chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Trigeminal neuralgia, Vaccination complication
Clinical narrative: still stiff; trigeminal neuralgia/bells palsy type thing/flared up; had a severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (still stiff), TRIGEMINAL NEURALGIA (trigeminal neuralgia/bells palsy type thing/flared up) and VACCINATION COMPLICATION (had a severe reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN (GABUTIN) for Nerve pain, BACLOFEN and LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (still stiff), TRIGEMINAL NEURALGIA (trigeminal neuralgia/bells palsy type thing/flared up) and VACCINATION COMPLICATION (had a severe reaction). At the time of the report, MUSCULOSKELETAL STIFFNESS (still stiff) had not resolved and TRIGEMINAL NEURALGIA (trigeminal neuralgia/bells palsy type thing/flared up) and VACCINATION COMPLICATION (had a severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a severe reaction from the first shot and ended up at the emergency room (ER) where they gave her two pain shots and a pain pill in the ER.  No medical history information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Eye infection
Clinical narrative: Eye infection; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (Eye infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE INFECTION (Eye infection). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Eye infection, at an unspecified dose and frequency and DOXYCYCLINE for Eye infection, at an unspecified dose and frequency. At the time of the report, EYE INFECTION (Eye infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported The patient was scheduled to get 2nd dose of Moderna Vaccine on Friday, 12 Feb 2021.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: State says that his lot number for the first vaccine in their data base is for a Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (State says that his lot number for the first vaccine in their data base is for a Pfizer) 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (State says that his lot number for the first vaccine in their data base is for a Pfizer). On 18-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (State says that his lot number for the first vaccine in their data base is for a Pfizer) had resolved.            It was reported that, the patient received his first two Moderna COVID-19 vaccines at Health Care. Health Care administered two Moderna COVID-19 vaccines for his primary series.  However, the State says that his lot number for the first vaccine in their data base was for a Pfizer vaccine. On 15-Jan-2021, he received his first Pfizer vaccine in his left arm shoulder deltoid muscle. He reports no other side effects post first vaccine. On 18-Feb-2021, he received his second Moderna COVID-19 vaccine    No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow-up information received includes no new information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Influenza like illness
Clinical narrative: like having flu; like having allergy; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like having flu), HYPERSENSITIVITY (like having allergy) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like having flu) and HYPERSENSITIVITY (like having allergy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (like having flu), HYPERSENSITIVITY (like having allergy) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that two weeks ago, patient started to have headaches and are not constants but sometimes she gets them (one day on, one day off). No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: Anxious - after the 1st dose; Lightheaded - after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Anxious - after the 1st dose) and DIZZINESS (Lightheaded - after the 1st 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxious - after the 1st dose) and DIZZINESS (Lightheaded - after the 1st dose). At the time of the report, ANXIETY (Anxious - after the 1st dose) and DIZZINESS (Lightheaded - after the 1st dose) 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 reported. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose received in less than 25 days after the first dose.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received in less than 25 days after the first 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 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received in less than 25 days after the first dose.). On 02-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received in less than 25 days after the first dose.) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  It was reported that the patient took the second dose of the vaccine at day 24.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Feeling abnormal, Irritability, Lymph node pain
Clinical narrative: cervical lymph node on her right side was hurting which went away & is fine now; miserable feeling; irritated; angry; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (miserable feeling), IRRITABILITY (irritated), ANGER (angry) and LYMPH NODE PAIN (cervical lymph node on her right side was hurting which went away & is fine now) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced FEELING ABNORMAL (miserable feeling), IRRITABILITY (irritated) and ANGER (angry). On an unknown date, the patient experienced LYMPH NODE PAIN (cervical lymph node on her right side was hurting which went away & is fine now). In June 2021, FEELING ABNORMAL (miserable feeling), IRRITABILITY (irritated) and ANGER (angry) had resolved. At the time of the report, LYMPH NODE PAIN (cervical lymph node on her right side was hurting which went away & is fine now) had resolved.            No concomitant medications were reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle twitching, Myalgia
Clinical narrative: twitching of the feet and hand; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitching of the feet and hand), MYALGIA (body ache) and 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (twitching of the feet and hand), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, MUSCLE TWITCHING (twitching of the feet and hand), MYALGIA (body ache) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching/Uncontrollably itching; Red skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching/Uncontrollably itching), ERYTHEMA (Red skin) and HYPERSENSITIVITY (Allergic reactions) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034f21a, 025b21a and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRURITUS (Itching/Uncontrollably itching) and ERYTHEMA (Red skin). In December 2021, the patient experienced HYPERSENSITIVITY (Allergic reactions). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching/Uncontrollably itching), ERYTHEMA (Red skin) and HYPERSENSITIVITY (Allergic reactions) had not resolved.            Patient's MD and dermatologist mentioned it could be an allergic reactions 2 weeks after vaccination.  No concomitant medication was reported by reporter.  1 week and a half after receiving the booster dose patient started to experience the symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain after receiving the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain after receiving the vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain after receiving the vaccination). At the time of the report, PAIN (Pain after receiving the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was not reported No treatment medications were provided
Sex: M
Vaccine: COVID19
Symptoms: Osteoarthritis
Clinical narrative: Osteoarthritis; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis. Concomitant products included CELECOXIB (CELEBREX) and ASPIRIN [ACETYLSALICYLIC ACID] for Osteoarthritis.    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 OSTEOARTHRITIS (Osteoarthritis). At the time of the report, OSTEOARTHRITIS (Osteoarthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that aspirin and celebrax for osteoarthritis prior to taking the second shot of his Moderna COVID-19 vaccine which is scheduled for next Wednesday 17Mar2021. No Treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Needs to take antibiotics after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Needs to take antibiotics after vaccination) 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 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Needs to take antibiotics after vaccination). At the time of the report, VACCINATION COMPLICATION (Needs to take antibiotics after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient received .25 mL instead of 0.5 mL for his 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received .25 mL instead of 0.5 mL for his 2nd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069821A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received .25 mL instead of 0.5 mL for his 2nd dose). On 23-Dec-2021, ACCIDENTAL UNDERDOSE (Patient received .25 mL instead of 0.5 mL for his 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: missed his appointment for his second shot that was scheduled 23Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed his appointment for his second shot that was scheduled 23Feb2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included CODEINE for Arthritis.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed his appointment for his second shot that was scheduled 23Feb2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed his appointment for his second shot that was scheduled 23Feb2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that his physician advised him to wait to receive the vaccine because he was administered two codeine shot for arthritis. The patient was seeking assistance to make an appointment for his second shot.  No treatment information was provided by the reporter.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: cotton mouth; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (cotton mouth) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced DRY MOUTH (cotton mouth). At the time of the report, DRY MOUTH (cotton mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Products were reported. No Treatment information was reported.   This case was linked to MOD-2021-429306 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: On antibiotics after first dose, on steroids after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (On antibiotics after first dose, on steroids after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (On antibiotics after first dose, on steroids after first dose). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (On antibiotics after first dose, on steroids after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  The reporter was taking a course of steroids and antibiotic Amoxicillin after first dose. She was supposed to get second dose of Moderna COVID-19 vaccine and wanted to know if there are any drug interactions.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The vial did not undergone any temperature excursions.   This case was linked to MOD-2021-429240, MOD-2021-429269, MOD-2021-429289, MOD-2021-429321, MOD-2021-429337 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Six patients received expired Moderna vaccine booster shots after 30-day Use By Date /after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date /after manufacturer date of expiry) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date /after manufacturer date of expiry). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date /after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication was not provided.   This case was linked to MOD-2021-429306 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use By Date / after manufacturer date of expiry.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. Nurse reported that six patients received expired Moderna vaccine booster shots on 27-Dec-2021 after 30-day Use By Date / after manufacturer date of expiry. Number of doses/vials was 1 vial /10 dose.   This case was linked to MOD-2021-429306 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Myalgia, Rash, Vaccination site pain
Clinical narrative: Rashes popping up in the body; Joint pain; soreness in the arm; Feverish (in the arm); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes popping up in the body), ARTHRALGIA (Joint pain), MYALGIA (soreness in the arm) and VACCINATION SITE PAIN (Feverish (in the arm)) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included AMLODIPINE for Blood pressure high.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes popping up in the body), ARTHRALGIA (Joint pain), MYALGIA (soreness in the arm) and VACCINATION SITE PAIN (Feverish (in the arm)). At the time of the report, RASH (Rashes popping up in the body), ARTHRALGIA (Joint pain), MYALGIA (soreness in the arm) and VACCINATION SITE PAIN (Feverish (in the arm)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Antibody test: positive (Positive) Positive.         Treatment medication was not provided.   This case was linked to MOD-2021-428795 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her husband hurt his leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her husband hurt his leg) 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 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 PAIN IN EXTREMITY (Her husband hurt his leg). At the time of the report, PAIN IN EXTREMITY (Her husband hurt his leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient needs to take Tylenol Extra Strength for leg hurt. The 2nd dose of the Moderna COVID-19 vaccine scheduled on 06 Mar 2021.  No concomitant product information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Surgery
Clinical narrative: Scheduled for surgery; advised not to get second shot from surgeon because the patient was still recovering; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (Scheduled for surgery) and OFF LABEL USE (advised not to get second shot from surgeon because the patient was still recovering) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced OFF LABEL USE (advised not to get second shot from surgeon because the patient was still recovering). On 12-Jan-2021, the patient experienced SURGERY (Scheduled for surgery). On 04-Jan-2021, OFF LABEL USE (advised not to get second shot from surgeon because the patient was still recovering) had resolved. At the time of the report, SURGERY (Scheduled for surgery) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  The patient wanted to know whether the patient had to start the Moderna vaccine series over again or not.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: has a UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (has a UTI) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (has a UTI). At the time of the report, URINARY TRACT INFECTION (has a UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  Patient would getting the second dose of the Moderna COVID-19 vaccine but she had a UTI and thought the doctor would prescribe medication so she wanted to know if that would effect the vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: people are getting sick of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (people are getting sick of the vaccine) 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 ILLNESS (people are getting sick of the vaccine). At the time of the report, ILLNESS (people are getting sick of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient inquired if they could take Tylenol before getting the second dose of Moderna COVID-19 vaccine in order to prevent adverse events, because was told that people were getting sick of the vaccine and was strongly concerned.   No treatment information was provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Fatigue, Malaise, Nasal congestion
Clinical narrative: has been so sick ever since; nasal & chest congestion; feeling weak; chest congestion; vomiting; fatigue; Yesterday a doctor said his lungs were clear but he has phlegm in the bronchial area & throat; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (has been so sick ever since), NASAL CONGESTION (nasal & chest congestion), ASTHENIA (feeling weak), PRODUCTIVE COUGH (Yesterday a doctor said his lungs were clear but he has phlegm in the bronchial area & throat) and CHEST DISCOMFORT (chest congestion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis, COVID-19 (Patient had COVID in August 2021 & recovered with a lot of problems.) in August 2021, COVID-19 pneumonia (Had double Covid pneumonia, was reported.), White blood cell count low, Platelet count low and Hospitalization. Previously administered products included for COVID-19 treatment: Monoclonal antibodies and Remdesivir. Past adverse reactions to the above products included No adverse event with Monoclonal antibodies and Remdesivir. Concurrent medical conditions included Drug allergy (Had anaphylaxis as a child to a sulfa drug, was reported.).    On 24-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced PRODUCTIVE COUGH (Yesterday a doctor said his lungs were clear but he has phlegm in the bronchial area & throat). On an unknown date, the patient experienced MALAISE (has been so sick ever since), NASAL CONGESTION (nasal & chest congestion), ASTHENIA (feeling weak), CHEST DISCOMFORT (chest congestion), VOMITING (vomiting) and FATIGUE (fatigue). At the time of the report, MALAISE (has been so sick ever since), NASAL CONGESTION (nasal & chest congestion), ASTHENIA (feeling weak), PRODUCTIVE COUGH (Yesterday a doctor said his lungs were clear but he has phlegm in the bronchial area & throat), CHEST DISCOMFORT (chest congestion), VOMITING (vomiting) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 94-98 (normal) saturations go down to 94 then back up to 98.     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.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient had COVID in Aug, 2021, his platelets and white blood count went down, was hospitalized for 8 days, got treatment and recovered.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Productive cough, Vomiting
Clinical narrative: has been so sick ever since; nasal & chest congestion; feeling weak; chest congestion; vomiting; fatigue; Yesterday a doctor said his lungs were clear but he has phlegm in the bronchial area & throat; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (has been so sick ever since), NASAL CONGESTION (nasal & chest congestion), ASTHENIA (feeling weak), PRODUCTIVE COUGH (Yesterday a doctor said his lungs were clear but he has phlegm in the bronchial area & throat) and CHEST DISCOMFORT (chest congestion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis, COVID-19 (Patient had COVID in August 2021 & recovered with a lot of problems.) in August 2021, COVID-19 pneumonia (Had double Covid pneumonia, was reported.), White blood cell count low, Platelet count low and Hospitalization. Previously administered products included for COVID-19 treatment: Monoclonal antibodies and Remdesivir. Past adverse reactions to the above products included No adverse event with Monoclonal antibodies and Remdesivir. Concurrent medical conditions included Drug allergy (Had anaphylaxis as a child to a sulfa drug, was reported.).    On 24-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced PRODUCTIVE COUGH (Yesterday a doctor said his lungs were clear but he has phlegm in the bronchial area & throat). On an unknown date, the patient experienced MALAISE (has been so sick ever since), NASAL CONGESTION (nasal & chest congestion), ASTHENIA (feeling weak), CHEST DISCOMFORT (chest congestion), VOMITING (vomiting) and FATIGUE (fatigue). At the time of the report, MALAISE (has been so sick ever since), NASAL CONGESTION (nasal & chest congestion), ASTHENIA (feeling weak), PRODUCTIVE COUGH (Yesterday a doctor said his lungs were clear but he has phlegm in the bronchial area & throat), CHEST DISCOMFORT (chest congestion), VOMITING (vomiting) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 94-98 (normal) saturations go down to 94 then back up to 98.     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.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient had COVID in Aug, 2021, his platelets and white blood count went down, was hospitalized for 8 days, got treatment and recovered.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Patient is experiencing mild COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Patient is experiencing mild COVID Arm) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Patient is experiencing mild COVID Arm). At the time of the report, VACCINATION SITE REACTION (Patient is experiencing mild COVID Arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment details were reported.  Patient just wants to know if it is alright to receive the 2nd Dose to the other arm as patient is experiencing reaction in the arm for first dose.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; headache; fever; nausea; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and FATIGUE (fatigue) 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.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and FATIGUE (fatigue) 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.   The patient had vaccine in March and had symptoms of headache, fever, sore throat, nausea, fatigue.   No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) 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 URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.            Patient received the booster of the Moderna COVID19 vaccine and 11 days after her booster shot patient started to experience hives Concomitant information was not provided. Treatment information was not provided.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired 2nd dose of Moderna COVID-19 vaccine) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired 2nd dose of Moderna COVID-19 vaccine). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired 2nd dose of Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Muscle tightness, Musculoskeletal stiffness, Neck pain, Swelling of eyelid
Clinical narrative: upper eyelid was starting to swell/more swollen than yesterday; stiff neck; something hurts in my neck when I turn it a certain way; Her face felt tighter around the right eye; eye started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye started to hurt), SWELLING OF EYELID (upper eyelid was starting to swell/more swollen than yesterday), MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (something hurts in my neck when I turn it a certain way) and MUSCLE TIGHTNESS (Her face felt tighter around the right eye) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     Concurrent medical conditions included Perfume sensitivity (Allergic to a whole slew of things, like fragrances, was reported.).    On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced EYE PAIN (eye started to hurt), MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (something hurts in my neck when I turn it a certain way) and MUSCLE TIGHTNESS (Her face felt tighter around the right eye). On 28-Dec-2021, the patient experienced SWELLING OF EYELID (upper eyelid was starting to swell/more swollen than yesterday). At the time of the report, EYE PAIN (eye started to hurt), SWELLING OF EYELID (upper eyelid was starting to swell/more swollen than yesterday) and MUSCLE TIGHTNESS (Her face felt tighter around the right eye) had not resolved and MUSCULOSKELETAL STIFFNESS (stiff neck) and NECK PAIN (something hurts in my neck when I turn it a certain way) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported  Getting brown around the eyes like somebody socked her in the eye, was reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pounding headache on right side of the head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pounding headache on right side of the head) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced HEADACHE (Pounding headache on right side of the head). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in December 2021 for Adverse event, at a dose of 1 dosage form and SUMATRIPTAN in December 2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (Pounding headache on right side of the head) outcome was unknown.            She received the booster vaccine on 11 Dec 2021 that was administered on the left arm. After receiving the vaccine, she was experiencing pounding heading on the right side of the head. Daughter stated that she tried Tylenol which did not helped. Reached out to her HCP and HCP prescribed her medicine called Sumatriptan.  No concomitant drug were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered greater than 12  hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12  hours post puncture) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 37F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021 at 2:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021 at 2:45 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12  hours post puncture). On 28-Dec-2021 at 2:45 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12  hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date and time vial was first punctured: 27-Dec-2021 at 3 PM. The vial was stored in the refrigerator post puncture for 23 hours and 45 minutes. Date of administration of vaccine-28DEC2021 last shot at 2:45PM.Patients have not reported side effects No concomitant medication  were reported. No Treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose March 22 2021 and 2nd dose Jun 6 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose March 22 2021 and 2nd dose Jun 6 2021) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035l40a and 040m31a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose March 22 2021 and 2nd dose Jun 6 2021). On 06-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose March 22 2021 and 2nd dose Jun 6 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient