chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: PATIENT CAME INTO THE PHARMACY TO GET THE COVID PEDIATRIC BOOSTER DOSE AND THE PEDIATRIC VIAL WASN'T DILUTED BEFORE DRAWING UP THE 0.2 ML DOSE. PATIENT RECEIVED AN UNDILUTED 0.2ML COVID PEDIATRIC DOSE INSTEAD OF THE DILUTED CONCENTRATION. PATIENT RECEIVED HIGHER CONCENTRATION THAN RECOMMENDED
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bone pain, Chills, Headache, Injection site pain, Joint range of motion decreased
Clinical narrative: Injection site VERY SORE for 36 hours after injection. Impacting ROM. Very achy bones and skin. Headache. Chills. NO fever. Symptoms very intense for 24 hours. Symptoms have lingered throughout the week and have not resolved yet.  Did not experience anything like this with Moderna vaccines.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain of skin
Clinical narrative: Injection site VERY SORE for 36 hours after injection. Impacting ROM. Very achy bones and skin. Headache. Chills. NO fever. Symptoms very intense for 24 hours. Symptoms have lingered throughout the week and have not resolved yet.  Did not experience anything like this with Moderna vaccines.
Age: 27.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Arthralgia, Bone pain, Headache, Tinnitus
Clinical narrative: Approximately 18 hours after vaccination severe joint and bone pain. Approximately 36 hours after vaccination servers headache with pulsitile tinnitus resulting in ER care
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: The vaccinator used a 5/8" needle to administer the COVID-19 vaccine into the anterolateral thigh.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: The vaccinator used a 5/8" needle to administer the COVID-19 vaccine into the anterolateral thigh.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Wrong technique in product usage process
Clinical narrative: The vaccinator used a 5/8" needle to administer the COVID-19 vaccine into the anterolateral thigh.
Age: 68.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered
Clinical narrative: I was approached by LVN and RN who informed me that they had both vaccinated the same patient at different times.  Each nurse had documentation that each had administered 0.1mL Jynneos (Lot #: FDP00013) ID to the same patient.  Both nurses stated that Pt sat down at their table to be vaccinated with a card showing that he had not received any previous Jynneos doses.  Each nurse vaccinated  the Pt, documented everything in Epic, then approached me at approximately 1215 hours when they found the problem.  Pt has not be able to be reached; phone call was attempted multiple times, but each time disconnected without voicemail availability.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: Per vaccinating nurse, LPN written report to this Charge Nurse, RN: ?At 1042am (3rd dose) patient mother did not secure child's leg properly. Child moved leg out, needle came out. No vaccine was administered. Was 2nd nurse working with me, she went and advised Charge Nurse and Site Supervisor, as well as draw nurse. Vaccination site was inspected by both nurses, needle intact, no injury, advised to use other leg. 2nd attempt successful at 1050am.  Second Nurse, RN and pediatric draw nurse was, RN. Site Supervisor, RN advised spoke with the family and advised vaccinating nurse, LPN, who stayed with the patient the whole time, to vaccinate the opposite leg at the left thigh site which the nurses reported to Charge Nurse, RN as successful. Patient tolerated post-observation well, patient walked out of clinic safely with parent.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Eructation, Fall, Loss of consciousness, Nausea
Clinical narrative: On the morning after my booster vaccine (second booster shot), I was at the breakfast table at 9:30 a.m. about to eat a bowl of hot cereal. As I put my spoon in the bowl, I began to feel nauseous and belched several times, which seemed to relieve the stomach pain from the air pressure in my stomach. After belching, I abruptly fainted - passed out and my head fell over into the cereal bowl. I did not know that this happened until about a minute after I fainted, when I regained consciousness and found myself head-down in the cereal. After I became aware of what happened, My wife, who was sitting beside me at the table described the details of my fainting event
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: On the morning after my booster vaccine (second booster shot), I was at the breakfast table at 9:30 a.m. about to eat a bowl of hot cereal. As I put my spoon in the bowl, I began to feel nauseous and belched several times, which seemed to relieve the stomach pain from the air pressure in my stomach. After belching, I abruptly fainted - passed out and my head fell over into the cereal bowl. I did not know that this happened until about a minute after I fainted, when I regained consciousness and found myself head-down in the cereal. After I became aware of what happened, My wife, who was sitting beside me at the table described the details of my fainting event
Age: 16.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Moderna bivalent given to patient under age 18. No adverse reactions from patient.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Limb injury
Clinical narrative: Patient did not contact us at the time of the event. We received paperwork from the lawyer that she had a shoulder injury.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Neck pain
Clinical narrative: Severe back and neck pain.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: WIFE CALLED 09/17/2022 STATING PT IS EXPERIENCING HIVES AFTER THE SHOT,  PT HAS TAKEN BENADRYL AS THEY HAVE BEFORE FOR HIVES FROM A FLU SHOT PREVISOULY, COUNSELED PT TO GO TO ER IF REACTION GETS WORSE TO THE POINT OF DIFFICULTY BREATHING
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Patient was given Pfizer covid vaccine 5-11 years old on 09/10/22 by an LPN who is under my supervision.  The nurse missed that there was a new expiration date on the vaccine and gave the vaccine which expired on 08/31/2022.  The patient's mother was called and offered revaccination. She states the patient had soreness to his arm after the vaccination and will wait for the date of his second dose.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: PATIENT WAS COMING IN FOR HER FIRST COVID PEDIATRIC VACCINE. WE WENT TO DRAW UP THE DOSE BUT HAD FORGOTTEN TO DILUTE THE VIAL. PATIENT ENDED UP RECEIVED 0.2 ML OF UNDILUTED PEDIATRIC COVID VACCINE WHICH IS A HIGHER CONCENTRATION THAN RECOMMENDED. PATIENT'S PARENT CLAIM TO NOT HAVE ANY ADVERSE EVENTS OR SYMPTOMS.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Back pain, Chills, Computerised tomogram head, Computerised tomogram spine
Clinical narrative: lethargy by 7pm, woke up with headache, chills, dizziness, nausea at 3:30am,  letting dog out into backyard, feeling like going to pass out, sat down, don't remember falling from chair but woke up on tile floor with lacerated scalp, skinned knees, severe joint and muscular pain along left shoulder, forearm, upper back, and left knee, unable to bear weight on leg, crawled from dinning room to bedroom and fell asleep on floor, woke the next morning with headache and nausea and muscle soreness, left knee with acute pain when flexing,
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Electrocardiogram, Fall, Headache, Laboratory test
Clinical narrative: lethargy by 7pm, woke up with headache, chills, dizziness, nausea at 3:30am,  letting dog out into backyard, feeling like going to pass out, sat down, don't remember falling from chair but woke up on tile floor with lacerated scalp, skinned knees, severe joint and muscular pain along left shoulder, forearm, upper back, and left knee, unable to bear weight on leg, crawled from dinning room to bedroom and fell asleep on floor, woke the next morning with headache and nausea and muscle soreness, left knee with acute pain when flexing,
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lethargy, Mobility decreased, Myalgia, Nausea, Pain in extremity
Clinical narrative: lethargy by 7pm, woke up with headache, chills, dizziness, nausea at 3:30am,  letting dog out into backyard, feeling like going to pass out, sat down, don't remember falling from chair but woke up on tile floor with lacerated scalp, skinned knees, severe joint and muscular pain along left shoulder, forearm, upper back, and left knee, unable to bear weight on leg, crawled from dinning room to bedroom and fell asleep on floor, woke the next morning with headache and nausea and muscle soreness, left knee with acute pain when flexing,
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin laceration, Weight bearing difficulty
Clinical narrative: lethargy by 7pm, woke up with headache, chills, dizziness, nausea at 3:30am,  letting dog out into backyard, feeling like going to pass out, sat down, don't remember falling from chair but woke up on tile floor with lacerated scalp, skinned knees, severe joint and muscular pain along left shoulder, forearm, upper back, and left knee, unable to bear weight on leg, crawled from dinning room to bedroom and fell asleep on floor, woke the next morning with headache and nausea and muscle soreness, left knee with acute pain when flexing,
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: redness swelling
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Influenza, Nausea, Pyrexia
Clinical narrative: Flu symptoms: fever, chills, nausea, tired for 12 - 18 hours.
Age: 54.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given second dose one day too early. First dose given 8/25/2022 and second dose given 9/17/2022. Second dose given 23 days from first dose.  Patient did not report any adverse effects during 15 minute wait period post vaccination. Patient was notified of early vaccination and did not report any adverse reactions and the time of call (9/17/2022 @17:48. When called pt stated , " I feel fine." Pt was given information to health department.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Incorrect vaccine give.  Pt is not 65 years of age and should have not received FLUAD 65+.  Pt states she is "feeling just fine."
Age: 60.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pharmacy administered  Fluad 65 +  to patient and he is only 60 years old.  When follow up with pt he states "he feels just fine."
Age: 15.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient given bivalent Moderna, patient is under 18 years of age
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Paraesthesia
Clinical narrative: Because of my previous hospitalization due to an allergic reaction with anyphylaxis (due to food allergies) they observed me for 30 minutes instead of 15. About one hour after the vaccine my entire face started tingling. The tingling continued for 6-7 hours. I then had a sharp headache located on the right forefront of my head that lasted for 24 hours.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes simplex, Skin lesion
Clinical narrative: 3 days after this COVID vax injection, onset of a herpes lesion on lower back, above coccyx; took Rx acyclovir to lessen duration of lesion. (Note: patient has approx. 50-yr Hx of occasional herpes lesion outbreaks on lower back or buttocks, usually occurring after sun exposure or brought on by stressful situation or illness.) This was not serious and was initially thought to be coincidental, but it occurred again after first COVID booster dose and later after updated COVID booster.
Age: 64.0
Sex: M
Vaccine: FLUA4
Symptoms: Incorrect product formulation administered
Clinical narrative: 64 YO GIVEN HD FLU SHOT
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event, she was inadvertently given old version as a booster rather than the new bivalent version.  She was revaccinated with new version
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event from vaccine - but was given the old version as a booster rather than new bivalent one. Was informed by corporate to revaccinate same day with correct vaccine or in 2 months and he chose to get revaccinated with bivalent form same day.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal stiffness, Shoulder injury related to vaccine administration
Clinical narrative: Patient received vaccine and had shoulder pain that evening into the night. She went to her prescriber and was diagnosed with SIRVA. Patient just reported the event on 9/17/22 when she came in for another vaccine. She is still experiencing pain and stiffness in the mornings due to the injury.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes virus infection
Clinical narrative: 3 days after this COVID vax injection, onset of crop of herpes lesions on right buttock (never had herpes lesions before in this same spot; took Rx acyclovir to lessen severity and duration of lesions. (Note: patient has approx. 50-yr Hx of occasional herpes lesion outbreaks on lower back or buttocks, usually occurring after sun exposure or brought on by stressful situation or illness.)
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: The patient called the pharmacy to report that around 8pm around 8pm she noticed redness and itchiness at the injection site. She is using Benadryl for the itchiness. She is monitoring the redness and will go to urgent care if it worsens or does not resolve within the next several days.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event, but was given wrong form. Was given primary series version rather than new bivalent dose. She opted to return in 2 months for the bivalent version.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oral herpes
Clinical narrative: Cold sores all across bottom lip
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Condition aggravated, Herpes virus infection
Clinical narrative: 4 days after this updated COVID vax booster injection, onset of cluster of herpes lesions on right buttock; took Rx acyclovir to lessen duration of lesions. (Note: patient has approx. 50-yr Hx of occasional herpes lesion outbreaks on lower back or buttocks, usually occurring after sun exposure or brought on by stressful situation or illness.) This September 2022 herpes outbreak site was the same as after the previous booster dose of COVID vax in October 2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bundle branch block left, Dyspnoea, Electrocardiogram, Electroencephalogram, Headache
Clinical narrative: Developed trouble breathing, extremely high heart rate nausea vomiting headache etc lasting on and off for 8 months. Developed Left bundle branch block of heart.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Magnetic resonance imaging heart, Nausea, Vomiting
Clinical narrative: Developed trouble breathing, extremely high heart rate nausea vomiting headache etc lasting on and off for 8 months. Developed Left bundle branch block of heart.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Per vaccinating nurse RN?s written report given to this Charge Nurse, RN who was not present at the incident that occurred 09/17/2022 at 2:00pm:   Begin Report regarding patient Date of birth: This RN went to get vaccine. Instead of asking for regular dose of Pfizer vaccine, RN obtained booster. As this RN was talking to family they did not hear 2nd nurse LPN notification that she was going to get a vaccine card. This RN assumed verification was complete and administered vaccine. Wrong vaccine dose administered. Patient was due 2nd dose of Pfizer vaccine. Booster dose of Bivalent Pfizer was administered. Site Supervisor pharmacist, and MD notified. Patient?s mother notified. Orders received from MD to have patient return in 2 months for second dose. No adverse effects noted. Mother aware of error and able to verbalize need to return for 2nd dose in two months? End Report.  The pharmacist in the above report, The on-call provider MD, The Site Supervisor and RN who includes her own written statement below.   Per Site Supervisor RN?s written report given to this Charge Nurse, RN who was not present at the incident:  Begin Report related to pt ?Dr called at 1:56pm by this Site Supervisor RN with information provided above by vaccinating nurse. Provider instructions are to inform parent to return in 2 month for 2nd dose for their child and also inform that child is not fully vaccinated until then. Provider further states no safety concerns or adverse side effects noted. On-site interpreter to provide this information to patient?s parent who stated she understood and would bring the child back in 2 months. This Site Supervisor gave parent their name and number to contact with any further concerns or questions.? End report.
Age: 50.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Delirium, Dizziness, Dysphagia, Erythema, Gait inability
Clinical narrative: Patient started feeling dizzy, her face became red, she was having trouble swallowing 10 to 15 minutes after vaccination. She did not have trouble breathing or did not break out into hives. She became even more delirious and could not walk after 10 more minutes. An epinephrine shot was administered, and she was watched for another 15 minutes. The symptoms subsided. Breathing and face color returned to normal, dizziness went away. I asked her if I could call 911, she said no. I advised her to visit ER.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Throat irritation, Urticaria
Clinical narrative: Called to an exam room to observe a patient after he received the Covid Booster. Injection was given at 1415. Benadryl 25mg Capsules x2 were given at 1420 (total of 50mg), because of c/o throat feeling itchy and dry. Of note, he reported having a previous reaction to the 2nd Covid shot he got. He stated he broke out in hives. With this vaccine, besides the scratchy throat, there were no other symptoms. Vital signs were taken. 146/85 P. 79, 02 sat 99% then 142/89 P.79 02 sat 99%. No respiratory distress observed. He continued to have conversation while being observed. At 1500, he stated he felt fine and wanted to go home. His wife was instructed to drive and to bring him to the urgent care if any serious symptoms came up. She verbalized understanding and willing to comply with follow up care.  She states that they only live 5 minutes away.
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Tdap was given the child by mistake
Age: 67.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Excessive and progressive pain, swelling, redness in Left Arm (Arm with Prevnar 20). Patient stated this started a couple days after vaccination and progressively worsened. Pt reported back the pharmacy 5 days later. Pharmacist advised patient to go to Urgent care or ER. Patient went to ER and was prescribed steroid and antibiotics.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Erythema, Headache, Muscle spasms, Nodule
Clinical narrative: Patient began to have a headache the night the vaccine was administered.  The following day she developed Muscle Spasms, Vertigo/dizziness and her arm became swollen (large knot on her arm and described as a bee sting with a center and red raised around in a circle) and red.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Vertigo
Clinical narrative: Patient began to have a headache the night the vaccine was administered.  The following day she developed Muscle Spasms, Vertigo/dizziness and her arm became swollen (large knot on her arm and described as a bee sting with a center and red raised around in a circle) and red.
Age: 62.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Patient received the HD vs the regular Infuenza Vaccine by error
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: On April 15 2022, , I was sent to have an ultra sound on my lower left leg as it was getting worse in the swelling, coloration and pain level. When it was completed and read by the dr I was told I had a blood clot and would need to go to the ER for evaluation. After a stay in the ER with blood work having been completed, I was started on Eliquis.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: On April 15 2022, , I was sent to have an ultra sound on my lower left leg as it was getting worse in the swelling, coloration and pain level. When it was completed and read by the dr I was told I had a blood clot and would need to go to the ER for evaluation. After a stay in the ER with blood work having been completed, I was started on Eliquis.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received a dose of Moderna for her first preliminary dose even though this vaccine is not recommended for her age. No major side effects occurred after receiving the dose so far. The patient's mother will continue to monitor and will report to the child's pediatrician if any adverse reactions occur.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Low grade fever (99deg F) Muscle pain Joint pain Headache
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Pruritus, Throat irritation, Wheelchair user
Clinical narrative: 39 years old female patient receive Pfizer bivalent booster lot # GH9694 on 9/17/22. Patient started feeling dizzy at 1415. Patient has been transferred to the gurney. Patient stated of having itchiness and scratchy feeling on her throat area. Benadryl IM 50mg/1ml was administered on patient's RD. Patient's VS were as the following: At 1415 BP 158/95 HR 88 O2. At 1420 BP 158/90 HR 88 O2 98%. 1435 BP 178/97 HR 86 O2 98%. At 1440 Patient was stable and stated of feeling better. Patient was educated regarding side effects of Benadryl and instructed to seek medical services for any unusual feeling. Patient was transferred with a wheelchair to the car. Patient left the clinic with her husband.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash erythematous, Urticaria
Clinical narrative: Several red welt like pimples on my cheek (face) and on my chest : Red dot rash in under abdomen skin.
Age: 96.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Chest discomfort, Dehydration, Dizziness, Dysstasia
Clinical narrative: Acute Vomiting, Nausea, feels Faint, dizzy, high BP, sick to stomach w sit, unable to safely stand, arm sore, HA on 9/15-16 +dehydration w muscle cramping at home.  I gave mom sips of water, Gatorade prn till paramedics arrived. Onset Chest discomforts 9/17
Age: 96.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Hypertension, Muscle spasms, Nausea, Pain in extremity
Clinical narrative: Acute Vomiting, Nausea, feels Faint, dizzy, high BP, sick to stomach w sit, unable to safely stand, arm sore, HA on 9/15-16 +dehydration w muscle cramping at home.  I gave mom sips of water, Gatorade prn till paramedics arrived. Onset Chest discomforts 9/17
Age: 96.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Acute Vomiting, Nausea, feels Faint, dizzy, high BP, sick to stomach w sit, unable to safely stand, arm sore, HA on 9/15-16 +dehydration w muscle cramping at home.  I gave mom sips of water, Gatorade prn till paramedics arrived. Onset Chest discomforts 9/17
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: On Thursday, September 16th, 2022 we administered the new bivalent Modena Booster Vaccines to the following patients (listed below). Our Nurse Practitioner on duty was used to the ?0.25mg per dose' booster vaccines which yields 20 doses per vial. She was aware of a difference between the previous monovalent and the new bivalent but wasn?t aware of a vast difference. The bivalent vaccines appear to give 5 doses per vial (0.5mg per dose) versus the monovalent which yielded 20 doses per vial. Our provider was under the impression that it yielded 10 doses per vial. Since 10 doses per vial were administered each patient received 0.25mg instead of 0.5mg.   Each patient did not receive the recommended amount. The POC at the facility is aware of this. There were no adverse reactions noted and everyone seemed to be in good health status prior to our departure.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: On Thursday, September 16th, 2022, at Healthcare, we administered the new bivalent Modena Booster Vaccines to the following patients (listed below). Our Nurse Practitioner on duty was used to the ?0.25mg per dose' booster vaccines which yields 20 doses per vial. She was aware of a difference between the previous monovalent and the new bivalent but wasn?t aware of a vast difference. The bivalent vaccines appear to give 5 doses per vial (0.5mg per dose) versus the monovalent which yielded 20 doses per vial. Our provider was under the impression that it yielded 10 doses per vial. Since 10 doses per vial were administered each patient received 0.25mg instead of 0.5mg.   Each patient did not receive the recommended amount. The POC at the facility is aware of this. There were no adverse reactions noted and everyone seemed to be in good health status prior to our departure.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Based on the current recommendations, patient need to only get one Prevnar20 in a lifetime.  When patient was asked if she wanted to get the pneumonia vaccination, she said yes.  Our computer system did not alert the pharmacist that the patient had already received this same vaccine 61 days prior... this could have been because a different policy was billed so we did not get flagged.  In any case, we have called the patient numerous times but she has not returned our call back and as such, I do not have any facts or information on how the patient is doing or whether the patient has experienced any adverse events due to getting the same vaccination in the span of two months.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Delirium, Fall, Feeding disorder, Feeling hot
Clinical narrative: The wife called the pharmacy on Sept 15, 2022, informing us that her husband was rushed to the emergency room on Sept 13, 2022. According  to her, the husband was fine after the vaccination (Sept 12th) but on the morning the next day (Sept 13th), he suddenly fell from a chair and he was so weak, hot, sweaty, delirious, speaking garbled. She brought him to the emergency room and was treated with IV fluids and antibiotics. Doctors from the ER said his condition might have come from the vaccine. He was discharged the same day. His husband was just in bed since then, not able to eat, drinks only water.   I called on Sept 16th to check on patient's condition and she said he still weak. Her husband who is healthy and never gets sick suddenly  became weak after getting the Pfizer Bivalent booster dose.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Speech disorder
Clinical narrative: The wife called the pharmacy on Sept 15, 2022, informing us that her husband was rushed to the emergency room on Sept 13, 2022. According  to her, the husband was fine after the vaccination (Sept 12th) but on the morning the next day (Sept 13th), he suddenly fell from a chair and he was so weak, hot, sweaty, delirious, speaking garbled. She brought him to the emergency room and was treated with IV fluids and antibiotics. Doctors from the ER said his condition might have come from the vaccine. He was discharged the same day. His husband was just in bed since then, not able to eat, drinks only water.   I called on Sept 16th to check on patient's condition and she said he still weak. Her husband who is healthy and never gets sick suddenly  became weak after getting the Pfizer Bivalent booster dose.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Underdose
Clinical narrative: On Thursday, September 16th, 2022, at a HCF, we administered the new bivalent Modena Booster Vaccines to the following patients (listed below). Our Nurse Practitioner on duty was used to the ?0.25mg per dose' booster vaccines which yields 20 doses per vial. She was aware of a difference between the previous monovalent and the new bivalent but wasn?t aware of a vast difference. The bivalent vaccines appear to give 5 doses per vial (0.5mg per dose) versus the monovalent which yielded 20 doses per vial. Our provider was under the impression that it yielded 10 doses per vial. Since 10 doses per vial were administered each patient received 0.25mg instead of 0.5mg.   Each patient did not receive the recommended amount. The POC at the facility is aware of this. There were no adverse reactions noted and everyone seemed to be in good health status prior to our departure. ??
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: On Thursday, September 16th, 2022, at Healthcare, we administered the new bivalent Modena Booster Vaccines to the following patients (listed below). Our Nurse Practitioner on duty was used to the ?0.25mg per dose' booster vaccines which yields 20 doses per vial. She was aware of a difference between the previous monovalent and the new bivalent but wasn?t aware of a vast difference. The bivalent vaccines appear to give 5 doses per vial (0.5mg per dose) versus the monovalent which yielded 20 doses per vial. Our provider was under the impression that it yielded 10 doses per vial. Since 10 doses per vial were administered each patient received 0.25mg instead of 0.5mg.   Each patient did not receive the recommended amount. The POC at the facility is aware of this. There were no adverse reactions noted and everyone seemed to be in good health status prior to our departure.
Age: 42.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Abdominal pain, Lipase increased, Pancreatitis acute, Pyrexia
Clinical narrative: Acute Pancreatitis - developed fever and moderate abdominal pain 8 days after vaccine administration. 10 days after vaccination, sought medical care due to abdominal pain. Was diagnosed with pancreatitis based on lipase result and symptoms.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Rash erythematous, Rash pruritic
Clinical narrative: In my 63 yrs I had never been allergic to an antibiotic. Within th past 3 months I have had an allergic reaction to 2 different ones. The most recent being reaction to Amoxicillan. Red, itchy, burning rash all over my body requiring 2 trips to urgent care facility.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient requested a booster Bivalent Moderna vaccine. However was given the old Monovalent Moderna in errror.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Genital lesion, Herpes virus test, Skin necrosis
Clinical narrative: Necrotic genital sores
Age: 33.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: Pharmacy administered the incorrect dose (and later stated that they've done this for every administration of the bivalent Moderna dose)
Age: 33.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Pharmacy administered the incorrect dose (and later stated that they've done this for every administration of the bivalent Moderna dose)
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Muscle fatigue
Clinical narrative: Headaches, muscle fatigue, joint pain, fatigue
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: MONOVALENT VACCINE GIVEN WHEN NOT RECOMMENDED ANYMORE
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: MONOVALENT VACCINE GIVEN NOT RECOMMENDED ANYMORE. BIVALENT SHOULD HAVE BEEN GIVEN
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: MONOVALENT VACCINE GIVEN WHEN NO LONGER RECOMMENDED
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No known adverse events. Nurse not aware that monovalent vaccine should no longer be used as a COVID booster Dose.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Incorrect product formulation administered, No adverse event
Clinical narrative: No known adverse events. Nurse not aware that monovalent vaccine should no longer be used as a COVID booster Dose.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Incorrect product formulation administered, No adverse event
Clinical narrative: No known adverse events. Nurse not aware that monovalent vaccine should no longer be used as a COVID booster Dose.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: No known adverse events. Nurse not aware that monovalent vaccine should no longer be used as a COVID booster Dose.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Incorrect product formulation administered
Clinical narrative: COVID booster Dose.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Incorrect product formulation administered, No adverse event
Clinical narrative: No known adverse events. Nurse not aware that monovalent vaccine should no longer be used as a COVID booster Dose.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No known adverse events. Nurse not aware that monovalent vaccine should no longer be used as a COVID booster Dose.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No known adverse events. Nurse not aware that monovalent vaccine should no longer be used as a COVID booster dose.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Incorrect product formulation administered, No adverse event
Clinical narrative: No known adverse events. Nurse not aware that monovalent vaccine should no longer be used as a COVID booster Dose.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: COVID booster Dose.
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 15-Jun-2022, 3rd  25-Aug-2022; 1st dose 23-Mar-2022, 2nd 15-Jun-2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received HBV (Engerix B) (batch number 98X5P, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 98X5P, expiry date unknown) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 25th August 2022, the patient received the 3rd dose of Engerix B. On 15th June 2022, the patient received the 2nd dose of Engerix B. On 15th June 2022, Engerix B, the patient experienced drug dose administration interval too long. On 25th August 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.   Additional Information: GSK receipt date: 07-Sept-2022 Reporters comment: As per the reporter, all doses were from lot 98X5P. As no other patient identifiers were reported, as per the reporter, patients received the same product on the same dates, same lot number. The reporter consent to follow-up. Additional Supportive information: The patient received the 2nd dose of Engerix B later than the recommended interval and 3rd dose of Engerix B earlier than the recommended interval, which led to  lengthening of vaccination schedule and shortening of vaccinations schedule. This case has been linked to the case US2022AMR129963, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR129963:Same reporter
Age: 63.0
Sex: M
Vaccine: COVID19-2, COVID19, COVID19-2
Symptoms: Dizziness, Ear discomfort, Pain in extremity, Vertigo
Clinical narrative: I had bivalent and flu shot same day same arm.  4 days after shot I started to have severe vertigo and dizziness.   It is 9 days later and I still have symptoms.  I went to my ENT and he ran several tests, including hearing test.  I have no sign of inner ear issues.  He said it is a side effect of booster shot.  He prescribed Meclizine.    I cannot find any information on this symptom other than blogs.  Is there any information on how long it lasts?
Age: 63.0
Sex: M
Vaccine: COVID19-2, COVID19, COVID19-2
Symptoms: Acoustic stimulation tests normal, Dizziness, Vertigo
Clinical narrative: I had bivalent and flu shot same day same arm.  4 days after shot I started to have severe vertigo and dizziness.   It is 9 days later and I still have symptoms.  I went to my ENT and he ran several tests, including hearing test.  I have no sign of inner ear issues.  He said it is a side effect of booster shot.  He prescribed Meclizine.    I cannot find any information on this symptom other than blogs.  Is there any information on how long it lasts?
Age: 63.0
Sex: M
Vaccine: COVID19-2, COVID19, COVID19-2
Symptoms: Dizziness, Vertigo
Clinical narrative: I had bivalent and flu shot same day same arm.  4 days after shot I started to have severe vertigo and dizziness.   It is 9 days later and I still have symptoms.  I went to my ENT and he ran several tests, including hearing test.  I have no sign of inner ear issues.  He said it is a side effect of booster shot.  He prescribed Meclizine.    I cannot find any information on this symptom other than blogs.  Is there any information on how long it lasts?
Age: 0.75
Sex: M
Vaccine: UNK
Symptoms: Crying, Hypotonia, Injection site pain, Irritability, Lethargy
Clinical narrative: September 1 - runny nose, lethargic September 2 - see above, plus unhappy Sept 3 - see above, plus fever and crying, no smiles Sept 4 - see above, plus pain at injection site, low muscle tone, moaning day and night Sept 5 - fever gone, but very clingy and crabby, no smiles Sept 6 - crying a lot, covered in a rash Sept 7 0 rash spread beyond chest and back, now on legs, arms, face and feel as well.  Was barely happy, maybe for 1/2 hour of all awake time Sept 8 - slightly happier, still has rash, very clingy Sept 9 - much happier, mostly back to himself.
Age: 0.75
Sex: M
Vaccine: UNK
Symptoms: Moaning, Pyrexia, Rash, Reduced facial expression, Rhinorrhoea
Clinical narrative: September 1 - runny nose, lethargic September 2 - see above, plus unhappy Sept 3 - see above, plus fever and crying, no smiles Sept 4 - see above, plus pain at injection site, low muscle tone, moaning day and night Sept 5 - fever gone, but very clingy and crabby, no smiles Sept 6 - crying a lot, covered in a rash Sept 7 0 rash spread beyond chest and back, now on legs, arms, face and feel as well.  Was barely happy, maybe for 1/2 hour of all awake time Sept 8 - slightly happier, still has rash, very clingy Sept 9 - much happier, mostly back to himself.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Cough, Malaise
Clinical narrative: Cough, 104 temperature for 2 days, cough for 14 days, malaise for 10 days
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Renal pain
Clinical narrative: I got flu like symptoms for three days and now I have nausea and pain in my kidney area.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Productive cough
Clinical narrative: Continue none productive cough all night
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Injection site erythema, Injection site nodule, Muscle spasms, Pain
Clinical narrative: Huge amount of swelling .  Big  red patch and knot in thigh at injection site, constant cramping and muscle spasms in back, hips, buttock, thighs and calfs, High fever, Severe headache,  retching and .  Almost as painful as when I had C-Diff.  If they're just going to get more painful each time, I'm out.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Retching, Swelling
Clinical narrative: Huge amount of swelling .  Big  red patch and knot in thigh at injection site, constant cramping and muscle spasms in back, hips, buttock, thighs and calfs, High fever, Severe headache,  retching and .  Almost as painful as when I had C-Diff.  If they're just going to get more painful each time, I'm out.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Cellulitis, Chills, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Fever-Medium, Systemic: cellulitis, needed doxycycline-Medium, Additional Details: Pt needed doxycycline to cure infection after vaccine, she states the way it was given was not sanitary with not using alcohol to clean blood.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Fever-Medium, Systemic: cellulitis, needed doxycycline-Medium, Additional Details: Pt needed doxycycline to cure infection after vaccine, she states the way it was given was not sanitary with not using alcohol to clean blood.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Burning sensation, Cellulitis, Erythema, Injection site haemorrhage, Mass
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Fever-Medium, Systemic: cellulitis, needed doxycycline-Medium, Additional Details: Pt needed doxycycline to cure infection after vaccine, she states the way it was given was not sanitary with not using alcohol to clean blood.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Confusional state, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Medium, Systemic: Unable to Sleep-Medium, Additional Details: pain in left arm, pt can not raise arm over head with out pain.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Medium, Systemic: Unable to Sleep-Medium, Additional Details: pain in left arm, pt can not raise arm over head with out pain.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild.
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme, Rash
Clinical narrative: Erythema multiforme starting 10 days post vaccine administration. No fever or respiratory symptoms. Rash covered trunk, abdomen, back, neck, face, all 4 extremities, hands and feet. Currently receiving prednisolone taper.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Tinnitus
Clinical narrative: Had four bruises under the opposite arm (right arm) two days after vaccine given.  No injury or explanation for the bruising  Also moderate tinnitus started in both ears for no apparent reason about two months after vaccination and continues until present ?-awaiting an ENT referral visit in early November since it has not resolved
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Hearing loss/Tinnitus right ear
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paranoia, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: I woke up in the middle of the night suffering paranoia with thoughts that didn?t make sense. It lasted for three hours roughly.  I do not have a history of mental illness or paranoia. It was something I have never experienced before, I?ve been researching since this happened and found Covid itself may cause this. I test negative so I think my immune response caused this but this could cause danger to someone.