chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The caller was sick the whole week and he has been told by his doctor that he is positive for Covid and he started to get symptoms when he took the vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Sep2024, outcome "unknown", described as "The caller was sick the whole week and he has been told by his doctor that he is positive for Covid and he started to get symptoms when he took the vaccine". The events "the caller was sick the whole week and he has been told by his doctor that he is positive for covid and he started to get symptoms when he took the vaccine" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient is calling about Pfizer Covid-19 vaccine. On the set of the call, he said that he is really upset because he took the vaccine last week (Sep2024) and at the pharmacy. He was sick the whole week and he has been told by his doctor that he is positive for Covid, and he started to get symptoms when he took the vaccine. He needs appropriate information because he is not certain that his doctor was telling the truth.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Headache
Clinical narrative: Headache; Bad asthma attack; This is a spontaneous report received from a consumer, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma caused by pollen" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ASTHMA (non-serious) with onset 24Sep2024, outcome "recovered" (27Sep2024), described as "Bad asthma attack"; HEADACHE (non-serious) with onset 24Sep2024, outcome "recovered" (27Sep2024). Therapeutic measures were taken as a result of asthma.  Additional Information: The patient had the new COVID-19 vaccine on 24Sep2024 and, in addition to the headache, during the night (about 13 hours later), the patient had a bad asthma attack. The patient did have asthma generally caused by pollen. The patient had inhalers. It lasted 3 days during the time of the headache but was controllable with the patient's inhalers. The patient would just like to know if the company had anybody else report this as a side effect and/or if this could have been a side effect to the vaccine.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, FLUX, RVX
Symptoms: Malaise
Clinical narrative: not feeling too well after getting them and advised can be normal to feel a little bad after getting a vaccine; Initial information received on 20-Sep-2024 regarding an unsolicited valid non-serious case received from the patient.  This case involves an approximately 52 year old female patient who was treated with DUPILUMAB [DUPIXENT] via prefilled pen, INFLUENZA VACCINE, COVID-19 VACCINE and RSV VACCINE and complained that she was not feeling too well after getting them and advised can be normal to feel a little bad after getting a vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date in Aug-2024, the patient started taking subcutaneous DUPIXENT (DUPILUMAB) Solution for injection at a dose of 300 mg QOW (every other week) (strength: 300 mg/2ml) via prefilled pen for Asthma and Chronic obstructive pulmonary disease.  On an unknown date in 2024, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date in 2024, the patient received a dose of suspect RSV VACCINE and COVID-19 VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On an unknown date in 2024 the patient developed a non-serious event "not feeling too well after getting them and advised can be normal to feel a little bad after getting a vaccine" (malaise) (unknown latency) following the first dose intake (unknown batch number and expiration date) of DUPILUMAB, COVID-19 VACCINE, INFLUENZA VACCINE and RSV VACCINE.  It was reported "PT (Patient) reported got covid/flu/and RSV (Respiratory Syncytial Virus Vaccine) vaccines and wanted to confirm no issues with dupixent. Unknown exact date pt received the vacines. Confirmed no issues. Pt reported not feeling too well after getting them and advised can be normal to feel a little bad after getting a vaccine however advised to continue to monitor and if not improving to contact MD (Doctor of Medicine). No other information provided."  DUPILUMAB (DUPIXENT) was continued for the event. Action taken with COVID-19 VACCINE, INFLUENZA VACCINE and RSV VACCINE was not applicable for the event.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 1.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients with no reported adverse event; All patients involved in this administration range were one year of age with no reported adverse event; Initial information received on 25-Sep-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 1 years old and unknown gender 26 patient(s) where diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients with no reported adverse event and all patients involved in this administration range were one year of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Aug-2024, the patient(s) received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot- 2CA77C1/3CA03C3 and expiration date- unknown) via intramuscular route in unknown administration site (dose, strength and expiration date: not provided) for Immunistion and vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients with no reported adverse event (product storage error) and all patients involved in this administration range were one year of age with no reported adverse event (poor quality product administered) (latency- same day for both events).  Reportedly, From 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was administered in which only the ACTHIB was given, and it was reconstituted with sterile water with no reported adverse event; Pentacel was administered in which only the ACTHIB was given, and it was reconstituted with sterile water with no reported adverse event; Initial information received on 16-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old male patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered in which only the ACTHIB was given, and it was reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine; and Rotavirus vaccine both for Immunisation.  On 13-Sep-2024, the patient was administered 0.5 ml once dose 3 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot UK109AA and Expiration date:  30-SEP-2025) via intramuscular route in the left thigh for Immunization in which only the acthib was given, and it was reconstituted with sterile water with no reported adverse event (single component of a two-component product administered) (product preparation error) (latency; same day).   The DTAP/IPV was not administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
Clinical narrative: adacel was administered to 33 weeks pregnant patient with no reported adverse event; first dose was administered on 02AUG2024 and the second dose of ADACEL administered on 16SEP2024 with no reported adverse event; Initial information received on 16-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 31 years old female patient who was administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] while 33 weeks pregnant; first dose was administered on 02-Aug-2024 and the second dose of Adacel administered on 16sep2024 with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported adacel was administered to 33 weeks pregnant patient with no reported adverse event occurred at 33 weeks of pregnancy and first dose was administered on 02AUG2024 and the second dose of ADACEL administered on 16SEP2024 with no reported adverse event occurred at 33 weeks of pregnancy and the patient was exposed to vaccine at 28 weeks of pregnancy, during third pregnancy trimester for diphtheria-2/tetanus/5 ac pertussis Vaccine.  The date of last menstrual period was reported as 24-Jan-2024.  The estimated due date is 24-Oct-2024.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Sep-2024, the patient received 0.5 ml dose 1 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (strength- standard) via intramuscular route in the left deltoid and On 02-Aug-2024 she also received 0.5 ml dose 2 of vaccine (lot- U8015AA and expiration date- 01-MAR-2026) via intramuscular route in the left deltoid for Immunisation and adacel was administered to 33 weeks pregnant patient with no reported adverse event (maternal exposure during pregnancy) and first dose was administered on 02aug2024 and the second dose of adacel administered on 16sep2024 with no reported adverse event (inappropriate schedule of product administration) (latency- same day for both events).  Additionally, at time of reporting, the pregnancy is still ongoing.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired product to a patient with no reported adverse event; Initial information received on 16-Sep-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5-year-old female patient and administration of an expired product diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Polio vaccine inact (Ipv); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); and Varicella zoster vaccine for Immunisation.  On 16-Sep-2024, the patient received a 0.5 ml dose (dose 5) of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot C6013AA and expiry date: 05-Jul-2024  via intramuscular route in the right thigh for immunization and administration of an expired product to a patient with no reported adverse event (expired product administered)(latency: on same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 17-Sep-2024 regarding an unsolicited valid  non-serious case received from a Pharmacist.  This case is linked to case US-SA-2024SA281942  This case involves a 85 years old female patient who had inappropriate use due to administration of an expired vaccine with no reported adverse event for influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine for Immunisation.  On 16-Sep-2024, the patient had an inappropriate use due to administration of an expired influenza quadrival A-B high dose HV vaccine (strength and formulation unknown) at of dose 0.7 ml x1 (once)  (lot U8135BA; expiry-30-Jun-2024) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA281942:
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired dose of fluzone high dose qiv with no reported adverse event; Initial information received on 17-Sep-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case- 2024SA281919  This case involves a 71 years old male patient who was administered expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Sep-2024, the patient was administered expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE dose 0.7 ml x1 (once) lot U8135BA, expiry-30-Jun-2024 via intramuscular route in the left deltoid for Immunization (strength, form unknown) with no reported adverse event (expired product administered) (latency same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA281919:
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: accidentally administering vaccine to pediatric patient, with no reported adverse event; Initial information received on 17-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 12 years old male patient who accidentally got administered Influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] vaccine to pediatric patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP rL1 9v (yeast) (Gardasil 9).  On 20-Aug-2024, the patient received 0.5 ml dose of suspect Influenza usp trival a-b subvirion no preservative vaccine (Strength- High Dose) (Frequency- once) Suspension for injection (lot- UT8415JA and expiration date- 30-JUN-2025) via intramuscular route in the right deltoid for Influenza and accidentally administering vaccine to pediatric patient, with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACT-HIB, which was prepared using the sterile water diluent from an MMR vaccine instead of the appropriate diluent with no adverse event; Initial information received on 18-Sep-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 5 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] which was prepared using the sterile water diluent from an MMR vaccine instead of the appropriate diluent with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (route, dose, strength, lot and expiry) which was prepared using the sterile water diluent from an MMR vaccine instead of the appropriate diluent with no adverse event (product preparation error) (latency same day) in unknown administration site for Prophylactic Vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swollen face 6 hours after administration of vaccine. Patient self treated using Benadryl and symptoms resolved. Of note, patient noted past allergies to ibuprofen and Sudafed.
Age: 63.0
Sex: M
Vaccine: COVID19, FLU3, RSV
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Right hand, mainly index finger, would not function. Severe cramping and pain. Could not make a fist. Went to the ER and got a steroid shot. A week later, the left hand did the same thing, but not as badly.
Age: 67.0
Sex: F
Vaccine: CHIK
Symptoms: Contraindication to vaccination
Clinical narrative: per travel directive patient was to receive ixchiq vaccine.  patient is immunocompromised and received this live vaccine
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: bruising around injection site noticed when patient got home and removed the band-aid.  as of 10/1/24 bruising is approximately half dollar size, yellow and green on the edges and dark purple towards the center
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Product packaging confusion, Wrong product administered
Clinical narrative: Patient, age 53, was administered Fluzone High Dose instead of Fluzone 6 months +.  No reported reaction.  Medical assistant reported the Fluzone and Fluzone High Dose look a lot alike.  Physican contacted patient immediately and advised him that he might be more likely to get a local or systemic reaction to it.  He states he understands.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Our program received the updated COVID vaccine for 2024-25 on 9/19/24. Our administrative assistant followed the usual process for receiving a vaccine shipment, but it wasn't until the following day that we realized the cold chain had not been maintained during shipping to our site. As it turned out, we had a clinic scheduled early on the morning of 9/20/24 and by the time it was discovered by our vaccine coordinator that the cold chain was not maintained, six (6) vaccines had been administered to patients.  After confirmation from our state health department and the manufacturer, we then contacted the patients to let them know that they need to be revaccinated.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: redness, light swelling and fever. advised patient to take extra strength tylenol as needed and ice pack
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Large hive at injection site, it s 27 hours post shot, it s hot to the touch, about 2-2.5  wide in an imperfect circle
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Our program received the updated COVID vaccine for 2024-25 on 9/19/24. Our administrative assistant followed the usual process for receiving a vaccine shipment, but it wasn't until the following day that we realized the cold chain had not been maintained during shipping to our site. As it turned out, we had a clinic scheduled early on the morning of 9/20/24 and by the time it was discovered by our vaccine coordinator that the cold chain was not maintained, six (6) vaccines had been administered to patients.  After confirmation from our state health department and the manufacturer, we then contacted the patients to let them know that they need to be revaccinated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Our program received the updated COVID vaccine for 2024-25 on 9/19/24. Our administrative assistant followed the usual process for receiving a vaccine shipment, but it wasn't until the following day that we realized the cold chain had not been maintained during shipping to our site. As it turned out, we had a clinic scheduled early on the morning of 9/20/24 and by the time it was discovered by our vaccine coordinator that the cold chain was not maintained, six (6) vaccines had been administered to patients. After confirmation from our state health department and the manufacturer, we then contacted patients to let them know that they need to be revaccinated.
Age: 1.58
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Vomiting
Clinical narrative: Patient was given 12 and up dose of Covid vaccine. Mom was contacted after incident occurred. Mom denied any reactions to the vaccine. States he had one episode of vomiting two days prior, but does not believe that this was a vaccine related issue and has not had vomiting since. Denied fever, lethargy, SOB, weakness. States he is sleeping well. Eating more yogurt and pouches at dinner, but otherwise eating normally. Patient was seen in office on 09/06/24 and had a normal vision screen and normal physical exam.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, heat at injection site.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Accidentally administered pediatric dose (6mo-11y) instead of adult dose (12+)
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: Patient reported swollen tongue lasting 3 weeks
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: Staff member reported to Employee Health that on Thursday 9/26/2024 she started having a red arm, painful, she placed ice on it. Then she started to get nawing pain to her neck down to her elbow. Pt reports she is having difficulty sleeping due to the nawing pain.  She states she is taking NSAIDS, rest and ice.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: pt had soreness all the way up to her neck
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dry skin, Pruritus, Rash, Rash erythematous
Clinical narrative: PATIENT RECEIVED FLUCELVAX VACCINE ON 09/06, NOTICED ON 09/07 RASH DEVELOPED BOTH HANDS ITCHY, RED, DRY, ESPECIALLY ON PALMS AND BETWEEN FINGERS, LITTLE RED BUMPS. PATIENT DID NOT CONTACT MD ONLY REPORTED ON 10/01 TO PHARMACIST AFTER 2 WEEKS, "GLOVE LIKE" RASH HAS SUBSIDED. ONLY COUPLE LITTLE RED BUMPS STILL ON HANDS REMAINING.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Nervousness
Clinical narrative: patient (new) came to the drop off window requesting a COVID vaccine just before 6pm EST. added the patient information into database as well as checking system for vaccine history. patient had never received a covid dose in the past for informed the patient that NOVAVAX would be a two dose series, three weeks apart from shot one and two and confirmed patient was okay with this before handing over the consent form and submission thru patient insurance. also notified the patient of the waiting period of fifteen minutes was a requirement to guarantee patient safety and response to the admin of the COVID dose. during the administration of vaccine the patient was fine (alert and conquerent and stated that she barely felt the injection). She went to go sit on the bench in front of the pharmacy pickup window to wait her time of 15 min.  went to check her around 15 min mark and she stated she felt shaky; gave her some water and checked on her a little later and she was waiting for her ride to come pick up her (also had a significant other on facetime on her cellular phone). upon ringing out a customer she started to spasm with her right arm stiff and crossed up over her chest. a customer and pharmacy associate protected the patient and got her to lay down flat and then off her side while I called 911 to have EMS dispatched as well as asking a sales associate to get the sheriff officer from the door to come help assist while I was on the phone with EMS. they came within 5-7 min and checked her vitals out in each her pulse/pressure and glucose reading(102) were within the normal range. she was then team lifted on to the stretcher and left the building in EMS vehicle. was coherent at the time of leaving the building to head to local emergency department.
Age: 75.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Blood pressure decreased, Dizziness, Feeling hot, Heart rate decreased
Clinical narrative: Patient started getting lightheaded and Warm after getting vaccine, EMS team checked out BP and HR and it was Low. he was sent to ER after activating emergency protocol
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient received vaccine and went to sit with her dad. She sat for about 10 minutes then got up to leave. When she got up, she passed out. She was very pale. We elevated her feet and called 911. She came around quickly. EMTs checked her out. She went home with family.
Age: 32.0
Sex: M
Vaccine: COVID19, HEP
Symptoms: Eye pain, Hyperhidrosis, Loss of consciousness, Nausea, Skin discolouration
Clinical narrative: After the second vaccine pt passed out.  Technician reported to Rph.  10:20am BP 126/90 90 Pulse patient woke while taking his Blood pressure.  He reported nausea and eye pain.  Temp 95.1   At 10:28am 99 pulse ox 88 pulse. 10.33am pt returning to normal skin color and no longer sweating.  At 10:37 pt still nauseous when lifting his head, but states he is improving .  At 10:41am pt has chosen to lay down as he recovers.  10:45am BP 96/72  pulse 75  Called EMS.  Paramedics met him in the parking lot.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: seizure - EMS arrived. pt refused transport to hospital. was fine after a few minutes
Age: 41.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Cold sweat, Dizziness, Eye movement disorder, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient received the flu shot first with no issues. After the COVID vaccine was administered patient became non-cognizant to his surroundings. Then his eyes rolled into the back of his head and he became rigid. He appeared to be having a seizure. After about 30 seconds he came back to and was able to speak normally. He knew his name and address and where he was, he said he just blacked out. He was dizzy, sweating, and his face was very pale and clammy. He never fell over or hit his head. 911 was called and he was taken to the nearest hospital in an ambulance.
Age: 41.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: Patient received the flu shot first with no issues. After the COVID vaccine was administered patient became non-cognizant to his surroundings. Then his eyes rolled into the back of his head and he became rigid. He appeared to be having a seizure. After about 30 seconds he came back to and was able to speak normally. He knew his name and address and where he was, he said he just blacked out. He was dizzy, sweating, and his face was very pale and clammy. He never fell over or hit his head. 911 was called and he was taken to the nearest hospital in an ambulance.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC20, RAB
Symptoms: Blister, Erythema, Injection site warmth, Swelling
Clinical narrative: Redness, swelling. Patient reports that the lower left deltoid (site of the Prevnar 20 vaccination) was warm to the touch. Concern about redness and "bubbling." Patient sought treatment on 09/28/24 due to symptoms. Symptoms have begun to resolve.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC20, RAB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, swelling. Patient reports that the lower left deltoid (site of the Prevnar 20 vaccination) was warm to the touch. Concern about redness and "bubbling." Patient sought treatment on 09/28/24 due to symptoms. Symptoms have begun to resolve.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Periorbital swelling, Pruritus, Rash
Clinical narrative: Swelling, itching, rash to face and neck. Periorbital swelling. Pain and significant swelling to injection site
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Swelling face
Clinical narrative: Swelling, itching, rash to face and neck. Periorbital swelling. Pain and significant swelling to injection site
Age: 71.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Atrial fibrillation, Blood pressure decreased, Catheterisation cardiac normal, Electrocardiogram normal
Clinical narrative: Patient started to feel very weak and was evaluated with extremely low blood pressure requiring hospitalization. According to the patient, they did a heart catheter and had heart evaluated. Patient described atrial fibrillation and hypotension. Patient stated that the cardiologist was perplexed and had never seen anything like this before with no blockages or issues with the heart.
Age: 71.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Hypotension
Clinical narrative: Patient started to feel very weak and was evaluated with extremely low blood pressure requiring hospitalization. According to the patient, they did a heart catheter and had heart evaluated. Patient described atrial fibrillation and hypotension. Patient stated that the cardiologist was perplexed and had never seen anything like this before with no blockages or issues with the heart.
Age: 35.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: woke up earlier than expected to a possible hallucination (noises in the wall) at 7am; then headache, fever, fatigue, lack of appetite that was mild 8am to Noon, became moderate Noon through evening
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Per patient: developed rash (whole body, down arms, legs. back, armpits) late Thursday night 09/19/24 11pm - started itching. Have used Benadryl and Hydrocortisone 1% cream since Friday morning 09/20/24 and still has rash under armpits and chest. No rash @ injection sites.  Patient stated rash changed to hives couple of days after vaccinations. Patient believes it is Moderna (Spikevax) shot since she only had Pfizer shots before.   FYI- PHARMACY TRIED FAXING WRITTEN FORM TO 877-721-0366 SINCE 09/23/24 BUT HAD BUSY SIGNAL ALL THE TIME*
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Lymphadenitis, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Inflamed lymph nodes, stiff arm and neck as well as cramping, headache in base of skull, numbness and severe pain up and dow are as well as facial nerve numbness  all along right side of face and body .
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Inflamed lymph nodes, stiff arm and neck as well as cramping, headache in base of skull, numbness and severe pain up and dow are as well as facial nerve numbness  all along right side of face and body .
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two doses of Comirnaty instead of one plus a flu shot.  No adverse effects at this time, will follow up with patient.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pruritus, Scab, Urticaria
Clinical narrative: patient had hives that looked similar to chicken pox (round, pink, hard dots) across her arms and back of shoulder region. She was scratching the marks and had several scabs from where she scratched the heads off the marks.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dyspnoea, Heart rate increased, Nervousness
Clinical narrative: Shortly after receiving the 2nd immunization (flu) patient stated that she felt short of breath. Patient had rescue albuterol inhaler on hand and used several puffs over the course of 5-7 minutes. I asked if patient felt like her throat was swelling or closing and she stated no. After using albuterol inhaler she started to feel better and less short of breath. By the time she left the pharmacy she was back to her baseline. Patient did state that she had increasing shortness of breath and need for rescue inhaler over the  last several months. Patient has never had a reaction in the past to either vaccine. I called patient to follow up before the end of business the same day and she said she was feeling better, she was shaky and had increased heart rate for some time after, most likely due to the use of albuterol.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Magnetic resonance imaging, Pain in extremity
Clinical narrative: Pt came to pharmacy 10/1/24 and reported her arm was sore since the vaccine date and had a hard time raising her left arm. She said she just had a MRI and doctor indicate there might be a lesion on her left shoulder that could be the cause. She left a message for her Doctor to discuss. I recommended customer to take ibuprofen up to 800mg q6-8hours and icing. The injection site  was not warm to touch or red.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: The patient had requested the Pfizer Covid vaccine but was given the Fluad Flu vaccine even though she had already received the flu shot on 9/3/24 from at her doctor's office.  She did not report any adverse event from receiving two doses of the flu shot in one month.
Age: 52.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Please contact pharmacy for the information about the vaccines as our clinic did not administer and unable to find this information.  red/swelling/hot at injection site/pain after getting covid and flu vaccine in left arm.  She complains of worsening swelling and getting larger in the past 5 days(lesion is circular over injection site about 10cm by 6cm). She also has headache and fatigue. Patient treated at home with cold compress and Benadryl and ibuprofen. Benadryl and cold compress did not help. Ibuprofen helped with headache. patient had many covid vaccines before with no issue. concerned that this was covid vaccine. Patient concerned for cellulitis patient told that this most likely reaction of the vaccine (most likely not bacterial) however since it is worsening swelling and getting larger did cover for possible bacterial infection with keflex for 10days also given kenalog topical cream for allergic reaction. Recommended daily antihistamine like zyrtec. Patient explained this could be a side effect of the vaccine or even could be covid arm- which in is an exaggerated response to the vaccine-patient is aware. Patient aware if not improving or worsening to follow up with PCP/urgent care or urgent care or Er if worsening
Age: 52.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site warmth, Treatment failure
Clinical narrative: Please contact pharmacy for the information about the vaccines as our clinic did not administer and unable to find this information.  red/swelling/hot at injection site/pain after getting covid and flu vaccine in left arm.  She complains of worsening swelling and getting larger in the past 5 days(lesion is circular over injection site about 10cm by 6cm). She also has headache and fatigue. Patient treated at home with cold compress and Benadryl and ibuprofen. Benadryl and cold compress did not help. Ibuprofen helped with headache. patient had many covid vaccines before with no issue. concerned that this was covid vaccine. Patient concerned for cellulitis patient told that this most likely reaction of the vaccine (most likely not bacterial) however since it is worsening swelling and getting larger did cover for possible bacterial infection with keflex for 10days also given kenalog topical cream for allergic reaction. Recommended daily antihistamine like zyrtec. Patient explained this could be a side effect of the vaccine or even could be covid arm- which in is an exaggerated response to the vaccine-patient is aware. Patient aware if not improving or worsening to follow up with PCP/urgent care or urgent care or Er if worsening
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient contacted HD on 9/26/24 reporting red bumps that itch on legs, thighs, arms, stomach, and chest.  Patient recognized red bumps starting on 9/20/24 and they have not gotten worse or progressed. Patient did recognize redness and swelling to arm at site of vaccine starting 9/11/24 and this cleared up. I recommended following up with a provider and patient informed me that she would go to urgent care today. On 10/1/24 I followed-up with patient. She reported provider informed her she did not have chicken pox and prescribed a steroid. The steroid did clear up all red bumps and all are gone as of today.  Reaction to something, but provider did not specify to vaccine. No information provided for future VZV vaccines. I recommended patient contact primary provider before receiving another chicken pox vaccine.
Age: 63.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received wrong vaccine, presented prescription for IPV and received HPV due to handwriting on script. Patient did not have adverse reaction, and felt ok after vaccine.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient is 69 years old and inadvertently received a regular dose Fluzone rather than High Dose
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: We discovered that patient went to 2 different and received the same vaccine. First one was 8/9/2024, and second one 10/1/2024. To our knowledge, no adverse signs or symptoms have occurred.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Malaise, Pyrexia, Rash, Rash pruritic
Clinical narrative: Mild discomfort and malaise after shot. Oneish day fever. Unexplained itching/painful full body rash for about 3-5 days after.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Wheezing
Clinical narrative: wheezing
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Patient stated she felt dizzy and blacked out.  Patient was very pale.  Instructed patient to hold legs to elevate lower extremities.  After providing cold compress and candy, patient stated she felt better.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal swelling, Rash
Clinical narrative: Rash all over body and throat swelling
Age: 4.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Blood lactate dehydrogenase, C-reactive protein, Crying, Differential white blood cell count
Clinical narrative: The patient is a 4 y.o. male who is previously healthy with no chronic medical conditions, who presents with dark red/purple rash over the buttocks and bilateral lower extremities as well as bilateral foot & knee pain. He recently had hand-foot-mouth disease about one month ago and a sore throat one week ago.   The patient received the flu and covid vaccines yesterday (9/30) and he noticed a slight painful rash on his buttocks later that evening. The rash continued to progress until today, where he now has rash over his lower extremities as well. He did go to school this morning, but his parents sent a message and pictures of his rash to his pediatrician who advised them to bring him to the ED. On the car ride to the ED, he was crying from pain in his feet and hands, and he now cannot walk due to pain and needed to be carried to the bathroom in the ED. No reported fevers at home. Appetite has been at baseline. He denies cough, runny nose, sore throat, headache, neck pain/stiffness. He reports the ankles are the worse pain.    He has no family history of bleeding or clotting disorders. His immunizations are up to date.   ROS: no diarrhea, no bloody stools, no abdominal pain, no nausea/vomiting, making good urine, eating and drinking well
Age: 4.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Full blood count, Gait inability, Haptoglobin, Metabolic function test, Pain in extremity
Clinical narrative: The patient is a 4 y.o. male who is previously healthy with no chronic medical conditions, who presents with dark red/purple rash over the buttocks and bilateral lower extremities as well as bilateral foot & knee pain. He recently had hand-foot-mouth disease about one month ago and a sore throat one week ago.   The patient received the flu and covid vaccines yesterday (9/30) and he noticed a slight painful rash on his buttocks later that evening. The rash continued to progress until today, where he now has rash over his lower extremities as well. He did go to school this morning, but his parents sent a message and pictures of his rash to his pediatrician who advised them to bring him to the ED. On the car ride to the ED, he was crying from pain in his feet and hands, and he now cannot walk due to pain and needed to be carried to the bathroom in the ED. No reported fevers at home. Appetite has been at baseline. He denies cough, runny nose, sore throat, headache, neck pain/stiffness. He reports the ankles are the worse pain.    He has no family history of bleeding or clotting disorders. His immunizations are up to date.   ROS: no diarrhea, no bloody stools, no abdominal pain, no nausea/vomiting, making good urine, eating and drinking well
Age: 4.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Rash, Rash erythematous, Urinary sediment, Urine analysis
Clinical narrative: The patient is a 4 y.o. male who is previously healthy with no chronic medical conditions, who presents with dark red/purple rash over the buttocks and bilateral lower extremities as well as bilateral foot & knee pain. He recently had hand-foot-mouth disease about one month ago and a sore throat one week ago.   The patient received the flu and covid vaccines yesterday (9/30) and he noticed a slight painful rash on his buttocks later that evening. The rash continued to progress until today, where he now has rash over his lower extremities as well. He did go to school this morning, but his parents sent a message and pictures of his rash to his pediatrician who advised them to bring him to the ED. On the car ride to the ED, he was crying from pain in his feet and hands, and he now cannot walk due to pain and needed to be carried to the bathroom in the ED. No reported fevers at home. Appetite has been at baseline. He denies cough, runny nose, sore throat, headache, neck pain/stiffness. He reports the ankles are the worse pain.    He has no family history of bleeding or clotting disorders. His immunizations are up to date.   ROS: no diarrhea, no bloody stools, no abdominal pain, no nausea/vomiting, making good urine, eating and drinking well
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: TECHNICIAN WAS GIVING THE PATIENT THE VACCINE WHEN THE ENTIRE CONTENTS LEAKED OUT OF THE SYRINGE