chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; She states that the pink cap bivalent vaccine was given to an unvaccinated patient who was 5 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states that the pink cap bivalent vaccine was given to an unvaccinated patient who was 5 years old) and NO ADVERSE EVENT (No adverse event) in a 5-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 09-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (She states that the pink cap bivalent vaccine was given to an unvaccinated patient who was 5 years old). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states that the pink cap bivalent vaccine was given to an unvaccinated patient who was 5 years old) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (She states that the pink cap bivalent vaccine was given to an unvaccinated patient who was 5 years old).    Concomitant drugs were not reported. It was reported that the unvaccinated patient was administered with pink cap bivalent vaccine. Treatment medications were not provided.
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Drug eruption, Pain, Pain of skin, Rash
Clinical narrative: skin pain; painful chills; painful chills; She also had a rash back in late March; she went to a dermatologist, and they said it was a possible drug eruption; This spontaneous case was reported by a patient and describes the occurrence of PAIN OF SKIN (skin pain), PAIN (painful chills), CHILLS (painful chills), RASH (She also had a rash back in late March) and DRUG ERUPTION (she went to a dermatologist, and they said it was a possible drug eruption) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced RASH (She also had a rash back in late March) and DRUG ERUPTION (she went to a dermatologist, and they said it was a possible drug eruption). On 25-Mar-2023, the patient experienced PAIN OF SKIN (skin pain), PAIN (painful chills) and CHILLS (painful chills). At the time of the report, PAIN OF SKIN (skin pain), PAIN (painful chills) and CHILLS (painful chills) had not resolved and RASH (She also had a rash back in late March) and DRUG ERUPTION (she went to a dermatologist, and they said it was a possible drug eruption) had resolved.            Concomitant product included steroids.  It was reported that patient had skin pale and painful chills on 25-Apr-2023.  someone she spoke to had the same problem. Her last vaccine Oct-2022 and wondering if side effects would be active this year and if she was using a new medication. No one had any answers on what's causing the side effects. She was currently still experiencing skin pain and painful chills. She also had a rash back in late March and she went to a dermatologist, and they said it was a possible drug eruption. she used steroid cream, and the rash went away and used another cream on Apr-2023.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt came in for a provider appt. and to catch up due to vaccine delay. Varicella was one of the vaccines needed. The provider ordered the vaccine. The MA brought the vaccine to me (LVN) to get it verified. During my verification I did not catch that the pt had received the MMR vaccine just 2 weeks prior on 4/11/23. Since it had not been 4 weeks since the previous live vaccine the pt should not have received the varicella that day.  The pt received the varicella vaccine and due to it being too soon it did not count as a viable vaccine requiring the pt to need to get the first dose again.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest discomfort, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: On February 15, 2023, I woke up with body aches and fatigue.  I had a doctor visit already scheduled the next day.  I tested positive for COVID-19 while at the doctor.  I then began to feel like I had a heavy chest but not congested.  I had a mild sore throat.  I was prescribed Paxlovid and Prednisone.  I began to feel better within a couple of days.  But, as soon as I stopped taking medications, I began to have congestion and runny nose and was considered I had a rebound.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On February 15, 2023, I woke up with body aches and fatigue.  I had a doctor visit already scheduled the next day.  I tested positive for COVID-19 while at the doctor.  I then began to feel like I had a heavy chest but not congested.  I had a mild sore throat.  I was prescribed Paxlovid and Prednisone.  I began to feel better within a couple of days.  But, as soon as I stopped taking medications, I began to have congestion and runny nose and was considered I had a rebound.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia
Clinical narrative: Pt. described experiencing numbness in her left leg that has slowly been improving.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Biopsy, Diffuse alopecia
Clinical narrative: Severe hair loss.  Approximately 60% volume of hair.  Especially on crown of head  down back of head.  Massive daily hair loss. started slowly in January and became severe amounts  by March.  Have enough loss that it is hard to conceal bald spots.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: she had a fever of 105 with nausea and vomiting
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Autoimmune thyroiditis, Blood thyroid stimulating hormone, Cervical spinal stenosis, Hypothyroidism, Intervertebral disc degeneration
Clinical narrative: In June of 2021 pain, stiffness, and muscle wasting on my left upper body resulted in a doctor visit. I underwent MRI and was diagnosed with mild to severe spinal stenosis and disc degeneration in my cervical spine.  The following year I was diagnosed  with hypothyroidism and Hashimoto?s.  Please note that I do not suspect that the vaccine caused these conditions. When I reported these conditions on the VSafe survey, I was encouraged to report this information on VAERS.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Magnetic resonance imaging spinal abnormal, Muscle atrophy, Musculoskeletal stiffness, Pain, Thyroxine
Clinical narrative: In June of 2021 pain, stiffness, and muscle wasting on my left upper body resulted in a doctor visit. I underwent MRI and was diagnosed with mild to severe spinal stenosis and disc degeneration in my cervical spine.  The following year I was diagnosed  with hypothyroidism and Hashimoto?s.  Please note that I do not suspect that the vaccine caused these conditions. When I reported these conditions on the VSafe survey, I was encouraged to report this information on VAERS.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Tri-iodothyronine
Clinical narrative: In June of 2021 pain, stiffness, and muscle wasting on my left upper body resulted in a doctor visit. I underwent MRI and was diagnosed with mild to severe spinal stenosis and disc degeneration in my cervical spine.  The following year I was diagnosed  with hypothyroidism and Hashimoto?s.  Please note that I do not suspect that the vaccine caused these conditions. When I reported these conditions on the VSafe survey, I was encouraged to report this information on VAERS.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site reaction, Rash erythematous
Clinical narrative: PT ACTUALLY GOT THE BIVALENT PFIZER BOOSTER BUT IT WOULDN'T LET ME PICK THAT ONE. PT CAME TO THE PHARMACY TODAY 6/8/23 TO SHOW ME HIS LEFT ARM. HE SAID HE RECIEVED THE PFIZER BIVALENT BOOSTER ON 6/2/23 AND THEN HIS ARM TURNED REALLY RED WITH A RASH DOWN BELOW THE INJECTION SITE AND NOW IS TURNING PURPLE AND YELLOW. THIS WEIRD RASH STARTS LIKE 2 OR 3 INCHES BELOW THE INJECTION SITE AND CONTINUES TO ALMOST THE ELBOW.  PT SAID IT DOESN'T HURT AND IT IS NOT WARM TO THE TOUCH AND HE HAS NO OTHER SYMPTOMS
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt developed pruritic hives to her back. She has taken Benadryl and applied topical cortisone.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of bivalent Moderna when they were up to date at the time per responses on vaccine screening questionnaire.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Booster dose given on 5/3/23from vaccine lot that expired  4/17/2023. No known issues. contacting manufacturer for guidance if patient needs to  re administer dose.  no known problems following administration.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Moderate headache requiring Advil for relief. Severe dizziness and mild nausea throughout the day. Dizziness is at its worst when sitting upright from lying down.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received second dose of bivalent Moderna, and 2nd dose dose of flu (for the season) when their screening questions indicate they were up to date already.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: redness, swelling, pain
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Anion gap, Blood ketone body, Blood pH decreased, Metabolic function test abnormal
Clinical narrative: Reportedly received Shingrix vaccine on June 1, 2023. The following 2-3 days, complained of symptoms of abdominal pain, nausea, vomiting. Presented to emergency department 6/5/23 with signs and symptoms concerning for diagnosis of diabetic ketoacidosis.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Reportedly received Shingrix vaccine on June 1, 2023. The following 2-3 days, complained of symptoms of abdominal pain, nausea, vomiting. Presented to emergency department 6/5/23 with signs and symptoms concerning for diagnosis of diabetic ketoacidosis.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Blood pressure fluctuation, Breast cancer female, Breast operation, Cardiac failure congestive, Cardiac function test normal
Clinical narrative: Had 1 st dose Moderna 1/15/2021.immediately, in the next 4 days, she experienced, pain at the vacc. site, fatigue and Flu-like sx. The 5 days after: She had extreme fatigue, severe lightheadedness, like drifting away. She had repetitive, pulsating sharp chest pains, left-sided, lasting 5-8 sec., stop and then return 10-30 minutes later. Not nocturnal. Had some BP variations, low HR noted in the 48-50 beats /min. Diastolic BP in the 60's. She had the second dose of Moderna 2/12/2021. The same sx of odd heart sensation with pilsating chest pains, excessive fatigue were there. Had pulsating chest pains for about 5 days after the vaccine. With the 3rd dose of Moderna, she had COVID arm x 2 weeks. The 4th dose, was the 4th dose of Moderna caused similar sx as COVID arm, but less intense and lasted 7-8 days.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Cardiac perfusion defect, Cardiomyopathy acute, Catheterisation cardiac abnormal, Chest pain, Dizziness
Clinical narrative: Had 1 st dose Moderna 1/15/2021.immediately, in the next 4 days, she experienced, pain at the vacc. site, fatigue and Flu-like sx. The 5 days after: She had extreme fatigue, severe lightheadedness, like drifting away. She had repetitive, pulsating sharp chest pains, left-sided, lasting 5-8 sec., stop and then return 10-30 minutes later. Not nocturnal. Had some BP variations, low HR noted in the 48-50 beats /min. Diastolic BP in the 60's. She had the second dose of Moderna 2/12/2021. The same sx of odd heart sensation with pilsating chest pains, excessive fatigue were there. Had pulsating chest pains for about 5 days after the vaccine. With the 3rd dose of Moderna, she had COVID arm x 2 weeks. The 4th dose, was the 4th dose of Moderna caused similar sx as COVID arm, but less intense and lasted 7-8 days.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Ejection fraction decreased, Fatigue, Feeling abnormal, Heart rate decreased, Hypertrophy
Clinical narrative: Had 1 st dose Moderna 1/15/2021.immediately, in the next 4 days, she experienced, pain at the vacc. site, fatigue and Flu-like sx. The 5 days after: She had extreme fatigue, severe lightheadedness, like drifting away. She had repetitive, pulsating sharp chest pains, left-sided, lasting 5-8 sec., stop and then return 10-30 minutes later. Not nocturnal. Had some BP variations, low HR noted in the 48-50 beats /min. Diastolic BP in the 60's. She had the second dose of Moderna 2/12/2021. The same sx of odd heart sensation with pilsating chest pains, excessive fatigue were there. Had pulsating chest pains for about 5 days after the vaccine. With the 3rd dose of Moderna, she had COVID arm x 2 weeks. The 4th dose, was the 4th dose of Moderna caused similar sx as COVID arm, but less intense and lasted 7-8 days.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Immunisation reaction, Influenza like illness, Laboratory test normal, Left atrial enlargement, Left ventricular dilatation
Clinical narrative: Had 1 st dose Moderna 1/15/2021.immediately, in the next 4 days, she experienced, pain at the vacc. site, fatigue and Flu-like sx. The 5 days after: She had extreme fatigue, severe lightheadedness, like drifting away. She had repetitive, pulsating sharp chest pains, left-sided, lasting 5-8 sec., stop and then return 10-30 minutes later. Not nocturnal. Had some BP variations, low HR noted in the 48-50 beats /min. Diastolic BP in the 60's. She had the second dose of Moderna 2/12/2021. The same sx of odd heart sensation with pilsating chest pains, excessive fatigue were there. Had pulsating chest pains for about 5 days after the vaccine. With the 3rd dose of Moderna, she had COVID arm x 2 weeks. The 4th dose, was the 4th dose of Moderna caused similar sx as COVID arm, but less intense and lasted 7-8 days.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Left ventricular dysfunction, Left ventricular end-diastolic pressure decreased, Left ventricular enlargement, Mitral valve incompetence, Myocardial fibrosis
Clinical narrative: Had 1 st dose Moderna 1/15/2021.immediately, in the next 4 days, she experienced, pain at the vacc. site, fatigue and Flu-like sx. The 5 days after: She had extreme fatigue, severe lightheadedness, like drifting away. She had repetitive, pulsating sharp chest pains, left-sided, lasting 5-8 sec., stop and then return 10-30 minutes later. Not nocturnal. Had some BP variations, low HR noted in the 48-50 beats /min. Diastolic BP in the 60's. She had the second dose of Moderna 2/12/2021. The same sx of odd heart sensation with pilsating chest pains, excessive fatigue were there. Had pulsating chest pains for about 5 days after the vaccine. With the 3rd dose of Moderna, she had COVID arm x 2 weeks. The 4th dose, was the 4th dose of Moderna caused similar sx as COVID arm, but less intense and lasted 7-8 days.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Myocardial infarction, Pulmonary arterial pressure increased, Pulmonary arterial pressure normal, Pulmonary hypertension, Right ventricular failure
Clinical narrative: Had 1 st dose Moderna 1/15/2021.immediately, in the next 4 days, she experienced, pain at the vacc. site, fatigue and Flu-like sx. The 5 days after: She had extreme fatigue, severe lightheadedness, like drifting away. She had repetitive, pulsating sharp chest pains, left-sided, lasting 5-8 sec., stop and then return 10-30 minutes later. Not nocturnal. Had some BP variations, low HR noted in the 48-50 beats /min. Diastolic BP in the 60's. She had the second dose of Moderna 2/12/2021. The same sx of odd heart sensation with pilsating chest pains, excessive fatigue were there. Had pulsating chest pains for about 5 days after the vaccine. With the 3rd dose of Moderna, she had COVID arm x 2 weeks. The 4th dose, was the 4th dose of Moderna caused similar sx as COVID arm, but less intense and lasted 7-8 days.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Scan myocardial perfusion, Sensory disturbance, Single photon emission computerised tomogram abnormal, Vaccination site pain, Ventricular hypokinesia
Clinical narrative: Had 1 st dose Moderna 1/15/2021.immediately, in the next 4 days, she experienced, pain at the vacc. site, fatigue and Flu-like sx. The 5 days after: She had extreme fatigue, severe lightheadedness, like drifting away. She had repetitive, pulsating sharp chest pains, left-sided, lasting 5-8 sec., stop and then return 10-30 minutes later. Not nocturnal. Had some BP variations, low HR noted in the 48-50 beats /min. Diastolic BP in the 60's. She had the second dose of Moderna 2/12/2021. The same sx of odd heart sensation with pilsating chest pains, excessive fatigue were there. Had pulsating chest pains for about 5 days after the vaccine. With the 3rd dose of Moderna, she had COVID arm x 2 weeks. The 4th dose, was the 4th dose of Moderna caused similar sx as COVID arm, but less intense and lasted 7-8 days.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Angina pectoris, Asthenia, Blood pressure decreased, Dizziness, Heart rate decreased
Clinical narrative: Had 1 st dose Moderna 1/15/2021.immediately, in the next 4 days, she experienced, pain at the vacc. site, fatigue and Flu-like sx. The 5 days after: She had extreme fatigue, severe lightheadedness, like drifting away. She had repetitive, pulsating sharp chest pains, left-sided, lasting 5-8 sec., stop and then return 10-30 minutes later. Not nocturnal. Had some BP variations, low HR noted in the 48-50 beats /min. Diastolic BP in the 60's. She had the second dose of Moderna 2/12/2021. The same sx of odd heart sensation with pilsating chest pains, excessive fatigue were there. Had pulsating chest pains for about 5 days after the vaccine. With the 3rd dose of Moderna, she had COVID arm x 2 weeks. The 4th dose, was the 4th dose of Moderna caused similar sx as COVID arm, but less intense and lasted 7-8 days.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Left ventricular failure
Clinical narrative: Had 1 st dose Moderna 1/15/2021.immediately, in the next 4 days, she experienced, pain at the vacc. site, fatigue and Flu-like sx. The 5 days after: She had extreme fatigue, severe lightheadedness, like drifting away. She had repetitive, pulsating sharp chest pains, left-sided, lasting 5-8 sec., stop and then return 10-30 minutes later. Not nocturnal. Had some BP variations, low HR noted in the 48-50 beats /min. Diastolic BP in the 60's. She had the second dose of Moderna 2/12/2021. The same sx of odd heart sensation with pilsating chest pains, excessive fatigue were there. Had pulsating chest pains for about 5 days after the vaccine. With the 3rd dose of Moderna, she had COVID arm x 2 weeks. The 4th dose, was the 4th dose of Moderna caused similar sx as COVID arm, but less intense and lasted 7-8 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Redness and warm to touch at vaccine site
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood lactic acid, Chest X-ray, Computerised tomogram head, Electrocardiogram
Clinical narrative: Feeling more tired than usual, weakness all over and slight fever. On 06/07/23 put her feet down to get out of bed and they just collapsed under her. She called for help and was taken to Hospital where they did a battery of tests and nothing came up as unusual. We took her home with a slightly elevated temperature of 99.9 gave her advil after lunch. By that evening she felt a little better. This morning on 6/8/23 she was feeling a little more energetic, hungry, etc but still weaker than normal but better than the day before. She is being more careful after her initial fall and hospital visit trying to drink more water and o be mindful of the previous day not to repeat.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Fatigue, Full blood count, Hunger, Laboratory test
Clinical narrative: Feeling more tired than usual, weakness all over and slight fever. On 06/07/23 put her feet down to get out of bed and they just collapsed under her. She called for help and was taken to Hospital where they did a battery of tests and nothing came up as unusual. We took her home with a slightly elevated temperature of 99.9 gave her advil after lunch. By that evening she felt a little better. This morning on 6/8/23 she was feeling a little more energetic, hungry, etc but still weaker than normal but better than the day before. She is being more careful after her initial fall and hospital visit trying to drink more water and o be mindful of the previous day not to repeat.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Metabolic function test, Microscopy, Pyrexia, Syncope
Clinical narrative: Feeling more tired than usual, weakness all over and slight fever. On 06/07/23 put her feet down to get out of bed and they just collapsed under her. She called for help and was taken to Hospital where they did a battery of tests and nothing came up as unusual. We took her home with a slightly elevated temperature of 99.9 gave her advil after lunch. By that evening she felt a little better. This morning on 6/8/23 she was feeling a little more energetic, hungry, etc but still weaker than normal but better than the day before. She is being more careful after her initial fall and hospital visit trying to drink more water and o be mindful of the previous day not to repeat.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Troponin I, Urine analysis
Clinical narrative: Feeling more tired than usual, weakness all over and slight fever. On 06/07/23 put her feet down to get out of bed and they just collapsed under her. She called for help and was taken to Hospital where they did a battery of tests and nothing came up as unusual. We took her home with a slightly elevated temperature of 99.9 gave her advil after lunch. By that evening she felt a little better. This morning on 6/8/23 she was feeling a little more energetic, hungry, etc but still weaker than normal but better than the day before. She is being more careful after her initial fall and hospital visit trying to drink more water and o be mindful of the previous day not to repeat.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Blood electrolytes, Blood gases, Computerised tomogram, Electroencephalogram, Laboratory test
Clinical narrative: Prolonged seizure
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Prolonged seizure
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Patient called the pharmacy and reported experiencing joint pain that feel like her joints were on fire. Pt stated that the symptoms started the morning after she received the covid19 vaccine on 6/6/23. She stated that the pain made walking difficult.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient had several recent admissions, most recently 10/2-10/7 for COVID-19 infection,
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Temps went out of range overnight, was still used to adminster in the morning. DOH was closed 1/17 unable to report at the time
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Incorrect dose administered, Product administration error
Clinical narrative: Administration error: Mistakenly Covid Vaccine was mixed with 0.90 ml of 0.9 % diluent instead of 1.8 ml resulting in a more concentrated dose of vaccine. Patient was administered 60 mcg instead of 30 mcg recommended dose. I spoke to mom right away and informed to the mixing error. Advised that Pfizer had been contacted and that any information available regarding mixing errors was provided to me. Discussed with mom that there is information about the clinical trials where individuals that received 100mcg had more side effects specially severe pain at site of injection. 50 mcg patients did not show any adverse effects (side effects). Provided mom with my own personal phone number to be called at anytime (day and night) Advised to seek immediate medical attention, if chest pain, shortness of breath, fainting, urticarial lesion and moderate to severe itchiness  Mom expressed understanding and agreed with plan.  Follow up calls were made. Patient had mild tactile temperature, fatigue, mild headache. Felt warm (tactile) short period only. Symptoms were not different from the first dose.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error, Product preparation issue, Skin warm
Clinical narrative: Administration error: Mistakenly Covid Vaccine was mixed with 0.90 ml of 0.9 % diluent instead of 1.8 ml resulting in a more concentrated dose of vaccine. Patient was administered 60 mcg instead of 30 mcg recommended dose. I spoke to mom right away and informed to the mixing error. Advised that Pfizer had been contacted and that any information available regarding mixing errors was provided to me. Discussed with mom that there is information about the clinical trials where individuals that received 100mcg had more side effects specially severe pain at site of injection. 50 mcg patients did not show any adverse effects (side effects). Provided mom with my own personal phone number to be called at anytime (day and night) Advised to seek immediate medical attention, if chest pain, shortness of breath, fainting, urticarial lesion and moderate to severe itchiness  Mom expressed understanding and agreed with plan.  Follow up calls were made. Patient had mild tactile temperature, fatigue, mild headache. Felt warm (tactile) short period only. Symptoms were not different from the first dose.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal hernia, Abdominal hernia repair, Abdominal pain, COVID-19
Clinical narrative: 02/18/22 presents to ED for "abdominal wall pain and swelling". PMHx of "multiple ventral hernias after complicated intraperitoneal onlay mesh placement with mesh infection"
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Device related infection, SARS-CoV-2 test positive
Clinical narrative: 02/18/22 presents to ED for "abdominal wall pain and swelling". PMHx of "multiple ventral hernias after complicated intraperitoneal onlay mesh placement with mesh infection"
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W02; Patient is asymptomatic. No additional AE.; This spontaneous report was received from nurse, referring to patient of unknown gender and age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, (lot #W025274 has been verified to be a valid lot, expiration date: 10-AUG-2024) for prophylaxis (strength, dose regimen, and route of administration were not provided), while it had a temperature excursion of 24.4 Fahrenheit grades for 5 hours 51 minutes. There was not previous temperature excursion. The patient was asymptomatic, no additional adverse event was reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE/PQC.; She received her first dose of GARDASIL 9 around 5 years ago, and just received a second dose today on 06/06/2023; This spontaneous report has been received form a consumer, regarding to herself, a 23-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.   On an unspecified date on 2019 (reported as about 5 years ago), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDSIL 9) injection, as prophylaxis (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported).  On 06-JUN-2023, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDSIL 9) injection, as prophylaxis as well (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported) (Inappropriate schedule of product administration).  No additional event or information was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly stored administered GARDASIL 9; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 31-MAY-2023, the patient was vaccinated with one improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number w013388 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, expiration date reported and upon internal validation established as 16-DEC-2024) (product storage error). No adverse events were reported.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administered to a 26yo patient instead of varicella vaccine; inadvertently administered to a 26yo patient instead of varicella vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number 42YY3, expiry date 28-MAY-2024) for prophylaxis.   On 24-MAY-2023, the patient received Shingrix. On 24-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered to a 26yo patient instead of varicella vaccine) and wrong vaccine administered (Verbatim: inadvertently administered to a 26yo patient instead of varicella vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 05-JUN-2023 The error was discovered on the day of reporting. The patient was fine, no harm done. The reporter did not want to provide email address. She said PV could follow up The reporter consented to follow up. 26year old patient was inadvertently administered Shingrix instead of varicella vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: received his first Shingrix dose a little over 2 years ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (Zostavax 5 years ago) and Shingrix (received his first dose a little over 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received his first Shingrix dose a little over 2 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-JUN-2023 The reporter was the patient.  The patient could not afford the second dose of Shingrix 6 months later.  He planned to receive the second dose at the time of reporting (Inappropriate schedule of vaccine). Nothing else was reported. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: flu like symptoms; achy; dizzy; headache; Naucous; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), NAUSEA (Naucous) and PAIN (achy) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included AFib.    On 04-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Jun-2023, the patient experienced DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), NAUSEA (Naucous), PAIN (achy) and FATIGUE (tired). At the time of the report, DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), NAUSEA (Naucous), PAIN (achy) and FATIGUE (tired) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported. It was unknown if the patient experienced any additional symptoms/events.  The patient was suggested with bed rest until could go back to work.  It was unknown if the patient had any additional medical history, concomitant disease or risk factor. No treatment medication information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: flu like symptoms; achy; dizzy; headache; Naucous; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), NAUSEA (Naucous) and PAIN (achy) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included AFib.    On 04-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Jun-2023, the patient experienced DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), NAUSEA (Naucous), PAIN (achy) and FATIGUE (tired). At the time of the report, DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), NAUSEA (Naucous), PAIN (achy) and FATIGUE (tired) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported. It was unknown if the patient experienced any additional symptoms/events.  The patient was suggested with bed rest until could go back to work.  It was unknown if the patient had any additional medical history, concomitant disease or risk factor. No treatment medication information was reported.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error, Vaccination site erythema
Clinical narrative: injection site redness; 13 different patients" given Pfizer COVID vaccines for all age group "couple of weeks and some are less" after the 10 weeks beyond-use-date in the refrigerator.; 13 different patients" given Pfizer COVID vaccines for all age group "couple of weeks and some are less" after the 10 weeks beyond-use-date in the refrigerator.; The initial case was missing the following minimum criteria: (ICH- unspecified number of patients). Upon receipt of follow-up information on [06Jun2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 5-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Mar2023 at 11:23 as dose 3 (orange cap; booster), single (Lot number: GK1657) at the age of 5 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 20Mar2023, outcome "unknown" and all described as "13 different patients" given Pfizer COVID vaccines for all age group "couple of weeks and some are less" after the 10 weeks beyond-use-date in the refrigerator."; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Mar2023 at 11:23, outcome "recovered" (2023), described as "injection site redness". Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: No Prior Vaccinations, no medical history. No Relevant tests and specific relevant test for thromboembolic events with thrombocytopenia. Bivalent COVID vaccine given outside BUD. The patient did not experience any adverse event(s) as a consequence of the error.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years for COVID-19 immunisation; COVID-19 VACCINE (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: GABAPENTIN. Past drug history included: Ciprofloxacin, reaction: "Known allergies: Ciprofloxacin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 24May2023 to 28May2023.   The information on the batch/lot number for BNT162b2, BNT162b2 OMI BA.4-5 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: symptoms 4 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 26May2023 to 31May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: PMR Polymyalgia Rheumatica-severe pain in arm and shoulder, neck, hips trouble walking at first, also extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penacyllin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE; HYDROCODONE; PRAVASTATIN; TRAZODONE. Patient was tested for COVID post vaccination (unknown results). Past drug history included: Immetrex, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (disability, medically significant) with onset 04Oct2022, outcome "recovered with sequelae", described as "PMR Polymyalgia Rheumatica-severe pain in arm and shoulder, neck, hips trouble walking at first, also extreme fatigue". The events "pmr polymyalgia rheumatica-severe pain in arm and shoulder, neck, hips trouble walking at first, also extreme fatigue" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica which included steroids.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Tinnitus
Clinical narrative: I have horrible tinnitus, a pulsating tinnitus, a swishing noise in the ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "I have horrible tinnitus, a pulsating tinnitus, a swishing noise in the ear". The event "i have horrible tinnitus, a pulsating tinnitus, a swishing noise in the ear" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller developed tinnitus. A pulsating tinnitus, a swishing noise in the ear. Started getting after took the Covid Vaccines. Was looking things up and one of the side effects is tinnitus. Patient reported that "I have horrible tinnitus and have seen 2 ENTs and most recently a neurologist. It is a 'pulsating tinnitus' that is a swishing noise, not ringing in the ear. It is horrible and unbelievable, and it is 24/7. It has been suggested that it may be related to the Pfizer Covid 19 vaccine; I do not have my vaccination card with me so I don't know the dates of vaccination or formulation, but it is the Pfizer Covid 19 vaccine. The first dose was a couple of years ago, then 6 months later I got the second dose, so that was about a year ago. It did not occur with the first dose but was several months after the second vaccine dose when I noticed the pulsating tinnitus and getting worse now, where it bothers me a lot. MRI is normal. My neurologist is trying to figure it out.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.