chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling (approximately 3 inches x 2 niches), redness, heat at injection site lasting for 3 days, followed by bruising, which is still occurring at 4 days past swelling and redness
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Computerised tomogram, Vertigo
Clinical narrative: Acute Virtigo - debilitating
Age: 80.0
Sex: M
Vaccine: UNK
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: sore throat and dry cough within two days.  Very much like a cold.  As I write this, it's been 5 days since the injection, and the symptoms are worse and hopefully stable, i. e. not worsening.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT INADVERTENTLY RECEIVED BOTH HIB AND VAXELIS VACCINE ON SAME APPT DATE/TIME
Age: 72.0
Sex: F
Vaccine: UNK, COVID19-2
Symptoms: Chest X-ray normal, Fibrin D dimer normal, Pericarditis
Clinical narrative: Per doctor's note, based on recent vaccination, she suspects pericarditis.
Age: 72.0
Sex: F
Vaccine: UNK, COVID19-2
Symptoms: Pericarditis
Clinical narrative: Per doctor's note, based on recent vaccination, she suspects pericarditis.
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Crying, Loss of personal independence in daily activities, Mobility decreased, Muscle spasms, Neck pain
Clinical narrative: Uncontrollable spasm  back, neck and chest; Uncontrollable spasm  back, neck and chest; Uncontrollable spasm  back, neck and chest; Soreness in the  muscle; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Uncontrollable spasm  back, neck and chest), NECK PAIN (Uncontrollable spasm  back, neck and chest), CHEST PAIN (Uncontrollable spasm  back, neck and chest) and MYALGIA (Soreness in the  muscle) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Date of positive COVID-19 test: Jun2022, Emergency room) on 08-Jun-2022. Concurrent medical conditions included Allergy to antibiotic (Erythromycin allergy). Concomitant products included ALENDRONATE SODIUM, CLOBETASOL PROPIONATE and ESTRADIOL (IMVEXXY) for an unknown indication.    On 16-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Oct-2022, the patient experienced MUSCLE SPASMS (Uncontrollable spasm  back, neck and chest), NECK PAIN (Uncontrollable spasm  back, neck and chest), CHEST PAIN (Uncontrollable spasm  back, neck and chest) and MYALGIA (Soreness in the  muscle). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Uncontrollable spasm  back, neck and chest), NECK PAIN (Uncontrollable spasm  back, neck and chest), CHEST PAIN (Uncontrollable spasm  back, neck and chest) and MYALGIA (Soreness in the  muscle) outcome was unknown.            It was reported that patient  received the bivalent booster vaccine 2 weeks ago. The patient received the booster on 16 Oct 2022. The patient had soreness in the muscle, uncontrollable spasm in  back, neck, and chest. On Monday 17 Oct 2022 in the morning the patient started to improve. Saturday 22 Oct 2022 the same thing happened. She could not even go to the bathroom alone. Last night as mentioned on 26 Oct 2022 she had the same symptoms again. She has been taking Advil, Aleve, and Tylenol. The doctor gave her medication for muscle relieve it did nothing.   Patient was taking other medication. Health Care Professional was aware of the side effects.   No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   This case was linked to MOD-2022-665386 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pain
Clinical narrative: Uncontrollable spasm  back, neck and chest; Uncontrollable spasm  back, neck and chest; Uncontrollable spasm  back, neck and chest; Soreness in the  muscle; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Uncontrollable spasm  back, neck and chest), NECK PAIN (Uncontrollable spasm  back, neck and chest), CHEST PAIN (Uncontrollable spasm  back, neck and chest) and MYALGIA (Soreness in the  muscle) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Date of positive COVID-19 test: Jun2022, Emergency room) on 08-Jun-2022. Concurrent medical conditions included Allergy to antibiotic (Erythromycin allergy). Concomitant products included ALENDRONATE SODIUM, CLOBETASOL PROPIONATE and ESTRADIOL (IMVEXXY) for an unknown indication.    On 16-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Oct-2022, the patient experienced MUSCLE SPASMS (Uncontrollable spasm  back, neck and chest), NECK PAIN (Uncontrollable spasm  back, neck and chest), CHEST PAIN (Uncontrollable spasm  back, neck and chest) and MYALGIA (Soreness in the  muscle). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Uncontrollable spasm  back, neck and chest), NECK PAIN (Uncontrollable spasm  back, neck and chest), CHEST PAIN (Uncontrollable spasm  back, neck and chest) and MYALGIA (Soreness in the  muscle) outcome was unknown.            It was reported that patient  received the bivalent booster vaccine 2 weeks ago. The patient received the booster on 16 Oct 2022. The patient had soreness in the muscle, uncontrollable spasm in  back, neck, and chest. On Monday 17 Oct 2022 in the morning the patient started to improve. Saturday 22 Oct 2022 the same thing happened. She could not even go to the bathroom alone. Last night as mentioned on 26 Oct 2022 she had the same symptoms again. She has been taking Advil, Aleve, and Tylenol. The doctor gave her medication for muscle relieve it did nothing.   Patient was taking other medication. Health Care Professional was aware of the side effects.   No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   This case was linked to MOD-2022-665386 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Chest pain, Muscle spasms, Myalgia, Neck pain
Clinical narrative: Uncontrollable spasm  back, neck and chest; Uncontrollable spasm  back, neck and chest; Uncontrollable spasm  back, neck and chest; Soreness in the  muscle; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Uncontrollable spasm  back, neck and chest), NECK PAIN (Uncontrollable spasm  back, neck and chest), CHEST PAIN (Uncontrollable spasm  back, neck and chest) and MYALGIA (Soreness in the  muscle) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Date of positive COVID-19 test: Jun2022, Emergency room) on 08-Jun-2022. Concurrent medical conditions included Allergy to antibiotic (Erythromycin allergy). Concomitant products included ALENDRONATE SODIUM, CLOBETASOL PROPIONATE and ESTRADIOL (IMVEXXY) for an unknown indication.    On 16-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Oct-2022, the patient experienced MUSCLE SPASMS (Uncontrollable spasm  back, neck and chest), NECK PAIN (Uncontrollable spasm  back, neck and chest), CHEST PAIN (Uncontrollable spasm  back, neck and chest) and MYALGIA (Soreness in the  muscle). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Uncontrollable spasm  back, neck and chest), NECK PAIN (Uncontrollable spasm  back, neck and chest), CHEST PAIN (Uncontrollable spasm  back, neck and chest) and MYALGIA (Soreness in the  muscle) outcome was unknown.            It was reported that patient  received the bivalent booster vaccine 2 weeks ago. The patient received the booster on 16 Oct 2022. The patient had soreness in the muscle, uncontrollable spasm in  back, neck, and chest. On Monday 17 Oct 2022 in the morning the patient started to improve. Saturday 22 Oct 2022 the same thing happened. She could not even go to the bathroom alone. Last night as mentioned on 26 Oct 2022 she had the same symptoms again. She has been taking Advil, Aleve, and Tylenol. The doctor gave her medication for muscle relieve it did nothing.   Patient was taking other medication. Health Care Professional was aware of the side effects.   No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   This case was linked to MOD-2022-665386 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Derealisation, Discomfort, Dizziness, Electric shock sensation
Clinical narrative: peripheral neuropathy left side of body including left testicle Fatigue PEM Brain Fog Head Pressure back of the neck and behind ears Dizziness Floaty feeling being on an elevator Derealization burning eyes Electric teeth Muscle twitching Sudden weight loss Stiffness of muscles Joint pain Cold to touch on left side myocarditis occasionally tinnitus occasionally Sensitivity to loudness
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Eye irritation, Fatigue, Feeling abnormal, Hyperacusis, Laboratory test abnormal
Clinical narrative: peripheral neuropathy left side of body including left testicle Fatigue PEM Brain Fog Head Pressure back of the neck and behind ears Dizziness Floaty feeling being on an elevator Derealization burning eyes Electric teeth Muscle twitching Sudden weight loss Stiffness of muscles Joint pain Cold to touch on left side myocarditis occasionally tinnitus occasionally Sensitivity to loudness
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscle twitching, Musculoskeletal stiffness, Myocarditis, Neuropathy peripheral, Peripheral coldness
Clinical narrative: peripheral neuropathy left side of body including left testicle Fatigue PEM Brain Fog Head Pressure back of the neck and behind ears Dizziness Floaty feeling being on an elevator Derealization burning eyes Electric teeth Muscle twitching Sudden weight loss Stiffness of muscles Joint pain Cold to touch on left side myocarditis occasionally tinnitus occasionally Sensitivity to loudness
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Small fibre neuropathy, Tinnitus, Weight decreased
Clinical narrative: peripheral neuropathy left side of body including left testicle Fatigue PEM Brain Fog Head Pressure back of the neck and behind ears Dizziness Floaty feeling being on an elevator Derealization burning eyes Electric teeth Muscle twitching Sudden weight loss Stiffness of muscles Joint pain Cold to touch on left side myocarditis occasionally tinnitus occasionally Sensitivity to loudness
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Dental discomfort, Derealisation, Discomfort, Dizziness
Clinical narrative: peripheral neuropathy left side of body including left testicle Fatigue PEM Brain Fog Head Pressure back of the neck and behind ears Dizziness Floaty feeling being on an elevator Derealization burning eyes Electric teeth Muscle twitching Sudden weight loss Stiffness of muscles Joint pain Cold to touch on left side myocarditis occasionally tinnitus occasionally Sensitivity to loudness
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electric shock sensation, Eye irritation, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: peripheral neuropathy left side of body including left testicle Fatigue PEM Brain Fog Head Pressure back of the neck and behind ears Dizziness Floaty feeling being on an elevator Derealization burning eyes Electric teeth Muscle twitching Sudden weight loss Stiffness of muscles Joint pain Cold to touch on left side myocarditis occasionally tinnitus occasionally Sensitivity to loudness
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hyperacusis, Laboratory test, Malaise, Muscle twitching, Musculoskeletal discomfort
Clinical narrative: peripheral neuropathy left side of body including left testicle Fatigue PEM Brain Fog Head Pressure back of the neck and behind ears Dizziness Floaty feeling being on an elevator Derealization burning eyes Electric teeth Muscle twitching Sudden weight loss Stiffness of muscles Joint pain Cold to touch on left side myocarditis occasionally tinnitus occasionally Sensitivity to loudness
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Myocarditis, Neuropathy peripheral, Tinnitus, Weight decreased
Clinical narrative: peripheral neuropathy left side of body including left testicle Fatigue PEM Brain Fog Head Pressure back of the neck and behind ears Dizziness Floaty feeling being on an elevator Derealization burning eyes Electric teeth Muscle twitching Sudden weight loss Stiffness of muscles Joint pain Cold to touch on left side myocarditis occasionally tinnitus occasionally Sensitivity to loudness
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: mononucleosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jul2022 at 15:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SIMPONI; CELECOXIB. Past drug history included: L-arginine, reaction(s): "Known allergies: L-Arginine". Vaccination history included: BNT162b2 (Dose 3, Single, Batch/Lot No: FJ6369, Location of injection: Arm Left), administration date: 21Mar2022, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: FF2593, Location of injection: Arm Left), administration date: 05Nov2021, when the patient was 70-year-old, for COVID-19 immunization; janssen (Dose 1, Single, Batch/Lot No: 1805022, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 70-year-old, for COVID-19 Immunization.  The following information was reported: INFECTIOUS MONONUCLEOSIS (non-serious) with onset 12Jul2022 at 12:00, outcome "recovered with sequelae" (2022), described as "mononucleosis". The event "mononucleosis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infectious mononucleosis, SARS-CoV-2 test
Clinical narrative: mononucleosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jul2022 at 15:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SIMPONI; CELECOXIB. Past drug history included: L-arginine, reaction(s): "Known allergies: L-Arginine". Vaccination history included: BNT162b2 (Dose 3, Single, Batch/Lot No: FJ6369, Location of injection: Arm Left), administration date: 21Mar2022, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: FF2593, Location of injection: Arm Left), administration date: 05Nov2021, when the patient was 70-year-old, for COVID-19 immunization; janssen (Dose 1, Single, Batch/Lot No: 1805022, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 70-year-old, for COVID-19 Immunization.  The following information was reported: INFECTIOUS MONONUCLEOSIS (non-serious) with onset 12Jul2022 at 12:00, outcome "recovered with sequelae" (2022), described as "mononucleosis". The event "mononucleosis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I tested positive for Covid 19 on October 18, 2022, I experienced a bad cough, no fever, lots of congestion, nasal drainage, tiredness.  I was taking Tylenol, Sudafed, and Paxlovid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I tested positive for Covid 19 on October 18, 2022, I experienced a bad cough, no fever, lots of congestion, nasal drainage, tiredness.  I was taking Tylenol, Sudafed, and Paxlovid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sinus operation
Clinical narrative: I tested positive for Covid 19 on October 18, 2022, I experienced a bad cough, no fever, lots of congestion, nasal drainage, tiredness.  I was taking Tylenol, Sudafed, and Paxlovid.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: She could not do anything, she lost her job since she could not work; Her energy disappeared completely; She was always fighting to do something in the house, suffering like crazy. It has not improved nor gone worse; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (She could not do anything, she lost her job since she could not work), ASTHENIA (Her energy disappeared completely) and FEELING ABNORMAL (She was always fighting to do something in the house, suffering like crazy. It has not improved nor gone worse) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 01120A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Opioids), Hypertension and Diabetes (Beginning of diabetes). Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MOBILITY DECREASED (She could not do anything, she lost her job since she could not work), ASTHENIA (Her energy disappeared completely) and FEELING ABNORMAL (She was always fighting to do something in the house, suffering like crazy. It has not improved nor gone worse). At the time of the report, MOBILITY DECREASED (She could not do anything, she lost her job since she could not work), ASTHENIA (Her energy disappeared completely) and FEELING ABNORMAL (She was always fighting to do something in the house, suffering like crazy. It has not improved nor gone worse) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After getting the 2nd dose, she could not do anything, her energy disappeared completely, she was always fighting to do something in the house, she lost her job since she could not work, they had to borrow money to pay for the bills. She states that she was suffering like crazy. It was not improved nor gone worse.  The AE cause patient to seek medical care consulted with her healthcare provider who said they could not do anything, all blood works were fine.  Patient did not have COVID-19 positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine and also patient did not experienced a similar event in the past  Treatment Medication use information was not provided by reporter.   This case was linked to MOD-2022-664525 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Feeling abnormal, Mobility decreased
Clinical narrative: She could not do anything, she lost her job since she could not work; Her energy disappeared completely; She was always fighting to do something in the house, suffering like crazy. It has not improved nor gone worse; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (She could not do anything, she lost her job since she could not work), ASTHENIA (Her energy disappeared completely) and FEELING ABNORMAL (She was always fighting to do something in the house, suffering like crazy. It has not improved nor gone worse) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 01120A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Opioids), Hypertension and Diabetes (Beginning of diabetes). Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MOBILITY DECREASED (She could not do anything, she lost her job since she could not work), ASTHENIA (Her energy disappeared completely) and FEELING ABNORMAL (She was always fighting to do something in the house, suffering like crazy. It has not improved nor gone worse). At the time of the report, MOBILITY DECREASED (She could not do anything, she lost her job since she could not work), ASTHENIA (Her energy disappeared completely) and FEELING ABNORMAL (She was always fighting to do something in the house, suffering like crazy. It has not improved nor gone worse) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After getting the 2nd dose, she could not do anything, her energy disappeared completely, she was always fighting to do something in the house, she lost her job since she could not work, they had to borrow money to pay for the bills. She states that she was suffering like crazy. It was not improved nor gone worse.  The AE cause patient to seek medical care consulted with her healthcare provider who said they could not do anything, all blood works were fine.  Patient did not have COVID-19 positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine and also patient did not experienced a similar event in the past  Treatment Medication use information was not provided by reporter.   This case was linked to MOD-2022-664525 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Sluggishness
Clinical narrative: Sluggishness for a few hours after the Moderna Vaccines; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (Sluggishness for a few hours after the Moderna Vaccines) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggishness for a few hours after the Moderna Vaccines). At the time of the report, SLUGGISHNESS (Sluggishness for a few hours after the Moderna Vaccines) had resolved.            No concomitant medications were reported. Reported that she had normal sluggishness for a few hours after the Moderna Vaccines. No treatment medications were reported.   This case was linked to MOD-2022-664897 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sluggishness
Clinical narrative: Sluggishness for a few hours after the Moderna Vaccines; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (Sluggishness for a few hours after the Moderna Vaccines) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggishness for a few hours after the Moderna Vaccines). At the time of the report, SLUGGISHNESS (Sluggishness for a few hours after the Moderna Vaccines) had resolved.            No concomitant medications were reported. Reported that she had normal sluggishness for a few hours after the Moderna Vaccines. No treatment medications were reported.   This case was linked to MOD-2022-664897 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Hypersomnia, Insomnia, Pain, Pyrexia
Clinical narrative: during the hospitalization, patient was positive with Covid; during the hospitalization, patient was positive with Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200), on 15Mar2021 as dose 2, single (Lot number: EN6208), on 21Aug2021 as dose 3 (booster), single (Lot number: FC3181, Expiration Date: 31Oct2021) and on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "heart transplant recipient", start date: 09Apr2020 (unspecified if ongoing); "Metastatic breast cancer", start date: 2007 (unspecified if ongoing), notes: did not have chemo or radiation.; "prevent organ rejection" (unspecified if ongoing); "Headache" (unspecified if ongoing); "blood clot" (unspecified if ongoing); "water retension" (unspecified if ongoing); "something for stomach" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX as dose number unknown, 0.5ml single; PREDNISONE taken for organ preservation, start date: 09Apr2020 (ongoing); TACROLIMUS taken for organ preservation (ongoing); TYLENOL taken for headache (ongoing); ELIQUIS taken for thrombosis (ongoing); FUROSEMIDE taken for fluid retention (ongoing); LOSARTAN taken for blood pressure abnormal (ongoing); PANTOPRAZOLE taken for abdominal discomfort (ongoing); ROSUVASTATIN taken for diabetes mellitus (ongoing); CARVEDILOL taken for blood pressure abnormal (ongoing); CALCIUM CITRATE + D (ongoing); ALBUTEROL [SALBUTAMOL] resp inhalation (ongoing); MIRALAX (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Aug2022, outcome "not recovered" and all described as "during the hospitalization, patient was positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2021) positive; (13Apr2022) negative, notes: The fourth booster shot, they did the Covid test that came up negative; (22Aug2022) positive; (23Oct2022) positive, notes: after Third Booster shot; (Aug2021) unknown results; (23Oct2022) unknown results.  On 22Aug2022, after receiving the second booster, the patient was hospitalized. That one time, she went to site name withheld for the Covid test and she was positive. The reporter clarified that during the hospitalization, patient was positive with Covid. It was also reported tested positive for Covid once after third booster shot, the third booster she went to the hospital for having Covid (pending clarification).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256326 Same patient/drug, different dose and different event (after dose 5);
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: during the hospitalization, patient was positive with Covid; during the hospitalization, patient was positive with Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200), on 15Mar2021 as dose 2, single (Lot number: EN6208), on 21Aug2021 as dose 3 (booster), single (Lot number: FC3181, Expiration Date: 31Oct2021) and on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "heart transplant recipient", start date: 09Apr2020 (unspecified if ongoing); "Metastatic breast cancer", start date: 2007 (unspecified if ongoing), notes: did not have chemo or radiation.; "prevent organ rejection" (unspecified if ongoing); "Headache" (unspecified if ongoing); "blood clot" (unspecified if ongoing); "water retension" (unspecified if ongoing); "something for stomach" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX as dose number unknown, 0.5ml single; PREDNISONE taken for organ preservation, start date: 09Apr2020 (ongoing); TACROLIMUS taken for organ preservation (ongoing); TYLENOL taken for headache (ongoing); ELIQUIS taken for thrombosis (ongoing); FUROSEMIDE taken for fluid retention (ongoing); LOSARTAN taken for blood pressure abnormal (ongoing); PANTOPRAZOLE taken for abdominal discomfort (ongoing); ROSUVASTATIN taken for diabetes mellitus (ongoing); CARVEDILOL taken for blood pressure abnormal (ongoing); CALCIUM CITRATE + D (ongoing); ALBUTEROL [SALBUTAMOL] resp inhalation (ongoing); MIRALAX (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Aug2022, outcome "not recovered" and all described as "during the hospitalization, patient was positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2021) positive; (13Apr2022) negative, notes: The fourth booster shot, they did the Covid test that came up negative; (22Aug2022) positive; (23Oct2022) positive, notes: after Third Booster shot; (Aug2021) unknown results; (23Oct2022) unknown results.  On 22Aug2022, after receiving the second booster, the patient was hospitalized. That one time, she went to site name withheld for the Covid test and she was positive. The reporter clarified that during the hospitalization, patient was positive with Covid. It was also reported tested positive for Covid once after third booster shot, the third booster she went to the hospital for having Covid (pending clarification).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256326 Same patient/drug, different dose and different event (after dose 5);
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: during the hospitalization, patient was positive with Covid; during the hospitalization, patient was positive with Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200), on 15Mar2021 as dose 2, single (Lot number: EN6208), on 21Aug2021 as dose 3 (booster), single (Lot number: FC3181, Expiration Date: 31Oct2021) and on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "heart transplant recipient", start date: 09Apr2020 (unspecified if ongoing); "Metastatic breast cancer", start date: 2007 (unspecified if ongoing), notes: did not have chemo or radiation.; "prevent organ rejection" (unspecified if ongoing); "Headache" (unspecified if ongoing); "blood clot" (unspecified if ongoing); "water retension" (unspecified if ongoing); "something for stomach" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX as dose number unknown, 0.5ml single; PREDNISONE taken for organ preservation, start date: 09Apr2020 (ongoing); TACROLIMUS taken for organ preservation (ongoing); TYLENOL taken for headache (ongoing); ELIQUIS taken for thrombosis (ongoing); FUROSEMIDE taken for fluid retention (ongoing); LOSARTAN taken for blood pressure abnormal (ongoing); PANTOPRAZOLE taken for abdominal discomfort (ongoing); ROSUVASTATIN taken for diabetes mellitus (ongoing); CARVEDILOL taken for blood pressure abnormal (ongoing); CALCIUM CITRATE + D (ongoing); ALBUTEROL [SALBUTAMOL] resp inhalation (ongoing); MIRALAX (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Aug2022, outcome "not recovered" and all described as "during the hospitalization, patient was positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2021) positive; (13Apr2022) negative, notes: The fourth booster shot, they did the Covid test that came up negative; (22Aug2022) positive; (23Oct2022) positive, notes: after Third Booster shot; (Aug2021) unknown results; (23Oct2022) unknown results.  On 22Aug2022, after receiving the second booster, the patient was hospitalized. That one time, she went to site name withheld for the Covid test and she was positive. The reporter clarified that during the hospitalization, patient was positive with Covid. It was also reported tested positive for Covid once after third booster shot, the third booster she went to the hospital for having Covid (pending clarification).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256326 Same patient/drug, different dose and different event (after dose 5);
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: blood sugar was averaging 200 or even up to 300 after a vaccine or booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2022 as dose 3 (booster), single (Lot number: FL9896) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2007 (unspecified if ongoing); "Severe Osteoporosis", start date: 2020, stop date: 2021, notes: Severe Osteoporosis , It was recently. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. Vaccination history included: BNT162b2 (Lot: EW0191, probably afternoon between 10am-12:00, Unknown arm. She is right handed, so she thinks it was left arm. Dose: 1), administration date: 09Jul2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "blood sugar was averaging 200 or even up to 300 after a vaccine or booster"; BNT162b2 (Dose: 2, Lot F19 or A F197484, then said it was FA7484. Unknown arm. She can't be 100%, she is right handed, and would usually get in left arm.), administration date: 30Jul2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "blood sugar was averaging 200 or even up to 300 after a vaccine or booster"; Flu shot (This was years ago), for vaccination, reaction(s): "felt like she had the flu after it". The following information was reported: BLOOD GLUCOSE INCREASED (medically significant) with onset 2022, outcome "unknown", described as "blood sugar was averaging 200 or even up to 300 after a vaccine or booster".  The patient underwent the following laboratory tests and procedures: Blood glucose: (2021); (Jul2021); (2022) averaging 200 or even up to 300; (15Oct2022) notes: before starting Paxlovid, was 106, 64, 141, 166 after something to eat, 92, 113, 86. Therapeutic measures were not taken as a result of blood glucose increased. Clinical course: Caller added that each time she had a Pfizer COVID 19 vaccine or booster, she always had high blood sugars. Caller stated her blood sugar was averaging 200 or even up to 300 after a vaccine or booster. Caller stated she did not have a lack of appetite and was on a low card diet to control her diabetes noting that she does not use insulin. Caller stated prior to any vaccine, her A1C went from 9 to 6.6 to 6.4 and she was doing so well her HCP cut her glipizide dose in half. Caller stated after the vaccine she had to go back to her regular dose. Caller stated it took a while for her blood sugar to go where it usually is. Caller provided the information that she had 2 vaccines that first came out and 1 booster shortly after. Caller stated she intended to get the newest one, bivalent, but she got COVID.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar was averaging 200 or even up to 300 after a vaccine or booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2022 as dose 3 (booster), single (Lot number: FL9896) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2007 (unspecified if ongoing); "Severe Osteoporosis", start date: 2020, stop date: 2021, notes: Severe Osteoporosis , It was recently. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. Vaccination history included: BNT162b2 (Lot: EW0191, probably afternoon between 10am-12:00, Unknown arm. She is right handed, so she thinks it was left arm. Dose: 1), administration date: 09Jul2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "blood sugar was averaging 200 or even up to 300 after a vaccine or booster"; BNT162b2 (Dose: 2, Lot F19 or A F197484, then said it was FA7484. Unknown arm. She can't be 100%, she is right handed, and would usually get in left arm.), administration date: 30Jul2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "blood sugar was averaging 200 or even up to 300 after a vaccine or booster"; Flu shot (This was years ago), for vaccination, reaction(s): "felt like she had the flu after it". The following information was reported: BLOOD GLUCOSE INCREASED (medically significant) with onset 2022, outcome "unknown", described as "blood sugar was averaging 200 or even up to 300 after a vaccine or booster".  The patient underwent the following laboratory tests and procedures: Blood glucose: (2021); (Jul2021); (2022) averaging 200 or even up to 300; (15Oct2022) notes: before starting Paxlovid, was 106, 64, 141, 166 after something to eat, 92, 113, 86. Therapeutic measures were not taken as a result of blood glucose increased. Clinical course: Caller added that each time she had a Pfizer COVID 19 vaccine or booster, she always had high blood sugars. Caller stated her blood sugar was averaging 200 or even up to 300 after a vaccine or booster. Caller stated she did not have a lack of appetite and was on a low card diet to control her diabetes noting that she does not use insulin. Caller stated prior to any vaccine, her A1C went from 9 to 6.6 to 6.4 and she was doing so well her HCP cut her glipizide dose in half. Caller stated after the vaccine she had to go back to her regular dose. Caller stated it took a while for her blood sugar to go where it usually is. Caller provided the information that she had 2 vaccines that first came out and 1 booster shortly after. Caller stated she intended to get the newest one, bivalent, but she got COVID.  Follow-up attempts are completed. No further information is expected.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; A vaccine coordinator called to report an AE where improperly stored dose of  were administered to a patient on 24 OCT 2022. No adverse effects were reported. No additional information was provided to further clarify these details. No additional AE.; This spontaneous report was received from vaccine coordinator, referring to an 18-month-old patient of unknown gender. The patient's medical history, concurrent conditions  and concomitant therapies were not reported.  On 24-OCT-2022, the patient was vaccinate with hepatitis a vaccine, inactivated (VAQTA) (lot #w023937 has been verified to be a valid lot for VAQTA, expiration date 06-DEC-2023) (strength, dose regimen, route of administration and anatomical location were not provided). In addition the vaccinate with hepatitis a vaccine, inactivated (VAQTA) underwent to temperature excursion of 33.6 degree Fahrenheit for 3 hours and 46.9 degree Fahrenheit for 1 hour and 48 minutes (product storage error). The time frame of temperature excursion was 4 hours and 48 minutes. On an unknown dates, there were previously temperature excursion of 34.3 degree Fahrenheit for 48 minutes, 34.3 degree Fahrenheit  for 1 hour and 42 minutes, 34.9 degree Fahrenheit  for 1 hour and 18 minutes and 34.3 degree Fahrenheit  for 1 hour and 18 minutes. No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; Nurse reports they had a patient that is 1 year old that has already completed the ROTATEQ series and was administered an additional dose of ROTATEQ today. Nurse does not have patient demographic information at this time and does not give consent to; This spontaneous report has been received from a nurse, concerning to a 1-years-old patient. The patient pertinent medical history, historical drug, concomitant therapies and concurrent conditions were not reported.  On 25-10-2022, the patient received an additional dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot# W011280, expiration date 03-NOV-2023) (strength and dose regimen were not reported. after had completed the series of vaccine scheduled (extradose administered). No additional adverse event was reported.
Sex: M
Vaccine: HPV4, HPV9, MEN, TTOX
Symptoms: Cough, Dizziness, Headache, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: He reported headache and dizziness; Congestion; Cough; runny nose; He reported headache and dizziness; This spontaneous report was received from a Company Representative and refers to an 11-year-old male patient.  No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 24-OCT-2022, the patient was vaccinated with meningococcal vaccine; tetanus vaccine as prophylaxis; quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, dose description, lot #, expiry date, route of administration were not provided) for human papilloma virus (HPV).   On 25-OCT-2022, the patient experienced headache and dizziness, additionally the patient had a runny nose and congestion that started on the morning of 24-OCT-2022 and developed a slight cough in the afternoon. The runny nose and cough increased and the congestion remained the same. It was reported that the patient had no fever. The outcome of the adverse event with the suspect therapy and the causality assessment were not provided.
Age: 0.92
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE details were provided; patient who received their first dose of MMR-II and VARIVAX 7 days too early. The caller states that the patient turns 12 months old on 1NOV2022 and that was when she should have received.; This spontaneous report was received from a medical assistant regarding a 11-month-old patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-OCT-2022, the patient was vaccinated with the first doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 ml, lot #W009104, expiration date: 04-DEC-2023, administered subcutaneously, as prophylaxis; and  varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot #W017551, expiration date: 01-JUN-2024, administered subcutaneously, as prophylaxis (Product administered to patient of inappropriate age). It was stated that the patient was vaccinated 7 days too early. No adverse events were reported.; Sender's Comments:  US-009507513-2210USA009786:
Sex: F
Vaccine: MMR
Symptoms: Exposure via eye contact, Eye pruritus, Ocular hyperaemia
Clinical narrative: Provider now has a red and itchy right eye.; Priming an MMRII vaccine a small amount may have gotten in her right eye.; This spontaneous report has been received from a nurse practitioner referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.      On 26-OCT-2022, when the patient was priming a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number U013035 had been verified to be a valid number; expiration date 23-APR-2023, and upon internal validation established as the same date), for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection were not reported) vaccine, a small amount may have gotten in her right eye (exposure via eye contact). It was reported that the event "occurred at approximately 14:40 Eastern Time. The patient now has a red and itchy right eye (ocular hyperaemia). She has experienced no vison changes or blurring at this time." The outcome of ocular hyperaemia was not provided.     The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the event ocular hyperaemia was not provided.