chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026L20A) for COVID-19 immunization. Concurrent medical conditions included hypertension. Concomitant products/medication included vitamins (NOS) used for an unknown indication, and high blood pressure medication. On Jan 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pyrexia (fever). At the time of the report, pyrexia (fever) resolved. No treatment information provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I did not feel very well after neither of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 19-May-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 COMPLICATION (I did not feel very well after neither of the vaccine). At the time of the report, VACCINATION COMPLICATION (I did not feel very well after neither of the vaccine) 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.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-233532 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Discomfort, Feeling cold, Medication error
Clinical narrative: temperature excursion; neck aches; Felt very very cold/ could not get warm for a couple hours; It was just a discomfort; shoulder aches; felt very chilled; body aches, had neck and should aches; This spontaneous case was reported by a consumer and describes the occurrence of MEDICATION ERROR (temperature excursion), NECK PAIN (neck aches), FEELING COLD (Felt very very cold/ could not get warm for a couple hours), DISCOMFORT (It was just a discomfort) and ARTHRALGIA (shoulder aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M2OA and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced NECK PAIN (neck aches), FEELING COLD (Felt very very cold/ could not get warm for a couple hours), DISCOMFORT (It was just a discomfort), ARTHRALGIA (shoulder aches), CHILLS (felt very chilled) and MYALGIA (body aches, had neck and should aches). On an unknown date, the patient experienced MEDICATION ERROR (temperature excursion). On 27-Feb-2021, NECK PAIN (neck aches), FEELING COLD (Felt very very cold/ could not get warm for a couple hours), DISCOMFORT (It was just a discomfort), ARTHRALGIA (shoulder aches), CHILLS (felt very chilled) and MYALGIA (body aches, had neck and should aches) had resolved. At the time of the report, MEDICATION ERROR (temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient drank fluids, juice and water to help with his symptoms. No further treatment was provided for the events.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: TCR form added.No new information
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neck pain
Clinical narrative: temperature excursion; neck aches; Felt very very cold/ could not get warm for a couple hours; It was just a discomfort; shoulder aches; felt very chilled; body aches, had neck and should aches; This spontaneous case was reported by a consumer and describes the occurrence of MEDICATION ERROR (temperature excursion), NECK PAIN (neck aches), FEELING COLD (Felt very very cold/ could not get warm for a couple hours), DISCOMFORT (It was just a discomfort) and ARTHRALGIA (shoulder aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M2OA and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced NECK PAIN (neck aches), FEELING COLD (Felt very very cold/ could not get warm for a couple hours), DISCOMFORT (It was just a discomfort), ARTHRALGIA (shoulder aches), CHILLS (felt very chilled) and MYALGIA (body aches, had neck and should aches). On an unknown date, the patient experienced MEDICATION ERROR (temperature excursion). On 27-Feb-2021, NECK PAIN (neck aches), FEELING COLD (Felt very very cold/ could not get warm for a couple hours), DISCOMFORT (It was just a discomfort), ARTHRALGIA (shoulder aches), CHILLS (felt very chilled) and MYALGIA (body aches, had neck and should aches) had resolved. At the time of the report, MEDICATION ERROR (temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient drank fluids, juice and water to help with his symptoms. No further treatment was provided for the events.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: TCR form added.No new information
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Patient did not receive his 2nd shot because he was advised to wait 90 days after his monoclonal treatments; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive his 2nd shot because he was advised to wait 90 days after his monoclonal treatments) 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 COVID-19.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive his 2nd shot because he was advised to wait 90 days after his monoclonal treatments). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive his 2nd shot because he was advised to wait 90 days after his monoclonal treatments) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported .  Treatment medication were not reported .
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain in extremity, Sneezing
Clinical narrative: Sore arm; Coughing; Sneezing; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Coughing), SNEEZING (Sneezing) and PAIN IN EXTREMITY (Sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], PARACETAMOL (TYLENOL), ATORVASTATIN CALCIUM (LIPITOR) and METFORMIN for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced COUGH (Coughing) and SNEEZING (Sneezing). On 24-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, COUGH (Coughing), SNEEZING (Sneezing) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        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.   Treatment- Alka Seltzer Sinus was reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Panic attack
Clinical narrative: progressively had more anxiety; depression symptoms; Any kind of exercise...panic attack and anxiety all day long; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (progressively had more anxiety), DEPRESSION (depression symptoms) and PANIC ATTACK (Any kind of exercise...panic attack and anxiety all day long) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 023B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL CR) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced ANXIETY (progressively had more anxiety), DEPRESSION (depression symptoms) and PANIC ATTACK (Any kind of exercise...panic attack and anxiety all day long). At the time of the report, ANXIETY (progressively had more anxiety) had not resolved and DEPRESSION (depression symptoms) and PANIC ATTACK (Any kind of exercise..panic attack and anxiety all day long) outcome was unknown.            Treatment details were not provided.   This case was linked to MOD-2021-234381 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fever; chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and FATIGUE (tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-May-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and FATIGUE (tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 17-May-2021, CHILLS (chills) and FATIGUE (tired) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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.   This case was linked to MOD-2021-234374 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Nausea, Pyrexia, Retching
Clinical narrative: Cough; Gagging; nausea; Fever; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (Cough), RETCHING (Gagging), PYREXIA (Fever), CHILLS (chills) and NAUSEA (nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal).    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). On 24-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Cough), RETCHING (Gagging) and NAUSEA (nausea). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) at an unspecified dose and frequency. On 17-May-2021, CHILLS (chills) had resolved. At the time of the report, COUGH (Cough), RETCHING (Gagging), PYREXIA (Fever) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication also include water.   This case was linked to MOD-2021-234368 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Fatigue, Musculoskeletal discomfort, Neck pain
Clinical narrative: After 2nd dose, anxiety got worse; Her back would tighten; Her neck and chest would feel achy; Her neck and chest would feel achy; Any kind of physical exercise is exhausting as of now; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (After 2nd dose, anxiety got worse), MUSCULOSKELETAL DISCOMFORT (Her back would tighten), NECK PAIN (Her neck and chest would feel achy), CHEST PAIN (Her neck and chest would feel achy) and FATIGUE (Any kind of physical exercise is exhausting as of now) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023B21A and 044B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-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 ANXIETY (After 2nd dose, anxiety got worse), MUSCULOSKELETAL DISCOMFORT (Her back would tighten), NECK PAIN (Her neck and chest would feel achy), CHEST PAIN (Her neck and chest would feel achy) and FATIGUE (Any kind of physical exercise is exhausting as of now). The patient was treated with PIROXICAM (PAXIL [PIROXICAM]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ANXIETY (After 2nd dose, anxiety got worse), MUSCULOSKELETAL DISCOMFORT (Her back would tighten), NECK PAIN (Her neck and chest would feel achy), CHEST PAIN (Her neck and chest would feel achy) and FATIGUE (Any kind of physical exercise is exhausting as of now) outcome was unknown.            No lab data was provided by the reporter.   This case was linked to MOD-2021-234367 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given the second dose past the 12 hour pierced vial time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given the second dose past the 12 hour pierced vial time) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given the second dose past the 12 hour pierced vial time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given the second dose past the 12 hour pierced vial time) 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.   Relevant concomitant medications were not provided.  Treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Many side effects; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Many side effects) 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 VACCINATION COMPLICATION (Many side effects). At the time of the report, VACCINATION COMPLICATION (Many side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days since the first shot was given; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since the first shot was given) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since the first shot was given). On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since the first shot was given) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information is not applicable.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: he missed his second dose and is now past 42 days mark.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (he missed his second dose and is now past 42 days mark.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (he missed his second dose and is now past 42 days mark.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (he missed his second dose and is now past 42 days mark.) 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.   Concomitant medication information was not reported. Treatment information as not reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness). At the time of the report, MYALGIA (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the window for getting the second dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the window for getting the second dose of the Moderna vaccine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (not related to the Moderna vaccine).    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the window for getting the second dose of the Moderna vaccine). On 04-May-2021, PRODUCT DOSE OMISSION ISSUE (missed the window for getting the second dose of the Moderna vaccine) 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.   The pharmacist confirms the patient did not experience any adverse events after the first dose. The pharmacist did not know if the patient is on any daily medication. The pharmacist explained the patient received the first dose and then went for a routine surgery (not related to the Moderna vaccine) and was in the hospital longer than predicted and missed the window forgetting the second dose of the Moderna vaccine. no concomitant and treatment medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in my thumbs and forefingers on both hands; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in my thumbs and forefingers on both hands) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in my thumbs and forefingers on both hands). At the time of the report, HYPOAESTHESIA (Numbness in my thumbs and forefingers on both hands) outcome was unknown.            Patient took second dose of the vaccine on 08/Jun  No concomitant medications were reported  No treatment medications were reported   Reporter did not allow further contact
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pre-drawn syringes that were withdrawn and left out at room temperature for over 12 hours. At least one to three of the doses were administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pre-drawn syringes that were withdrawn and left out at room temperature for over 12 hours. At least one to three of the doses were administered to patients) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pre-drawn syringes that were withdrawn and left out at room temperature for over 12 hours. At least one to three of the doses were administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pre-drawn syringes that were withdrawn and left out at room temperature for over 12 hours. At least one to three of the doses were administered to patients) outcome was unknown.        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 concomitant medication was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up information received on 07-JUL-2021 contains no new information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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 02-Apr-2021, 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 experienced PRURITUS (itchiness). At the time of the report, PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Sore arm; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 004M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.   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 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (Nausea). On 03-Mar-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. Not Provided          Patient used cold pack   and Marijuana infused cream as treatment.   This case was linked to MOD-2021-031230 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspnoea, Fatigue, Headache, Influenza
Clinical narrative: Metal taste in her mouth; Heart palpitations; Felt like she had the flu; Couldn't move left arm; Shortness of breath (gets more winded); Fatigue; Muscle aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal taste in her mouth), PALPITATIONS (Heart palpitations), INFLUENZA (Felt like she had the flu), MOBILITY DECREASED (Couldn't move left arm) and DYSPNOEA (Shortness of breath (gets more winded)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DYSGEUSIA (Metal taste in her mouth), PALPITATIONS (Heart palpitations), INFLUENZA (Felt like she had the flu), MOBILITY DECREASED (Couldn't move left arm), DYSPNOEA (Shortness of breath (gets more winded)), FATIGUE (Fatigue), MYALGIA (Muscle aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, DYSGEUSIA (Metal taste in her mouth), PALPITATIONS (Heart palpitations), INFLUENZA (Felt like she had the flu), MOBILITY DECREASED (Couldn't move left arm), DYSPNOEA (Shortness of breath (gets more winded)), FATIGUE (Fatigue), MYALGIA (Muscle aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant mediations were reported. No treatment medication was reported. Patient received second dose of Moderna COVID-19 Vaccine on 12-mar-2021 in left arm with unknown batch no. Patient called to Moderna Customer Care to ask whether Moderna vaccine offered protection against the Delta variance?
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Palpitations, Pyrexia
Clinical narrative: Metal taste in her mouth; Heart palpitations; Felt like she had the flu; Couldn't move left arm; Shortness of breath (gets more winded); Fatigue; Muscle aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal taste in her mouth), PALPITATIONS (Heart palpitations), INFLUENZA (Felt like she had the flu), MOBILITY DECREASED (Couldn't move left arm) and DYSPNOEA (Shortness of breath (gets more winded)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DYSGEUSIA (Metal taste in her mouth), PALPITATIONS (Heart palpitations), INFLUENZA (Felt like she had the flu), MOBILITY DECREASED (Couldn't move left arm), DYSPNOEA (Shortness of breath (gets more winded)), FATIGUE (Fatigue), MYALGIA (Muscle aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, DYSGEUSIA (Metal taste in her mouth), PALPITATIONS (Heart palpitations), INFLUENZA (Felt like she had the flu), MOBILITY DECREASED (Couldn't move left arm), DYSPNOEA (Shortness of breath (gets more winded)), FATIGUE (Fatigue), MYALGIA (Muscle aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant mediations were reported. No treatment medication was reported. Patient received second dose of Moderna COVID-19 Vaccine on 12-mar-2021 in left arm with unknown batch no. Patient called to Moderna Customer Care to ask whether Moderna vaccine offered protection against the Delta variance?
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient is receiving the second dose of the Moderna covid-19 vaccine more than 36 days after the first dose/missed his second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving the second dose of the Moderna covid-19 vaccine more than 36 days after the first dose/missed his second dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving the second dose of the Moderna covid-19 vaccine more than 36 days after the first dose/missed his second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving the second dose of the Moderna covid-19 vaccine more than 36 days after the first dose/missed his 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 concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever after second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever after second dose). At the time of the report, PYREXIA (high fever after second dose) outcome was unknown.            Concomitant and treatment medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Has Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Has Covid-19) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Has Covid-19). At the time of the report, COVID-19 (Has Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were mentioned.  The patient had the vaccine series in January and February.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swelling in arm) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced peripheral swelling (swelling in arm). At the time of the report, peripheral swelling (swelling in arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Drug intolerance, Feeling abnormal, Hypoaesthesia
Clinical narrative: tightness under left arm running through his chest and throat; Anxiety; Patient was prescribed Zoloft, Duloxetine and Celexa but could not tolerate it; felt like lymph node reacting; tightness under left arm running through his chest and throat; numbness in mouth and extremeties; numbness in extremeties; extreme brain fog; full blown panic attack; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (tightness under left arm running through his chest and throat), PANIC ATTACK (full blown panic attack), FEELING ABNORMAL (extreme brain fog), HYPOAESTHESIA ORAL (numbness in mouth and extremeties) and HYPOAESTHESIA (numbness in extremeties) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, LORAZEPAM for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PANIC ATTACK (full blown panic attack), FEELING ABNORMAL (extreme brain fog), HYPOAESTHESIA ORAL (numbness in mouth and extremeties) and HYPOAESTHESIA (numbness in extremeties). On an unknown date, the patient experienced THROAT TIGHTNESS (tightness under left arm running through his chest and throat), CHEST DISCOMFORT (tightness under left arm running through his chest and throat), DRUG INTOLERANCE (Patient was prescribed Zoloft, Duloxetine and Celexa but could not tolerate it), ANXIETY (Anxiety) and LYMPHADENOPATHY (felt like lymph node reacting). The patient was treated with SERTRALINE HYDROCHLORIDE (ZOLOFT) at an unspecified dose and frequency; DULOXETINE at an unspecified dose and frequency and CELECOXIB (CELEXA [CELECOXIB]) at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (tightness under left arm running through his chest and throat), PANIC ATTACK (full blown panic attack), FEELING ABNORMAL (extreme brain fog), HYPOAESTHESIA ORAL (numbness in mouth and extremeties), HYPOAESTHESIA (numbness in extremeties), CHEST DISCOMFORT (tightness under left arm running through his chest and throat), DRUG INTOLERANCE (Patient was prescribed Zoloft, Duloxetine and Celexa but could not tolerate it), ANXIETY (Anxiety) and LYMPHADENOPATHY (felt like lymph node reacting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-234546 (Patient Link).
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lymphadenopathy, Panic attack, Throat tightness
Clinical narrative: tightness under left arm running through his chest and throat; Anxiety; Patient was prescribed Zoloft, Duloxetine and Celexa but could not tolerate it; felt like lymph node reacting; tightness under left arm running through his chest and throat; numbness in mouth and extremeties; numbness in extremeties; extreme brain fog; full blown panic attack; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (tightness under left arm running through his chest and throat), PANIC ATTACK (full blown panic attack), FEELING ABNORMAL (extreme brain fog), HYPOAESTHESIA ORAL (numbness in mouth and extremeties) and HYPOAESTHESIA (numbness in extremeties) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, LORAZEPAM for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PANIC ATTACK (full blown panic attack), FEELING ABNORMAL (extreme brain fog), HYPOAESTHESIA ORAL (numbness in mouth and extremeties) and HYPOAESTHESIA (numbness in extremeties). On an unknown date, the patient experienced THROAT TIGHTNESS (tightness under left arm running through his chest and throat), CHEST DISCOMFORT (tightness under left arm running through his chest and throat), DRUG INTOLERANCE (Patient was prescribed Zoloft, Duloxetine and Celexa but could not tolerate it), ANXIETY (Anxiety) and LYMPHADENOPATHY (felt like lymph node reacting). The patient was treated with SERTRALINE HYDROCHLORIDE (ZOLOFT) at an unspecified dose and frequency; DULOXETINE at an unspecified dose and frequency and CELECOXIB (CELEXA [CELECOXIB]) at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (tightness under left arm running through his chest and throat), PANIC ATTACK (full blown panic attack), FEELING ABNORMAL (extreme brain fog), HYPOAESTHESIA ORAL (numbness in mouth and extremeties), HYPOAESTHESIA (numbness in extremeties), CHEST DISCOMFORT (tightness under left arm running through his chest and throat), DRUG INTOLERANCE (Patient was prescribed Zoloft, Duloxetine and Celexa but could not tolerate it), ANXIETY (Anxiety) and LYMPHADENOPATHY (felt like lymph node reacting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-234546 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Blister, Colitis, Erythema, Vaccination site reaction
Clinical narrative: Covid hands; blisters on both hands bilaterally, & between & atop his knuckles & between his knuckles, & on knuckles/big patches of redness with tiny blisters on top of the patches; big patches of redness with tiny blisters on top of the patches / hands stay red for a long time; a lot of colitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Covid hands), BLISTER (blisters on both hands bilaterally, & between & atop his knuckles & between his knuckles, & on knuckles/big patches of redness with tiny blisters on top of the patches), ERYTHEMA (big patches of redness with tiny blisters on top of the patches / hands stay red for a long time) and COLITIS (a lot of colitis) 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 Colitis and COVID-19.    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 VACCINATION SITE REACTION (Covid hands), BLISTER (blisters on both hands bilaterally, & between & atop his knuckles & between his knuckles, & on knuckles/big patches of redness with tiny blisters on top of the patches), ERYTHEMA (big patches of redness with tiny blisters on top of the patches / hands stay red for a long time) and COLITIS (a lot of colitis). At the time of the report, VACCINATION SITE REACTION (Covid hands), ERYTHEMA (big patches of redness with tiny blisters on top of the patches / hands stay red for a long time) and COLITIS (a lot of colitis) outcome was unknown and BLISTER (blisters on both hands bilaterally, & between & atop his knuckles & between his knuckles, & on knuckles/big patches of redness with tiny blisters on top of the patches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The blisters went away and patient's hand remained reddened for extended periods. The patient visited dermatologist, who admitted to having never seen this before. He prescribed multiple creams but none had been effective.  No concomitant medications were provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not received the Second Shot, more than 6 weeks since  first Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the Second Shot, more than 6 weeks since  first Moderna shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the Second Shot, more than 6 weeks since  first Moderna shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the Second Shot, more than 6 weeks since  first Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise
Clinical narrative: Unwell; headache; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Unwell), HEADACHE (headache) and DIZZINESS (dizzy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Unwell), HEADACHE (headache) and DIZZINESS (dizzy). At the time of the report, MALAISE (Unwell), HEADACHE (headache) and DIZZINESS (dizzy) outcome was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site warmth; Vaccination site pruritus; Vaccination site erythema; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling ), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, METOPROLOL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling ) and VACCINATION SITE PAIN (Vaccination site pain). On 20-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 16-Jun-2021, VACCINATION SITE SWELLING (Vaccination site swelling ) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.