chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal discomfort
Clinical narrative: Left shoulder joint discomfort - Shooting pain occurs starting in left shoulder down to hand when holding an object of moderate weight; Shoulder pain when applying pressure on left hand, such as pressing a lid onto a cup or using hands on arm rest to push body up from a sitting position; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 09:00 as dose 4 (booster), single (Lot number: HF9275) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 27Sep2023 at 19:00, outcome "not recovered", described as "Left shoulder joint discomfort - Shooting pain occurs starting in left shoulder down to hand when holding an object of moderate weight"; ARTHRALGIA (non-serious) with onset 27Sep2023 at 19:00, outcome "not recovered", described as "Shoulder pain when applying pressure on left hand, such as pressing a lid onto a cup or using hands on arm rest to push body up from a sitting position". Therapeutic measures were not taken as a result of musculoskeletal discomfort, arthralgia.  Additional information: adverse event: Left shoulder joint discomfort - Shooting pain occurs starting in left shoulder down to hand when holding an object of moderate weight. Shoulder pain when applying pressure on left hand, such as pressing a lid onto a cup or using hands on arm rest to push such as pressing a lid onto a cup or using hands on arm rest to push body up from a sitting position.
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: I urinated 5 times last night, which is more often than usual; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, 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: POLLAKIURIA (non-serious), outcome "unknown", described as "I urinated 5 times last night, which is more often than usual". Additional information: The consumer also stated: "I also received the same Pfizer Covid 19 vaccine at the same time with my wife and I have no side effects whatsoever.  No discomfort of any kind.  I don't know if it did anything to me, but I urinated 5 times last night, which is more often than usual. I am not concerned about it.  Male patient; Age=87 years old."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Rash and warmth on injection site; Rash and warmth on injection site; itching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 14:00 as dose 1, single (Lot number: HG4628) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: FLUSONE taken for immunisation, start date: 19Sep2023, stop date: 19Sep2023; DOXAZOSIN; DOXYCYCLINE. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 26Sep2023, outcome "not recovered" and all described as "Rash and warmth on injection site"; PRURITUS (non-serious) with onset 26Sep2023, outcome "not recovered", described as "itching". Therapeutic measures were not taken as a result of vaccination site rash, vaccination site warmth, pruritus. Additional information: Patient had no known allergies and also received "Arexvy".   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Illness, Nausea, Presyncope, Vaccination site pain
Clinical narrative: felt very sick; nauseous; injection site is very sore; lightheaded like he was going to pass out; lightheaded like he was going to pass out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 6 (booster), single (Lot number: HG2282) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart attack" (unspecified if ongoing), notes: massive heart attack, widowmaker He had code blue died on the table for 6 minutes. The patient took concomitant medications. Vaccination history included: pfizer covid 19 vaccine (Dose:1, Lot: EL9262), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 Immunization; pfizer covid 19 vaccine (Dose:2 , Lot: EL9269), administration date: 11Feb2021, when the patient was 67-year-old, for COVID-19 Immunization; pfizer covid 19 vaccine (Dose: 3, Lot: 301308A), administration date: 26Sep2021, when the patient was 67-year-old, for COVID-19 Immunization; pfizer covid 19 vaccine (Dose: 4 , Lot: FG9943 or FY9943), administration date: 16Mar2022, when the patient was 68-year-old, for COVID-19 Immunization; pfizer covid 19 vaccine (Dose: 5 , Lot: GJ6796 or CJ6796), administration date: 13Dec2022, when the patient was 69-year-old, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), PRESYNCOPE (non-serious) all with onset 27Sep2023, outcome "unknown" and all described as "lightheaded like he was going to pass out"; ILLNESS (non-serious), outcome "unknown", described as "felt very sick"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site is very sore". Therapeutic measures were not taken as a result of dizziness, presyncope, illness, nausea, vaccination site pain. Additional information: He takes his blood pressure every day and it is good, his numbers are good, weight is good, and he takes his medication. Reports he is sick from being lightheaded. Feels a little nauseous and injection site is very sore which is normal. He is not feeling too hot right now. He is not sure what he should do yet.
Sex: U
Vaccine: COVID19
Symptoms: Dry eye, Immune system disorder
Clinical narrative: my immune system went into overdrive and severe dry eye; my immune system went into overdrive and severe dry eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, As with all the previous doses my immune system went into overdrive and severe dry eye.), for COVID-19 Immunization, reaction(s): "severe dry eye", "my immune system went into overdrive". The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), DRY EYE (non-serious), outcome "unknown" and all described as "my immune system went into overdrive and severe dry eye". The events "my immune system went into overdrive and severe dry eye" required physician office visit.  Additional information: It was reported that the patient was just administered the new vaccine last week. As with all the previous doses their immune system went into overdrive and severe dry eye. Patient had mentioned this to their eye doctor before and suspected it was a reaction to the vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: chills; 102 temperature/ a low grade fever; Ached all over; swollen glands under the arm where I received the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "not recovered", described as "102 temperature/ a low grade fever"; PAIN (non-serious), outcome "unknown", described as "Ached all over"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen glands under the arm where I received the shot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, pain. Additional information: About 15 hrs after receiving vaccine, patient began getting severe chills. Had 102 temperature. Ached all over too. Took Tylenol. After 2 days, patient still have a low grade fever and swollen glands under the arm where she received the shot.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: flu vaccine made me sick; Initial information received on 24-Sep-2023 regarding an unsolicited valid social media non-serious case received from a Patient.  This case involves a patient of unknown demographics whom flu vaccine made me sick after receiving vaccine Influenza Vaccine.  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 Influenza Vaccine produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).Information on the batch number was requested.  On an unknown date the patient developed flu vaccine made me sick (illness) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event flu vaccine made me sick.  At time of reporting, the outcome was Unknown for the event flu vaccine made me sick.
Sex: U
Vaccine: FLU4
Symptoms: Accident at work, Syringe issue
Clinical narrative: luer-lok broke during preparation and injured the employee preparing the vaccine; luer-lok broke during preparation; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from an Other health professional.  This case involves an unknown age and unknown gender patient where luer-lok broke during preparation and injured the employee preparing the vaccine and luer-lok broke during preparation after receiving vaccine influenza quadrival a-b vaccine [Fluzone qiv].  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date in Aug-23, the patient received a dose of suspect influenza quadrival a-b vaccine Suspension for injection (lot UT8069MA) via unknown route in unknown administration site (dose, strength and expiration date : not provided) for Immunisation.  On an unknown date in Aug-23, the luer-lok broke during preparation and injured the employee preparing the vaccine (accident at work) and luer-lok broke during preparation (product quality issue) (unknown latency) following the administration of influenza quadrival a-b vaccine.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events (luer-lok broke during preparation).  At time of reporting, the outcome was Unknown for the events.
Age: 25.0
Sex: F
Vaccine: FLUR4
Symptoms: Chest pain, Diarrhoea, Headache, Nausea
Clinical narrative: Chest pain, nausea, diarrhea, headache
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Decreased appetite, Diarrhoea, Headache, Injection site erythema
Clinical narrative: Very Low Grade Fever, Vomiting, Diarrhea, Joint Pain, Muscle aches, Uncontrolable body tremors (Similar to Fever Chills, but more violent in nature), injection site sensitivity-redness-warm to touch, loss of appetite, headache & isn't that enough
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site hypersensitivity, Injection site warmth, Myalgia, Pyrexia, Tremor
Clinical narrative: Very Low Grade Fever, Vomiting, Diarrhea, Joint Pain, Muscle aches, Uncontrolable body tremors (Similar to Fever Chills, but more violent in nature), injection site sensitivity-redness-warm to touch, loss of appetite, headache & isn't that enough
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Very Low Grade Fever, Vomiting, Diarrhea, Joint Pain, Muscle aches, Uncontrolable body tremors (Similar to Fever Chills, but more violent in nature), injection site sensitivity-redness-warm to touch, loss of appetite, headache & isn't that enough
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: Very Low Grade Fever, Vomiting, Diarrhea, Joint Pain, Muscle aches, Uncontrolable body tremors (Similar to Fever Chills, but more violent in nature), injection site sensitivity-redness-warm to touch, loss of appetite, headache & isn't that enough
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza, Insomnia, Nausea, Pain in extremity, Procedural pain
Clinical narrative: Very Low Grade Fever, Vomiting, Diarrhea, Joint Pain, Muscle aches, Uncontrolable body tremors (Similar to Fever Chills, but more violent in nature), injection site sensitivity-redness-warm to touch, loss of appetite, headache & isn't that enough
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tremor, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Very Low Grade Fever, Vomiting, Diarrhea, Joint Pain, Muscle aches, Uncontrolable body tremors (Similar to Fever Chills, but more violent in nature), injection site sensitivity-redness-warm to touch, loss of appetite, headache & isn't that enough
Age: 76.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Arthralgia, Diarrhoea, Headache, Pyrexia
Clinical narrative: Symptoms: Fever, headache, whole body joint pain, diarrhea. Time course: beginning same day of vaccines, symptoms consistent for 2 days then self resolved
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction, Muscle tightness, Muscular weakness, Tremor
Clinical narrative: tightness of muscle in upper right shoulder. feeling of muscle weakness throughout right arm down to fingers. occasional shaking of fingers, primarily the pointer finger
Age: 85.0
Sex: F
Vaccine: FLUA4, PNC20, RSV
Symptoms: Blood pressure systolic increased
Clinical narrative: Patient complained about having blood pressure over 200/90 and went to urgent care and was referred to the ER. Patient was given Metoprolol  and the systolic blood pressure decreased to 170 and has been in the 170 ever since. Patient's normally systolic blood pressure is normally between 130-140 while on anti-hypertensive medications and has jumped up to 170-200 since getting vaccinated. She is currently in contact with her cardiologist to manage her blood pressure.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Pain, Rash papular, Rash pruritic
Clinical narrative: localized redness swelling pain and induration started 24 hours after injection raised itchy rash at its worse 48-72 hours after administration has improved on its own.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: localized redness swelling pain and induration started 24 hours after injection raised itchy rash at its worse 48-72 hours after administration has improved on its own.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Large rash at site of infection. Filled / received antibiotic from urgent care for possible infection
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Posture abnormal, Syncope
Clinical narrative: PT CAME IN FOR TWO VACCINES, FLU AND COVID.  SHE REQUESTED BOTH SHOTS IN HER LEFT ARM.  I GAVE HER THE FLU SHOT FIRST, NO PROBLEM.  THEN I GAVE HER THE COVID VACCINE.  AS I WAS APPLYING A BANDAGE, SHE LET GO OF THE PAPERS IN HER HAND AND BEGAN TO SLUMP IN HER CHAIR.  I HELD SO SHE WOULD NOT FALL OUT OF HER CHAIR.  SHE CAME TO IN ABOUT 30 SECONDS TO 1 MINUTE.  SHE FAINTED.  WHEN SHE CAME TO, I HAD HER REMAIN SITTING IN THE CHAIR FOR ABOUT 5 MORE MINUTES JUST TO BE ABSOLUTELY SURE SHE WAS FEELING OKAY.  SHE SAID SHE WAS  FEELING OKAY.  THEN SHE WAS ABLE TO STAND UP AND MOVE TO THE NEXT ROOM (WAITING ROOM) WHERE SHE WAITED ANOTHER 15 MINUTES.
Age: 37.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Oral herpes
Clinical narrative: Cold sore on lip
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block complete, Blood test, Cardiac pacemaker insertion, Electrocardiogram
Clinical narrative: Patient was admitted to the hospital with complete heart block requiring pacemaker placement
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Patient had hives and had difficulty breathing. Called 911 and paramedics administered IV benadryl
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over lower trunk and thighs, bad itching, gradually going away & itching better but its been 5 days, cortisone creme-
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Brain fog, Dizziness, Fatigue, Headache
Clinical narrative: Weakness, sore throat, muscle pain and cramps, fatigue, headaches, dizziness, foggy brain.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Oropharyngeal pain
Clinical narrative: Weakness, sore throat, muscle pain and cramps, fatigue, headaches, dizziness, foggy brain.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Device connection issue
Clinical narrative: there was an issue with the attached needle product where the needle hub popped off the safety part of it, and it was secure (not too tight or too loose) and upon removal of needle from deltoid the needle/hub stayed in the 15 month old's arm - patient did not move and no injury occurred but there was risk for it so we are removing the stock from use and notified distributor who is contacting manufacturing company
Age: 71.0
Sex: F
Vaccine: FLU4, RSV, TDAP, VARZOS
Symptoms: Dizziness, Feeling hot
Clinical narrative: pt felt dizzy and hot after receiving immunizations. about 15mins post admin. was managed on site with cold towels and water later
Age: 65.0
Sex: F
Vaccine: FLU4, PNC20, VARZOS
Symptoms: Anxiety, Chills, Headache, Nausea, Peripheral swelling
Clinical narrative: CHILLS, NAUSEA, HEADACHE, ANXIETY, LEFT FOOT SWELLING
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Seizure, Vomiting
Clinical narrative: PATIENT STATED THAT SHE FELT FAINT. PATIENT FELL TO THE FLOOR, HAD A SEIZURE, AND VOMITED. PATIENT WAS THAN TAKEN TO THE ER.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: A 67 years old patient came to the pharmacy with spouse and requested COVID Immunizations . During the administration process patient received RSV instead of SPIKEVAX 12+ .
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site rash, Injection site warmth, Nausea, Pain in extremity
Clinical narrative: Immediately after shot I felt nauseous and sore arm was nauseated for 3 hours after. My arm got progressively more sore throughout the night, I took a hot bath w/o relief and took some Tylenol just to get to bed the next day it was still sore and the injections today it was hot the end of the next day I noticed I had blotchy red hot spots on my arm near the injection site
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Immediately after shot I felt nauseous and sore arm was nauseated for 3 hours after. My arm got progressively more sore throughout the night, I took a hot bath w/o relief and took some Tylenol just to get to bed the next day it was still sore and the injections today it was hot the end of the next day I noticed I had blotchy red hot spots on my arm near the injection site
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: An itchy rash developed between the patient's right elbow and right hand during the waiting period after vaccine administration.  The patient also said she thinks her eyes swelled up a little but did not sound too sure about that. I did not see such swelling.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Loss of consciousness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Saturday 9/23 patient developed a fever of up to 102.7 towards the evening. On the morning of Sunday 9/24 patient felt dizziness and fainted in which her husband caught her before she hit her head. After fainting patient gained consciousness and began throwing up. After the incident patient's blood pressure was checked using an automatic blood pressure matching at home, reading 78/60. Monday 9/25 patient began feeling pain in her left leg. 9/26 there was no resolution in left leg pain, she began to notice a little swelling. 9/27 Wednesday patient noticed continued pain, worsened swelling in the left lower leg, and discoloration on her left shin. Patient went to her doctor who ordered an urgent ultrasound at 3pm. 3pm Ultrasound was completed and it was confirmed patient had a clot in her left leg leading form her thigh to her knee.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin discolouration, Syncope, Thrombosis, Ultrasound Doppler abnormal, Vomiting
Clinical narrative: Saturday 9/23 patient developed a fever of up to 102.7 towards the evening. On the morning of Sunday 9/24 patient felt dizziness and fainted in which her husband caught her before she hit her head. After fainting patient gained consciousness and began throwing up. After the incident patient's blood pressure was checked using an automatic blood pressure matching at home, reading 78/60. Monday 9/25 patient began feeling pain in her left leg. 9/26 there was no resolution in left leg pain, she began to notice a little swelling. 9/27 Wednesday patient noticed continued pain, worsened swelling in the left lower leg, and discoloration on her left shin. Patient went to her doctor who ordered an urgent ultrasound at 3pm. 3pm Ultrasound was completed and it was confirmed patient had a clot in her left leg leading form her thigh to her knee.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was administered to patient is not indicated based on age. Patient is 63 years of age. Fluzone is only indicated for 65 and over. No actual adverse side effects reported by patient.
Age: 58.0
Sex: M
Vaccine: PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired product administered. Expired in June 2023. Patient had no adverse event. Follow up vaccine given on 09/27/2023
Age: 16.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood pressure decreased, Dizziness, Extra dose administered, Pallor, Panic reaction
Clinical narrative: Patient received a second dose of the flu vaccine 15-20 mins after of receiving the first dose on the same day. After the patient found out he had received a second dose he panicked, became dizzy, pale, and stated he felt tingling in his hands and feet. A blood pressure reading was taken and showed low blood pressure. He was sitting down throughout the whole event. Patient stayed in the counsel room with his parent, a pharmacist in charge and fellow pharmacist for observation for 10 to 15 minutes. Patient was offered 911 services but turned it down. Patient received water and a candy bar and recovered well enough to walk with his mom out of pharmacy to go home.
Age: 16.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Paraesthesia
Clinical narrative: Patient received a second dose of the flu vaccine 15-20 mins after of receiving the first dose on the same day. After the patient found out he had received a second dose he panicked, became dizzy, pale, and stated he felt tingling in his hands and feet. A blood pressure reading was taken and showed low blood pressure. He was sitting down throughout the whole event. Patient stayed in the counsel room with his parent, a pharmacist in charge and fellow pharmacist for observation for 10 to 15 minutes. Patient was offered 911 services but turned it down. Patient received water and a candy bar and recovered well enough to walk with his mom out of pharmacy to go home.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Electrocardiogram, Headache, Pyrexia, Tinnitus
Clinical narrative: Fever- 12 hours Headache -ongoing, starting day after vaccination Shortness of Breath- 2 weeks Tinnitus- ongoing, starting day after vaccination
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Injection site erythema, Injection site swelling
Clinical narrative: Seizure within 20 minutes of injection and hives redness swelling at injection site within 10 hours
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Seizure
Clinical narrative: Seizure within 20 minutes of injection and hives redness swelling at injection site within 10 hours
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness
Clinical narrative: Dizziness at around 10:10 PM. Rested in bed as treatment. Unknown outcome yet
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Electroencephalogram, Infusion, Injury, Magnetic resonance imaging, Muscle atrophy
Clinical narrative: Severe palsy, with pain eating my nerves , both upper extremities,  mainly right dominate arm and hand , severe muscle atrophy, and loss of use of right hand.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Musculoskeletal disorder, Nerve conduction studies, Neuralgia, Pain in extremity, Paralysis
Clinical narrative: Severe palsy, with pain eating my nerves , both upper extremities,  mainly right dominate arm and hand , severe muscle atrophy, and loss of use of right hand.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: X-ray
Clinical narrative: Severe palsy, with pain eating my nerves , both upper extremities,  mainly right dominate arm and hand , severe muscle atrophy, and loss of use of right hand.
Age: 19.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dizziness
Clinical narrative: 10 minute after getting vaccine patient felt light headed and notified us. Ask allergy and medical history none noted. Gave 50 mg benadryl once po called EMS checked BP 90/48 pulse 73 Patient lay down and lifted leg up Patient started feeling better -> BP 129/79 Pulse 75 EMS arrived check patient and refused for further check up.
Age: 26.0
Sex: M
Vaccine: COVID19, FLU4, TDAP
Symptoms: Injection site haemorrhage, Syncope
Clinical narrative: After getting all three vaccine patient saw small drop of blood from injection site and fainted for 5 second. Called EMS. Lay pt down and checked BP 99/71 pulse 59  Pt did mention anxiety with needle and shot. No Medrol hx or allergy noted. BP rechecked 184/75 pulse 69
Age: 84.0
Sex: M
Vaccine: COVID19, PNC20, RSV
Symptoms: Asthenia, Chills, Gait disturbance, Tremor
Clinical narrative: Patient received all 3 vaccines at the same visit. Was fine for the remainder of that day. Symptoms began the following morning around 10:00. Patient experienced chills and shaking, took a nap in recliner for an hour then experienced severe weakness when he woke up. Was barely able to walk to the bathroom due to weakness he experienced. Wife called EMS as she as concerned about his status. Transported to hospital via ambulance where is currently an inpatient receiving treatment. ER physician feels his condition is likely due to receiving vaccines simultaneously.
Age: 76.0
Sex: M
Vaccine: RSV, TDAP
Symptoms: Product administration error
Clinical narrative: Patient came in to Arexvy vaccine and given Arexvy and Boostrix.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, FLUA4, FLUA4
Symptoms: Extra dose administered
Clinical narrative: Pt came in am received vaccine. he came around 4pm received another  Ask pt if he received before and said no. After receiving vaccine says he got it on other arm. MD contacted pt guardian.
Age: 45.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pharmacist calling to request dosing guidance on a 46 year old male patient who received his first dose of GARDASIL 9 10/2022, second dose 3/2023. He has since turned 46 years old and is looking to receive his last dose of GARDASIL 9. No PQC. No addi; Information has been received from a pharmacist, referring to a 46 years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in October 2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unspecified date in March 2023, he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   The reporting pharmacist stated that the patient has since turned 46 years old and was looking to receive his last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) .
Age: 14.0
Sex: M
Vaccine: HPV9, PNC15
Symptoms: No adverse event, Product design confusion, Product label confusion, Wrong product administered
Clinical narrative: No additional AE reported. No PQC reported; 14 year old male patient was suppose to receive GARDASIL 9, however he received VAXNEUVANCE; Medical assistant reported that 14 year old male patient was suppose to receive GARDASIL 9, however he received VAXNEUVANCE instead. VAXNEUVANCE was accidently administered to patient because HCP thought GARDASIL 9 and VAXNEUVANCE boxes looked simila; HCP thought GARDASIL 9 and VAXNEUVANCE boxes looked similar; This spontaneous report was received from a medical assistant and refers to a 14-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 14-SEP-2023, the patient was suppose to receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), however he received pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE lot number X019110 with expiration date 30-AUG-2025 instead, (dose, route and anatomical location were not reported) for prophylaxis.  Pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) was accidently administered to patient because healthcare professional thought rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) boxes looked similar and accidently grabbed the wrong product (product label confusion, wrong product administered and product design confusion). No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 16-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 21-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 22-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 28-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 31-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-SEP-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-SEP-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-SEP-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-SEP-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009930: