chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Illness, Pyrexia, Retching
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Not been able to eat), RETCHING (Dry heaving), ILLNESS (Sickness) and PYREXIA (Running a fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer COVID19 Vaccine (first dose; lot EJ1685) on 04-Jan-2021 and Pfizer COVID19 Vaccine (second dose;lot EL3302) on 25-Jan-2021.Past adverse reactions to the above products included No adverse event with Pfizer COVID19 Vaccine and Pfizer COVID19 Vaccine.On 18-Nov-2021 at 11:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced FEEDING DISORDER (Not been able to eat), RETCHING (Dry heaving) and PYREXIA (Running a fever). 18-Nov-2021, the patient experienced ILLNESS (Sickness). At the time of the report, FEEDING DISORDER (Not been able to eat), RETCHING (Dry heaving), ILLNESS (Sickness) and PYREXIA (Running a fever) outcome was unknown. Concomitant product use was not provided by the reporter.Treatment information was not provided.Around 6 o'clock in the evening, the patient had been sick. The patient was not been able to eat, running a fever and had dry heaving.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received dose from a vial punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times). On 19-Nov-2021, ACCIDENTAL UNDERDOSE (Received dose from a vial punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment details were reported.   This case was linked to MOD-2021-393407 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: I have a fever of 101.5; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (I have a fever of 101.5) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.No Medical History information was reported.On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (I have a fever of 101.5). At the time of the report, PYREXIA (I have a fever of 101.5) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Body temperature: 101.5 (High) High.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 drugs were not reported. Treatment medications were not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Palpitations
Clinical narrative: Palpitations; Facial flushing; Mild shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), FLUSHING (Facial flushing) and DYSPNOEA (Mild shortness of breath) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PALPITATIONS (Palpitations), FLUSHING (Facial flushing) and DYSPNOEA (Mild shortness of breath). In January 2021, PALPITATIONS (Palpitations), FLUSHING (Facial flushing) and DYSPNOEA (Mild shortness of breath) 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 Concomitants and Treatment medication were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm, I had that with the first 2 doses) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.  The patient's past medical history included Pain in thigh (in September or October), Surgery in November 2019 and Surgery ((right Leg) product of a clot for the previous surgery.) in January 2020.Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and IBUPROFEN (EXCEDRIN IB) for Anticoagulant therapy. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm, I had that with the first 2 doses). At the time of the report, VACCINATION SITE PAIN (sore arm, I had that with the first 2 doses) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.No Treatment informations were reported.Patient stated that since the surgery she takes a full aspirin and Excedrin to make the blood thinner.This case was linked to MOD-2021-395886 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Limited AE/report husband adverse reaction to the Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Limited AE/report husband adverse reaction to the Moderna vaccine.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Limited AE/report husband adverse reaction to the Moderna vaccine.). At the time of the report, VACCINATION COMPLICATION (Limited AE/report husband adverse reaction to the Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 12 weeks of horrible pain from the 2 doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (12 weeks of horrible pain from the 2 doses) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN (12 weeks of horrible pain from the 2 doses). At the time of the report, PAIN (12 weeks of horrible pain from the 2 doses) had not 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 relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-395987 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: normal side effect, having fever and nausea, 8 hours after the vaccine; normal side effect, having fever and nausea, 8 hours after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (normal side effect, having fever and nausea, 8 hours after the vaccine) and NAUSEA (normal side effect, having fever and nausea, 8 hours after the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PYREXIA (normal side effect, having fever and nausea, 8 hours after the vaccine) and NAUSEA (normal side effect, having fever and nausea, 8 hours after the vaccine). At the time of the report, PYREXIA (normal side effect, having fever and nausea, 8 hours after the vaccine) and NAUSEA (normal side effect, having fever and nausea, 8 hours after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Parosmia
Clinical narrative: Worsened Parosmia - smelling smoke when it's not there.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Muscle contracture, Night sweats, Pain
Clinical narrative: I felt painful pressure/contractions for about an hour starting about 25 mins after shot. I also woke up in sweat  that night.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flatulence, Headache, Nausea, Pain
Clinical narrative: Approx 12 hrs after shot began with headache, fever:102.5, chills,ache, nausea, abdominal gas,.  Lasted with some fever for 4 days.  Back to normal after about a week. Treated first with acetaminophen at first.  Switched to ibuprofen after 2 days.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Approx 12 hrs after shot began with headache, fever:102.5, chills,ache, nausea, abdominal gas,.  Lasted with some fever for 4 days.  Back to normal after about a week. Treated first with acetaminophen at first.  Switched to ibuprofen after 2 days.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain of skin, Pruritus
Clinical narrative: Large red painful,itchy lesion
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Sore arm, nausea
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Chronic pain in 2020 replacement hip and knee joints
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dysphagia, Pruritus, Swelling, Urticaria
Clinical narrative: Nov 26th 11pm: itchy armpits Nov 27th 10 am: itchy scalp Nov 27th 3pm: itchy lower back Nov 27th 11pm: noticed hives on thighs/groin Nov 28th 9am: itchy all over body, rotating scalp, legs, arms, neck Nov 28th 11am; took 1 Claritin pill Nov 28th 6pm: swelling/itching on back of neck.. Swelling bad enough to limit head movement Nov 28th 7pm: went to Urgent Care, received Kenalog 40 mg Dose 60mg intramuscular shot. Nov 28th 11pm: no relief. Have noticed swelling coming and going in different areas. Currently left index finger is swollen from base to first knuckle and unable to fully bend. Back of neck still swollen enough to be hard to the touch. Feels difficult to get a deep swallow, and indigestion pain comes and goes in waves. Intense itching sensation is rotating over body as well; arms, legs, back of neck, base of scalp.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Taken earlier that date at a doctor's office on 11/9/2021 at 1040- 120/80 Blood pressure taken 1650 (14mins post vaccine) after experiencing a headache- 145/103 Manual BP taken 1700- 148/110 Manual BP taken 1721- 142/102 Automatic BP taken 1744- 138/102  I was monitored until the doctor found it safe for me to be able to go home
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Skin odour abnormal
Clinical narrative: There are two new adverse effects:  Nose bleeds and pungent body odor in my arm pits.  I have never had a nosebleed in my life unless I was physically injured.  Since I received the Moderna Covid-19 vaccination I have had multiple nosebleeds each week.  They come at unexpected times for no apparent reason.  I checked my blood pressure after several of the nosebleeds and it was not abnormal.  So far, only my left nostril gets nosebleeds.  I also get terribly pungent body odor, which I have never had prior to the vaccination, in both arm pits.  When I awaken in the mornings it is disgustingly potent.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain of skin, Pustule, Skin lesion
Clinical narrative: Pain full puss filled sores from day after shot.still have them
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Back pain, Bowel movement irregularity, Burning sensation
Clinical narrative: At 22:00 hrs on the 24th (my shot was at 11:30 am that day), I started having a fever, my entire body was in great pain, it felt like fire ants or acid running through my veins, and cement in my lymphatic system. Completely unable to sleep, weak as a kitten. Maximum recorded temperature: 103 F. Freezing cold, boiling hot, swollen abdomen, out of breath, very frequent urination & inconsistent bowel movements. Fever persisted until later in the morning of the 28th. However, the evening of the 25th a tremendous pain in my lower back & pelvis became overwhelming - as of writing this still persists. I have only been able to lie down on my back for most of the time. My whole abdomen has been swollen out of proportion & I've had difficulty eating  - as of writing this still persists. Congestion, a chesty cough, & tickly throat.   Normally, I am very athletic swimming 3 km a day, cycling to commute, and diving. I've been 90% bed-ridden since the evening of the 24th & am very concerned for my welfare, particularly my abdomen and lower back pain, which is uncompromising. I do not earn enough money for health insurance.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Discomfort, Dyspnoea, Eating disorder, Feeling of body temperature change
Clinical narrative: At 22:00 hrs on the 24th (my shot was at 11:30 am that day), I started having a fever, my entire body was in great pain, it felt like fire ants or acid running through my veins, and cement in my lymphatic system. Completely unable to sleep, weak as a kitten. Maximum recorded temperature: 103 F. Freezing cold, boiling hot, swollen abdomen, out of breath, very frequent urination & inconsistent bowel movements. Fever persisted until later in the morning of the 28th. However, the evening of the 25th a tremendous pain in my lower back & pelvis became overwhelming - as of writing this still persists. I have only been able to lie down on my back for most of the time. My whole abdomen has been swollen out of proportion & I've had difficulty eating  - as of writing this still persists. Congestion, a chesty cough, & tickly throat.   Normally, I am very athletic swimming 3 km a day, cycling to commute, and diving. I've been 90% bed-ridden since the evening of the 24th & am very concerned for my welfare, particularly my abdomen and lower back pain, which is uncompromising. I do not earn enough money for health insurance.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mobility decreased, Pain, Pelvic pain, Pollakiuria
Clinical narrative: At 22:00 hrs on the 24th (my shot was at 11:30 am that day), I started having a fever, my entire body was in great pain, it felt like fire ants or acid running through my veins, and cement in my lymphatic system. Completely unable to sleep, weak as a kitten. Maximum recorded temperature: 103 F. Freezing cold, boiling hot, swollen abdomen, out of breath, very frequent urination & inconsistent bowel movements. Fever persisted until later in the morning of the 28th. However, the evening of the 25th a tremendous pain in my lower back & pelvis became overwhelming - as of writing this still persists. I have only been able to lie down on my back for most of the time. My whole abdomen has been swollen out of proportion & I've had difficulty eating  - as of writing this still persists. Congestion, a chesty cough, & tickly throat.   Normally, I am very athletic swimming 3 km a day, cycling to commute, and diving. I've been 90% bed-ridden since the evening of the 24th & am very concerned for my welfare, particularly my abdomen and lower back pain, which is uncompromising. I do not earn enough money for health insurance.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Throat irritation
Clinical narrative: At 22:00 hrs on the 24th (my shot was at 11:30 am that day), I started having a fever, my entire body was in great pain, it felt like fire ants or acid running through my veins, and cement in my lymphatic system. Completely unable to sleep, weak as a kitten. Maximum recorded temperature: 103 F. Freezing cold, boiling hot, swollen abdomen, out of breath, very frequent urination & inconsistent bowel movements. Fever persisted until later in the morning of the 28th. However, the evening of the 25th a tremendous pain in my lower back & pelvis became overwhelming - as of writing this still persists. I have only been able to lie down on my back for most of the time. My whole abdomen has been swollen out of proportion & I've had difficulty eating  - as of writing this still persists. Congestion, a chesty cough, & tickly throat.   Normally, I am very athletic swimming 3 km a day, cycling to commute, and diving. I've been 90% bed-ridden since the evening of the 24th & am very concerned for my welfare, particularly my abdomen and lower back pain, which is uncompromising. I do not earn enough money for health insurance.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: 5 days after the vaccine,  I began experiencing symptoms of chest pain, difficultly breathing, and light headiness. Symptoms worsen over the next 5 days. I nearly passed out from bending over and raising up. I followed up with a emergency room visit for chest pains and dizzy spells.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Muscular weakness, Paraesthesia
Clinical narrative: eight days after injection I got bad back back- lower lumbar, weakness and tingling in my legs and feet- called my Doctor, he said to take nati-inflamatories and possibly Prednisone if it gets worse.  I was injected on 11-11-21
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Head discomfort, Headache, Paraesthesia
Clinical narrative: Approx. four days to a week later, shortness of breath while leaning back on floor. Never happened before without exertion of any kind. Recall some pounding in chest.  - NOTE: Shortness of breath resolved. Lasted for a few days.  Chest tightness, pressure in chest, uncomfortable feelings persisted pretty consistently ever since almost every day to some degree, often in the morning in bed. Note: Continues.  Recent to the time of reporting this,  i) November 28th, unusual sensations in different areas around the top of the skull, sometimes as a minor headache, sometimes sensation with no pain. Note: New occurrence, becoming fairly common, at least one or twice daily. ii) Finally so tingling sensations in the lower extremities, very minor sensations close to the skin, around joints, blood vessels; very minor but I know my body and not something I've experienced before the shot. Usually subsides with movement.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Pericarditis
Clinical narrative: In the week after getting my second dose I developed a weird sensation in my chest near my heart that I just maybe thought was my lungs. After about a month it got a bit worse and went to an urgent care where they said I had pericarditis. I have been on anti inflammatory medications for past 3 weeks and it?s just now finally starting to get better but symptoms still persist.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Terrible arm pain
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Left sided Bell's palsy
Age: 25.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Feeling cold, Injection site pain
Clinical narrative: Pain at injection site and very intense chills, inability to get warm warm
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Apnoeic attack, Dyskinesia
Clinical narrative: Patient had a spell of unusual movements with coincident apneic episode while asleep several hours after receiving the vaccination. Self-resolved and did not require any immediate medical care. No residual effects.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Palpitations
Clinical narrative: Joint pain lasting over 6 weeks.  Heart palpitations  lasting over 4 weeks.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Red spot/it's getting bigger; Itched a little bit; Is tender; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot/it's getting bigger), VACCINATION SITE PRURITUS (Itched a little bit) and VACCINATION SITE PAIN (Is tender) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 08F21A, 044A20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot/it's getting bigger), VACCINATION SITE PRURITUS (Itched a little bit) and VACCINATION SITE PAIN (Is tender). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot/it's getting bigger) had not resolved and VACCINATION SITE PRURITUS (Itched a little bit) and VACCINATION SITE PAIN (Is tender) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The patient had booster dose on 17-Nov-2021 and got a red spot and it was getting bigger. Reportedly, it Itched a little bit and was tender but was not sore. The patient reported they had red spot there now.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Reporter Occupation and type has been changed to other Health care professional. The outcome of the event Vaccination site erythema has been changed to Not recovered from previously reported unknown.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Somnolence
Clinical narrative: Sleepy; Aches; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (Sleepy), MYALGIA (Aches) and PYREXIA (Fever) 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 18-Nov-2021, the patient 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 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 19-Nov-2021, the patient experienced SOMNOLENCE (Sleepy), MYALGIA (Aches) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (Sleepy), MYALGIA (Aches) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (Abnormal behavior (MI agent observation) after 2nd dose) and VACCINATION SITE REACTION (she had a COVID arm (Left arm injection Site).) 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. In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ABNORMAL BEHAVIOUR (Abnormal behavior (MI agent observation) after 2nd dose). On an unknown date, the patient experienced VACCINATION SITE REACTION (she had a COVID arm (Left arm injection Site).). At the time of the report, ABNORMAL BEHAVIOUR (Abnormal behavior (MI agent observation) after 2nd dose) and VACCINATION SITE REACTION (she had a COVID arm (Left arm injection Site).) outcome was unknown. No concomitant medication was provided.No treatment medication was provided. Patient stated that her last shot was in ??-AUG-2021 and she had a COVID arm (Left arm injection Site). And wants to know whether she can get booster shot in her left arm or in opposite arm.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Five new patients along with 7 previously reported were administered expired doses of the Moderna COVID-19 vaccine on 09 November; 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 (Five new patients along with 7 previously reported were administered expired doses of the Moderna COVID-19 vaccine on 09 November) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Five new patients along with 7 previously reported were administered expired doses of the Moderna COVID-19 vaccine on 09 November). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Five new patients along with 7 previously reported were administered expired doses of the Moderna COVID-19 vaccine on 09 November) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported It was reported that the 5 new patients received expired dose of Moderna vaccine on 09-Nov-2021. No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: patients received a booster dose but received a complete dose instead of half dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (patients received a booster dose but received a complete dose instead of half dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (patients received a booster dose but received a complete dose instead of half dose). At the time of the report, ACCIDENTAL OVERDOSE (patients received a booster dose but received a complete dose instead of half dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 20 patients were given expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 patients were given expired vaccine) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 patients were given expired vaccine). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (20 patients were given expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter No treatment medications provided by the reporter.  It was reported vial did not undergo any temperature excursions. Date the vial was initially stored in the refrigerator: 19Nov2021   This case was linked to MOD-2021-395502, MOD-2021-395507, MOD-2021-395509, MOD-2021-395512, MOD-2021-395511, MOD-2021-395515, MOD-2021-395510, MOD-2021-395516, MOD-2021-395519, MOD-2021-395520, MOD-2021-395521, MOD-2021-395522, MOD-2021-395524, MOD-2021-395525, MOD-2021-395526, MOD-2021-395539, MOD-2021-395540, MOD-2021-395542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains no new information. On 19-Nov-2021: follow up appended; Initials updated and DOB added On 23-Nov-2021: Follow-up received contains updated vaccine route of administration ,body site and dose number and  secondary reporter's information added.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Lethargy, Nausea, Pain
Clinical narrative: 10 out of 10 pain/pain in every part of body from head to toe; lethargy; severe nausea; headache; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (10 out of 10 pain/pain in every part of body from head to toe), LETHARGY (lethargy), NAUSEA (severe nausea), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAIN (10 out of 10 pain/pain in every part of body from head to toe), LETHARGY (lethargy), NAUSEA (severe nausea) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 650 milligram. On 20-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN (10 out of 10 pain/pain in every part of body from head to toe), LETHARGY (lethargy), NAUSEA (severe nausea) and HEADACHE (headache) outcome was unknown.            No concomitants medications was reported.   This case was linked to MOD-2021-395725 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ALOPECIA (since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time). The patient was treated with FINASTERIDE on 11-Nov-2021 for Hair loss, at an unspecified dose and frequency. At the time of the report, ALOPECIA (since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time) had not resolved.            Concomitant product use was not provided by the reporter.  Patient's dermatologist gave her a steroid medication for her scalp.  Reporter stated that the blood work would be performed to see if there were any other reason for the hair loss. She did not get COVID.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Added date of birth and added treatment. On 23-Nov-2021: Updated reporter details and added event verbatim
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rash pruritic, Skin test
Clinical narrative: rash caused itching.; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash caused itching.) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hyperthyroidism.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced RASH PRURITIC (rash caused itching.). The patient was treated with PREDNISONE for Rash all over, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash caused itching.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) negative. On an unknown date, Skin test: negative (Negative) negative.         The reporter stated after the second dose she got the worse rash in her life. She stated she had going to see a dermatologist ever since. She reported the bad, severe rash was all over her body. The caller stated the rash caused itching. She stated the rash would come and go on her ankles and heals, but always remained on her back. She had prescribed steroids, prednisone, and a big jar of cream. She reported that she spent over 400 dollars worth on treatment medications. She mentioned that she had no drug or food allergies. She reported she takes a medication to treat hyperthyroidism. The caller stated she would be not going to get the booster dose.  This case concerns a 89-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected event of pruritus and non-serious expected event of rash. The events occurred on unknown date after second dose of mRNA 1273 vaccine. The patient had itchy rash all over her body, especially her back, ankles and heels. She has visited a dermatologist and taking a steroid for the rashes. The rechallenge is not applicable as patient had treatment for the events. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow Up Received contain Non-Significant information.; Sender's Comments: This case concerns a 89-year-old, female patient, with no relevant medical history, who experienced non-serious, unexpected event of Rash pruritic. The event occurred on unknown date after second dose of mRNA 1273 vaccine. The patient had itchy rash all over her body, especially her back, ankles and heels. She visited a dermatologist and she had prescribed steroids. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness over a 3X3 inch area below the injection site; This case was reported by a nurse via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient for him/her self. The age at vaccination was not reported. The patient received first dose of Shingrix and experienced a localized reaction. The reaction was unexpected and the redness remained for several day over a 3X3 inch below the injection site. The reporter asked dermatologist and She stated it had happened to most people. Consent to follow up was not granted as contact details not available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: I'm fully vaccinated for the shingles/suspected vaccination failure; I'm fully vaccinated for the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had them 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In November 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was fully vaccinated for the shingles and 3 weeks ago from the date of reporting had the start of shingles. It was much worse than the first time the patient had them 2 years ago from the date of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: vaccine that was reconstituted with a mispaired diluent; vaccine that was reconstituted with a mispaired diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number DC439, expiry date unknown) and (batch number 5393G, expiry date 1st April 2023) for prophylaxis.   On 22nd November 2021, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 22nd November 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   The reporter considered the inappropriate dose of vaccine administered to be unrelated to Shingrix.  Additional details were provided as follows: The reporter stated that, a male patient received Shingrix vaccine that was reconstituted with a mispaired diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The boxes had different lot numbers DC439 and 5393G. The reporter consented to follow up.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: administered Boostrix by intradermal route; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 26-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number C5863AA, expiry date 13th April 2023) for prophylaxis.   On 23rd November 2021, the patient received Boostrix (intradermal). On 23rd November 2021, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were reported as follows: The reporter stated that the patient was administered with a dose of Boostrix via intradermal route which led Intramuscular formulation administered by other route. The clinic had advised the patient to massage the area. Health care professional gave permission to follow up but denied to provide patient initials and date of birth.
Age: 0.92
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Kinrix vaccine instead of separate DTaP and IPV vaccines; administered Kinrix vaccine instead of separate DTaP and IPV vaccines; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 11-month-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that, the patient was inadvertently administered Kinrix vaccine instead of separate DTaP and IPV vaccines which led to inappropriate age at vaccine administration and wrong vaccine administered. The nurse stated the physician had spoken with child's parent who reported that, infant has not had any side effects. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: blood pressure went up so high.; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure went up so high.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure went up so high.) (seriousness criterion hospitalization). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure went up so high.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood pressure measurement: high (High) high.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  Company Comment - This is a spontaneous case concerning a 65-year-old female patient with no reported medical history, who experienced the serious (hospitalization)  unexpected event Blood pressure increased. The event occurred one day after the second  dose of mRNA-1273.  Limited information has been  provided, further information has been requested.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-388714. Sender's Comments: This is a spontaneous case concerning a 65-year-old female patient with no reported medical history, who experienced the serious (hospitalization)  unexpected event Blood pressure increased. The event occurred one day after the second  dose of mRNA-1273.  Limited information has been  provided, further information has been requested.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache
Clinical narrative: labored breathing; dizziness; lost all his core strength and had trouble getting out of bed; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (labored breathing), DIZZINESS (dizziness), ASTHENIA (lost all his core strength and had trouble getting out of bed) and HEADACHE (severe headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021 at 1:00 AM, the patient experienced DYSPNOEA (labored breathing), DIZZINESS (dizziness), ASTHENIA (lost all his core strength and had trouble getting out of bed) and HEADACHE (severe headache). At the time of the report, DYSPNOEA (labored breathing), DIZZINESS (dizziness), ASTHENIA (lost all his core strength and had trouble getting out of bed) and HEADACHE (severe headache) was resolving.            Concomitant medication was not provided. The patient had a pretty severe reaction to the second dose at 1 AM in the morning on 27Mar2021 includes labored breathing, dizziness, severe headache and he lost all his core strength and had trouble getting out of bed. He went to the hospital, got rehydrated, and started getting back to normal. He was in the hospital from about 2 PM to 5 PM on 27Mar2021.   This case was linked to MOD-2021-390847 (Patient Link).