chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second dose were longer than recommended) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine)    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second dose were longer than recommended) and NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second dose were longer than recommended) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second dose were longer than recommended).    No concomitant medications were reported. Patient's age was reported as 2.7 years.  No treatment details were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Gait disturbance, Musculoskeletal chest pain
Clinical narrative: After taking first two doses of Pfizer vaccine, I started getting shortness of breath, rib pain, chest pains, sternum pain, stabbing in chest, unable to do basic daily things such as walking up and down stairs, walking normal distances. This has lasted ever since vaccine till now.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: drew up 0.3ml and injected instead on 0.5ml I called her back in after I realized it and administer 0.2ml more in same arm
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The above patient was given Bexsero Men B vaccine instead of Men-ACYW there is no adverse reaction, no harm to patient.  Parent, provider and supervisor all notified of incident.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test normal, Pain in extremity, Ultrasound Doppler, X-ray limb normal
Clinical narrative: I woke up on Nov 14th with extreme pain in my right arm, and I took some TYLENOL, it did not get better. But on the 17th I went to urgent care and they gave me tramadol, this is the same arm that I had a torn rotator cuff in, I took the medicine and I got worse. It was my birthday and then the November holiday and I did not want to go to the ER on those days but I went the next day and they did an x-ray and they could not find anything wrong. They gave me an injection of pain medicine and some things to take home, and sent me to an Orthopedic Dr., and he stated there was some kind of infection in my arm, some kind of blood infection or puss, and he sent me back to the ER and I was hospitalized on that day and was in the hospital for 3 days the 28-30th of November. They came back and took more tests and they could not find out what was wrong because there was no infection at all. They gave me more medicine and then discharged me from the hospital. I am still in pain, my daughter found an article that stated that the COVID-19 vaccine could cause frozen shoulder and that is what I believe that I have. This is something that effects people with Diabetes so this is what I think I have and I go back to my Orthopedic Dr. in Jan for my next cortisone shot.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Eye swelling, Urticaria
Clinical narrative: Swollen eyes, hives, redness and hives. Cellulites
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Pt received the vaccine when it was out of its best use date period. The expiration date was 10/2023 but it has been in the fridge for over 10 weeks.
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 12/5/22 from a vial that expired 12/4/22
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness
Clinical narrative: dizziness, weakness
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently given Pfizer-BioNTech age 12+ bivalent vaccine at age 8. Patient was informed by administering staff of the error and was monitored for more than 30 minutes and had no obvious adverse reaction. Patient was advised of precautions and normal side effects for vaccination with covid vaccine.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult dose flu vaccine given instead of pediatric dose
Age: 10.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose flu vaccine given instead of pediatric dose
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: starting the morning after vaccination (12/9) patient had pain and tingling in his hands, then starting the night after vaccination (12/9) patient started to also have tingling and pain in his feet
Age: 17.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult dose flu vaccine given instead of pediatric dose. No symptoms, no treatment given.
Age: 17.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult dose flu vaccine given instead of pediatric dose. No symptoms, no treatment given.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Ringing in ears. Constant high vibration sound
Age: 90.0
Sex: F
Vaccine: FLUA4, UNK
Symptoms: Injection site mass, Injection site vesicles
Clinical narrative: Patient received her flu shot on 10-29-22. On 10-30-22 she noticed a lump at the site of injection.  Once the band aid was removed, a clear tannish discharge was noticed by the patient from a blister that had formed at the injection site. Patient was concerned it was the vaccine itself being discharged.
Age: 90.0
Sex: F
Vaccine: FLUA4, UNK
Symptoms: Injection site discharge, Injection site mass
Clinical narrative: Patient received her flu shot on 10-29-22. On 10-30-22 she noticed a lump at the site of injection.  Once the band aid was removed, a clear tannish discharge was noticed by the patient from a blister that had formed at the injection site. Patient was concerned it was the vaccine itself being discharged.
Age: 14.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult dose flu vaccine given instead of pediatric dose. No symptoms, no treatment given.
Age: 14.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult dose flu vaccine given instead of pediatric dose. No symptoms, no treatment given.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Child and parent presented together for vaccinations. Environment chaotic. Likely that child received adult vaccine.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt dizzy and lightheaded and fainted after leaving the exam room and heading to lobby few minutes after getting the vaccine.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Child likely received vaccine intended for adult
Age: 13.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was given the wrong vaccine. Patient was told of this, now are waiting for Provider instruction.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Bundle branch block left, Cardiac monitoring, Cardiomyopathy, Catheterisation cardiac
Clinical narrative: SIGNS/SYMPTOMS Chest pain/angina SOB Reduced Ejection Fraction  TREATMENT ECHO ECG/EKG Nuclear stress test Left heart catheterization Heart Monitor
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Ejection fraction decreased, Electrocardiogram
Clinical narrative: SIGNS/SYMPTOMS Chest pain/angina SOB Reduced Ejection Fraction  TREATMENT ECHO ECG/EKG Nuclear stress test Left heart catheterization Heart Monitor
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Magnetic resonance imaging heart, Myocarditis, Scan myocardial perfusion
Clinical narrative: SIGNS/SYMPTOMS Chest pain/angina SOB Reduced Ejection Fraction  TREATMENT ECHO ECG/EKG Nuclear stress test Left heart catheterization Heart Monitor
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Haemorrhage, Injury associated with device
Clinical narrative: Child was given injection and moved while being injected. Child was immediately given second injection . Needle scrapped arm when child had moved and caused bleeding.  Child was given gauze to stop bleeding and band aid. Arm was cleaned and new band aid was applied. Ice pack was provided to ice arm.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body height increased, Ehlers-Danlos syndrome, Immunology test, Magnetic resonance imaging, Menstruation irregular
Clinical narrative: Irregular periods, trigger of Ehlers Danlos hypoermobility syndrome, growth of 2+ inches
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Positron emission tomogram
Clinical narrative: Irregular periods, trigger of Ehlers Danlos hypoermobility syndrome, growth of 2+ inches
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Antinuclear antibody, Asthenia, Blood triglycerides decreased, Chest discomfort, Chest pain
Clinical narrative: Weakness, disproportionate fatigue, chest pain and tightness with exertion, shortness of breath with exertion. Unable to continue working retail job, dance for college dance classes, and photography due to symptom onset and worsening. Unable to participate in desired social activities due to weakness and fatigue. Can only walk short distances and not stand for long, because of symptoms. Tachycardia with minimal exertion such as walking and activities of daily living. Difficulty washing hair, folding clothes due to weakness and fatigue.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Dyspnoea exertional, Exercise tolerance decreased, Fatigue, Fibrin D dimer increased, Haemoglobin normal
Clinical narrative: Weakness, disproportionate fatigue, chest pain and tightness with exertion, shortness of breath with exertion. Unable to continue working retail job, dance for college dance classes, and photography due to symptom onset and worsening. Unable to participate in desired social activities due to weakness and fatigue. Can only walk short distances and not stand for long, because of symptoms. Tachycardia with minimal exertion such as walking and activities of daily living. Difficulty washing hair, folding clothes due to weakness and fatigue.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Impaired work ability, Laboratory test normal, Loss of personal independence in daily activities, Metabolic function test normal, Tachycardia
Clinical narrative: Weakness, disproportionate fatigue, chest pain and tightness with exertion, shortness of breath with exertion. Unable to continue working retail job, dance for college dance classes, and photography due to symptom onset and worsening. Unable to participate in desired social activities due to weakness and fatigue. Can only walk short distances and not stand for long, because of symptoms. Tachycardia with minimal exertion such as walking and activities of daily living. Difficulty washing hair, folding clothes due to weakness and fatigue.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: White blood cell count normal
Clinical narrative: Weakness, disproportionate fatigue, chest pain and tightness with exertion, shortness of breath with exertion. Unable to continue working retail job, dance for college dance classes, and photography due to symptom onset and worsening. Unable to participate in desired social activities due to weakness and fatigue. Can only walk short distances and not stand for long, because of symptoms. Tachycardia with minimal exertion such as walking and activities of daily living. Difficulty washing hair, folding clothes due to weakness and fatigue.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: The patient's chart had stated patient is due for a flu vaccine and covid booster. The patient said he had received his covid booster but not the flu vaccine and so medical assistant administered the flu vaccine. However, she queried the immunization registry after the patient left to find the patient's covid booster and that's when the chart updated and showed the patient already received the flu vaccine for this flu season on 10/4/2022. Per CDC guidelines: "If a larger dose (volume) of influenza vaccine is inadvertently administered, count the dose as valid. Revaccination with additional vaccine is not needed." Patient was called about an hour after he left to notify him of the error but did not answer.  message was sent to the patient to notify him of the error. Patient has yet to respond or call back.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient came in and requested to get moderna bivalent shot, but was given the flu shot. Patient stated he had received his flu shot from his primary care doctor a month ago, I tried to call the doctor's office to confirm , but doctor;s office was closed for the day. So i called insurance to confirm, and the agaent i spoke with told me that based on  his records patient had not received any flushot during this flu season apart from the one he received today 12/09/2022 at our location. and that if patient had received any previous flu shot, the insurance won't allow us bill for the flushot the scond time
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: On 10/15/2022, at approximately 1150, patient presented with his parent to the vaccination site for Infant Pfizer, age 6 months-4 years, COVID-19 Vaccine. At approximately 1205, the client did not receive the dose (0.2 ml) of Infant Pfizer, age 6 months-4 years, 3rd dose COVID-19 Vaccine (Lot# FT9142). The patient moved the arm before EMT started pushing the syringe plunger into the patient's deltoid muscle. The RPh, submitted a medical consult via phone and text message to Dr. MD PRIVATE, regarding the patient's vaccination status after this incident. Since Dr. MD PRIVATE, did not respond back, the RPh, spoke via the phone with Clinical Project Coordinator RN, regarding the patient's vaccination status after this incident. Clinical Project Coordinator RN, recommended, per CDC Interim Guidelines for COVID-19 Vaccine, that since the patient had not been administered the dose (0.2 ml) of Infant Pfizer, age 6 months-4 years, 3rd dose COVID-19 Vaccine, the vaccine should be administered. Patient's parent requested that patient receive the dose on the opposite arm. At 1225, the patient received the Infant Pfizer, age 6 months-4 years, 3rd dose COVID-19 Vaccine (Lot# FT9142) on his left arm (deltoid) by the EMT. The EMT, educated the patient and the patient's parent on the signs and symptoms of adverse reactions when to seek medical care and suggested the patient to register on V-Safe. The patient and the patient's parent both verbalized understanding. At approximately 1240, the patient left the facility with his parent with unlabored respirations and a steady gait.
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Vaccine Error: Pharmacist was supposed to administer the influenza vaccine and gave the bivalent covid booster, which was a second bivalent booster to the one given on November 5, 2022. Reporting since 14 year old patient had 2 bivalent boosters within about 30 days. Immunization Information System not verified.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Administered Pfizer Bivalent 12 and up for a 10 year old patient. Pharmacist consulted father that patient does not need extra booster dose.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeding disorder, Loss of personal independence in daily activities, Sneezing
Clinical narrative: Chronic coughing and sneezing, disturbing normal routine and eating, coughing and sneezing every 2-10 minutes. Persistent for 11 months without relief from OTC medication or Rx medication.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: pt received bivalent Pfizer booster on 9/11/2022.  she presented to pharmacy for another booster today and we administered bivalent Pfizer today
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Medication error, Product preparation issue
Clinical narrative: Six year old patient was given the Pfizer 5-11 year old Bivalent Booster at 0.2mL with no diluent used. Patient was notified by doctor about medication error and advised on next steps of care. No symptoms at this time.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient has no side effects to report at this time.  Patient requested  the Bivalent Pfizer vaccine and was given Monovalent Pfizer vaccine.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave FluBlok instead of Fluzone.  Individual was 17 not 18 and should have been given Fluzone.  NO adverse effects noted by patient.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient requested Pfizer Bivalent vaccine and was given Pfizer Monovalent Vaccine. There are no adverse events to report at this time.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient requested Pfizer Bivalent vaccine and was given Pfizer Monovalent Vaccine. There are no adverse events to report at this time.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient requested Pfizer Bivalent vaccine and was given Pfizer Monovalent Vaccine. There are no adverse events to report at this time.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Electrocardiogram, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: After getting vaccine, patient was standing and fainted and was unconscious for a few seconds. Mom was next to him holding him, pharmacy staff called 911, patient awoke and was sweaty, nauseous, pale, dizzy. Sat up and began to feel normal in a couple minutes. The paramedics did come just to check him out and after checking pulse and talking with patient, everything seemed normal but they went out to ambulance to run EKG just to make sure no abnormalities were detected.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pallor, Syncope
Clinical narrative: After getting vaccine, patient was standing and fainted and was unconscious for a few seconds. Mom was next to him holding him, pharmacy staff called 911, patient awoke and was sweaty, nauseous, pale, dizzy. Sat up and began to feel normal in a couple minutes. The paramedics did come just to check him out and after checking pulse and talking with patient, everything seemed normal but they went out to ambulance to run EKG just to make sure no abnormalities were detected.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Vaccine was administered too high in the arm, near the shoulder region.  Not in the deltoid muscle. Injection was immediately painful followed by increased pain and very limited arm mobility within 3 hours.   Follow up appt with medical office within 2 weeks, with no resolution after a prescribed course of prednisone.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Tissue injury, X-ray
Clinical narrative: Vaccine was administered too high in the arm, near the shoulder region.  Not in the deltoid muscle. Injection was immediately painful followed by increased pain and very limited arm mobility within 3 hours.   Follow up appt with medical office within 2 weeks, with no resolution after a prescribed course of prednisone.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient requested Pfizer Bivalent vaccine and was given Pfizer Monovalent Vaccine. There are no adverse events to report at this time.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient requested Pfizer Bivalent vaccine and was given Pfizer Monovalent Vaccine. There are no adverse events to report at this time.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient requested Pfizer Bivalent vaccine and was given Pfizer Monovalent Vaccine. There are no adverse events to report at this time.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient requested Pfizer Bivalent vaccine and was given Pfizer Monovalent Vaccine. There are no adverse events to report at this time.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient requested Pfizer Bivalent vaccine and was given Pfizer Monovalent Vaccine. There are no adverse events to report at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Pt. had redness around the nape of her neck and her ears earlier the  morning following the vaccinations.  No other symptoms at that time, 6 hours later I have noticed hives. A few on her neck and some on her lower back.  I gave her Benadryl at 8:30 Friday ( day after vaccine) night and she was rash free the next morning but then around 3:30pm it came back and it was odd because it was red almost opposite of where it was red the day before.  It appeared to me to look like a chemical burn from the inside out. I would like to share photos if able.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient requested Pfizer Bivalent vaccine and was given Pfizer Monovalent Vaccine. There are no adverse events to report at this time.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient requested a Pfizer bivalent booster and was given a Pfizer monovalent booster. Patient has a history of receiving Pfizer monovalent COVID vaccine and no history of receiving a bivalent vaccine.  The patient was notified in the morning of 12/09/22 as soon as the pharmacy became aware. Per the CDC guidelines, a repeat dose is not recommended and a bivalent booster can be administered if desired 2 months following this current dose. The patient was encouraged to contact the pharmacy with any questions or concerns.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient requested a Pfizer bivalent booster and was given a Pfizer monovalent booster. Patient has a history of receiving Pfizer monovalent COVID vaccine and no history of receiving a bivalent vaccine.  The patient was notified in the morning of 12/09/22 as soon as the pharmacy became aware. Per the CDC guidelines, a repeat dose is not recommended and a bivalent booster can be administered if desired 2 months following this current dose. The patient was encouraged to contact the pharmacy with any questions or concerns.
Age: 0.08
Sex: F
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Given adult vaccine Prevnar 20 instead of pediatric vaccine Prevnar 13
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal discomfort, Feeling cold, Tremor, Vomiting
Clinical narrative: During the night I had a server upset stomach.  Felt like vomiting. I finally got up and did vomit.  My right leg and arm shook. I felt very cold. did not take my temperature. This lasted for about 30 minutes. I was able to get back to sleep.   Next day I felt fine.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was supposed to receive booster, however an additional dose of the primary series was given mistakenly. No adverse effect reported after contacting parent. Informed booster may be received after 2 months
Age: 19.0
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: The Patient Requested the BiValent Form of the Vaccine and Received the Booster Instead
Age: 7.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Fatigue, Incorrect dose administered, Injection site pain, Somnolence
Clinical narrative: Pt was given 0.5 mL of Moderna Bivalent instead of correct dose of 0.25 ml  12-9-22, called and spoke with patient mom, patient mom reported pain at injection site and patient was tired/sleppt all evening last night.  -Denies symptoms of fever, dizziness, headaches, cough, shortness of breath, or fatigue today.   Patient mom reports he is doing ok.
Age: 23.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient Requested the Bivalent Form of the Vaccine and Received the Booster instead
Age: 51.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: The Patient Requested the Bivalent FoRm of the vaccine and received the Booster Instead
Age: 10.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Injection site pain, Underdose
Clinical narrative: Wrong dosage - should have been .25 insteade of 0.5.   12-9-22 - Called and spoke with patient mom, patient mom reports patient had pain at injection site.   Patient is doing well today, patient mom denies symptoms of fever, dizziness, headaches, cough, shortness of breath or fatigue.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nausea, Peripheral swelling
Clinical narrative: Swollen arm, feeling very hot, and nausea
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Cardiac arrest, Cardiac failure, Chest discomfort, Delirium
Clinical narrative: 54-year-old male brought in code 3 for acute respiratory distress and chest tightness. EMS stated that they spoke with the wife who noted that the patient had been having some trouble breathing for the last few nights with chest tightness intermittently but had not had any known significant illness. Patient does have a history of hypertension. When patient was first found he was significantly hypoxic into the 80s and attempts were made to provide oxygen for the patient but he was fairly agitated and a bit delirious having difficulty with both CPAP as well as facemask and nasal cannula flow repeatedly trying to remove the delivery devices. He apparently was complaining of shortness of breath and chest tightness but history is otherwise difficult to obtain. EKG was obtained which showed a diffuse amount of artifact and some nonspecific precordial changes concerning for the possibility of cardiac process but not clearly demonstrating ST elevation given artifact. He was transported here on arrival unable to provide history with fairly rapid decompensation due to cardiac arrest.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Hypoxia, Imaging procedure artifact, Intentional product use issue
Clinical narrative: 54-year-old male brought in code 3 for acute respiratory distress and chest tightness. EMS stated that they spoke with the wife who noted that the patient had been having some trouble breathing for the last few nights with chest tightness intermittently but had not had any known significant illness. Patient does have a history of hypertension. When patient was first found he was significantly hypoxic into the 80s and attempts were made to provide oxygen for the patient but he was fairly agitated and a bit delirious having difficulty with both CPAP as well as facemask and nasal cannula flow repeatedly trying to remove the delivery devices. He apparently was complaining of shortness of breath and chest tightness but history is otherwise difficult to obtain. EKG was obtained which showed a diffuse amount of artifact and some nonspecific precordial changes concerning for the possibility of cardiac process but not clearly demonstrating ST elevation given artifact. He was transported here on arrival unable to provide history with fairly rapid decompensation due to cardiac arrest.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Positive airway pressure therapy, Respiratory distress
Clinical narrative: 54-year-old male brought in code 3 for acute respiratory distress and chest tightness. EMS stated that they spoke with the wife who noted that the patient had been having some trouble breathing for the last few nights with chest tightness intermittently but had not had any known significant illness. Patient does have a history of hypertension. When patient was first found he was significantly hypoxic into the 80s and attempts were made to provide oxygen for the patient but he was fairly agitated and a bit delirious having difficulty with both CPAP as well as facemask and nasal cannula flow repeatedly trying to remove the delivery devices. He apparently was complaining of shortness of breath and chest tightness but history is otherwise difficult to obtain. EKG was obtained which showed a diffuse amount of artifact and some nonspecific precordial changes concerning for the possibility of cardiac process but not clearly demonstrating ST elevation given artifact. He was transported here on arrival unable to provide history with fairly rapid decompensation due to cardiac arrest.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: series of temperature excursions; poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, 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. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered).    No concomitant product reported by reporter.  It was reported that there was a few excursions (4) over the past 5 months since 10-Aug-2022. There were 4 instances where temperatures were out of range which included both the Monovalent adult and Bivalent booster for adults. On 10-Aug-2022 temperature excursion occurred. Storage condition at the time of the excursion was refrigerated storage. Individual vials or unbroken cartons were 1 vial 4. Vial size was reported as 5.5 mL. Vials were reached maximum 8.6 degrees for 29 minutes and 8.5 degree for 34 minutes. Vials were normally taken out one vial at a time the day. Caller has a series of temperature excursions to report. Vials were not undergone any temperature excursions. Reporter was not sure exactly how many patients received doses from these vials following the temperature excursions but does believe the doses have been administered. No visual changes were observed in the vial.  No treatment medication reported by reporter.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Full blood count normal, Headache, Inflammatory marker test, Metabolic function test normal
Clinical narrative: Error: Incorrect Reconstitution-
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation error, Pyrexia
Clinical narrative: Error: Incorrect Reconstitution-
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Exposed 2x to COVID-19 and never got it; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Guillain-Barre Syndrome" (unspecified if ongoing), notes: Guillain-Barre Syndrome(GBS) 16 years ago following a case of shingles; "Shingles" (unspecified if ongoing), notes: Guillain-Barre Syndrome(GBS) 16 years ago following a case of shingles; "Peripheral neuropathy in her feet" (unspecified if ongoing), notes: developed Peripheral neuropathy in her feet after having GBS. The patient's concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "Exposed 2x to COVID-19 and never got it".  Additional information: It was reported that, she had Guillain-Barre Syndrome (GBS) 16 years ago following a case of shingles. Patient developed Peripheral neuropathy in her feet after having GBS. Patient has been Exposed 2x to COVID-19 and never got it.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201356556 same patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposed 2x to COVID-19 and never got it; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Guillain-Barre Syndrome" (unspecified if ongoing), notes: Guillain-Barre Syndrome(GBS) 16 years ago following a case of shingles; "Shingles" (unspecified if ongoing), notes: Guillain-Barre Syndrome(GBS) 16 years ago following a case of shingles; "Peripheral neuropathy in her feet" (unspecified if ongoing), notes: developed Peripheral neuropathy in her feet after having GBS. The patient's concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "Exposed 2x to COVID-19 and never got it".  Additional information: It was reported that, she had Guillain-Barre Syndrome (GBS) 16 years ago following a case of shingles. Patient developed Peripheral neuropathy in her feet after having GBS. Patient has been Exposed 2x to COVID-19 and never got it.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201356556 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received an incorrect vaccine (the Monovalent pediatric booster) instead of the Moderna Bivalent booster; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received an incorrect vaccine (the Monovalent pediatric booster) instead of the Moderna Bivalent booster) and NO ADVERSE EVENT (No Adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient received an incorrect vaccine (the Monovalent pediatric booster) instead of the Moderna Bivalent booster) and NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received an incorrect vaccine (the Monovalent pediatric booster) instead of the Moderna Bivalent booster) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received an incorrect vaccine (the Monovalent pediatric booster) instead of the Moderna Bivalent booster).    No concomitant medications were reported. It was reported that  patient received a Moderna covid19 booster dose for children was given to adult and reports 0.5mL of the NDC 8077727599 which is the Moderna Covid 19 vaccine booster doses for pediatrics blue cap/purple border label. Caller does not know what is the next step for the patient in resolving this issue. Caller does not have patient information at this time. Caller provided phone number if safety team needed to follow up. No treatment medications were reported.
Sex: U
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: developed cellulitis from the vaccines; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Nov2022 as dose number unknown, single (Lot number: FW6029) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset Nov2022, outcome "unknown", described as "developed cellulitis from the vaccines".; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of CELLULITIS cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202200115716 same reporter, drug and event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: always get a sore arm where I get the shot; 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 73-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FF2588, Expiration Date: 28Sep2021), in arm for covid-19 immunisation. The patient's relevant medical history included: "hip replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin for hip replacement, notes: caller had to go to a dentist appointment and because caller had hip replacement caller usually takes 4 antibiotics., had to take amoxicillin due to history of a hip replacement. Vaccination history included: Bnt162b2 (Dose: 1 Pfizer BioNTech COVID-19 vaccine 30mcg/0.3mL , Lot number: EN5318 , Expiration date: 31May2021 , NDC number: Unknown), for COVID-19 Immunization, reaction(s): "always get a sore arm where I get the shot"; Bnt162b2 (Dose: 2 Pfizer BioNTech COVID-19 vaccine 30mcg/0.3mL , Lot number: EN6203 , Expiration date: 30Jun2021 , NDC number: Unknown), for COVID-19 Immunization, reaction(s): "always get a sore arm where I get the shot". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "always get a sore arm where I get the shot".  Additional Information: Reporter had hip replacement and usually takes 4 antibiotics. She confirmed that her 4 prior doses were all the Pfizer BioNTech COVID-19 vaccine and mentioned that she always got a sore arm where she got the shot.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single at the age of 35 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks. Treatment start date was 24Nov2022 and stop date was 28Nov2022.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOCETIRIZINE; PANTOPRAZOLE; FISH OIL; CARVEDILOL; ATORVASTATIN; AMLODIPINE BENAZEPRIL; BAYER ASPIRIN. Past drug history included: Hydrocodone, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" 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. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks included one a day multi vitamin. Therapeutic measures included anti viral Paxlovid from 23Nov2022 to 27Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: other medical history: Obese. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication was received in 2weeks. Patient received treatment with paxlovid from 23Nov2022 to 27Nov2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.