chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Pain in arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAY-2024 This case was reported by a patient via interactive digital media. The patient stated that the truth was he did not feel anything, had a little pain in his arm. This case had been linked with the case US2024AMR058661, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR058661:Same reporter Female patient
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAY-2024 This case was reported by a patient's husband via interactive digital media. The reporter reported that his wife (patient) got very sick. This case had been linked with the case US2024AMR058647, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR058647:Same reporter male patient
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired vaccine with no reported adverse event; Initial information was received on 08-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient who was given 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 08-May-2024, the patient received an unknown dose of suspect  diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot number, expiry date, strength: unknown) via intramuscular route in unknown administration site for prophylactic vaccination (Immunization) and patient was given an expired vaccine with no reported adverse event (expired product administered) (Latency: same day).  The information on the batch number was requested.  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: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: a dose of YF-VAX have been given with sterile water as the diluent instead of the supplied diluent with no reported adverse event; yf-vax was given with sterile water as the diluent instead of the supplied diluent with no adverse event; Initial information received on 30-Apr-2024 regarding an unsolicited valid  non-serious case received from non health care professional..  This case involves an unknown age/gender patient who received a dose of YELLOW FEVER VACCINE - [YF-VAX] have been given with sterile water as the diluent instead of the supplied diluent 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 a  dose of suspect YELLOW FEVER VACCINE - Solution for injection with sterile water as the diluent instead of the supplied diluent with no reported adverse event (product preparation error and Poor quality product administered, latency same day) (dose, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  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.   Additional information was received on 06-May-2024 from non health care professional: Event of Poor quality product administered added. Texta amended.
Age: 37.0
Sex: F
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient got administered a vaccine post-expiration with no reported adverse event; Initial information received on 06-May-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 37 years old female patient who got administered a Yellow fever vaccine - [YF-VAX] vaccine post-expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-May-2024, the patient received a dose of suspect yellow fever vaccine -Solution for injection (lot- UJ783AB and expiry date- 13-Apr-2024) via subcutaneous route in the right deltoid (expired product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: used a different sterile diluent with different dose instead of Act-Hib diluent with no reported adverse event; Initial information received on 06-May-2024 regarding an unsolicited valid non-serious case received via pharmacist.  This case involves a 15-month-old male patient who had used a different sterile diluent with different dose instead of HIB (PRP/T) VACCINE [ACT-HIB] diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 06-May-2024, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength, expiry date: unknown) (lot: UJ978AA) via unknown route in unknown administration site for Prophylactic Vaccination (immunization) and used a different sterile diluent with different dose instead of act-hib diluent with no reported adverse event (product preparation error) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient got administered expired vaccine with no reported adverse event; Initial information received on 09-May-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who got administered expired HIB (PRP/T) [ACT-HIB] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Mar-2024, the patient received a dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot- UJ863AA and expiry- 25-Mar-2024) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (expired product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bronchitis, Headache, Immunisation reaction, Inflammation
Clinical narrative: 2 hours after injection I started getting a terrible headache. After a couple more hours I started running fever 100.5, and started breaking out with a handful of hives on my stomach back and arm.  I took 500 mg of Advil for the headache and fever and I took 20mg of Zyrtec for the hives.  The fever and hives lasted for 3-4 days. The headache lasted for a solid week. I called my doctor and was seen on 9/15. She scheduled a CT scan on 9/17.  Initially prescribed Maxalt but didn?t help. Then prescribed Topamax and referred to Neurologist. Neurologist confirmed I had migraine headaches most likely caused by inflammation triggered from the COViD-19 vaccination
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nasopharyngitis, Pyrexia, Urticaria
Clinical narrative: 2 hours after injection I started getting a terrible headache. After a couple more hours I started running fever 100.5, and started breaking out with a handful of hives on my stomach back and arm.  I took 500 mg of Advil for the headache and fever and I took 20mg of Zyrtec for the hives.  The fever and hives lasted for 3-4 days. The headache lasted for a solid week. I called my doctor and was seen on 9/15. She scheduled a CT scan on 9/17.  Initially prescribed Maxalt but didn?t help. Then prescribed Topamax and referred to Neurologist. Neurologist confirmed I had migraine headaches most likely caused by inflammation triggered from the COViD-19 vaccination
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Severe headache severe nausea vomiting muscle pain back and leg pain
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Severe headache severe nausea vomiting muscle pain back and leg pain
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Infection, Skin discolouration
Clinical narrative: Infection; Patient developed cellulities; cellulitis left discoloration; This serious case was reported by a physician via sales rep and described the occurrence of infection in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2024, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced infection (Verbatim: Infection) (serious criteria other: Serious as reporter), cellulitis (Verbatim: Patient developed cellulities) and skin discoloration (Verbatim: cellulitis left discoloration). The patient was treated with ceftriaxone. Shingrix was discontinued. The outcome of the infection, cellulitis and skin discoloration were resolved.   The reporter considered the infection and cellulitis to be related to Shingrix. It was unknown if the reporter considered the skin discoloration to be related to Shingrix.     The company considered the infection and cellulitis to be related to Shingrix. It was unknown if the company considered the skin discoloration to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2024 The reporter was the patient who was also a physician. The patient developed cellulitis 2 days after the 1st dose of Shingrix. The patient was a medical doctor who received a dose and developed cellulitis two days later, ID physician to treat with Ceftriaxone for 2 days than oral cephalosporins for 8 more days. The cellulitis left discoloration which lasted few more days to weeks. The patient decided not to get the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I still got shingles; I am in agony; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I still got shingles) and pain (Verbatim: I am in agony). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAY-2024 The patient had the vaccine, and still got shingles. The patient was in agony. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 22.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: they accidentally gave an adult patient DAPTACEL instead of ADACEL with no reported adverse event; they accidentally gave an adult patient DAPTACEL instead of ADACEL with no reported adverse event; Initial information received on 10-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 22 years old female patient and reporter reported they accidentally gave an adult patient Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]  with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-May-2024, the patient received 0.5 ml total of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: 2CA28C1) (strength: standard) (Frequency: once) (with an unknown expiry date) via unknown route in the right deltoid for immunization.  On 10-MAY-2024,  they accidentally gave an adult patient Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]  with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (Latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Muscle Soreness in my arm, at injection site, which I still have after  7months!
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Tinnitus
Clinical narrative: Pulsatile Tinnitus in left ear
Age: 51.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Back pain, Condition aggravated, Injection site pain, Injection site pruritus, Migraine
Clinical narrative: 1. Occasional itching near the injection site.  (Still happening 2 weeks later.) 2. Back pain (trigger points, muscle knots, pain like little needles). Trigger points and muscle knots in the shoulder blade area on the side of the injection onset within 24 hours. Have not cleared up 17 days later. At first it felt like typical muscle soreness from a flu, but it shouldn't last so long, and it has turned into a constant "inflamed" feeling in my upper back.  3. Nerve pain. Occasional shooting pains down the arm with the injection site. Occasional zings from other nerves in my legs on both sides, and sometimes in lower legs and sometimes in upper legs.  4. Triggering migraines.
Age: 51.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Neuralgia, Pain
Clinical narrative: 1. Occasional itching near the injection site.  (Still happening 2 weeks later.) 2. Back pain (trigger points, muscle knots, pain like little needles). Trigger points and muscle knots in the shoulder blade area on the side of the injection onset within 24 hours. Have not cleared up 17 days later. At first it felt like typical muscle soreness from a flu, but it shouldn't last so long, and it has turned into a constant "inflamed" feeling in my upper back.  3. Nerve pain. Occasional shooting pains down the arm with the injection site. Occasional zings from other nerves in my legs on both sides, and sometimes in lower legs and sometimes in upper legs.  4. Triggering migraines.
Age: 21.0
Sex: F
Vaccine: TDAP, TTOX
Symptoms: Burning sensation, Rash, Rash erythematous, Urticaria
Clinical narrative: took the vaccine around 12:30 on May 12th. Rash started the next day and continued to get worse until Wed. 15th. Rash started burning and then decided to go to urgent care. Rash/hives are all over body and red
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Gait disturbance, Headache, Hypoaesthesia
Clinical narrative: I received the Pfizer COVID19 injection because my Government employer was threatening to take adverse action against me if I did not receive it. The injection caused extreme and debilitating joint pain, head pain, numbness in the lower body, and other symptoms. These limited my ability to walk, sleep, and perform other daily and work-related activities. I went to an emergency room and primary care doctor because of the multiple problems. The doctors advised against my receiving any further doses. Some improvements in my physical conditions occurred gradually over the course of a year.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Insomnia, Loss of personal independence in daily activities
Clinical narrative: I received the Pfizer COVID19 injection because my Government employer was threatening to take adverse action against me if I did not receive it. The injection caused extreme and debilitating joint pain, head pain, numbness in the lower body, and other symptoms. These limited my ability to walk, sleep, and perform other daily and work-related activities. I went to an emergency room and primary care doctor because of the multiple problems. The doctors advised against my receiving any further doses. Some improvements in my physical conditions occurred gradually over the course of a year.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I woke up the morning after my Moderna Covid 19 booster with tinnitus. I have never had tinnitus in my life before that morning and the ringing has not stopped since that day. I have gone online and found no help for this condition which I feel the vaccine has caused.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site injury, Loss of personal independence in daily activities, Pain, Product administered at inappropriate site
Clinical narrative: Per patient report pn 5/10/24: The RN that provided the injection placed it very high up in the shoulder vs. the deltoid. My shoulder is injured from the injection and it has been worsening. I was hoping that if I gave it time, it would improve but that has not been the case. I have a diminished range of motion and am having difficulties taking my clothes on and off. Ibuprofen gives minimal relief and I am waking up multiple times throughout the night in pain. What are the next steps here? It was by far the most painful vaccine I have received, and I knew right away that it was incorrect with the pain and when I saw where she placed the bandaid. This is incongruent with my experience of receiving the vaccine two times prior.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Sleep disorder
Clinical narrative: Per patient report pn 5/10/24: The RN that provided the injection placed it very high up in the shoulder vs. the deltoid. My shoulder is injured from the injection and it has been worsening. I was hoping that if I gave it time, it would improve but that has not been the case. I have a diminished range of motion and am having difficulties taking my clothes on and off. Ibuprofen gives minimal relief and I am waking up multiple times throughout the night in pain. What are the next steps here? It was by far the most painful vaccine I have received, and I knew right away that it was incorrect with the pain and when I saw where she placed the bandaid. This is incongruent with my experience of receiving the vaccine two times prior.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV1
Symptoms: Cardiac arrest, Death, Epistaxis, Laboratory test, Resuscitation
Clinical narrative: According to the physician, the patient was seen for routine three-month follow-up appointment. During the visit, he received thhis second dose of Pentacel, pneumococcal, and rotavirus vaccines. When returning home, the patient was put to sleep. Shortly after, the mother found blood coming from the patient's nose when checking on him. Emergency services were called, and CPR was performed Despite efforts, the patient was pronounced dead at the hospital due to cardiac arrest.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Developed large wheal approximately 3" x 3" at injection site.  Area is reddened and raised, warm to touch.  Area is painful to touch at almost 48 hrs post injection.  In addition, it is painful to move/lift left arm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: Developed large wheal approximately 3" x 3" at injection site.  Area is reddened and raised, warm to touch.  Area is painful to touch at almost 48 hrs post injection.  In addition, it is painful to move/lift left arm.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Antibody test, Chest pain, Headache, Nausea, Paraesthesia
Clinical narrative: fever, swollen arm, tingling in arms, tingling in hands, tingling in legs, tingling in feet, nausea, headache, chest pain,
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Viral titre
Clinical narrative: fever, swollen arm, tingling in arms, tingling in hands, tingling in legs, tingling in feet, nausea, headache, chest pain,
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Spoke with patient.  Got the pneumonia shot - huge welt appeared within 24 hours of injection Asking for reaction to be reported to pharmaceutical company   Symptoms: Red, raised large red welts at injection site following pneumococcal injection. doing heat pack - 6.5 x 4.5 welt - it has gone down now - is now 5 x 3  Characteristics: raised red and mad - 2 lumps looks almost like a bulls eye - quarter size inner red welt and outer ring of bigger size.   Pain: patient states painful  History: had injection on 5/9/24   Onset date/time: 5/9/24 afternoon - symptoms started within 24 hours on 5/10/24  Location: left bicep  Aggravating: nothing  Relieving: ice packs, tylenol, ibuprofen   Denies: temp is at 99.9 F , no trouble breathing or anaphylaxis. Alert and oriented, clear historian.    Patient declines UC visit - says it is going down. Agrees to be seen if symptoms worsen.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site urticaria
Clinical narrative: Spoke with patient.  Got the pneumonia shot - huge welt appeared within 24 hours of injection Asking for reaction to be reported to pharmaceutical company   Symptoms: Red, raised large red welts at injection site following pneumococcal injection. doing heat pack - 6.5 x 4.5 welt - it has gone down now - is now 5 x 3  Characteristics: raised red and mad - 2 lumps looks almost like a bulls eye - quarter size inner red welt and outer ring of bigger size.   Pain: patient states painful  History: had injection on 5/9/24   Onset date/time: 5/9/24 afternoon - symptoms started within 24 hours on 5/10/24  Location: left bicep  Aggravating: nothing  Relieving: ice packs, tylenol, ibuprofen   Denies: temp is at 99.9 F , no trouble breathing or anaphylaxis. Alert and oriented, clear historian.    Patient declines UC visit - says it is going down. Agrees to be seen if symptoms worsen.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Aching all over, chills, pain, swelling and redness at injection site.  Malaise.  Aches in neck and shoulder.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Neck pain, Pain
Clinical narrative: Aching all over, chills, pain, swelling and redness at injection site.  Malaise.  Aches in neck and shoulder.
Age: 18.0
Sex: F
Vaccine: COVID19-2, MNQ, TDAP
Symptoms: Fall, Head injury, Malaise, Nausea, Tremor
Clinical narrative: While I was giving her the vaccines, she mentioned she had a concussion right after her high school graduation. I asked her to have a seat outside after I administered the three vaccines in order for me to print her forms for school. She said she was feeling unwell, I offered her some water and she accepted it. She asked for a bucket  because she was feeling nauseous. As I was in the pharmacy getting a trash can, she fell off the chair. Her head was shaking back and forth. My technician tended to her while I called 911. He said she was alert and responsive. As we were waiting for the ambulance, she said this never happened before. When the paramedics arrived, he said he picked her up the previous day at fast food resturant when a box of cups hit her head and had a concussion. They took her to the ER to have her examined for any head injury.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: EXPIRED DOSE OF PREVNAR 13 VACCINE WAS INADVERTENTLY GIVEN, EXP DATE WAS 4/2024, LOT NUMBER FF7357. NO ADVERSE REACTIONS TO NOTE.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Deafness, Device therapy, Magnetic resonance imaging head normal, Tinnitus
Clinical narrative: Sudden onset severe tinnitus, persistent.  Occurred about 2 weeks after booster.  After one week of constant "roaring" sound, has settled into a consistent pattern of varying sounds.  No prior history of tinnitus.  Normal age-related hearing loss.  Clean MRI.  Treatment with Lenire device; so far, no significant improvement.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: wrong dose given
Age: 1.92
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS GIVEN QUADRACEL OUTSIDE OF RECOMMENDED AGE RANGE
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chills, Headache
Clinical narrative: EMPLOYEE REPORTED 45MIN AFTER SHOT. STARTED FEELING, WEAK, CHILLS, HEADACHE, NO FEVER.  SHOT GIVEN 4/14/24. ON 5/15/24 STILL FEELING WEAK, HEADACHE. NO TREATMENT. STATED JUST GOING TO REST.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Hepatic enzyme increased, Intensive care, Nausea
Clinical narrative: Resident began with nausea and vomiting on Sunday 5/12/2024. Reports that he was also having issues with headaches. On 5/13/2024 resident was seen by primary care physician and noted to have elevated liver enzymes. Sent to ER on 5/14/2024 following complaints of abdominal pain and vomiting. Admitted to ICU for suspected Viral Sepsis.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Viral sepsis, Vomiting
Clinical narrative: Resident began with nausea and vomiting on Sunday 5/12/2024. Reports that he was also having issues with headaches. On 5/13/2024 resident was seen by primary care physician and noted to have elevated liver enzymes. Sent to ER on 5/14/2024 following complaints of abdominal pain and vomiting. Admitted to ICU for suspected Viral Sepsis.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: Injection site reaction - redness, swelling and hives with itching
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Day after vaccination the patient developed a red bumpy rash on both cheeks on her face as well as both upper arms near injection sites. They reported to the ER and were given a dose of oral steroid. The rash continued for several days after.  She is now using OTC hydrocortisone 1% cream to help the rash.
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect vaccine given.  Patient should have been given Tdap, not DTaP.  No adverse effects.
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 73.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Abdominal pain upper, Polyarthritis
Clinical narrative: Client reports global 'arthritis' same day at night, Next day only 'stabbing' deep stomach pain , 2nd day only very light stomach pain
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 72.0
Sex: F
Vaccine: COVID19, PNC20, UNK
Symptoms: Asthenia, Balance disorder, Body temperature increased, Dizziness, Dysstasia
Clinical narrative: She got her vaccines, did not have any reactions to begin with or that evening.  When she woke up the following morning she felt tired and did not feel real good.  She did get up and up for a while and ate something.  Then a little while later she felt awful and needed to lay down.  From that point on she could hardly get up, she was dizzy, did not have any balance, could not stand straight up.  She stayed in bed from that point until this morning.  She was not able to function other than just lay in bed.  She tool Tylenol arthritis at one point mid morning yesterday.  She could barely get to the bathroom due to the weakness, could not get her muscles to work very well, she felt like she was going to fall over if she tried to get up.  She did not call her doctor regarding her symptoms as she was sure it was a reaction to the vaccines.  Today, she is feeling a little better, is able to get up and get around, feeding her animals and not feeling like she was going to pass out.  She does not feel like eating right now, but is drinking a lot of fluids.  She did call the pharmacist yesterday and told her that she was probably having a reaction to the vaccines, and that it differs in people and can last for a few hours to a few days.  She has never had a vaccine that made her feel so bad.  She had a temp up to 101.4 this time and felt worse than her previous reaction. .  She had a reaction to her 2nd COVID vaccine with a temp up to 103 but did not feel as bad as this time.
Age: 72.0
Sex: F
Vaccine: COVID19, PNC20, UNK
Symptoms: Fatigue, Feeling abnormal, Loss of personal independence in daily activities, Mobility decreased, Muscle disorder
Clinical narrative: She got her vaccines, did not have any reactions to begin with or that evening.  When she woke up the following morning she felt tired and did not feel real good.  She did get up and up for a while and ate something.  Then a little while later she felt awful and needed to lay down.  From that point on she could hardly get up, she was dizzy, did not have any balance, could not stand straight up.  She stayed in bed from that point until this morning.  She was not able to function other than just lay in bed.  She tool Tylenol arthritis at one point mid morning yesterday.  She could barely get to the bathroom due to the weakness, could not get her muscles to work very well, she felt like she was going to fall over if she tried to get up.  She did not call her doctor regarding her symptoms as she was sure it was a reaction to the vaccines.  Today, she is feeling a little better, is able to get up and get around, feeding her animals and not feeling like she was going to pass out.  She does not feel like eating right now, but is drinking a lot of fluids.  She did call the pharmacist yesterday and told her that she was probably having a reaction to the vaccines, and that it differs in people and can last for a few hours to a few days.  She has never had a vaccine that made her feel so bad.  She had a temp up to 101.4 this time and felt worse than her previous reaction. .  She had a reaction to her 2nd COVID vaccine with a temp up to 103 but did not feel as bad as this time.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: patient experienced nausea, vomiting, body aches and fever in the evening after getting vaccine in morning.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Provider accidentally administered 18m-11y Moderna vaccine dose to Adult 12y+ patient
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity, Pyrexia
Clinical narrative: Severe arm pain starting that night - fever of over 103 every evening for the next 3 years, periodic fever ~2 per week since till current date, joint and limb pain
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave Pediatric Formula.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave Pediatric Formula.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave Pediatric Formula.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Vitiligo
Clinical narrative: Tinnitus and Vitiligo
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Device malfunction, Syringe issue
Clinical narrative: syringe malfunctioned on giving 1st dose from vial lot un592, repeated dose according to clinical guideline .   used lot # 2kd99
Age: 30.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: Pt came in for appt at 3:15pm  and according to database pt needed MMR, Tdap, and HPV. Gave Menveo instead of MMR. Pt will be notified.
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired , no symptoms
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects known
Age: 68.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Mobility decreased
Clinical narrative: He got his vaccines and had no issues at all the rest of the day.  He woke up around 2:00 AM and felt so weak and had shaking chills.  His son heard him and turned up the heat and put some blankets on him as he was not able to get out of bed.  He has never experienced anything like that before.  He stayed in bed, and this morning when he woke up at 6:00 AM and had a severe headache, which he has not had any headaches in many many years.  He took a 81 mg aspirin for that and it was gone within 3 hours.  Right now he feels better, but still feels kind of weak and tired, headache is gone.  He has not had anymore episodes of chills.  He did not call his doctor.   He called his neighbor who is an RN who came over, took his temp and it was 99.9.   He never experienced a feeling like he had with this and has had many vaccines being in the health field, and felt that maybe he was having a stroke, but he is feeling better now.
Age: 68.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Tremor
Clinical narrative: He got his vaccines and had no issues at all the rest of the day.  He woke up around 2:00 AM and felt so weak and had shaking chills.  His son heard him and turned up the heat and put some blankets on him as he was not able to get out of bed.  He has never experienced anything like that before.  He stayed in bed, and this morning when he woke up at 6:00 AM and had a severe headache, which he has not had any headaches in many many years.  He took a 81 mg aspirin for that and it was gone within 3 hours.  Right now he feels better, but still feels kind of weak and tired, headache is gone.  He has not had anymore episodes of chills.  He did not call his doctor.   He called his neighbor who is an RN who came over, took his temp and it was 99.9.   He never experienced a feeling like he had with this and has had many vaccines being in the health field, and felt that maybe he was having a stroke, but he is feeling better now.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Pain in right arm
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was administered Engerix-B 10mcg/0.5ml,  pediatric dose in error. Patient received correct dose on 03/27/2024
Age: 61.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Palpitations, Rash
Clinical narrative: Patient reported having heart palpitations and a widespread rash after receiving vaccines. Patient has seen her cardiologist since and believes she had a reaction to Arexvy.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainting
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired covid vaccine
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Haematochezia, Infant irritability, Intussusception
Clinical narrative: Patient had bloody stools and fussiness beginning 5/13/24 PM, found to have intussusception.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effect noted
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Patient developed varicella like reaction to body 10 days after the varicella administration
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 33.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Dizziness, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: site swelling , redness, painful. Lightheaded and diaphoretic.
Age: 0.42
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Coagulation factor IX level, Coagulation test, Differential white blood cell count, Echoencephalogram, Full blood count
Clinical narrative: Patient received 2 month vaccines and after going home and waking up from nap a few hours later woke up with purpuric lesions on both feet. Sent to clinic for labs and evaluation. He was admitted overnight for evaluation.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Metabolic function test, Purpura, Skin lesion, Urine analysis, Von Willebrand's factor activity test
Clinical narrative: Patient received 2 month vaccines and after going home and waking up from nap a few hours later woke up with purpuric lesions on both feet. Sent to clinic for labs and evaluation. He was admitted overnight for evaluation.
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired , no symptoms
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This patient was given a kinrix (DTaP and IPV) even though it is for patients over 4 years with this patient only being 2 years old
Age: 58.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Patient presented to the clinic the day after vaccine administration with an erythematous rash on her right arm and generalized itchiness. She was treated with solumedrol injection and a prescription was given to take benadryl 25mg every 6 hours.
Age: 0.5
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: infant administered HPV vaccine in error
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects known
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, adverse effects noted
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: patient started with a rash on arm at site of injection, went to dr and they believe it may be shingles and prescibed valtrex
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Contusion, Erythema, Hyperhidrosis, Local reaction
Clinical narrative: patient experienced both local reaction (redness, arm soreness, bruise on arm) along with systemic reaction (fever,chills,sweating)
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: patient experienced both local reaction (redness, arm soreness, bruise on arm) along with systemic reaction (fever,chills,sweating)
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 12.0
Sex: M
Vaccine: FLU4, HEPA, IPV, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: COVID19 vaccine Spikevax administered 4 days after expiration date.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired , no symptoms
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PT reported on 5/14/2024 she started having a redness where the shot was given along with itching. Surrounding area noted with redness approximately 7 in.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired , no symptoms
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea
Clinical narrative: Nausea, headache
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no sypmtoms
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Rash, Rash erythematous
Clinical narrative: Noted by mom to have a sporadic fine pink rash to small area of abdomen and her feet and R. hand
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired , no symptoms
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Pt fell in room 11 while attempting to sit down on a chair to get dressed, pt had received HPV vaccines 10 minutes prior to fall.  Pt hit her head on the floor and was unconscious approximately 1 min, doctor immediately came to room to assess pt.  Prior to fall pt did not report feeling dizzy or lightheaded. Pt given juice and water following fall, no injuries noted, pt sat on the floor for 2-3 minutes before being helped to her feet, pt left the office alert and oriented x4.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Muscular weakness, Pain in extremity
Clinical narrative: right arm pain and weakness, lump at shot sight in 1st week. Time of pain is 3 to 4 days in past 3 weeks. Unbareable pain by day 4.
Age: 1.83
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms