chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: fluzone high dose qiv leaked during administration, resulting in patient receiving unknown partial dose with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 83 years old female patient who reported that influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] was leaked during administration, resulting in patient receiving unknown partial dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Sep-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot UT8043AA, Expiry date : 30-Jun-2024, formulation, strength was unknown) via intramuscular route in the left deltoid for Immunization.  On 25-Sep-2023 the patient developed a non-serious event of fluzone high dose qiv leaked during administration, resulting in patient receiving unknown partial dose with no reported adverse event (incorrect dose administered) (latency : same day).  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone high dose qiv leaked during administration, resulting in patient receiving unknown partial dose with no reported adverse event.  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: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient being administered an expired dose of Tenivac with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves patient with unknown demographics who was being administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Sep-2023, the patient received a dose 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection lot U7183AA expiry date: 24-Sep-2023 via unknown route in unknown administration site for immunization.  On 25-SEP-2023 the patient being administered an expired dose of tenivac with no reported adverse event (expired product administered) on the same day following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient being administered an expired dose of tenivac with no reported adverse event.   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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACT-HIB was reconstituted with a different diluent than what it is supplied with with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 1 years old male patient for whom act-hib was reconstituted with a different diluent than what it is supplied 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 diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix), Hepatitis A Vaccine Inact (Havrix), pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13), measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine live (OKA/MERCK) (Varivax) for Prophylactic vaccination.  On 30-Aug-2023, the patient received suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection lot UJ835AA via intramuscular route in the left thigh for prophylactic vaccination (strength, dose, expiry date: unknown), was reconstituted with a different diluent than what it is supplied with with no reported adverse event (product preparation error) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product preparation error.  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: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received an expired dose of adacel with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 36 years old male patient who received an expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past vaccination(s) included TDAP in 2014. The patient's past medical history, medical treatment(s) and family history were not provided.   On 09-Sep-2023, the patient received a 0.5 ml, once (dose 2) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot C5921AA, expiry date: 29-Jul-2023, strength: standard) via intramuscular route in the left arm for Immunization and received an expired dose of adacel with no reported adverse event (extra dose administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 70.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: tenivac that expired on 24Sep2023 was administered to a patient today with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 70 years old female patient who reported that diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] that expired on 24sep2023 was administered to a patient today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2023, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT lot U7183AA, Expiry date : 24-Sep-2023,strength was unknown) via intramuscular route in unknown administration site for Immunization .  On 26-Sep-2023 the patient developed a non-serious event of tenivac that expired on 24sep2023 was administered to a patient today with no reported adverse event (expired product administered) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event tenivac that expired on 24sep2023 was administered to a patient today with no reported adverse event.  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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: medical technician administered a patient with only the diluent part of acthib and the incident has been found 4 days after with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient to whom medical technician administered only the diluent part of HIB (PRP/T) vaccine [ACT-HIB] and the incident has been found 4 days after with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Sep-2023, the patient received an unknown dose (Booster dose, once) of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ856AB expiry date, strength: unknown) via intramuscular route in unknown administration site for Immunization and was administered only the diluent part of acthib and the incident has been found 4 days after with no reported adverse event (Product preparation error) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired doses of fluzone high dose qiv were administered with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA297201(CLUSTER).  This case involves a 81 years old female patient who was administered expired doses 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 25-Sep-2023, the patient received a 0.7 ml, once dose of suspect  influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot UT7733CA, expiry date: 30-Jun-2023, unknown strength) via intramuscular route in the left arm for Immunization and expired doses of fluzone high dose qiv were administered with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: stating that they have administered an expired PENTACEL to a patient with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient to whom they have administered an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported 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 an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UJ736AAA; Expiration Date :18-SEP-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency: on same day).  Action taken : not applicable.  Outcome : Unknown.   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: 24.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: expired tenivac vaccine was giving to a patient with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 24 years old female patient to whom expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine was giving to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On 27-Sep-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U7183AA) via intramuscular route in the arm nos (dose, strength, and expiration date: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 53.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered with expired TENIVAC with no adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 53 years old male patient who was administered with expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2023, the patient was administered with expired standard dose of 0.5 ml total of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U7183AA, expiry date- 24-SEP-2023) via intramuscular route in the deltoid NOS (not otherwise specified) for Immunization with no adverse event (expired product administered) (latency- same day).   Reportedly, Nurse asks for recommendations on safety and re-vaccination following administration of tenivac.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 29.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administrated the incorrect flu vaccine on 10/3/23. This individual received the high dose Fluad meant for individuals 65 and older instead of the Flucelvax 6 months and older flu vaccine accidently. Patient has been notified. Administrator has been notified and re-educated on proper administration and has reported the error. No adverse reactions, signs or symptoms from the recipient reported.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Blood glucose, Blood pressure decreased, Chills, Cold sweat
Clinical narrative: Typical fever, chills an aches night of vaccination, rapid pulse and higher blood pressure.  Took Tylenol in the morning and was feeling better, at 11:30, I suddenly felt very clammy and like I was going to pass out.  I made it down the hall to my spouse.  He took my blood pressure and it was 70 over 43  .  Did not actually pass out, and got better then called my doctor and they got me an appointment within 3 hours but told me to call emergency services if it happened again before then.  about 30 minutes latter it happened again, this time rather than clammy I felt very nauseous and and like I was going to pass out.  Again my blood pressure and pulse were similar to before.  By the time the medics came, it was up to 100 over (I don't recall).  No fever, heart appeared normal.  At Doctors they found that my blood pleasure dropped markedly when rising but could not find a cause.  I had stomach pain, but I get that with Tylenol.  I slept the remainder of the day and through the night.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Electrocardiogram, Heart rate increased, Hypersomnia, Hypertension
Clinical narrative: Typical fever, chills an aches night of vaccination, rapid pulse and higher blood pressure.  Took Tylenol in the morning and was feeling better, at 11:30, I suddenly felt very clammy and like I was going to pass out.  I made it down the hall to my spouse.  He took my blood pressure and it was 70 over 43  .  Did not actually pass out, and got better then called my doctor and they got me an appointment within 3 hours but told me to call emergency services if it happened again before then.  about 30 minutes latter it happened again, this time rather than clammy I felt very nauseous and and like I was going to pass out.  Again my blood pressure and pulse were similar to before.  By the time the medics came, it was up to 100 over (I don't recall).  No fever, heart appeared normal.  At Doctors they found that my blood pleasure dropped markedly when rising but could not find a cause.  I had stomach pain, but I get that with Tylenol.  I slept the remainder of the day and through the night.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test, Nausea, Pyrexia
Clinical narrative: Typical fever, chills an aches night of vaccination, rapid pulse and higher blood pressure.  Took Tylenol in the morning and was feeling better, at 11:30, I suddenly felt very clammy and like I was going to pass out.  I made it down the hall to my spouse.  He took my blood pressure and it was 70 over 43  .  Did not actually pass out, and got better then called my doctor and they got me an appointment within 3 hours but told me to call emergency services if it happened again before then.  about 30 minutes latter it happened again, this time rather than clammy I felt very nauseous and and like I was going to pass out.  Again my blood pressure and pulse were similar to before.  By the time the medics came, it was up to 100 over (I don't recall).  No fever, heart appeared normal.  At Doctors they found that my blood pleasure dropped markedly when rising but could not find a cause.  I had stomach pain, but I get that with Tylenol.  I slept the remainder of the day and through the night.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Urticaria
Clinical narrative: Hives on right thigh
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Lethargy, Pallor, Slow response to stimuli, Syncope
Clinical narrative: Patient experienced syncope in car.  By the time nurse arrived to patients side he had regained consciousness.  Patient was alert and oriented but lethargic and slow to answer basic questions.  Patients vitals checked and were within normal range.  Skin  pale and clammy.  Ice pack was placed on back of head, and fluids provided.  Patient did not fully recover within 15 minutes, EMS call was placed.  Nurse remained with patient till arrival and report given to paramedics.  Paramedics evaluated patient vitals rechecked and still within range, EKG normal.  Paramedics  determined patient  was ok to go home and be monitored by parent.  Parent advised to monitor patient and to call EMS, if it needed.   Parent verbalized understanding and agreed with plan.
Age: 62.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was due for a flu shot recommended for 65 years and older patients. Medical administrator at facility assisted pharmacist in paperwork and  communicated to pharmacist  that patient was over 65 years old. After flu clinic was completed and paperwork was inspected afterwards, it was noted that patient was not over 65 years old.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Developed "pain in left arm at injection site approximately 48 hours after vaccine administration that grew worse and began radiating out from shoulder. Only has about 50% ROM and unable to raise arm past shoulder or rotate it. Arm feels tingly upon waking in the morning and unable to sleep on left side. "
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: Developed "pain in left arm at injection site approximately 48 hours after vaccine administration that grew worse and began radiating out from shoulder. Only has about 50% ROM and unable to raise arm past shoulder or rotate it. Arm feels tingly upon waking in the morning and unable to sleep on left side. "
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Fever of 99.6, chills, slight headache, tiredness
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Blister, Brain fog, Chills
Clinical narrative: 11 days of low-grade fever mixed with high grade fever reaching 103.5 on multiple occasions. chills, heavy fatigue, mental fogginess, spiked-top of the head headache with muscle pain in neck, down spinal column to lumbar region.  Night sweats  A patch of non-painful  blisters on right hip with a few  scattered non-painful blisters on right side of back and front. Around the 13-day point non-painful spots/rash appeared on right lower leg/calf which lead to shin-splint pain in the right leg  with edema of the right foot, ankle and lower leg.  Right hip achiness was also present. The shin-splints incurred swelling.  I experience a few occurrences of low-grade fever after the 11 day point but it would come and go. numbness in right thumb. Achiness in both wrists and hands. I'm still dealing with the edema and shin-splint pain of the right lower leg and a lesser degree of night sweats.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Headache, Hypoaesthesia, Medial tibial stress syndrome, Myalgia
Clinical narrative: 11 days of low-grade fever mixed with high grade fever reaching 103.5 on multiple occasions. chills, heavy fatigue, mental fogginess, spiked-top of the head headache with muscle pain in neck, down spinal column to lumbar region.  Night sweats  A patch of non-painful  blisters on right hip with a few  scattered non-painful blisters on right side of back and front. Around the 13-day point non-painful spots/rash appeared on right lower leg/calf which lead to shin-splint pain in the right leg  with edema of the right foot, ankle and lower leg.  Right hip achiness was also present. The shin-splints incurred swelling.  I experience a few occurrences of low-grade fever after the 11 day point but it would come and go. numbness in right thumb. Achiness in both wrists and hands. I'm still dealing with the edema and shin-splint pain of the right lower leg and a lesser degree of night sweats.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Neck pain, Night sweats, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: 11 days of low-grade fever mixed with high grade fever reaching 103.5 on multiple occasions. chills, heavy fatigue, mental fogginess, spiked-top of the head headache with muscle pain in neck, down spinal column to lumbar region.  Night sweats  A patch of non-painful  blisters on right hip with a few  scattered non-painful blisters on right side of back and front. Around the 13-day point non-painful spots/rash appeared on right lower leg/calf which lead to shin-splint pain in the right leg  with edema of the right foot, ankle and lower leg.  Right hip achiness was also present. The shin-splints incurred swelling.  I experience a few occurrences of low-grade fever after the 11 day point but it would come and go. numbness in right thumb. Achiness in both wrists and hands. I'm still dealing with the edema and shin-splint pain of the right lower leg and a lesser degree of night sweats.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Rash, Rash macular, Spinal pain, Swelling
Clinical narrative: 11 days of low-grade fever mixed with high grade fever reaching 103.5 on multiple occasions. chills, heavy fatigue, mental fogginess, spiked-top of the head headache with muscle pain in neck, down spinal column to lumbar region.  Night sweats  A patch of non-painful  blisters on right hip with a few  scattered non-painful blisters on right side of back and front. Around the 13-day point non-painful spots/rash appeared on right lower leg/calf which lead to shin-splint pain in the right leg  with edema of the right foot, ankle and lower leg.  Right hip achiness was also present. The shin-splints incurred swelling.  I experience a few occurrences of low-grade fever after the 11 day point but it would come and go. numbness in right thumb. Achiness in both wrists and hands. I'm still dealing with the edema and shin-splint pain of the right lower leg and a lesser degree of night sweats.
Age: 58.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was due for a flu shot recommended for 65 years and older patients. Medical administrator at facility assisted pharmacist in paperwork and  communicated to pharmacist  that patient was over 65 years old. After flu clinic was completed and paperwork was inspected afterwards, it was noted that patient was not over 65 years old.
Age: 57.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Depressed level of consciousness, Disorientation, Seizure
Clinical narrative: Pt received the flu shot and Comirnaty (23-24) shot simultaneously (flu shot in right arm and covid in the left). He seemed fine at the time of vaccination, was joking and talk to me.  About 10- 15 minutes later someone came up to the pharmacy and stated that there was a medical emergency in one of the aisles.  Patient was lying on the floor, breathing and semi-conscious.  He evidently had had a seizure (evidenced by foam around his mouth and his disorientation). Paramedics arrived shortly after and took him away. No updates currently.
Age: 59.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Vomiting
Clinical narrative: Severe, non stop vomitting
Age: 59.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Dizziness, Headache, Hypersomnia, Nausea, Vomiting
Clinical narrative: Severe, non stop vomitting
Age: 67.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Dizziness, Dyspnoea, Fatigue, Pallor
Clinical narrative: Patient looked pale and said she was dizzy and lightheaded a little sweaty.  She also was breathing more heavily than expected.  We got her an ice pack to hold on her head and neck as that felt good to her and some apple juice to sip on.  We got her feet up and had her sit back and as time went on she said she was feeling better.  We called a caregiver to pick her up and drive her home.  She was probably in the waiting room for about 45 minutes during this episode waiting for her caregiver to arrive. She already had a walker and her caregiver already had a transport chair for her in his car.   She was able to get in transport chair and leave with her caregiver/ family member.  I called her back around 6:30 this evening to check in and she said she was doing ok, still a little tired and fatigued but doing ok.
Age: 62.0
Sex: M
Vaccine: FLUC4, RSV
Symptoms: Erythema, Magnetic resonance imaging normal, Peripheral swelling
Clinical narrative: Redness/swelling from shoulder to wrist
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Blister rupture, Injection site vesicles
Clinical narrative: blister developed at injection site, popped then another blister formed
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient Received Corminaty 30 mcg/0.3ML inj PFizer dose on September 28th, symptoms started on September 29th. Symptom was a rash that started across chest and arms. Patient went to see doctor who prescribed clobetasol propionate external ointment 0.05% on 10/03/2023.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, Limb discomfort, Muscular weakness
Clinical narrative: Faintness, cold sweats, and nausea 2 minutes after injection. Weakness/heaviness of injected arm immediately after injection. Joint aching in injected arm immediately after injection.  Patient sat down after onset of symptoms and waited 10 minutes for faintness to subside. Patient then felt well enough to stand and leave facility. Arm weakness and aching continued for about an hour after injection.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain
Clinical narrative: Faintness, cold sweats, and nausea 2 minutes after injection. Weakness/heaviness of injected arm immediately after injection. Joint aching in injected arm immediately after injection.  Patient sat down after onset of symptoms and waited 10 minutes for faintness to subside. Patient then felt well enough to stand and leave facility. Arm weakness and aching continued for about an hour after injection.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Pain
Clinical narrative: Fatigue - 8pm October 1 until 3pm, October 2 Fever and Chills 12midnight October 2 until 4am October 2 Body Aches 8pm October 1 until 3pm October 2nd Left arm swollen (size of egg), hurt, red and hot 8pm October 1 until 4pm October 4 (still)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fatigue - 8pm October 1 until 3pm, October 2 Fever and Chills 12midnight October 2 until 4am October 2 Body Aches 8pm October 1 until 3pm October 2nd Left arm swollen (size of egg), hurt, red and hot 8pm October 1 until 4pm October 4 (still)
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Diarrhoea, Headache, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Headache sore throat vomiting diarrhea fever
Age: 70.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt received the vaccination in May and informed us today that he had a reaction. States the arm was swollen and red, and he went to urgent care.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient has broken out in an itchy rash around the top elastic of bottom under ware and around the bra area.  Patient was advised to take an antihistamine and apply topical cortisone to the affected area. If the symptoms got worst or did not get better she should contact her physician.  The patient was advised to contact her physician and she if she did not see better improvement in 72 hours she should be seen.  We are not sure the vaccine caused the rash since the vaccine was administrated six days ago.
Age: 63.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluad given to patient that is 63 years and 11.5 months old. Not yet 65 years of age
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: No adverse event.  Error in administration.  Patient given pediatric dose of Covid vaccine (0.3 mL/10 mcg)
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: red, warm patch on arm near injection site
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Shivering, Nausea and Vomiting, Fever, Fatigue, Headache
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Shivering, Nausea and Vomiting, Fever, Fatigue, Headache
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Diarrhoea, Fatigue
Clinical narrative: 9/23/23: 10:45AM vaccination received. Onset of symptoms 4:30PM: severe fatigue, fever and chills, mild to moderate muscle and joint pain, mild headache, and mild soreness at injection site.  9/24/22: Nausea, malodorous diarrhea, post nasal drip and sinus congestion, profound fatigue, moderate to severe diffuse joint and muscle pain; moderate soreness, redness, swelling, and itching at injection site; restlessness, tachycardia and palpitations, sharp chest pains, fever and chills, moderate headache.    9/25/23: Moderate fatigue. Mild diffuse joint and muscle pain. Mild soreness, redness, and itching at injection site.  Nausea, restlessness, fever and chills, diarrhea, postnasal drip, sinus congestion, and headache resolved.  9/26/23: All above symptoms resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 9/23/23: 10:45AM vaccination received. Onset of symptoms 4:30PM: severe fatigue, fever and chills, mild to moderate muscle and joint pain, mild headache, and mild soreness at injection site.  9/24/22: Nausea, malodorous diarrhea, post nasal drip and sinus congestion, profound fatigue, moderate to severe diffuse joint and muscle pain; moderate soreness, redness, swelling, and itching at injection site; restlessness, tachycardia and palpitations, sharp chest pains, fever and chills, moderate headache.    9/25/23: Moderate fatigue. Mild diffuse joint and muscle pain. Mild soreness, redness, and itching at injection site.  Nausea, restlessness, fever and chills, diarrhea, postnasal drip, sinus congestion, and headache resolved.  9/26/23: All above symptoms resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Palpitations, Pyrexia, Restlessness
Clinical narrative: 9/23/23: 10:45AM vaccination received. Onset of symptoms 4:30PM: severe fatigue, fever and chills, mild to moderate muscle and joint pain, mild headache, and mild soreness at injection site.  9/24/22: Nausea, malodorous diarrhea, post nasal drip and sinus congestion, profound fatigue, moderate to severe diffuse joint and muscle pain; moderate soreness, redness, swelling, and itching at injection site; restlessness, tachycardia and palpitations, sharp chest pains, fever and chills, moderate headache.    9/25/23: Moderate fatigue. Mild diffuse joint and muscle pain. Mild soreness, redness, and itching at injection site.  Nausea, restlessness, fever and chills, diarrhea, postnasal drip, sinus congestion, and headache resolved.  9/26/23: All above symptoms resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion, Tachycardia, Upper-airway cough syndrome
Clinical narrative: 9/23/23: 10:45AM vaccination received. Onset of symptoms 4:30PM: severe fatigue, fever and chills, mild to moderate muscle and joint pain, mild headache, and mild soreness at injection site.  9/24/22: Nausea, malodorous diarrhea, post nasal drip and sinus congestion, profound fatigue, moderate to severe diffuse joint and muscle pain; moderate soreness, redness, swelling, and itching at injection site; restlessness, tachycardia and palpitations, sharp chest pains, fever and chills, moderate headache.    9/25/23: Moderate fatigue. Mild diffuse joint and muscle pain. Mild soreness, redness, and itching at injection site.  Nausea, restlessness, fever and chills, diarrhea, postnasal drip, sinus congestion, and headache resolved.  9/26/23: All above symptoms resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling lymph nodes right axilla , painful
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Vaccination error
Clinical narrative: There was a vaccine error with Kinrix Dtap/IPV. Upon checking patient's Immunization list and doing the prediction check. Dtap and IPV were one of the vaccines needed. I scanned the Kinrix and along with the Hep A Vaccine. An alert came up,  I then took the vaccines to Dr. to verify and approve. The vaccine was administered to the patient.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Orbital swelling
Clinical narrative: bi-lateral Orbital swelling, though more pronounced on right eye, indicative of allergic reaction
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Asthma, Bronchospasm, Condition aggravated, Eosinophil count increased
Clinical narrative: Developed cholinergic urticaria which is now chronic. Prior to vaccines-regularly exercised without issue. Now, anytime I run 3 miles and start sweating, I break out in head to toe hives and get bronchospasms. I get hives all the time now.  I also have significantly worsened  allergy-induced asthma
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Laboratory test abnormal, Urticaria, Urticaria cholinergic
Clinical narrative: Developed cholinergic urticaria which is now chronic. Prior to vaccines-regularly exercised without issue. Now, anytime I run 3 miles and start sweating, I break out in head to toe hives and get bronchospasms. I get hives all the time now.  I also have significantly worsened  allergy-induced asthma
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Musculoskeletal pain
Clinical narrative: Significant musculoskeletal pain, most severe in the shoulders and neck (L>R) and severe headache that has improved but not totally gone away.  It has gotten to the point that I do not feel I need to see my doctor.  However I do feel it was severe enough that I should report it.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin swelling, Skin warm
Clinical narrative: Patient reports her arm looks red and puffy (flat shaped area the size of a small lemon) that is warm and itchy. She also reports small spots that are flat and red around this area the size of a pencil eraser. She reports this today, 10/4/23.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Peripheral coldness, Rash pruritic
Clinical narrative: Arm felt internally like it was sitting in an ice bath with intermittent numbness and small bumps around body that itch.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chest discomfort, Chills, Headache, Hyperhidrosis, Pallor
Clinical narrative: 8-12 hours after shot: Extreme chills with uncontrollable shaking, skin paleness, chest tightness, 12-28 hours hours after shot: Severe headache 30-38 hour after shot: extreme sweating, without apparent fever or feeling hot  COVID Vaccine COMIRNATY 2023-24(12Y UP) SYRG
Age: 39.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Tremor
Clinical narrative: 8-12 hours after shot: Extreme chills with uncontrollable shaking, skin paleness, chest tightness, 12-28 hours hours after shot: Severe headache 30-38 hour after shot: extreme sweating, without apparent fever or feeling hot  COVID Vaccine COMIRNATY 2023-24(12Y UP) SYRG
Age: 70.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Back pain, Fatigue, Somnolence, Syncope
Clinical narrative: Pt came to pharmacy and said he want to report : he experienced back pain, tiredness, sleepiness for 2 days and couple hours after receiving vaccine, he was very sleepy and he got up one time during night to get glass of water and he fainted ( he is not sure for how long) , upon coming back to conscious , he went to sleep on his bed.  he said his tiredness lasted 2 days
Age: 82.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Confusional state, Decreased appetite, Dysstasia, Fall, Heart rate increased
Clinical narrative: generalized pain, confusion, unable to stand, falling,, low-grade fever, high blood pressure, increased pulse, malaise, decreased appetite.
Age: 82.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Hypertension, Malaise, Pain, Pyrexia
Clinical narrative: generalized pain, confusion, unable to stand, falling,, low-grade fever, high blood pressure, increased pulse, malaise, decreased appetite.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.5ml 10mcg Energix B instead of adult 1ml 20mcg Energix B
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Hypotension, Loss of consciousness
Clinical narrative: Pt marked on VAR that they have gotten dizzy in the past from vaccinations, she said she has never fainted but has gotten dizzy after some vaccines and blood draws. Pt received vaccination and said she was feeling fine. Pharmacist walked pt out to waiting chair and went into pharmacy. A few minutes later another customer alerted pharmacy staff that the patient slumped over and passed out in the chair. By the time the pharmacist ran out she was alert again. EMT's were called and the pt decided to go to hospital because her blood pressure was low and she was still feeling faint. Pt returned to pharmacy a few hours later to pick up her prescription and said she felt fine.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Myalgia
Clinical narrative: Continued tenderness in upper arm musculature.  Naproxin twice daily
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Hypertension
Clinical narrative: HYPERTENSION - BP 170/125, Patient admitted for 2 days, changed beta-blocker from metoprolol to carvedilol
Age: 86.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: I have no idea what version of flu vaccine was injected.   But I have a severe rash on chest, ares, shoulders and arms and lwgs
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Hyperacusis, Hypoacusis
Clinical narrative: Pain in ears,  partial hearing loss, dizziness, and hyperacusis
Age: 67.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 36 hours after swelling in bicep area of left arm,( enough to form large wrinkle) red and warm to touch. Achiness in arm.
Age: 11.0
Sex: F
Vaccine: FLU4, IPV, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Nausea, Nervousness, Pallor
Clinical narrative: 11 year old female patient came in with parents for school vaccines. She received 5 vaccines (tdap. flu, MCV4, varicella and polio). Immediately after being vaccinated patient became nervous, hot, paleness to skin, dizziness and some nausea. Vitals was taken and a wet cold cloth  was put behind her neck.  Pt. drank small sips of water and after a few minutes she started to get color back to her skin. She then open her eyes, raised her head. Recovered in 5 minutes.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I became  very dizzy when I would move my head and neck toward the left side- it has since steadily decreased - dizziness almost gone now/ never had that before
Age: 20.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: IMMEDIATELY AFTER THE INJECTIONS WERE GIVEN THE PATIENT FAINTED. THE NURSE SUPPORTED HER IN THE CHAIR AND AN INTERN CAME OUT TO HELP LOWER HER TO THE GROUND. THE PATIENT REGAINED CONSCIOUSNESS AND THE INTERN PLACED AN ICE PACK ON THE BACK OF HER NECK. THE PATIENT STATED THAT SHE HADN'T EATEN ALL DAY AND HAD PASSED OUT DURING CLASS THE WEEK PRIOR. THE INTERN GAVE HER A PACK OF GUMMIES TO EAT. WE OBSERVED HER FOR 20 ADDITIONAL MINUTES AND SHE SAID SHE WAS FEELING FINE. SHE LEFT WITH HER FRIEND WHO WAS DRIVING.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Pain in extremity, Peripheral swelling
Clinical narrative: Injection given in R Deltoid, pt. developed an eythematous papular rash at site, swelling of R arm, pain R arm
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose a couple of years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-Sept-2023 The pharmacist stated that she would sometimes had patients come into the pharmacy stating they received first dose of Shingrix a couple of years ago but never got the second dose.   She would estimate 10 patients.  At the time of reporting, she did not have any patient specific information. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. This is 1 of 10 linked reports reported by the same reporter. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023AMR132663:Original Case : US2023131765 US-GSK-US2023AMR132664:Original Case : US2023131765 US-GSK-US2023AMR132661:Original Case : US2023131765 US-GSK-US2023AMR132660:Original Case : US2023131765 US-GSK-US2023AMR132659:Original Case : US2023131765 US-GSK-US2023AMR132665:Original Case : US2023131765 US-GSK-US2023AMR132657:Original Case : US2023131765 US-GSK-US2023AMR132658:Original Case : US2023131765 US-GSK-US2023131765:Original Case : US2023131765