, Is still feeling a bit nauseous; Pain at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at site of injection) and NAUSEA (Felt nauseous the day, Is still feeling a bit nauseous) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at site of injection). On 07-Mar-2021, the patient experienced NAUSEA (Felt nauseous the day, Is still feeling a bit nauseous). The patient was treated with PARACETAMOL (TYNELOL) at an unspecified dose and frequency. On 07-Mar-2021, VACCINATION SITE PAIN (Pain at site of injection) had resolved. At the time of the report, NAUSEA (Felt nauseous the day, Is still feeling a bit nauseous) 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.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: tremors; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors), HEADACHE (headache) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced TREMOR (tremors), HEADACHE (headache) and PYREXIA (fever). At the time of the report, TREMOR (tremors), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had put ice on the back of her neck.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very Painful Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very Painful Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Very Painful Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Painful arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Very Painful Sore arm) had not resolved. Patient reported her adverse event of very painful sore arm , after vaccination stopped and restarted on 15Feb2021      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature fluctuation, Cough, Dizziness
Clinical narrative: Wonky and lightheaded; Felt weak and lacked energy; "Cold cold chills then got hot hot hot."; Hot, itchy, cold all the time, and sick to the stomach; Coughing a lot and also has a running nose.; Coughing a lot and also has a running nose.; Having the flu; Itchy all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Wonky and lightheaded), ASTHENIA (Felt weak and lacked energy), BODY TEMPERATURE FLUCTUATION ("Cold cold chills then got hot hot hot."), ABDOMINAL DISCOMFORT (Hot, itchy, cold all the time, and sick to the stomach) and COUGH (Coughing a lot and also has a running nose.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 medical history reported).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Wonky and lightheaded), ASTHENIA (Felt weak and lacked energy), BODY TEMPERATURE FLUCTUATION ("Cold cold chills then got hot hot hot."), ABDOMINAL DISCOMFORT (Hot, itchy, cold all the time, and sick to the stomach), COUGH (Coughing a lot and also has a running nose.), RHINORRHOEA (Coughing a lot and also has a running nose.), INFLUENZA LIKE ILLNESS (Having the flu) and PRURITUS (Itchy all over her body.). At the time of the report, DIZZINESS (Wonky and lightheaded), ASTHENIA (Felt weak and lacked energy), BODY TEMPERATURE FLUCTUATION ("Cold cold chills then got hot hot hot."), ABDOMINAL DISCOMFORT (Hot, itchy, cold all the time, and sick to the stomach), COUGH (Coughing a lot and also has a running nose.), RHINORRHOEA (Coughing a lot and also has a running nose.), INFLUENZA LIKE ILLNESS (Having the flu) and PRURITUS (Itchy all over her body.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included none
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pruritus, Rhinorrhoea
Clinical narrative: Wonky and lightheaded; Felt weak and lacked energy; "Cold cold chills then got hot hot hot."; Hot, itchy, cold all the time, and sick to the stomach; Coughing a lot and also has a running nose.; Coughing a lot and also has a running nose.; Having the flu; Itchy all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Wonky and lightheaded), ASTHENIA (Felt weak and lacked energy), BODY TEMPERATURE FLUCTUATION ("Cold cold chills then got hot hot hot."), ABDOMINAL DISCOMFORT (Hot, itchy, cold all the time, and sick to the stomach) and COUGH (Coughing a lot and also has a running nose.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 medical history reported).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Wonky and lightheaded), ASTHENIA (Felt weak and lacked energy), BODY TEMPERATURE FLUCTUATION ("Cold cold chills then got hot hot hot."), ABDOMINAL DISCOMFORT (Hot, itchy, cold all the time, and sick to the stomach), COUGH (Coughing a lot and also has a running nose.), RHINORRHOEA (Coughing a lot and also has a running nose.), INFLUENZA LIKE ILLNESS (Having the flu) and PRURITUS (Itchy all over her body.). At the time of the report, DIZZINESS (Wonky and lightheaded), ASTHENIA (Felt weak and lacked energy), BODY TEMPERATURE FLUCTUATION ("Cold cold chills then got hot hot hot."), ABDOMINAL DISCOMFORT (Hot, itchy, cold all the time, and sick to the stomach), COUGH (Coughing a lot and also has a running nose.), RHINORRHOEA (Coughing a lot and also has a running nose.), INFLUENZA LIKE ILLNESS (Having the flu) and PRURITUS (Itchy all over her body.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included none
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Nasopharyngitis, Pyrexia
Clinical narrative: Feeling hot; Cold; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), FEELING HOT (Feeling hot) and NASOPHARYNGITIS (Cold) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), FEELING HOT (Feeling hot) and NASOPHARYNGITIS (Cold). At the time of the report, CHILLS (Chills), PYREXIA (Fever), FEELING HOT (Feeling hot) and NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided. Treatment information was not provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Broke out into bumps that were itchy on both his legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Broke out into bumps that were itchy on both his legs) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (Broke out into bumps that were itchy on both his legs). At the time of the report, PRURITUS (Broke out into bumps that were itchy on both his legs) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines reported. Treatment information for events included anti-itch products.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received on 22-Jul-2021 and included No new information.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Moderna COVID-19 vaccine on 27-JAN-2021 an second shot was 20-FEB-2021; A spontaneous report was received from a consumer who was a 40-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced first dose of Moderna COVID-19 vaccine on 27-JAN-2021 an second shot was 20-FEB-2021 (inappropriate schedule of vaccine administered).   The patient's medical history, was not provided by the reporter.  No concomitant medications were reported.  On 27-Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection. She reported that she had one rabies shot on 27-Feb-2021 and a second one on  02-Mar-2021.  She reported that she was feeling fine and had no side effects.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, inappropriate schedule of vaccine administered, was considered recovered/resolved.  Follow up received on 26Mar2021 included no new information.; Reporter's Comments: This report refers to a 40-year-old, female patient, who experienced who received first dose of Moderna COVID-19 vaccine on 27-JAN-2021 (013L20A) and second shot was 20-FEB-2021 (023M20A.  The second dose was 24 days after the first dose (inappropriate schedule of vaccine administered). There were no reported AEs associated with this case of inappropriate schedule of vaccine administered.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: dizziness; vomiting; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), HEADACHE (headaches) and DIZZINESS (dizziness) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), HEADACHE (headaches) and DIZZINESS (dizziness). At the time of the report, VOMITING (vomiting), HEADACHE (headaches) and DIZZINESS (dizziness) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Loss of personal independence in daily activities, Mobility decreased, Neck pain
Clinical narrative: can´t sleep; Couldn't turn head; Could not drive a car for approximately 3 days; Severe pain both sides of head and back of head; almost passed out; very bad neck pain; unbearable pain that wont go away; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (almost passed out), NECK PAIN (very bad neck pain), PAIN (unbearable pain that wont go away), INSOMNIA (can´t sleep) and MOBILITY DECREASED (Couldn't turn head) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac) in 2017. Concurrent medical conditions included Atrial fibrillation since February 2005, Contrast media allergy (allergy to dye - not specified) and Blood pressure high. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL) for Blood pressure high.   On 01-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 PRESYNCOPE (almost passed out), NECK PAIN (very bad neck pain), PAIN (unbearable pain that wont go away) and HEADACHE (Severe pain both sides of head and back of head). 03-Mar-2021, the patient experienced MOBILITY DECREASED (Couldn't turn head) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive a car for approximately 3 days). On an unknown date, the patient experienced INSOMNIA (can´t sleep). The patient was treated with TRAMADOL on 03-Mar-2021 for Pain, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (almost passed out), NECK PAIN (very bad neck pain), PAIN (unbearable pain that wont go away) and INSOMNIA (can´t sleep) outcome was unknown and MOBILITY DECREASED (Couldn't turn head), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive a car for approximately 3 days) and HEADACHE (Severe pain both sides of head and back of head) had resolved.            Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow Up information received on 26 Jul 2021 contains updated patient demographics, relevant medical history, batch #''s, new events (couldn't turn head/couldn't drive a car), reporter causality and event outcomes.; 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: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Presyncope
Clinical narrative: can´t sleep; Couldn't turn head; Could not drive a car for approximately 3 days; Severe pain both sides of head and back of head; almost passed out; very bad neck pain; unbearable pain that wont go away; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (almost passed out), NECK PAIN (very bad neck pain), PAIN (unbearable pain that wont go away), INSOMNIA (can´t sleep) and MOBILITY DECREASED (Couldn't turn head) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac) in 2017. Concurrent medical conditions included Atrial fibrillation since February 2005, Contrast media allergy (allergy to dye - not specified) and Blood pressure high. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL) for Blood pressure high.   On 01-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 PRESYNCOPE (almost passed out), NECK PAIN (very bad neck pain), PAIN (unbearable pain that wont go away) and HEADACHE (Severe pain both sides of head and back of head). 03-Mar-2021, the patient experienced MOBILITY DECREASED (Couldn't turn head) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive a car for approximately 3 days). On an unknown date, the patient experienced INSOMNIA (can´t sleep). The patient was treated with TRAMADOL on 03-Mar-2021 for Pain, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (almost passed out), NECK PAIN (very bad neck pain), PAIN (unbearable pain that wont go away) and INSOMNIA (can´t sleep) outcome was unknown and MOBILITY DECREASED (Couldn't turn head), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive a car for approximately 3 days) and HEADACHE (Severe pain both sides of head and back of head) had resolved.            Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow Up information received on 26 Jul 2021 contains updated patient demographics, relevant medical history, batch #''s, new events (couldn't turn head/couldn't drive a car), reporter causality and event outcomes.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site rash
Clinical narrative: rash around the injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and VACCINATION SITE RASH (rash around the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was given.  Concomitant products included ESCITALOPRAM, ARIPIPRAZOLE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FATIGUE (Tired). On 18-Feb-2021, the patient experienced VACCINATION SITE RASH (rash around the injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. At the time of the report, FATIGUE (Tired) and VACCINATION SITE RASH (rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Anti-depressants (Names were not specified).   This case was linked to MOD-2021-036334 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received on 5-Aug-2021 contains significant information. Additional  event Rash around vaccination site, Concomitant medications- Anti-depressants was added On 05-Aug-2021: Non Significant follow up
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny Nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny Nose) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced RHINORRHOEA (Runny Nose). On 08-Mar-2021, RHINORRHOEA (Runny Nose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant mediations were reported.  No treatment medication was provided.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Urticaria
Clinical narrative: flu-like symptoms; broke out in whelps on arm, stomach and neck; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) and URTICARIA (broke out in whelps on arm, stomach and neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02920A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and URTICARIA (broke out in whelps on arm, stomach and neck). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and URTICARIA (broke out in whelps on arm, stomach and neck) outcome was unknown.            No relevant concomitant medications are provided. No treatment information was provided. Action taken with mRNA-1273 in responsible to the events were not applicable
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Vaccination site pain
Clinical narrative: Received second dose 65 days after first dose; Body ache; Vaccination site pain; A spontaneous report was received from an other healthcare professional concerning a 28-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) received the second dose 65 days after first dose.and experienced pain at the site of injection,and body ache,     The patient's medical history was not  provided by the reporter. Concomitant medications were not reported.  On 30 Dec 2020,  the patient received her first of two planned doses of mRNA-1273 (Lot number: 036A21A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection.   On 4 Mar 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration in the unknown for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient felt pain at the site of injection, body ache, and received the second dose 65 days after first dose. Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported..   The events, received second dose 65 days after first dose, pain at the site of injection, and body ache, were considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with  associated injection site pain and body aches reported.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue
Clinical narrative: Pressing around heart 25 minutes after 1st dose; Hard to breathe after 1st dose; Tired for 2-3 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Pressing around heart 25 minutes after 1st dose), DYSPNOEA (Hard to breathe after 1st dose) and FATIGUE (Tired for 2-3 days after 1st dose) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced CHEST DISCOMFORT (Pressing around heart 25 minutes after 1st dose), DYSPNOEA (Hard to breathe after 1st dose) and FATIGUE (Tired for 2-3 days after 1st dose). On 20-Feb-2021, CHEST DISCOMFORT (Pressing around heart 25 minutes after 1st dose) and DYSPNOEA (Hard to breathe after 1st dose) had resolved. On 22-Feb-2021, FATIGUE (Tired for 2-3 days after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Fatigue, Headache, Lethargy, Lymph node pain
Clinical narrative: breast area and throat inflamed; Body was lethargic; Feverish feeling; Bad Headache; Deep Soreness even to touch; Lymph node tender; felt very depleted; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOMFORT (breast area and throat inflamed), LETHARGY (Body was lethargic), PYREXIA (Feverish feeling), HEADACHE (Bad Headache) and MYALGIA (Deep Soreness even to touch) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and HERBS FOR YOUR SKIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced BREAST DISCOMFORT (breast area and throat inflamed), LETHARGY (Body was lethargic), PYREXIA (Feverish feeling), HEADACHE (Bad Headache), MYALGIA (Deep Soreness even to touch), LYMPH NODE PAIN (Lymph node tender) and FATIGUE (felt very depleted). At the time of the report, BREAST DISCOMFORT (breast area and throat inflamed), LETHARGY (Body was lethargic), PYREXIA (Feverish feeling), HEADACHE (Bad Headache), MYALGIA (Deep Soreness even to touch), LYMPH NODE PAIN (Lymph node tender) and FATIGUE (felt very depleted) outcome was unknown.            Treatment includes Advil. Action taken with mRNA-1273 in responsible to the events were not applicable   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: breast area and throat inflamed; Body was lethargic; Feverish feeling; Bad Headache; Deep Soreness even to touch; Lymph node tender; felt very depleted; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOMFORT (breast area and throat inflamed), LETHARGY (Body was lethargic), PYREXIA (Feverish feeling), HEADACHE (Bad Headache) and MYALGIA (Deep Soreness even to touch) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and HERBS FOR YOUR SKIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced BREAST DISCOMFORT (breast area and throat inflamed), LETHARGY (Body was lethargic), PYREXIA (Feverish feeling), HEADACHE (Bad Headache), MYALGIA (Deep Soreness even to touch), LYMPH NODE PAIN (Lymph node tender) and FATIGUE (felt very depleted). At the time of the report, BREAST DISCOMFORT (breast area and throat inflamed), LETHARGY (Body was lethargic), PYREXIA (Feverish feeling), HEADACHE (Bad Headache), MYALGIA (Deep Soreness even to touch), LYMPH NODE PAIN (Lymph node tender) and FATIGUE (felt very depleted) outcome was unknown.            Treatment includes Advil. Action taken with mRNA-1273 in responsible to the events were not applicable   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Lip dry, Lip swelling, Pain in jaw
Clinical narrative: Bottom lip doubled in size; Bottom lip cracked in the middle; Jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Bottom lip doubled in size), LIP DRY (Bottom lip cracked in the middle) and PAIN IN JAW (Jaw pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Bottom lip doubled in size), LIP DRY (Bottom lip cracked in the middle) and PAIN IN JAW (Jaw pain). At the time of the report, LIP SWELLING (Bottom lip doubled in size), LIP DRY (Bottom lip cracked in the middle) and PAIN IN JAW (Jaw pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for covid; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested positive for covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 immunization.     No Medical History information was reported.    On 05-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 COVID-19 (Tested positive for covid). At the time of the report, COVID-19 (Tested positive for covid) 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.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site pruritus
Clinical narrative: cold sores, canker sore on mouth; Lymph nodes; sore arm that itched; sore arm that itched; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (sore arm that itched), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes), ORAL HERPES (cold sores, canker sore on mouth) and VACCINATION SITE PAIN (sore arm that itched) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes, Hypertension and Surgery (heart surgery). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, METFORMIN, MONTELUKAST SODIUM (SINGULAIR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ACETAMINOPHEN and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP).    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (sore arm that itched) and VACCINATION SITE PAIN (sore arm that itched). On 04-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Lymph nodes). On 06-Mar-2021, the patient experienced ORAL HERPES (cold sores, canker sore on mouth). At the time of the report, VACCINATION SITE PRURITUS (sore arm that itched), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes), ORAL HERPES (cold sores, canker sore on mouth) and VACCINATION SITE PAIN (sore arm that itched) had not resolved.    No treatment information was provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Product dose omission issue
Clinical narrative: Patient did not receive second dose; Left arm pain; Right arm pain; Received 1st and 2nd dose on the same day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Left arm pain), PAIN IN EXTREMITY (Right arm pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st and 2nd dose on the same day) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 (Left arm pain), PAIN IN EXTREMITY (Right arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st and 2nd dose on the same day). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st and 2nd dose on the same day) had resolved. On 05-Mar-2021, PAIN IN EXTREMITY (Left arm pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Right arm pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.   This case was linked to MOD-2021-036560 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received as no new information. On 06-Aug-2021: Follow-up received: added patient middle name and event.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site inflammation
Clinical narrative: Inflamed arm about 3inches out from the injection site; Redness at injection site; Knot around injection site; A spontaneous report was received from a consumer concerning a 87-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events inflamed arm at injection site, redness at injection site, knot around injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events inflamed arm at injection site, redness at injection site, knot around injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events inflamed arm, at injection site, redness at injection site,knot around injection site was unknown on 8 Mar 2021.