chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Chest X-ray abnormal, Dyspnoea, Hypoxia
Clinical narrative: Presents to the ED for management of worsening shortness of breath. admitted with Acute hypoxic respiratory failure secondary to COVID-19 pneumonia: evidence of pneumonia on chest x-ray, and hypoxia requiring low-flow oxygen,Steroids &  remdesivir.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Oxygen saturation decreased, Speech disorder
Clinical narrative: SUMMARY OF PATIENT PROGRESS:   STATUS: Progressing as expected towards goals - continuing present plan   Primary Problem: Acute respiratory failure COVID 19   Key findings related to primary problem: Pt is awake and pretty much nonverbal. Not in any pain or distress. Pt was desating to 84% on room air this morning. Pt back on 2L oxygen and sating 93-97%. Pt is discharging later this afternoon once the oxygen gets delivered. Pt's father will take the patient home in car. Treated per MAR. POC reviewed with patient.   Other key findings: Fall precaution maintained.         Note Details  Author (R.N.) File Time 9/9/2023  2:52 PM Author Type REGISTERED NURSE Status Signed Last Editor  (R.N.) Specialty GENERAL, OTHER Hospital Acct # Admit Date 8/28/2023  ED to Hosp-Admission (Discharged) on 8/28/2023  ED to Hosp-Admission (Discharged) on 8/28/2023   Detailed Report  Note shared with patient Care Timeline  08/28   Admitted from ED 1916 09/09   Discharged 2024
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: After vaccination, patient waited in the lobby with dad and brother for about 5 minutes. When they got on the elevator, patient states she started to feel dizzy and fainted, hitting her head on the way down. Dad quickly hit the button to open the elevator since it had not started to go down yet. They came to one of the clinic rooms and patient was told to lay down. Patients BP was 87/51, Pulse 70, R 18, Temp 98.7, and was pale. We gave her a granola bar and water. After about 5 minutes, patient stated feeling better and color started returning to face. Denies nausea or any additional symptoms. At 3:15pm her BP was 108/77. At 3:25pm, her BP was 113/64. Patient remained feeling  well after sitting up on the cot. Explained to dad it is his choice to go to FMD or ER to have treatment from fall. Discussed symptoms to be aware of in regards to head injury. Dad states understanding. Denies additional questions/concerns. Patient ambulates to car with no issues.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chronic respiratory failure, Dyspnoea, Pulmonary oedema, Respiratory failure
Clinical narrative: Presented to the ED  with SOB,- appears to be from pulm edema, with superimposed OHS,chronic hypoxic respiratory failure, COVID pneumonia, solumedrol, duonebs,cefepime,lasix,HFNC, remdesevir,  zinc
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site vesicles, Pain
Clinical narrative: Skin started out sore to touch. I then got tiny blisters around injection site that spread around my arm by day 4. Fever for 2 days, headache, joints felt like ice pick stabbing in them. Body aches, skin hurt like th flu. Exhausted. I used advil, benadryl oral and topical. I felt better on third day but had blisters till fifth day
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Pyrexia, Tenderness
Clinical narrative: Skin started out sore to touch. I then got tiny blisters around injection site that spread around my arm by day 4. Fever for 2 days, headache, joints felt like ice pick stabbing in them. Body aches, skin hurt like th flu. Exhausted. I used advil, benadryl oral and topical. I felt better on third day but had blisters till fifth day
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, COVID-19 pneumonia
Clinical narrative: Admitted for Pneumonia due to COVID -19  Acute respiratory failure with hypoxia. Decadron, ZINC, magnesium, Pepcid, LOVENOX. Remdesivir 2 L nasal cannula.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Magnetic resonance imaging
Clinical narrative: On 5/9/23, I went in to a office for a physical check up. She recommended to me to get get the shingles vaccine due to my age. I agree because I had a shingles outbreak the year before. When the  medical assistant administered the for shot, I immediately felt some pain and noticed the bandaid was on my shoulder. Four hours later, my arm started to feel numbness, burning and stabbing pains. I couldn?t move my arm. I called the physicians hotline and they informed me take Ibuprofen or Tylenol. I came in for a visit in 5/11/23 to discuss vaccine reactions. My physician ordered a x-ray and a MRI and referred me to a C-Spine doctor who referred me to get a MRI and a nerve test. I continue to experience pain everyday and my symptoms have not subsided.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Magnetic resonance imaging spinal, Nerve conduction studies, Pain, Pain in extremity, Spinal X-ray
Clinical narrative: On 5/9/23, I went in to a office for a physical check up. She recommended to me to get get the shingles vaccine due to my age. I agree because I had a shingles outbreak the year before. When the  medical assistant administered the for shot, I immediately felt some pain and noticed the bandaid was on my shoulder. Four hours later, my arm started to feel numbness, burning and stabbing pains. I couldn?t move my arm. I called the physicians hotline and they informed me take Ibuprofen or Tylenol. I came in for a visit in 5/11/23 to discuss vaccine reactions. My physician ordered a x-ray and a MRI and referred me to a C-Spine doctor who referred me to get a MRI and a nerve test. I continue to experience pain everyday and my symptoms have not subsided.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: X-ray limb
Clinical narrative: On 5/9/23, I went in to a office for a physical check up. She recommended to me to get get the shingles vaccine due to my age. I agree because I had a shingles outbreak the year before. When the  medical assistant administered the for shot, I immediately felt some pain and noticed the bandaid was on my shoulder. Four hours later, my arm started to feel numbness, burning and stabbing pains. I couldn?t move my arm. I called the physicians hotline and they informed me take Ibuprofen or Tylenol. I came in for a visit in 5/11/23 to discuss vaccine reactions. My physician ordered a x-ray and a MRI and referred me to a C-Spine doctor who referred me to get a MRI and a nerve test. I continue to experience pain everyday and my symptoms have not subsided.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site pruritus, Injection site swelling, Pain, Pain in extremity, Urticaria
Clinical narrative: Reports Left arm became painful with swelling and itching around injection site following vaccination on Thursday (9/7/2023). States she developed hives on Friday (9/8/2023). Still had swelling around injection site and arm painful to move on 9/11/2023. Denies fever, difficulty breathing, or other generalized symptoms. Was advised by Triage to follow up at Urgent Care for Assessment.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Rash, Rash erythematous, Rash papular, Urticaria
Clinical narrative: States she woke up this morning at 09:30am and she is covered in a red, raised hive like rash over her entire body and extremeties.  The rash is now starting to spread to her face.  She denies swelling in her tongue, throat, scratch throat or difficulty breathing.  She has had previous Flulaval vaccine last year without a reaction.  She called her PCP and was instructed to go to the ED.  She was seen in the ED and given prednisone and Benadryl.  They gave her an Epi pen for home.  She is better.  She still has injection site soreness and a rash, but the rash has not gotten worse.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Cardiac disorder, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: I had a sudden worsening of COPD symptoms that at first I put down to heart issues developing.  My doctor later added inhalers for asthma (anoro elipta daily and albuterol for emergencies)..  I had NEVER had to use inhalers for breathing before and quit smoking 6 years prior to this so it wasnt that!  I still have to use the inhalers to this day and this represented a SUDDEN worsening of my symptoms which had been stable for years prior to the shot and have stabilized since!
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Dizziness, Pain in extremity
Clinical narrative: During the night I woke up to all my joints feeling like they were on fire. The next morning it got better but then I had a lot of dizziness. I have a sore arm, which I expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: I do not know the manufacturer.  Pain, local swelling, warmth, redness (About 2.5 x 3" oval). This has lasted 1 week so far. Improving but still painful, red and warm. Have not needed treatment. Notified MD
Age: 66.0
Sex: F
Vaccine: FLUA4, RSV, FLUA4, RSV
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: Patient reported pain in right arm a couple hours after vaccine was administered.  She reported that she is unable to lift her arm without pain/discomfort.  Patient reported side effects to pharmacy late afternoon/early evening on 09/11/2023 and was advised to use acetaminophen for pain and to contact PMD if pain persisted.  Patient saw PMD on 09/12/20023 and was given a methylprednisolone dose pack.
Age: 66.0
Sex: F
Vaccine: FLUA4, RSV, FLUA4, RSV
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Patient reported pain in right arm a couple hours after vaccine was administered.  She reported that she is unable to lift her arm without pain/discomfort.  Patient reported side effects to pharmacy late afternoon/early evening on 09/11/2023 and was advised to use acetaminophen for pain and to contact PMD if pain persisted.  Patient saw PMD on 09/12/20023 and was given a methylprednisolone dose pack.
Age: 66.0
Sex: F
Vaccine: FLUA4, RSV, FLUA4, RSV
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: RSV Vaccine given too high in shoulder, 2.5 hrs after vaccine right arm sore and I was unable to move it without excessive pain. Still painful the next day.
Age: 66.0
Sex: F
Vaccine: FLUA4, RSV, FLUA4, RSV
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: RSV Vaccine given too high in shoulder, 2.5 hrs after vaccine right arm sore and I was unable to move it without excessive pain. Still painful the next day.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cerebral artery embolism, Cerebrovascular accident, Death, Fall
Clinical narrative: Had a mass of tiny blood clots went to his brain and he had a stroke.   He had recovered from this event for months and fell down (while still recovering) re-injuring himself and this led to his eventual death from "unknown" causes.  He had a low lying fever which I have come to believe was the body attempting to reabsorb the blood clots and the hospital admitted him and "Cared for him" to death (they stuck an 82 year old man on an ice sheet because of the low fever and left him like that for a week until he lost all strength and died....he was ALLOWED to come home the day before his passing.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Injury, Laboratory test, Magnetic resonance imaging, Pyrexia
Clinical narrative: Had a mass of tiny blood clots went to his brain and he had a stroke.   He had recovered from this event for months and fell down (while still recovering) re-injuring himself and this led to his eventual death from "unknown" causes.  He had a low lying fever which I have come to believe was the body attempting to reabsorb the blood clots and the hospital admitted him and "Cared for him" to death (they stuck an 82 year old man on an ice sheet because of the low fever and left him like that for a week until he lost all strength and died....he was ALLOWED to come home the day before his passing.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a 2nd bivalent formulation inadvertently. No previous monovalent doses. No anaphylactic signs or reactions after administration.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administration error
Clinical narrative: ADMINISTRATION ERROR
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: pt got bivalent covid vaccine a few hours before the fda revoked them
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administration error
Clinical narrative: ADMINISTRATION ERROR
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administration error
Clinical narrative: ADMINISTRATION ERROR
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: patient got moderna bivalent shot a few hours before the fda revoked the authorization
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administration error
Clinical narrative: ADMINISTRATION ERROR
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: patient had starting having symptoms end of feb 2023.......patient states she was diagnosed with guillan barre post vaccination; numbness in extremities and face, weakness in extremities which caused her to be unable to walk. was hospitalized for nearly a month.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Eructation
Clinical narrative: Nausea, Vomiting, Diarrhea, Number of episodes, Greater than 10 x, Decreased appetite, Weak, Dizzy, Belching x 3 days after receiving Tdap vaccine
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, Vomiting, Diarrhea, Number of episodes, Greater than 10 x, Decreased appetite, Weak, Dizzy, Belching x 3 days after receiving Tdap vaccine
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administration error
Clinical narrative: ADMINISTRATION ERROR
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: dose given past expiry date of 04 Sept. 2023.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: shingrix vaccine was given to pt under age 50 instead of flu shot
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The second dose bivalent Covid vaccine  given on 7/29/2023 was outside of the recommended schedule. With the most recent guidelines, patients 5 years and older that have been vaccinated with a bivalent vaccine are considered completely vaccinated until they are 65 years old unless they are moderately or severely immunocompromised. This patient did not have  any exception noted for the second dose.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tennitis - ringing in my ears
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered Vaccine a month too early.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmenorrhoea, Haemorrhage urinary tract, Headache, Heavy menstrual bleeding
Clinical narrative: a few hours after injection developed headache, felt ill, dizzy, feverish--eventually subsided the following day. I skipped my next period (2 weeks later) and i was constantly regular--this was unusual. My period changed was super thin and intense bleeding with heavy blood clots w/ heavy cramping. I bled through my tampon and through my pants the bleeding was so heavy and intense. My period also lasted longer than it would have normally and, again, it threw off the timing of my period, I missed my normal date and the date of my period changed. It was very abnormal. No other events or things or meds or anything I was doing at that time to explain these symptoms I had shortly after getting the vaccine.  My vertigo has gotten worse, more frequent since getting this vaccine too.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Menstruation irregular, Pyrexia, Thrombosis
Clinical narrative: a few hours after injection developed headache, felt ill, dizzy, feverish--eventually subsided the following day. I skipped my next period (2 weeks later) and i was constantly regular--this was unusual. My period changed was super thin and intense bleeding with heavy blood clots w/ heavy cramping. I bled through my tampon and through my pants the bleeding was so heavy and intense. My period also lasted longer than it would have normally and, again, it threw off the timing of my period, I missed my normal date and the date of my period changed. It was very abnormal. No other events or things or meds or anything I was doing at that time to explain these symptoms I had shortly after getting the vaccine.  My vertigo has gotten worse, more frequent since getting this vaccine too.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The second dose bivalent Covid vaccine  given on 7/08/2023 was outside of the recommended schedule. With the most recent guidelines, patients 5 years and older that have been vaccinated with a bivalent vaccine are considered completely vaccinated until they are 65 years old unless they are moderately or severely immunocompromised. This patient did not have  any exception noted for the second dose.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Asthenia, Balance disorder, Fall, Fatigue
Clinical narrative: In October 2022, I began feeling fatigued and experienced muscle aches, weakness, and difficulty walking. On November 8, 2022, I had stomach cramps and visited Hospital, where I received antibiotics and was discharged.  On November 9, while at work, I noticed heaviness in my feet and worsening balance issues. The next day, November 10, my symptoms escalated, leading to a fall down the stairs. After another visit to Hospital, I was given medication but sent home.  On November 10, while trying to get into an car, I fell again, and I required assistance to enter the vehicle. Later that day, I collapsed while approaching my front door, and my family called an ambulance.  On November 11, 2022, I was transp
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Limb discomfort, Myalgia, Syncope
Clinical narrative: In October 2022, I began feeling fatigued and experienced muscle aches, weakness, and difficulty walking. On November 8, 2022, I had stomach cramps and visited Hospital, where I received antibiotics and was discharged.  On November 9, while at work, I noticed heaviness in my feet and worsening balance issues. The next day, November 10, my symptoms escalated, leading to a fall down the stairs. After another visit to Hospital, I was given medication but sent home.  On November 10, while trying to get into an car, I fell again, and I required assistance to enter the vehicle. Later that day, I collapsed while approaching my front door, and my family called an ambulance.  On November 11, 2022, I was transp
Age: 0.5
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLU4, PNC15, RV5, COVID19, DTPPVHBHPB, FLU4, PNC15, RV5
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage.   Nursing states that the vial of 5-11 vaccine was in the incorrect bin and was then drawn up and labeled as 6mo-4yr. Nursing then administered this dose and it was not caught through medication scanning as it was labeled incorrectly.   Patient family to be notified to monitor for any reactions.
Age: 0.5
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLU4, PNC15, RV5, COVID19, DTPPVHBHPB, FLU4, PNC15, RV5
Symptoms: Product administered to patient of inappropriate age, Product storage error, Product use issue
Clinical narrative: Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage.   Nursing states that the vial of 5-11 vaccine was in the incorrect bin and was then drawn up and labeled as 6mo-4yr. Nursing then administered this dose and it was not caught through medication scanning as it was labeled incorrectly.   Patient family to be notified to monitor for any reactions.
Age: 48.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: vaccine expired 6/24/2023
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: The second dose bivalent Covid vaccine  given on 7/14/2023 was outside of the recommended schedule. With the most recent guidelines, patients 5 years and older that have been vaccinated with a bivalent vaccine are considered completely vaccinated until they are 65 years old unless they are moderately or severely immunocompromised. This patient did not have  any exception noted for the second dose.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Administration site erythema, Pain in extremity
Clinical narrative: Patient called today to state that he had a reaction to the Arexvy vaccine he reveived on 9/10/23.  Yesterday, his arm was sore  but this morning after showering he noticed that about 3 inches around the administration area of the vaccine  that it was very red. He saw his physician and was prescribed Augmentin 875mg bid for 7 days
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Eye pain, Headache, Ocular hyperaemia, Photophobia, Rhinorrhoea
Clinical narrative: Got shot in left arm  .Came home, looked in mirror left eye normal,  went for walk, started feeling like something was stabbing me in eye. Came home looked in mirror and left eye tomato red.  Thought I had pink eye.  Went to Opthamologist  next day and it was Intraoccular Pressure.  Had pain in eye, left side headache, left nostril dripped for about 3 days, extreme light sensitivity.  Have been on Prednisolne Acetate for 2 weeks>  Have been to Opthomologist 3x so can monitor eye pressure.  He believes it was from RSV Vaccinee
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: The second dose bivalent Covid vaccine  given on 7/14/2023 was outside of the recommended schedule. With the most recent guidelines, patients 5 years and older that have been vaccinated with a bivalent vaccine are considered completely vaccinated until they are 65 years old unless they are moderately or severely immunocompromised. This patient did not have  any exception noted for the second dose.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Postural orthostatic tachycardia syndrome
Clinical narrative: Extreme constant tachycardia (heart rate between140 and 165, even at rest. Testing showed no underlying cardiac issues. Positive for POTS
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tachycardia
Clinical narrative: Extreme constant tachycardia (heart rate between140 and 165, even at rest. Testing showed no underlying cardiac issues. Positive for POTS
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Abnormal sensation in eye, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: 4 Hours after the vaccine, I started feeling run down. Very tired. I went to bed early and I woke up at  3:56am with a fever and a headache and chills that lasted an hour. I took tylenol and I fell asleep til about 11:30am or 12pm. I still have an annoying headache above my eyes. I dont have an appetite either. My eyes feel a little hot and I am exhausted.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Malaise, Pyrexia
Clinical narrative: 4 Hours after the vaccine, I started feeling run down. Very tired. I went to bed early and I woke up at  3:56am with a fever and a headache and chills that lasted an hour. I took tylenol and I fell asleep til about 11:30am or 12pm. I still have an annoying headache above my eyes. I dont have an appetite either. My eyes feel a little hot and I am exhausted.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: The second dose bivalent Covid vaccine  given on 7/29/2023 was outside of the recommended schedule. With the most recent guidelines, patients 5 years and older that have been vaccinated with a bivalent vaccine are considered completely vaccinated until they are 65 years old unless they are moderately or severely immunocompromised. This patient did not have  any exception noted for the second dose.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Headache, Tinnitus
Clinical narrative: Tinnitus and severe headaches, brain fog ongoing for two years plus
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Infection, Pain, Pruritus, Rash, Skin warm
Clinical narrative: PATIENT DESCRIBED ADVERSE EVENTS / SYMPTOMS TO BE RASH, ITCHY, PAINFUL, HOT AND INFECTED
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was accidentally administered high dose flu shot instead of regular dose, no adverse reaction, patient feels fine
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Hive with itching on body.  Vaccine given at PCP.  Other clinic filling form.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: Donor was given Tdap immunization on 9/10/23. Donor stated on 9/11/23 she had started to develop a nodule, swelling, and itching at the injection site. Donor tried to massage the area and when that did not help, she poured an entire bottle of isopropyl alcohol all over the injection site and arm and then allowed to air dry.  When that failed to help she followed her parents' advice and went and worked out.  Donor states on 9/12/23 the symptoms have worsened and she has no developed hives that extend from her elbow to the side of her neck on the left side.  Donor had called clinic to notify medical staff of the reaction and as of that calling, she was awaiting a ride to go to the emergency room. Unknown if any further issues.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: No additional AE; Medical Tech calls to report vaccine given during an excursion.  No PQC. No further AE  TE Case02454494; This spontaneous report was received from the consumer referring to a patient of unspecified age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On unspecified day, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number W038815 expiration date: 04-JUN-2023, (strength, route of administration and vaccination site were not reported).  On 16-AUG-2023, the patient experienced fever (pyrexia).   The reporter did not provide causality assessment between the events and the suspect therapies.
Age: 52.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE.; he had a patient at the pharmacy who was 52 years old and had received 2 doses of GARDASIL 9 on unknown dates in 2022.; This spontaneous report was received from a pharmacist regarding a 52-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown dates in 2022, the patient was vaccinated with the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prophylaxis (dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) (Product administered to patient of inappropriate age). The patient reported he was due for a 3rd dose, it had not been administered. No adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No further AE details; dose of expired PNEUMOVAX 23 was given to a patient; This spontaneous report was received from a medical assistant and refers to an unknown patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-SEP-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5ml/once, lot #U032086, expiration date: 29-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). It was reported that product has had no previous temperature excursions (TEs).  There were no adverse events reported (no adverse event).  This is a non-valid report due to lack of patient's identifiers.
Sex: U
Vaccine: PNC15
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC; inadvertent administration of VAXNEUVANCE to a patient on 08/30/2023 after experiencing a temperature excursion / Temperature: (-0.4C); temperature excursion on 8/28/2023 for 3 hours 31 minutes with a high of 10.7C, 8/29/2023 for 32 minutes for a low of 0.5C, 8/30/2023 for 2 hours 1 minute with a low of 1.0C; This spontaneous report was received from nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 30-AUG-2023, the patient was inadvertently administered the single dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringe, 0.5 mL (lot #X011332, expiration date: 01-JAN-2025) for prophylaxis, after experiencing temperature excursions of a high of 10.7 decree Celsius (C) for 3 hours and 31 minutes (on 28-AUG-2023), a low of 0.5 C for 32 minutes (on 29-AUG-2023), and a low of 1.0 C for 2 hours and 1 minute (on 30-AUG-2023) (Product storage error and poor quality product administered). It was confirmed that no symptomatic adverse events were reported. No additional adverse event (AE) and product quality complaint (PQC) were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2309USA002616:AE case #02467646 US-009507513-2309USA002803:AE case #02467649 US-009507513-2309USA002781:AE case #02467647
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE; inadvertent administration of GARDASIL 9 to a patient on 08/29/2023 after experiencing a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient´s medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not provided.   On 29-AUG-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5ml/once, lot#: W026152, expiration date: 29-JAN-2025; strength was not provided) for prophylaxis. The vaccine administered inadvertently experienced a temperature excursion before at -0.4C for 6 hours 5 minutes (product storage error). The vaccine also experienced previous temperature excursion at 0.5C for 32 minutes and 1 C for 2 hours 1 minutes. No additional adverse events (AE) were reported (no adverse event).   This case was received from the same reporter with 2309USA002781, 2309USA002616, and 2309USA002803.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report inadvertent administration of MMR-II to a patient on 08/29/2023 after experiencing a temperature excursion. Additional vaccines during the temperature excursion were administered to multiple patients (See AE case #02467645, #0246; This spontaneous report was received from a nurse and refers to a unknown patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-AUG-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinat human albumin (rHa) (M-M-R II) injection, 0.5 milliliter, lot #W028734, expiration date  08-SEP-2024, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -0.4 degree Celsius for 3 hours 32 minutes (Product storage error). This vaccine underwent previous temperature excusion in 0.5 degree Celsius for 32 minutes, in 1 degree Celsius fro 2 hours 1 minute and in 10.7 degree Celsius for 3 hours 31 minutes. No additional adverse event was reported.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Did not meet temperature control during shipment; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2582F) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Did not meet temperature control during shipment).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt date: 05-SEP-2023 The case was reported by the other health care professional. The reporter consented to follow up. The Boostrix did not meet temperature control during shipment, which led to incorrect storage of drug.
Sex: U
Vaccine: RSV
Symptoms: Device malfunction, Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: when pressing the plunger, more than a drop but less than ½ the dose escaped between; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incomplete dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: when pressing the plunger, more than a drop but less than ½ the dose escaped between).  The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 5-Sept-2023 The pharmacist reported that they gave an Arexvy shot to a gentleman and the vaccine tech had a syringe malfunction. The reporter consented to follow-up. When pressing the plunger, more than a drop but less than half the dose escaped between the interface between the needle and the barrel while the remainder was injected into the patient, which led to incomplete dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Chills, Cognitive disorder, Diarrhoea, Fatigue
Clinical narrative: diarrhea; cognitive dysfunction due to fatigue; painful lump under arm of vaccination; extreme fatigue; shivers; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 31-AUG-2023, 1 days after receiving Shingrix, the patient experienced cognitive disturbance (Verbatim: cognitive dysfunction due to fatigue), axillary lump (Verbatim: painful lump under arm of vaccination), fatigue (Verbatim: extreme fatigue), shivers (Verbatim: shivers) and fever (Verbatim: fever). On 05-SEP-2023, the patient experienced diarrhea (Verbatim: diarrhea).  On 05-SEP-2023, the outcome of the shivers and fever were resolved (duration 5 days). The outcome of the diarrhea was not resolved and the outcome of the cognitive disturbance and fatigue were resolved and the outcome of the axillary lump was resolving.   It was unknown if the reporter considered the diarrhea, cognitive disturbance, axillary lump, fatigue, shivers and fever to be related to Shingrix.     It was unknown if the company considered the diarrhea, cognitive disturbance, axillary lump, fatigue, shivers and fever to be related to Shingrix.   Additional Information: GSK Receipt date: 05-SEP-2023 The reporter reported about herself she had side effects after receiving Shingrix vaccine on August 30, 2023.  The day following her injection, she experienced fever, shivers and extreme fatigue leading to cognitive dysfunction (she left a pan on her stove which caught on fire) and she also reports a lump 2 inches in diameter appearing under the same arm of the vaccination about one half inch below the axilla, which was very painful.  The fever, shivers and some of the fatigue and the cognitive dysfunction had resolved and the lump was now smaller at about a half inch diameter.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: diarrhea; cognitive dysfunction due to fatigue; painful lump under arm of vaccination; extreme fatigue; shivers; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 31-AUG-2023, 1 days after receiving Shingrix, the patient experienced cognitive disturbance (Verbatim: cognitive dysfunction due to fatigue), axillary lump (Verbatim: painful lump under arm of vaccination), fatigue (Verbatim: extreme fatigue), shivers (Verbatim: shivers) and fever (Verbatim: fever). On 05-SEP-2023, the patient experienced diarrhea (Verbatim: diarrhea).  On 05-SEP-2023, the outcome of the shivers and fever were resolved (duration 5 days). The outcome of the diarrhea was not resolved and the outcome of the cognitive disturbance and fatigue were resolved and the outcome of the axillary lump was resolving.   It was unknown if the reporter considered the diarrhea, cognitive disturbance, axillary lump, fatigue, shivers and fever to be related to Shingrix.     It was unknown if the company considered the diarrhea, cognitive disturbance, axillary lump, fatigue, shivers and fever to be related to Shingrix.   Additional Information: GSK Receipt date: 05-SEP-2023 The reporter reported about herself she had side effects after receiving Shingrix vaccine on August 30, 2023.  The day following her injection, she experienced fever, shivers and extreme fatigue leading to cognitive dysfunction (she left a pan on her stove which caught on fire) and she also reports a lump 2 inches in diameter appearing under the same arm of the vaccination about one half inch below the axilla, which was very painful.  The fever, shivers and some of the fatigue and the cognitive dysfunction had resolved and the lump was now smaller at about a half inch diameter.  The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe Shoulder pain at injection site (Left Deltoid); Unable to lift arm (left arm); This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9B2Y4, expiry date 20-OCT-2024) for prophylaxis.   On 03-SEP-2023, the patient received Arexvy (intramuscular, left deltoid). On 03-SEP-2023, less than a day after receiving Arexvy, the patient experienced injection site pain (Verbatim: Severe Shoulder pain at injection site (Left Deltoid)) and injected limb mobility decreased (Verbatim: Unable to lift arm (left arm)).  The outcome of the injection site pain and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Arexvy.     It was unknown if the company considered the injection site pain and injected limb mobility decreased to be related to Arexvy.   Additional Information: GSK receipt date: 03-SEP-2023 The patient and received the RSV vaccine today around 12 noon and within a couple of hours the patient was having shoulder pain and what the patient meant by shoulder pain was could not raise arm on the side of the injection.  The HCP left message on after hours VM box, stated could call phone number provided to obtain additional information.  However, specific details for Safety team follow-up was not provided.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Engerix-B given instead of second dose of Twinrix on 08/21/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 39-year-old female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 21-AUG-2023, the patient received Engerix B. On 21-AUG-2023, an unknown time after receiving Engerix B and an unknown time after receiving TWINRIX, the patient experienced wrong vaccine administered (Verbatim: Engerix-B given instead of second dose of Twinrix on 08/21/2023).The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter was reporting that Engerix-B given instead of second dose of Twinrix, which led to wrong vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up by safety team.
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: male adult received Havrix pediatric second dose; male adult received Havrix pediatric second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 61-year-old male patient who received HAV (Havrix pediatric) (batch number 943Y2, expiry date 05-MAY-2025) for prophylaxis.   On 05-SEP-2023, the patient received the 2nd dose of Havrix pediatric. On 05-SEP-2023, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: male adult received Havrix pediatric second dose) and adult use of a child product (Verbatim: male adult received Havrix pediatric second dose).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 5-Sept-2023 The clinic manager reported that an adult patient received Havrix pediatric second dose by error. The reporter consented to follow-up via email. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of child product.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccine administered was actually expired since 2/26/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-month-old female patient who received HAV (Havrix) (batch number T57F3, expiry date 16-FEB-2023) for prophylaxis.   On 08-MAR-2023, the patient received Havrix. On 08-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: vaccine administered was actually expired since 2/26/2023).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 5-Sept-2023 The medical assistant reported that on the day of reporting, while going through the records, they found that the vaccine administered was actually expired. The patient was doing fine. Treating physician was aware. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: after receiving the complete scheme of Shingrix relief on general neuralgia; Pain; This non-serious case was reported by a physician via call center representative and described the occurrence of unexpected therapeutic effect in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included trigeminal neuralgia and pain. Concomitant products included carbamazepine.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: after receiving the complete scheme of Shingrix relief on general neuralgia) and pain (Verbatim: Pain). The outcome of the unexpected therapeutic effect was unknown and the outcome of the pain was not resolved.   It was unknown if the reporter considered the unexpected therapeutic effect and pain to be related to Shingrix.     It was unknown if the company considered the unexpected therapeutic effect and pain to be related to Shingrix.   Additional Information: GSK receipt date: 05-SEP-2023 This case was reported by husband on behalf of his wife.  The patient suffered from Trigeminal Neuralgia and her pain subsided after her second dose of Shingrix in 2021 (Unexpected Benefits). The pain had returned after two years, however, patient was happy to be pain free for approximately two years. This case was identified as duplicate of case US2023121047. All future correspondence would be added in this case, which stands as case of record for this patient and the case US2023121047 would be deleted. The reporter did not consent to follow-up.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B Pediatric dose to an adult patient; Engerix-B Pediatric dose to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) (batch number KR3XD, expiry date 17-FEB-2025) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix-B Pediatric dose to an adult patient) and adult use of a child product (Verbatim: Engerix-B Pediatric dose to an adult patient).The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 06-SEP-2023 The reporter called to ask for information about the administration of a pediatric Engerix-B dose to an adult patient, which led to underdose and adult use of a child product. The reporter asked how to proceed with this patient. The reported did not provide information about the patient and mentioned that she did not know the date of administration. The reporter consented to follow up via email.