chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Skin reaction
Clinical narrative: skin reaction; rash; Tiredness; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN REACTION (skin reaction), RASH (rash) and FATIGUE (Tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 033B21) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-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 SKIN REACTION (skin reaction), RASH (rash) and FATIGUE (Tiredness). The patient was treated with HYDROGEN PEROXIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN REACTION (skin reaction), RASH (rash) and FATIGUE (Tiredness) 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.   Concomitant medications was not reported. Treatment information was not reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypoaesthesia, Nerve injury, Peripheral swelling
Clinical narrative: He had chest pain after both shots; Nerves wrapping around, agitated nerve issue from his back surgery; Had no feeling/ bump with spongy dead tissue.; Little bump in the arm and tissue, a bump with spongy dead tissue; He had  headache after both shots; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (He had chest pain after both shots), NERVE INJURY (Nerves wrapping around, agitated nerve issue from his back surgery), PERIPHERAL SWELLING (Little bump in the arm and tissue, a bump with spongy dead tissue), HEADACHE (He had  headache after both shots) and HYPOAESTHESIA (Had no feeling/ bump with spongy dead tissue.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Back surgery (patient says he has an agitated nerve issue from his back surgery and always has some sort of chest pain). Concurrent medical conditions included COPD.   On 29-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 CHEST PAIN (He had chest pain after both shots), NERVE INJURY (Nerves wrapping around, agitated nerve issue from his back surgery), PERIPHERAL SWELLING (Little bump in the arm and tissue, a bump with spongy dead tissue), HEADACHE (He had  headache after both shots) and HYPOAESTHESIA (Had no feeling/ bump with spongy dead tissue.). At the time of the report, CHEST PAIN (He had chest pain after both shots), NERVE INJURY (Nerves wrapping around, agitated nerve issue from his back surgery) and HEADACHE (He had  headache after both shots) had resolved and PERIPHERAL SWELLING (Little bump in the arm and tissue, a bump with spongy dead tissue) and HYPOAESTHESIA (Had no feeling/ bump with spongy dead tissue.) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   The concomitant medications were not reported.   The treatment information was not provided.   This case was linked to MOD-2021-296249 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Superficial vein thrombosis
Clinical narrative: My legs and feet are tingling, my hands are tingling, face is tingling, my lips are tingling; I ended up with a surface blood cloth in my leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOPHLEBITIS SUPERFICIAL (I ended up with a surface blood cloth in my leg) and PARAESTHESIA (My legs and feet are tingling, my hands are tingling, face is tingling, my lips are tingling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Autoimmune disorder.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021, the patient experienced THROMBOPHLEBITIS SUPERFICIAL (I ended up with a surface blood cloth in my leg). In August 2021, the patient experienced PARAESTHESIA (My legs and feet are tingling, my hands are tingling, face is tingling, my lips are tingling). At the time of the report, THROMBOPHLEBITIS SUPERFICIAL (I ended up with a surface blood cloth in my leg) had resolved and PARAESTHESIA (My legs and feet are tingling, my hands are tingling, face is tingling, my lips are tingling) had not resolved.            It was reported that patient takes steroids as concomitant medication Treatment information was not reported by reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Used a vial that was expired yesterday to administer 7 employees, today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used a vial that was expired yesterday to administer 7 employees, today) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used a vial that was expired yesterday to administer 7 employees, today). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Used a vial that was expired yesterday to administer 7 employees, today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Body temperature, Dizziness, Ear pain, Illness
Clinical narrative: From the bottom of her elbow all the way to her shoulder blade she could not move; ears are hurting; legs were like jelly; fever 101.5; arm is hurting from her shoulder to her elbow; nauseated; getting sick; sore throat; plugged up nose; can't smell anything; light-headed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything) and DIZZINESS (light-headed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything), DIZZINESS (light-headed), PAIN IN EXTREMITY (arm is hurting from her shoulder to her elbow) and NAUSEA (nauseated). On an unknown date, the patient experienced MOBILITY DECREASED (From the bottom of her elbow all the way to her shoulder blade she could not move), EAR PAIN (ears are hurting), LIMB DISCOMFORT (legs were like jelly) and PYREXIA (fever 101.5). At the time of the report, ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything), DIZZINESS (light-headed), MOBILITY DECREASED (From the bottom of her elbow all the way to her shoulder blade she could not move), EAR PAIN (ears are hurting), LIMB DISCOMFORT (legs were like jelly), PAIN IN EXTREMITY (arm is hurting from her shoulder to her elbow), NAUSEA (nauseated) and PYREXIA (fever 101.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Symptoms: It was reported that the patient could not take any food and water down, she took a sleeping pill and she fell down and broke her left side toe. Treatment medication was taken but not specified.  No concomitant medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Mobility decreased, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: From the bottom of her elbow all the way to her shoulder blade she could not move; ears are hurting; legs were like jelly; fever 101.5; arm is hurting from her shoulder to her elbow; nauseated; getting sick; sore throat; plugged up nose; can't smell anything; light-headed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything) and DIZZINESS (light-headed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything), DIZZINESS (light-headed), PAIN IN EXTREMITY (arm is hurting from her shoulder to her elbow) and NAUSEA (nauseated). On an unknown date, the patient experienced MOBILITY DECREASED (From the bottom of her elbow all the way to her shoulder blade she could not move), EAR PAIN (ears are hurting), LIMB DISCOMFORT (legs were like jelly) and PYREXIA (fever 101.5). At the time of the report, ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything), DIZZINESS (light-headed), MOBILITY DECREASED (From the bottom of her elbow all the way to her shoulder blade she could not move), EAR PAIN (ears are hurting), LIMB DISCOMFORT (legs were like jelly), PAIN IN EXTREMITY (arm is hurting from her shoulder to her elbow), NAUSEA (nauseated) and PYREXIA (fever 101.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Symptoms: It was reported that the patient could not take any food and water down, she took a sleeping pill and she fell down and broke her left side toe. Treatment medication was taken but not specified.  No concomitant medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: From the bottom of her elbow all the way to her shoulder blade she could not move; ears are hurting; legs were like jelly; fever 101.5; arm is hurting from her shoulder to her elbow; nauseated; getting sick; sore throat; plugged up nose; can't smell anything; light-headed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything) and DIZZINESS (light-headed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything), DIZZINESS (light-headed), PAIN IN EXTREMITY (arm is hurting from her shoulder to her elbow) and NAUSEA (nauseated). On an unknown date, the patient experienced MOBILITY DECREASED (From the bottom of her elbow all the way to her shoulder blade she could not move), EAR PAIN (ears are hurting), LIMB DISCOMFORT (legs were like jelly) and PYREXIA (fever 101.5). At the time of the report, ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything), DIZZINESS (light-headed), MOBILITY DECREASED (From the bottom of her elbow all the way to her shoulder blade she could not move), EAR PAIN (ears are hurting), LIMB DISCOMFORT (legs were like jelly), PAIN IN EXTREMITY (arm is hurting from her shoulder to her elbow), NAUSEA (nauseated) and PYREXIA (fever 101.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Symptoms: It was reported that the patient could not take any food and water down, she took a sleeping pill and she fell down and broke her left side toe. Treatment medication was taken but not specified.  No concomitant medications were reported
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle discomfort, Nausea, Neck pain, Pain in jaw
Clinical narrative: There is something or pain in the left neck area.; Pain went up to her jaw and to her left temple; She felt like she had to throw up, and she still feels that way.; Massive headache; Something in the muscle between arm and neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (There is something or pain in the left neck area.), PAIN IN JAW (Pain went up to her jaw and to her left temple), NAUSEA (She felt like she had to throw up, and she still feels that way.), HEADACHE (Massive headache) and MUSCLE DISCOMFORT (Something in the muscle between arm and neck) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (a couple of heart procedures last year.). Concurrent medical conditions included Diabetes and Cancer.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced NECK PAIN (There is something or pain in the left neck area.), PAIN IN JAW (Pain went up to her jaw and to her left temple), NAUSEA (She felt like she had to throw up, and she still feels that way.), HEADACHE (Massive headache) and MUSCLE DISCOMFORT (Something in the muscle between arm and neck). At the time of the report, NECK PAIN (There is something or pain in the left neck area.), PAIN IN JAW (Pain went up to her jaw and to her left temple), NAUSEA (She felt like she had to throw up, and she still feels that way.), HEADACHE (Massive headache) and MUSCLE DISCOMFORT (Something in the muscle between arm and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  Patient consented to safety follow up through her phone or email. She consented to safety follow up to her doctor.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered more than 24 hours after the vial was first punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 24 hours after the vial was first punctured) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021 at 4:28 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 24 hours after the vial was first punctured). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 24 hours after the vial was first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The syringe was pre-drawn from a previously unopened vial at 12:27 pm on 24-Aug-2021 and was administered at  4:28 pm all on 25 Aug 2021
Sex: U
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: Mouth ulcers; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (Mouth ulcers) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced MOUTH ULCERATION (Mouth ulcers). At the time of the report, MOUTH ULCERATION (Mouth ulcers) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given more than 24 hours after the vial was first punctured; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given more than 24 hours after the vial was first punctured) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given more than 24 hours after the vial was first punctured). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (dose given more than 24 hours after the vial was first punctured) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information provided.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Didn't turned all the way in into the patient/not all the vaccine was actually injected into the patient; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Didn't turned all the way in into the patient/not all the vaccine was actually injected into the patient) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (Didn't turned all the way in into the patient/not all the vaccine was actually injected into the patient). On 26-Aug-2021, ACCIDENTAL UNDERDOSE (Didn't turned all the way in into the patient/not all the vaccine was actually injected into the patient) 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.   The reported wanted to know if should re administer. No concomitant medications provided. No treatment medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: the injection site was red and warm to the touch; injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the injection site was red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site was red) 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 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE WARMTH (the injection site was red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site was red). At the time of the report, VACCINATION SITE WARMTH (the injection site was red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site was red) had not resolved.            No concomitant medication was reported.                   No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient experienced side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient experienced 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient experienced side effects). At the time of the report, VACCINATION COMPLICATION (Patient experienced side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not  provided.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tooth injury
Clinical narrative: Bottom teeth pulled, as she has jagged teeth underneath the bridge; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INJURY (Bottom teeth pulled, as she has jagged teeth underneath the bridge) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (was hospitalized.) in November 2020 and Arm discomfort (Patient was attacked by some kinds on November 2019. Required surgeries and rehab).). Concurrent medical conditions included Blood disorder and Spinal disorder (Had a spine condition that didn't let patient put the hands in front of the body when falls. Patient went to see a lot of doctors: her general practitioner, but also a neurologist to check if she hit her head when she fell. Patient got a brain scan.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    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 CHILLS (Chills). On 18-May-2021, the patient experienced TOOTH INJURY (Bottom teeth pulled, as she has jagged teeth underneath the bridge). The patient was treated with Surgery (bottom teeth pulled) for Tooth injury. On 17-May-2021, CHILLS (Chills) had resolved. At the time of the report, TOOTH INJURY (Bottom teeth pulled, as she has jagged teeth underneath the bridge) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. The had other operations: knee cap replacement surgery, shoulder surgery, and a cataracts surgery, that had to be postponed due to the symptoms experienced after the second shot.   This case was linked to MOD-2021-297469 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm (left); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (left)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm (left)). At the time of the report, PAIN IN EXTREMITY (Sore arm (left)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-297408.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired dose at 17 hours and 35 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired dose at 17 hours and 35 minutes) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0939901 and 023D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired dose at 17 hours and 35 minutes). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered expired dose at 17 hours and 35 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Feeling hot, Headache, Muscular weakness
Clinical narrative: Anxiety; Bad nasty headaches; Pain in arm/ Bizarre pain in his arms; His weakened arm on fire; His weakened arm on fire; Severe pain on the injection site; Hang over effects/ Feeling awful, crappy/ Noise upsetting him; His body hurting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Hang over effects/ Feeling awful, crappy/ Noise upsetting him), FEELING HOT (His weakened arm on fire), ANXIETY (Anxiety), PAIN IN EXTREMITY (Pain in arm/ Bizarre pain in his arms) and PAIN (His body hurting) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Pericarditis (Patient's father had pericarditis when he was younger).    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced FEELING HOT (His weakened arm on fire), MUSCULAR WEAKNESS (His weakened arm on fire) and VACCINATION SITE PAIN (Severe pain on the injection site). On 26-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm/ Bizarre pain in his arms). On an unknown date, the patient experienced FEELING ABNORMAL (Hang over effects/ Feeling awful, crappy/ Noise upsetting him), ANXIETY (Anxiety), PAIN (His body hurting) and HEADACHE (Bad nasty headaches). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Hang over effects/ Feeling awful, crappy/ Noise upsetting him), FEELING HOT (His weakened arm on fire), PAIN (His body hurting), MUSCULAR WEAKNESS (His weakened arm on fire), VACCINATION SITE PAIN (Severe pain on the injection site) and HEADACHE (Bad nasty headaches) had resolved, ANXIETY (Anxiety) outcome was unknown and PAIN IN EXTREMITY (Pain in arm/ Bizarre pain in his arms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  The patient experienced events following vaccination for a week.  The patient experienced pain in arm which then it disappeared and now it comes and goes in the same spot on the injection site. The patient took ibuprofen but it did not helped.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Anxiety; Bad nasty headaches; Pain in arm/ Bizarre pain in his arms; His weakened arm on fire; His weakened arm on fire; Severe pain on the injection site; Hang over effects/ Feeling awful, crappy/ Noise upsetting him; His body hurting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Hang over effects/ Feeling awful, crappy/ Noise upsetting him), FEELING HOT (His weakened arm on fire), ANXIETY (Anxiety), PAIN IN EXTREMITY (Pain in arm/ Bizarre pain in his arms) and PAIN (His body hurting) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Pericarditis (Patient's father had pericarditis when he was younger).    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced FEELING HOT (His weakened arm on fire), MUSCULAR WEAKNESS (His weakened arm on fire) and VACCINATION SITE PAIN (Severe pain on the injection site). On 26-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm/ Bizarre pain in his arms). On an unknown date, the patient experienced FEELING ABNORMAL (Hang over effects/ Feeling awful, crappy/ Noise upsetting him), ANXIETY (Anxiety), PAIN (His body hurting) and HEADACHE (Bad nasty headaches). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Hang over effects/ Feeling awful, crappy/ Noise upsetting him), FEELING HOT (His weakened arm on fire), PAIN (His body hurting), MUSCULAR WEAKNESS (His weakened arm on fire), VACCINATION SITE PAIN (Severe pain on the injection site) and HEADACHE (Bad nasty headaches) had resolved, ANXIETY (Anxiety) outcome was unknown and PAIN IN EXTREMITY (Pain in arm/ Bizarre pain in his arms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  The patient experienced events following vaccination for a week.  The patient experienced pain in arm which then it disappeared and now it comes and goes in the same spot on the injection site. The patient took ibuprofen but it did not helped.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient never received her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient never received her 2nd 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 13-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 PRODUCT DOSE OMISSION ISSUE (Patient never received her 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient never received her 2nd dose) had resolved.            No concomitant medications were reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 0.33
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: low grade fever; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (low grade fever) and FATIGUE (fatigue) in a 4-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3004956 and 3003657) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-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 PYREXIA (low grade fever) and FATIGUE (fatigue). At the time of the report, PYREXIA (low grade fever) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dysphonia, Dyspnoea, Headache
Clinical narrative: got sick after both shots; fever; chills; headache; developed a chronic, raspy sound; it's like a raspy cough; voice and throat have been groggy; throat gets sore; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick after both shots), DYSPHONIA (developed a chronic, raspy sound), COUGH (it's like a raspy cough), SOMNOLENCE (voice and throat have been groggy) and OROPHARYNGEAL PAIN (throat gets sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced ILLNESS (got sick after both shots), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). In April 2021, the patient experienced DYSPHONIA (developed a chronic, raspy sound), COUGH (it's like a raspy cough), SOMNOLENCE (voice and throat have been groggy), OROPHARYNGEAL PAIN (throat gets sore) and DYSPNOEA (short of breath). In April 2021, PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, ILLNESS (got sick after both shots), DYSPHONIA (developed a chronic, raspy sound), COUGH (it's like a raspy cough), SOMNOLENCE (voice and throat have been groggy), OROPHARYNGEAL PAIN (throat gets sore) and DYSPNOEA (short of breath) had not resolved.            Concomitant product was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-297681 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal pain, Pyrexia, Somnolence
Clinical narrative: got sick after both shots; fever; chills; headache; developed a chronic, raspy sound; it's like a raspy cough; voice and throat have been groggy; throat gets sore; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick after both shots), DYSPHONIA (developed a chronic, raspy sound), COUGH (it's like a raspy cough), SOMNOLENCE (voice and throat have been groggy) and OROPHARYNGEAL PAIN (throat gets sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced ILLNESS (got sick after both shots), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). In April 2021, the patient experienced DYSPHONIA (developed a chronic, raspy sound), COUGH (it's like a raspy cough), SOMNOLENCE (voice and throat have been groggy), OROPHARYNGEAL PAIN (throat gets sore) and DYSPNOEA (short of breath). In April 2021, PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, ILLNESS (got sick after both shots), DYSPHONIA (developed a chronic, raspy sound), COUGH (it's like a raspy cough), SOMNOLENCE (voice and throat have been groggy), OROPHARYNGEAL PAIN (throat gets sore) and DYSPNOEA (short of breath) had not resolved.            Concomitant product was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-297681 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a little tiredness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included PROBIOTICS NOS for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FATIGUE (a little tiredness). At the time of the report, FATIGUE (a little tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication was reported.   This case was linked to MOD-2021-297572 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Gastrooesophageal reflux disease
Clinical narrative: She also has burning sensation.; She started noticing that everything that she drank or ate, she feels that she gets reflux; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (She started noticing that everything that she drank or ate, she feels that she gets reflux) and BURNING SENSATION (She also has burning sensation.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LINACLOTIDE (LINZESS), FLUOXETINE HYDROCHLORIDE (PROZAC), LORATADINE (CLARITINE) and PHENTERMINE for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (She started noticing that everything that she drank or ate, she feels that she gets reflux). On an unknown date, the patient experienced BURNING SENSATION (She also has burning sensation.). The patient was treated with ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) for Acid reflux (esophageal) and Burning sensation, at an unspecified dose and frequency and SIMETICONE (GAS RELIEF) for Acid reflux (esophageal) and Burning sensation, at an unspecified dose and frequency. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (She started noticing that everything that she drank or ate, she feels that she gets reflux) and BURNING SENSATION (She also has burning sensation.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A vial that has been opened for 9 days was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported No Treatment information was reported
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Ex husband got so sick after second dose with flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Ex husband got so sick after second dose with flu like symptoms) 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 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 INFLUENZA LIKE ILLNESS (Ex husband got so sick after second dose with flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Ex husband got so sick after second dose with flu like symptoms) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-297997 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Vials that were more than 30 days in refrigerator administered to patients; 125 individuals received 2 vaccinations that had a temp excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials that were more than 30 days in refrigerator administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (125 individuals received 2 vaccinations that had a temp excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) 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 EXPIRED PRODUCT ADMINISTERED (Vials that were more than 30 days in refrigerator administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (125 individuals received 2 vaccinations that had a temp excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials that were more than 30 days in refrigerator administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (125 individuals received 2 vaccinations that had a temp excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Significant follow up : new event was added. On 01-Sep-2021: Follow up received : included no new information.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered this expired vaccine vial to one patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered this expired vaccine vial to one patient) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered this expired vaccine vial to one patient). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered this expired vaccine vial to one patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This vaccine vial was moved from the freezer to a refrigerator on 31Jul2021 and had been stored in the refrigerator since. No Concomitant medications was provided.  No Treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Patients initial was updated. Product dose information was added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: headache; gotten red; painful, tender; site of injection started itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site of injection started itching), VACCINATION SITE ERYTHEMA (gotten red), VACCINATION SITE PAIN (painful, tender) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049EL1A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis in 1990 and Ankylosing spondylitis in 1990. Concomitant products included MAGNESIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection started itching). On 27-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (gotten red) and VACCINATION SITE PAIN (painful, tender). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, VACCINATION SITE PRURITUS (site of injection started itching), VACCINATION SITE ERYTHEMA (gotten red), VACCINATION SITE PAIN (painful, tender) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was provided.  No Treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Non Significant Follow up appended. Concomitant medications were updated. Medical history was updated.