chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I received my first Pfizer booster for COVID-19 on 12/3/2021. On 9/3/2022, I woke up with a cough and congestion. I took an antigen test that day and got a positive result. My symptoms worsened a little on 9/4/2022, because I was much more fatigued, plus I had dizziness. At some point, I developed a fever of about 100 or 101. On 9/5/2022, my symptoms were much worse. I normally try to shower every day, but when I showered that day, I was so dizzy after showering that I couldn't even finish putting my clothes on when I went back to bed afterwards. I checked my blood oxygen level, also, and it was 93-94%. I contacted the on-call staff at my doctor's office to see if I could get a prescription for an antiviral or something to treat the symptoms, but they didn't think my oxygen level was low enough to cause concern. They also felt that if I took an antiviral, the side effects would far outweigh the benefits, so they were hesitant to give me an antiviral. On 9/6/2022, I had a telehealth visit with my doctor, because I had a severe cough at this point and I needed relief, because the cough was keeping me from sleeping. Also, I was afraid that it could turn into bronchitis, as I am prone to get bronchitis. My doctor prescribed me codeine guaifenesin to treat the cough, plus azithromycin, because he thought that putting me on an antibiotic would probably reduce my chances of developing bronchitis. After beginning the medicine, I was able to sleep more. I spent most of the rest of the week in bed because I still had weakness and dizziness. It wasn't until about 9/10/2022 that I began to finally get out of bed and was able to shower with less difficulty. I was able to return to work on 9/12/2022, though I still had residual weakness, fatigue, and shortness of breath. At the time of this writing, I still experience some shortness of breath at occasional, random times. Aside from the occasional shortness of breath, I feel that I have made a full recovery.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient had J&J 1/18/2022, external admin on 7/8/2022 and Novavax on 10/19/2022  2021: Pfizer admin 3/15/2021, 4/5/2021, 8/15//2021
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Insomnia, Pain in extremity, Pyrexia, Restless legs syndrome
Clinical narrative: Pt called stating she has had pain in the hips and legs, restless legs, difficulty sleeping, sinus congestion and runny nose, fever of 101.7F, since around midnight of 12/3/22 after receiving her Moderna booster.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, Sinus congestion
Clinical narrative: Pt called stating she has had pain in the hips and legs, restless legs, difficulty sleeping, sinus congestion and runny nose, fever of 101.7F, since around midnight of 12/3/22 after receiving her Moderna booster.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Malignant melanoma, Surgery
Clinical narrative: In April,  patient developed melanoma and required surgery and treatment
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Patient said that she has pain at site and around site sometimes
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Metastatic salivary gland cancer, Nephritis
Clinical narrative: In September pt developed nephritis and then in October 2022 patient developed metastatic melanoma to parotid gland.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Waiting to hear back from CDC about possible reactions, patients are being notified about possible increase of symptoms.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient came with her daughter to the pharmacy and stated that her upper arm has been having long lasting pain since the last moderna booster. The pain started 1 day after the injection. The injection site was warm to touch and tenderness after the shot but went away, but the pain has been lasting. Patient had seen by PCP and recommended massage and pain relief cream/lotion. Her pain was relieved with massage but came back next day.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Starting 12/2 Patient reports an itchy rash appeared on her right arm that over the next few days spread to her front and back of thighs, upper back, arms, shoulders, sides and buttocks. She has taken benadryl and used cortisone cream to treat the symptoms.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Medication administration error: Pt received 0.3mL instead of 0.5mL. No known adverse reaction.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary mass
Clinical narrative: LUMP ON THE UNDERARM
Age: 79.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Medication administration error: Pt received 0.3mL of Bivalent Moderna instead of 0.5mL. No known adverse reaction.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Pain in extremity, Product preparation issue
Clinical narrative: Patient received a double dose of vaccine. The vial was not diluted. Patient family notified. Parent stated that other than sore arms no other symptoms had occurred
Age: 62.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Medication administration error: Pt received 0.3mL of Bivalent Moderna instead of 0.5mL. No known adverse reaction.
Age: 3.0
Sex: F
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Area of Induration Red, firm, slightly warm. No fever, no diarrhea, no vomiting. No other complaints. Child running and playing.
Age: 70.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Product administration error, Underdose
Clinical narrative: Medication administration error: Pt received 0.3mL of Bivalent Moderna instead of 0.5mL. No known adverse reaction.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: patient complains she felt tingling in ring and pinky finger and wrist of right hand after the vaccine. She has not seen her doctor or seek health care yet.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Allergy test positive, Antibody test positive, Atrial septal defect, Blood immunoglobulin A
Clinical narrative: -within a month of getting the vaccine the patient started getting winded with exercise progressively getting worse, she came to us in  2/2022 and as specialists started working it up after a wait to get in the Echo came back abnormal and then got the medical records from previous  obgyn with normal echo only thing new was the covid vaccine
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin M, Chest X-ray normal, Chest discomfort, Condition aggravated, Constipation
Clinical narrative: -within a month of getting the vaccine the patient started getting winded with exercise progressively getting worse, she came to us in  2/2022 and as specialists started working it up after a wait to get in the Echo came back abnormal and then got the medical records from previous  obgyn with normal echo only thing new was the covid vaccine
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram normal, Faeces discoloured
Clinical narrative: -within a month of getting the vaccine the patient started getting winded with exercise progressively getting worse, she came to us in  2/2022 and as specialists started working it up after a wait to get in the Echo came back abnormal and then got the medical records from previous  obgyn with normal echo only thing new was the covid vaccine
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hepatitis viral test negative, Hypersensitivity, Laboratory test normal, Liver function test increased
Clinical narrative: -within a month of getting the vaccine the patient started getting winded with exercise progressively getting worse, she came to us in  2/2022 and as specialists started working it up after a wait to get in the Echo came back abnormal and then got the medical records from previous  obgyn with normal echo only thing new was the covid vaccine
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Low density lipoprotein increased, Palpitations, Pulmonary valve incompetence, Respiratory tract congestion, Right atrial dilatation
Clinical narrative: -within a month of getting the vaccine the patient started getting winded with exercise progressively getting worse, she came to us in  2/2022 and as specialists started working it up after a wait to get in the Echo came back abnormal and then got the medical records from previous  obgyn with normal echo only thing new was the covid vaccine
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Right ventricular dilatation, SARS-CoV-2 antibody test, SARS-CoV-2 test, Smear cervix normal, Tricuspid valve incompetence
Clinical narrative: -within a month of getting the vaccine the patient started getting winded with exercise progressively getting worse, she came to us in  2/2022 and as specialists started working it up after a wait to get in the Echo came back abnormal and then got the medical records from previous  obgyn with normal echo only thing new was the covid vaccine
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal, Ultrasound liver normal
Clinical narrative: -within a month of getting the vaccine the patient started getting winded with exercise progressively getting worse, she came to us in  2/2022 and as specialists started working it up after a wait to get in the Echo came back abnormal and then got the medical records from previous  obgyn with normal echo only thing new was the covid vaccine
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patients were double dosed with the bivalent vaccine
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Medication administration error: Pt received 0.3mL of Bivalent Moderna instead of 0.5mL. No known adverse reaction.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient recieved a double dose of the vaccine. Vial wasn't diluted properly
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error, Underdose
Clinical narrative: Medication administration error: Pt received 0.3mL of Bivalent Moderna instead of 0.5mL. No known adverse reaction.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient received a double dose of bivalent vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Medication administration error: Pt received 0.3mL of Bivalent Moderna instead of 0.5mL. No known adverse reaction.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Medication administration error: Pt received 0.3mL of Bivalent Moderna instead of 0.5mL. No known adverse reaction.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Medication administration error: Pt received 0.3mL of Bivalent Moderna instead of 0.5mL. No known adverse reaction.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast discomfort, Full blood count normal, Magnetic resonance imaging breast normal, Mammogram normal
Clinical narrative: Left axillary and left lateral breast fullness and discomfort. Started on the day following the vaccine, and persists through the date of this report.  Several visits to her primary Internist.  Initially worked up as a mass.  Evaluated for possible association with her breast.  Eventually referred to a breast general surgeon for evaluation.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Ultrasound breast normal, Ultrasound scan normal
Clinical narrative: Left axillary and left lateral breast fullness and discomfort. Started on the day following the vaccine, and persists through the date of this report.  Several visits to her primary Internist.  Initially worked up as a mass.  Evaluated for possible association with her breast.  Eventually referred to a breast general surgeon for evaluation.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: This is an administration error.  Patient brought me in their Covid card today (12/5/2022) so we could fill out his info of his shot he received on 10/13/2022.  There was only 1 previous dose listed on the card.  He said the October vaccine was only his second.  I thought maybe he had a second card so I looked him up on our registry and that also showed that that was his second shot.  His second shot should have been a monovalent Moderna shot.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error, Underdose
Clinical narrative: Medication administration error: Pt received 0.3mL of Bivalent Moderna instead of 0.5mL. No known adverse reaction.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching lower half of the body
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Anaphylactic shock, Erythema, Eye disorder, Lip swelling
Clinical narrative: Hives and itching lower half of the body
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives and itching lower half of the body
Age: 31.0
Sex: M
Vaccine: COVID19-2, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient passed out minute after second shot was given. he was unconscious for short period of time.
Age: 55.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Arthralgia, Back pain, Gait disturbance, Myalgia
Clinical narrative: Began having sever pain in shoulders, lower back, hips, moderate pain in elbows, knees about 2hrs after vaccines. On 12/04 began having muscle pain in legs and arms. Have had difficulty walking and lifting.  Have taken prednisone along with aspirin and Tylenol to help. Have a dr. appt on 12/06
Age: 74.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was expecting to receive COVID19 PFIZER UPDATED BOOSTER 12+, instead received COVID19 (PFIZER AGE 12+) GRAY CAP
Age: 36.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was expecting to receive COVID19 PFIZER UPDATED BOOSTER 12+, instead received COVID19 (PFIZER AGE 12+) GRAY CAP
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Patient says he thinks he has SIRVA from injection site
Age: 29.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was expecting to receive COVID19 PFIZER UPDATED BOOSTER 12+, instead received COVID19 (PFIZER AGE 12+) GRAY CAP
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was expecting to receive COVID19 PFIZER UPDATED BOOSTER 12+, instead received COVID19 (PFIZER AGE 12+) GRAY CAP
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was expecting to receive COVID19 PFIZER UPDATED BOOSTER 12+, instead received COVID19 (PFIZER AGE 12+) GRAY CAP
Age: 63.0
Sex: M
Vaccine: FLUR4
Symptoms: Vertigo
Clinical narrative: Pt states the day after vaccination pt developed vertigo
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was expecting to receive COVID19 PFIZER UPDATED BOOSTER 12+, instead received COVID19 (PFIZER AGE 12+) GRAY CAP
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus
Clinical narrative: Itching at site of injection, apply cortisone
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was expecting to receive COVID19 PFIZER UPDATED BOOSTER 12+, instead received COVID19 (PFIZER AGE 12+) GRAY CAP
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Urticaria
Clinical narrative: Patient reported hives/rash following reaction.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Feeling abnormal, Head discomfort, Neck pain, Pain
Clinical narrative: PRESSURE IN THE HEAD THAT HASN'T RESOLVED FOR 4 DAYS (FLOATING HEAD FEELING). PAIN IN NECK THAT IS TRAVELING FROM SHOULDERS TO ARM.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: PRESSURE IN THE HEAD THAT HASN'T RESOLVED FOR 4 DAYS (FLOATING HEAD FEELING). PAIN IN NECK THAT IS TRAVELING FROM SHOULDERS TO ARM.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: Patient had fainted almost immediately after giving the Fluarix dose, managed to catch the patient and prevent them from further sliding down the chair. Patient woke up within several seconds, and reported by dizzy and needing to sit down. Told patient to sit down for 15 minutes. Patient sat down in front of the pharmacy counter and then left after some time.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Ear pain, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: Minimal soreness of arm, but day 2 whole body aches and moderate severe headaches intermittent since, now at 1 week post vaccine. Earaches moderate beginning day 6. Joint aches intermittent since vaccine. Symptoms disrupted health enough to miss work as an RN which has never happened, it feels as bad as actually getting sick.  As a nurse myself I did not require a hospital or urgent care visit, treated at home with supportive care.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: Minimal soreness of arm, but day 2 whole body aches and moderate severe headaches intermittent since, now at 1 week post vaccine. Earaches moderate beginning day 6. Joint aches intermittent since vaccine. Symptoms disrupted health enough to miss work as an RN which has never happened, it feels as bad as actually getting sick.  As a nurse myself I did not require a hospital or urgent care visit, treated at home with supportive care.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Decreased appetite, Dizziness, Gait disturbance, Hypotension
Clinical narrative: This happens every time I get the Covid vaccine. About 4-5 hours after injection I get the chills and shake slightly.   I then go to sleep.  When I wake the next morning my blood pressure is very low.  So low that it is hard to walk because of dizziness.  So much so that I will  crawl to go to the restroom or to get water.  I have very little appetite and just want to sleep.  This will last an entire day.  On the second morning after the injection my blood pressure will not be as low as the first day afterwards, and good enough to carefully walk around the house (and sometimes forced to sit on the floor or hold onto an object to regain control) to get water, a bit of food, and go to the bathroom, and this slowly improves throughout the day, and by the second night i'm much better, but not 100% yet and have an appetite back.  On the third day after the injection, I'm back to normal.  I never feel nauseous nor have a fever.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Somnolence, Tremor
Clinical narrative: This happens every time I get the Covid vaccine. About 4-5 hours after injection I get the chills and shake slightly.   I then go to sleep.  When I wake the next morning my blood pressure is very low.  So low that it is hard to walk because of dizziness.  So much so that I will  crawl to go to the restroom or to get water.  I have very little appetite and just want to sleep.  This will last an entire day.  On the second morning after the injection my blood pressure will not be as low as the first day afterwards, and good enough to carefully walk around the house (and sometimes forced to sit on the floor or hold onto an object to regain control) to get water, a bit of food, and go to the bathroom, and this slowly improves throughout the day, and by the second night i'm much better, but not 100% yet and have an appetite back.  On the third day after the injection, I'm back to normal.  I never feel nauseous nor have a fever.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Pyrexia, Rash, Swelling
Clinical narrative: Swelling and rash/redness for at least three days (still experiencing this) Fever of 99-101 for 48 hours (I usually run about a 96-96.5) Soreness soon after up until 3 days after
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Pain in extremity, Weight decreased
Clinical narrative: Onset of severe joint paint in both feet and right knee in September 2022 as well as unexplained weight loss, saw primary care doctor in late October 2022 and have been referred to rheumatologist for evaluation for possible rheumatoid arthritis (long wait to get in, scheduled for January 2023)
Age: 68.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Abdominal pain lower, Blood glucose increased, Chest X-ray normal, Computerised tomogram abdomen normal, Electrocardiogram normal
Clinical narrative: 10/7/2022: Received both vaccines as mentioned above. 10/9/2022: Brought into emergency department (ED) for persistent hyperglycemia (blood sugar>500) despite normal dosages of insulin. IV fluids and additional subcutaneous insulin given. Chest x-ray normal, CT abdomen/pelvis done due to complaints of LLQ abdominal pain - negative for abnormality explaining the hyperglyemia. EKG normal. Negative for UTI or other signs of infection. Discharged back to assisted living facility (ALF) that night. 10/13/2022: Brought to ED for same Issue as on 10/9/2022, IV fluids given and additional Insulin given and discharged that night back to ALF.
Age: 68.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Hyperglycaemia
Clinical narrative: 10/7/2022: Received both vaccines as mentioned above. 10/9/2022: Brought into emergency department (ED) for persistent hyperglycemia (blood sugar>500) despite normal dosages of insulin. IV fluids and additional subcutaneous insulin given. Chest x-ray normal, CT abdomen/pelvis done due to complaints of LLQ abdominal pain - negative for abnormality explaining the hyperglyemia. EKG normal. Negative for UTI or other signs of infection. Discharged back to assisted living facility (ALF) that night. 10/13/2022: Brought to ED for same Issue as on 10/9/2022, IV fluids given and additional Insulin given and discharged that night back to ALF.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse reaction. No issues with patient. Patient was given 0.25 mL of Moderna Bivalent Booster. Patient will be called and notified.
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP, MMRV, VARCEL
Symptoms: Rash
Clinical narrative: pt tolerated well at the visit, when I was notified on 11.29.22. I notified mom on 11/30/22 and she mentioned a rash that she stated started on 11/28/22 and that noticed she seen stated that she would look her over. 20 mins later she called back out rate because she now had to notify dad who is against vaccination. We scheduled them to come in baby was looked over by the doctor and they decided not to vax anymore.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Myalgia, Pyrexia, Rash
Clinical narrative: Pt reported that she had muscle aches for 5 days after then developed a rash after she had chills, fever day 6
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Electrocardiogram, Myocarditis, Pyrexia, Troponin increased
Clinical narrative: Following the vaccine, patient developed fever and chest pain He was seen in the emergency department on 12/2 and again on 12/3. He was on Motrin and colcicene. He was diagnosed with myocarditis
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertently given Pfizer Monovalent.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to received Pfizer Bivalent Vaccine and was inadvertently given Pfizer Monovalent.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer monovalent.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was Inadvertantly given Pfizer Monovalent.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU4, HEPA, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: N/A  COVID19 (Pfizer) and Varivax was not recorded correctly, patient has 3 accounts with first and  middle name mixed up, patient didn't bring in any immunization record including COVID19 (white) Card. Extra dose of Covid19 and Varivax were given.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Foetal hypokinesia, Gestational diabetes, Oropharyngeal pain
Clinical narrative: 10/29/22 presents to Triage for "decreased fetal movement in Baby B" "32w1d" " "nonproductive cough and sore throat" "gestational diabetes" PMHx of "ADHD, Hashimoto's thyroiditis, asthma"
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 10/29/22 presents to Triage for "decreased fetal movement in Baby B" "32w1d" " "nonproductive cough and sore throat" "gestational diabetes" PMHx of "ADHD, Hashimoto's thyroiditis, asthma"
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: No adverse event; Expired Moderna vaccine administered on 29Nov2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered on 29Nov2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Nov-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered on 29Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered on 29Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered on 29Nov2022).    No concomitant medications were reported. Vial size was reported as 5.5 mL. The vial did not undergo any temperature excursions. No treatment details were reported.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired Moderna vaccine administered on 29Nov2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered on 29Nov2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Nov-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered on 29Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered on 29Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered on 29Nov2022).    No concomitant medications were reported. Vial size was reported as 5.5 mL. The vial did not undergo any temperature excursions. No treatment details were reported.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients that were vaccinated with this vaccine after the excursion; No adverse event; patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and High cholesterol.    On 10-Apr-2022 at 8:45 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Apr-2022 at 8:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion).    No concomitant medication was reported. It was unknown if the patient had ever been diagnosed or tested positive for Covid-19. Acute illness at the time of vaccination and up to one month before was unknown. It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events. No treatment information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; vaccine administered after temperature excursion; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  On 04-NOV-2022, the patient was vaccinated with a dose of varicella virus vaccine live (VARIVAX) after temperature excursion, 0.5 milliliter, administered subcutaneously (SQ), lot #W017551, expiration date 01-JUN-2024 (anatomical location was not reported) for prophylaxis.   Administered dose of vaccine underwent temperature excursion of -11.7 degrees Celsius (C) for 6 hours and 17 minutes (product storage error). No previous temperature excursion had occurred. No additional adverse events were reported (no adverse event).  This is one of the several reports from the same reporter (linked reports US-009507513-2211USA002447); Sender's Comments:  US-009507513-2211USA002447: US-009507513-2211USA002369:
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Pharmacist reports the administration of an expired dose of PNEUMOVAX 23 [ Lot: U010533; Exp:10/29/2022] to a patient on 03NOV2022.; This non-valid spontaneous report was received from a pharmacist, referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 03-NOV-2022, the patient was vaccinated with and expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number U010533, expiration date reported and validated as 29-OCT-2022) as prophylaxis (expired product administered). No additional adverse event reported (no adverse event). Caller confirmed vaccine was not involved in a temperature excursion and was stored in the recommended storage range until administration.  This case was considered non-valid due to the lack of patient's identifiers.  Follow up information has been received from the pharmacist on 01-DEC-2022. The patient was a female. This follow up made the case valid due to providing patient's identifier.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant reports one dose of improperly stored VARIVAX was administered to one patient.         ?     ?; This spontaneous report has been received from a medical assistant, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 21-NOV-2022, the patient was vaccinated with an improperly stored dose of with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX)injection, for prophylaxis (lot number: U033046, which was determined to be valid, with an expiration date on 21-OCT-2023) plus an sterile diluent (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 14 degrees Fahrenheit (F) up to 46 degrees Fahrenheit, during a time frame of 5 hours and 20 minutes (product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs; MMR and VARIVAX vaccines were administered via IM route vs SC route on/11/22/2022.; This spontaneous report was received from a pharmacist and refers to a 25-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-NOV-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered intramuscularly instead of subcutaneously (Incorrect route of product administration), 0.5 milliliter, once, both administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No additional adverse events (no adverse event) were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; Caller is a HCP reporting a patient received an expired dose of VARIVAX.; This spontaneous report was received from Physician and refers to a unspecified age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 29-NOV-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #T038830, expiration date: 17-NOV-2022 (who had been verified to be a valid number), administered for prophylaxis (strength, and route of administration were not provided). No additional adverse events was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information reported; doses were administered prior to temperature excursion/ stated there may have been additional previous temperature excursions for these products; This spontaneous report was received from other health professional and refers to patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-NOV-2022,  doses of varicella virus vaccine live (oka/merck) (VARIVAX), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent a temperature excursion of -12 Celsius degrees for 5 hour and 10 minutes. The vaccines underwent 2 previous temperature excursion.  On the same date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot #W004027, expiration date: 02-AUG-2023 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.  This one of several cases reported by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; doses were administered prior to temperature excursion/ stated there may have been additional previous temperature excursions for these products; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-NOV-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U033047, expiration date: 21-OCT-2023 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. It was informed that the vaccine underwent two previous temperature excursion. No adverse event was reported.  This is one of several cases reported by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; doses were administered prior to temperature excursion/ stated there may have been additional previous temperature excursions for these products; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 17-NOV-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U033047, expiration date: 21-OCT-2023 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. It was informed that the vaccine underwent two previous temperature excursion. No adverse event was reported.  This is one of several cases reported by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; doses were administered prior to temperature excursion/ stated there may have been additional previous temperature excursions for these products; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 18-NOV-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U033047, expiration date: 21-OCT-2023 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. It was informed that the vaccine underwent two previous temperature excursion. No adverse event was reported.  This is one of several cases reported by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; doses were administered prior to temperature excursion/ stated there may have been additional previous temperature excursions for these products; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-NOV-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U033047, expiration date: 21-OCT-2023 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. It was informed that the vaccine underwent three previous temperature excursion. No adverse event was reported.  This is one of several cases reported by the same reporter.
Sex: U
Vaccine: FLUN4, FLUN4
Symptoms: Medication error, Product storage error
Clinical narrative: VACCINE WITH AN OUT OF RANGE TEMPERATURE EXCURSION  AND WAS ADMINISTERED; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number PJ3267) (expiration date 26-DEC-2022), via nasal route, on 03-NOV-2022. The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.   No malfunction has been reported for FLUMIST QUADRIVALENT.    The report described a medication error for Flumist Quadrivalent and Flumist Quadrivalent. The reported term was "vaccine with an out of range temperature excursion  and was administered" (Preferred term: Product storage error).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v) and Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event was unknown.    The event was considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): vaccine with an out of range temperature excursion  and was administered.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 5 weeks Pregnant and Received Heplisav-B; Initial Report Received on 04-Oct-2022  This is a spontaneous report, received from a pregnant female patient aged 21 years, who received HEPLISAV-B for hepatitis B immunisation.  There was no medical history reported for the patient.  Concomitant medications were not reported.  On 30-Sep-2022, dose 1 of HEPLISAV B (Lot #937228, expiration date 30-Aug-2023, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.   On 30-Sep-202, the patient was 5 weeks pregnant. No adverse reactions were reported by the patient.  Action taken with HEPLISAV B was not reported.  The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.