chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain, Paranasal sinus discomfort
Clinical narrative: 04/02/2023 I started having sinus pressure, sore throat, coughing, fever and fatigue. I tested positive for COVID-19 on 04/04/2023. I contacted my Physician and was prescribed a 5 day course of Paxlovid. Symptoms lasted 6 days. I tested negative on 04/09/2023. I am feeling well but continue to have a lingering cough and chest congestion.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: 04/02/2023 I started having sinus pressure, sore throat, coughing, fever and fatigue. I tested positive for COVID-19 on 04/04/2023. I contacted my Physician and was prescribed a 5 day course of Paxlovid. Symptoms lasted 6 days. I tested negative on 04/09/2023. I am feeling well but continue to have a lingering cough and chest congestion.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Hypoxia
Clinical narrative: R09.02 HYPOXIA 9/10/2021 ANEMIA R09.02 HYPOXIA 9/10/2021 ANEMIA R09.02 HYPOXIA 9/10/2021 ANEMIA
Age: 102.0
Sex: M
Vaccine: COVID19
Symptoms: Dementia, Hypoxia
Clinical narrative: HYPOXEMIA 8/15/2021 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vasodilatation, Vision blurred, X-ray
Clinical narrative: A day after the vaccine I had a severe headache, and my eyes were getting cloudy to where I could not see I could barely see with glasses, The vein in the center and top of eyes were inflamed,
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Unable to contact pt to obtain information regarding adverse events
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: None. Expired Covid 19 vaccine on 10/25/2022,  given 01/26/2023
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Fatigue, Gingival pain, Nasopharyngitis, Pain
Clinical narrative: In general, my symptoms were like a cold.  I was achy, sinuses hurt, gums hurt and I physically tired.  The same day I tested positive the same day my symptoms began.  I got Paxlovid on the same day, the half-dose.  I got better and better.  As of Tuesday, April 11th, I was still testing positive.  Today I am still tired and I don't feel like I have recovered.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: SARS-CoV-2 test positive, Sinus pain
Clinical narrative: In general, my symptoms were like a cold.  I was achy, sinuses hurt, gums hurt and I physically tired.  The same day I tested positive the same day my symptoms began.  I got Paxlovid on the same day, the half-dose.  I got better and better.  As of Tuesday, April 11th, I was still testing positive.  Today I am still tired and I don't feel like I have recovered.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atelectasis, COVID-19, Chest X-ray abnormal, Influenza like illness, Nasopharyngitis
Clinical narrative: On 12/9/22, I had Flu like symptoms and that lasted for a couple days. I tested for COVID-19, and it was negative. I had a friend call me and tell me she tested positive on 12/14/22. I took another test and was positive. I had no symptoms at all, but I was testing positive. On 12/26/22, I came down with a bad cold that kept getting worse, so I went in to see urgent care. They prescribed azithromycin and benzonatate. I did not take the benzonatate because I wanted to cough up all the Phlegm. I was still not better, so I called my PCP, and they renewed my montelukast and albuterol. I still wasn't getting better, so I had to go back to urgent care on 3/15/23. They said because of all the respiratory issues I was having, that I was having a hyperactive Immune response. I was prescribed a nebulizer and prednisone. They also did a chest x-ray and it showed Minimal Bibasilar Atelectasis Changes.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Productive cough, Respiratory disorder, SARS-CoV-2 test positive
Clinical narrative: On 12/9/22, I had Flu like symptoms and that lasted for a couple days. I tested for COVID-19, and it was negative. I had a friend call me and tell me she tested positive on 12/14/22. I took another test and was positive. I had no symptoms at all, but I was testing positive. On 12/26/22, I came down with a bad cold that kept getting worse, so I went in to see urgent care. They prescribed azithromycin and benzonatate. I did not take the benzonatate because I wanted to cough up all the Phlegm. I was still not better, so I called my PCP, and they renewed my montelukast and albuterol. I still wasn't getting better, so I had to go back to urgent care on 3/15/23. They said because of all the respiratory issues I was having, that I was having a hyperactive Immune response. I was prescribed a nebulizer and prednisone. They also did a chest x-ray and it showed Minimal Bibasilar Atelectasis Changes.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/2/2021 NONTRAUMATIC ACUTE KIDNEY INJURY
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the beyond use date. Unable to contact pt to obtain information regarding adverse events
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery occlusion
Clinical narrative: I experienced my symptoms on January 15, 2023 my coronary arteries were blocked.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Headache, Laboratory test normal, Nasoendoscopy, SARS-CoV-2 test negative
Clinical narrative: Vertigo started around the beginning of December, closing following an upper respiratory infection.   Also, the sinus pain I experienced during the upper respiratory infection didn?t go away (until the current day).  It has been aggravating my dysfunction and headache disorder.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus pain, Temporomandibular joint syndrome, Upper respiratory tract infection, Vertigo
Clinical narrative: Vertigo started around the beginning of December, closing following an upper respiratory infection.   Also, the sinus pain I experienced during the upper respiratory infection didn?t go away (until the current day).  It has been aggravating my dysfunction and headache disorder.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Obstructive sleep apnoea syndrome
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/28/2022 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: Vaccine was fine when I got it.  What I reported yesterday was that I tested positive for COVID in mid-February after returning. I had no symptoms and called my doctor. She told me to isolate 5 days, then wear a mask. My sinuses have also been bad for the last month or so, as I reported.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient received vaccine from multi dose vial. Person administering vaccine gave 0.6 mL instead of 0.3 mL - equivalent to double the dose.
Age: 80.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient came into the Pharmacy 04/13/23 with a swollen upper arm @ injection site and stated that the area has been hot since she received the vaccine.  She stated she had been taking Tylenol but her arm still felt hot.  Advised pt to also take Benadryl.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Eye discharge, Feeling hot
Clinical narrative: We had some friends visiting, they did not know they were exposed, we went with them for the weekend, on Monday they called and recommended to be tested, I tested Positive on Tuesday, it lasted for about a week; very leaky nose and eyes, sneezing, coughing, felt warm. I called the doctor, and it was recommended to take Paxlovid.  I took it according to directions, by the 5th day I felt better, by the 8th day I was okay.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: We had some friends visiting, they did not know they were exposed, we went with them for the weekend, on Monday they called and recommended to be tested, I tested Positive on Tuesday, it lasted for about a week; very leaky nose and eyes, sneezing, coughing, felt warm. I called the doctor, and it was recommended to take Paxlovid.  I took it according to directions, by the 5th day I felt better, by the 8th day I was okay.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Erythema, Pain, Skin warm, Tenderness
Clinical narrative: Pt in clinic today for a different vaccine and reported this reaction:  angry red, tender, painful, warm left arm, had chills.  Photo on patient phone shows an irregularly shaped bright red area about 6 inches x 4 inches.  Spouse stated they postponed todays Hep B because he wanted this to be relieved.  Did not say when it was cleared up.  Left upper arm clear, free of erythema today, pt denies any s/s reported to be evident today.  There is nothing in patien'ts chart to indicate that our clinic was contacted about this reaction.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: HIVES ACROSS BODY.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature increased, Headache, Incoherent, Influenza like illness, Pain
Clinical narrative: While traveling I began to feel incoherent.  I had a headache, a temperature of 101.8 degrees, heart palpitations, and achy flu-like symptoms after getting the vaccine. I went to the urgent care and they prescribed Paxlovid.  The urgent care did not due a test but stated it may have been due to the vaccination due to I is a previous chemotherapy patient.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Palpitations
Clinical narrative: While traveling I began to feel incoherent.  I had a headache, a temperature of 101.8 degrees, heart palpitations, and achy flu-like symptoms after getting the vaccine. I went to the urgent care and they prescribed Paxlovid.  The urgent care did not due a test but stated it may have been due to the vaccination due to I is a previous chemotherapy patient.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Cardiac monitoring abnormal, Cardiac stress test normal, Computerised tomogram, Dysarthria
Clinical narrative: Started having garbled type of speech on 10/19/2022, went to my doctor a week later and blood pressure was up. Had a CT Scan and a Ceratoid Ultrasound to rule out TIA. Doctor increase my Metoprolol dose. On 12/01/2022 had started a new injection medication of PCSK9 then 2 weeks later started having episodes of raised heart rate and shortness of breath. It had gotten so bad it woke me up at times in the night. Medication requires regular lab work, went to have lab work done in 02/2023. My doctor decided to increase my dose of Metoprolol again. Doctor had me wear a Heart Monitor for 3 days and found that I had Sinus Tachycardia with rare PVC's. Doctor ordered a Stress Test and an Echocardiogram and both showed normal. Have been extremely fatigued the entire time.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Echocardiogram normal, Fatigue, Heart rate increased, Laboratory test
Clinical narrative: Started having garbled type of speech on 10/19/2022, went to my doctor a week later and blood pressure was up. Had a CT Scan and a Ceratoid Ultrasound to rule out TIA. Doctor increase my Metoprolol dose. On 12/01/2022 had started a new injection medication of PCSK9 then 2 weeks later started having episodes of raised heart rate and shortness of breath. It had gotten so bad it woke me up at times in the night. Medication requires regular lab work, went to have lab work done in 02/2023. My doctor decided to increase my dose of Metoprolol again. Doctor had me wear a Heart Monitor for 3 days and found that I had Sinus Tachycardia with rare PVC's. Doctor ordered a Stress Test and an Echocardiogram and both showed normal. Have been extremely fatigued the entire time.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus tachycardia, Sleep disorder, Ultrasound Doppler, Ventricular extrasystoles
Clinical narrative: Started having garbled type of speech on 10/19/2022, went to my doctor a week later and blood pressure was up. Had a CT Scan and a Ceratoid Ultrasound to rule out TIA. Doctor increase my Metoprolol dose. On 12/01/2022 had started a new injection medication of PCSK9 then 2 weeks later started having episodes of raised heart rate and shortness of breath. It had gotten so bad it woke me up at times in the night. Medication requires regular lab work, went to have lab work done in 02/2023. My doctor decided to increase my dose of Metoprolol again. Doctor had me wear a Heart Monitor for 3 days and found that I had Sinus Tachycardia with rare PVC's. Doctor ordered a Stress Test and an Echocardiogram and both showed normal. Have been extremely fatigued the entire time.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, COVID-19, Cough
Clinical narrative: I had low O2 levels 83-93, loss sense of smell, loss of taste, low grade fever, dry cough, pain in my left side, pain behind right knee, headache, blurred vision, high respiration rate, my middle finger got swollen and purple. I tested positive for COVID-19. I drunk lots of fluids and took my vitamins. I was sick for all the February. To this day I still have headache either everyday or a couple times a week.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Flank pain, Headache, Malaise, Oxygen saturation decreased, Peripheral swelling
Clinical narrative: I had low O2 levels 83-93, loss sense of smell, loss of taste, low grade fever, dry cough, pain in my left side, pain behind right knee, headache, blurred vision, high respiration rate, my middle finger got swollen and purple. I tested positive for COVID-19. I drunk lots of fluids and took my vitamins. I was sick for all the February. To this day I still have headache either everyday or a couple times a week.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory rate increased, SARS-CoV-2 test positive, Skin discolouration, Vision blurred
Clinical narrative: I had low O2 levels 83-93, loss sense of smell, loss of taste, low grade fever, dry cough, pain in my left side, pain behind right knee, headache, blurred vision, high respiration rate, my middle finger got swollen and purple. I tested positive for COVID-19. I drunk lots of fluids and took my vitamins. I was sick for all the February. To this day I still have headache either everyday or a couple times a week.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Burning sensation, Computerised tomogram, Facial pain
Clinical narrative: A week before  9/15/2022, I began experiencing pain in my ankles while walking on the treadmill.  The next day the pain had moved to my calf, a burning sensation.  I went to our local ER and they could not find a cause.  On 09/15 I sever burning pain in my lower legs and feet.   This feeling has begun to move into my arms and face.  I went to the ER and was admitted.  Upon test and spinal taps it was determined I had GBS and was treated with an infusion of IVIG over a five day window.  When  I left the hospital I left having to use a walker to walk and needing day and night assistance once home.  Prior I had lived alone and was very active.  I lost all independence withine a 2 week period.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test, Loss of personal independence in daily activities, Lumbar puncture
Clinical narrative: A week before  9/15/2022, I began experiencing pain in my ankles while walking on the treadmill.  The next day the pain had moved to my calf, a burning sensation.  I went to our local ER and they could not find a cause.  On 09/15 I sever burning pain in my lower legs and feet.   This feeling has begun to move into my arms and face.  I went to the ER and was admitted.  Upon test and spinal taps it was determined I had GBS and was treated with an infusion of IVIG over a five day window.  When  I left the hospital I left having to use a walker to walk and needing day and night assistance once home.  Prior I had lived alone and was very active.  I lost all independence withine a 2 week period.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging, Pain, Pain in extremity, Skin burning sensation, Walking aid user
Clinical narrative: A week before  9/15/2022, I began experiencing pain in my ankles while walking on the treadmill.  The next day the pain had moved to my calf, a burning sensation.  I went to our local ER and they could not find a cause.  On 09/15 I sever burning pain in my lower legs and feet.   This feeling has begun to move into my arms and face.  I went to the ER and was admitted.  Upon test and spinal taps it was determined I had GBS and was treated with an infusion of IVIG over a five day window.  When  I left the hospital I left having to use a walker to walk and needing day and night assistance once home.  Prior I had lived alone and was very active.  I lost all independence withine a 2 week period.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Dyspnoea, Fatigue, Malaise, Pyrexia
Clinical narrative: I had my vaccination on 10/07/2022. On 10/09/2022 I started to experience fatigue. I tested COVID-19 Positive on 10/10/2022. I fever shortness of breath and an overall sick feeling. I did start Paxlovid on 10/10/2022.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had my vaccination on 10/07/2022. On 10/09/2022 I started to experience fatigue. I tested COVID-19 Positive on 10/10/2022. I fever shortness of breath and an overall sick feeling. I did start Paxlovid on 10/10/2022.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: herpes zoster; post herpetic neuralgia; vision problems; balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning an approximately 64-year-old male patient (pt). Information about pt's concurrent conditions, medical history, and concomitant therapy was not reported. On or October 2015, the pt was vaccinated in his local pharmacy with a Zoster Vaccine Live (ZOSTAVAX) subcutaneous injection for the long-term prevention of shingles and zoster-related conditions (dose, anatomical location, lot # and expiration date not reported). Subsequently, the pt was treated by providers for the following injuries resulting from pt's Zoster Vaccine Live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, post herpetic neuralgia, vision problems, and balance problems. At the time of report, The pt outcome of the aforementioned events was unknown. The reporter considered all the above-mentioned events rto be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: HEP
Symptoms: Injury associated with device, Limb injury, Syringe issue, Wound haemorrhage
Clinical narrative: The broken glass cut the HCP on a finger and she began bleeding.; The broken glass cut the HCP on a finger and she began bleeding.; The broken glass cut the HCP on a finger and she began bleeding.; syringe was broken; This spontaneous report was received from a nurse referring to a 34-year-old female patient (herself). The patient's pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On 21-MAR-2023, the nurse reported that she picked a syringe up of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength: 5 mcg/0.5ml, product quantity: 1, lot #W022795, expiration date: 19-MAY-2025, administered for prophylaxis, dose and route of administration were not provided) from her tray and did not realize the syringe was broken, which had been broken into more than three pieces (syringe issue). The exact location of the breakage on the syringe was finger flange ring. The broken glass cut the nurse on a finger and she began bleeding (injury associated with device; wound haemorrhage; limb injury). The caller said no treatment was provided. On the same day, the patient had recovered from injury associated with device, wound haemorrhage and limb injury. The action taken with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) regarding all events was not applicable. This product was received on 27-MAR-2023.  The causal relationship between all events and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not reported.  This is one of the 2 reports from the same nurse. ; Sender's Comments:  US-009507513-2208USA002311:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; VARIVAX was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to an 12-month-old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 27-MAR-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (1 time dose, lot #W031811 has been verified to be a valid lot number, expiration date 05-OCT-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On 27-MAR-2023, the suspect vaccine experienced a temperature excursion of -14.9 degrees Celsius (C) for 59 minutes and -12.8 C for 33 minutes (product storage error). No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). No previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX was administered to patient with temperature excursion; This spontaneous report has been received from a nurse, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 29-MAR-2023, the patient was vaccinated with an improperly stored dose of with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) Subcutaneous Injection, at a dose of 0.5 millilites (ml), for prophylaxis (lot number: W008712, which was determined to be valid, with an expiration date on 14-MAR-2024) (strength, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 15.7 degrees Fahrenheit (F), during a time frame of 20 minutes (product storage error). There was no previous temperature excursion.  No additional adverse events were reported in the patient.
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Female in her 60s received GARDASIL 9; No Adverse Event; This spontaneous report was received from a physician refers to a female patient of unknown age (reported as: in her 60s).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HCP calling  to report a temperature excursion. Vaccine was administered after temperature excursion; This spontaneous report was received from a medical assistant referred to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant therapies were not reported.  On 23-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, administered for prophylaxis (lot # W02294 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiry date was reported as 13-JUL-2024; strength, anatomical location and route of administration were not provided). The vaccine underwent temperature excursions of 6.9 Fahrenheit Celsius (F) for 15 minutes (product storage error). The previous temperature excursion as follow: 7.1 F for 30 minutes and 11.6 F for 1 hour. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; 3 PATIENTS WERE ADMINSTERED THE VACCINE ON MARCH 3, 2023; This spontaneous report was received from a healthcare professional (HCP) referring to a 76-year-old patient with unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The HCP reported a temperature excursion (TE) with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F). The excursion was discovered upon looking at the data logs. Data logger recorded a 46.7F temp on 03-MAR-2023 and did not record again until logging a 43F temperature on 06-MAR-2023. Worst case scenario of 46.7F was used for the full 72 hours of the weekend per direction of the HCP.  The patient was vaccinated the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # W027449, expiration date 25-SEP-2024; strength and route were not reported) for prophylaxis on 03-MAR-2023 at the beginning of the excursion (product storage error). No adverse effects were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002650: US-009507513-2304USA002750: US-009507513-2304USA002694: US-009507513-2304USA002746: US-009507513-2304USA002667: US-009507513-2304USA002696: US-009507513-2304USA002675: US-009507513-2304USA002696: US-009507513-2304USA002776: US-009507513-2304USA002932: US-009507513-2304USA002696: US-009507513-2304USA002840:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; TE for GARDASIL 9, product administered after the excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 05-APR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that was under a temperature excursion (1x dose, lot # W010661 has been verified to be valid, expiration date was reported and established as 19-OCT-2024; route was not reported) for prophylaxis (product storage error).    The storage temperature of the vaccine was 61.7 degrees Fahrenheit for a time frame of 4 hours 39 minutes. There was no previous temperature excursion. No additional adverse events (AEs) or product quality complaints (PQCs) were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no additional AE; given PROQUAD and VARIVAX in error simultaneously; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 08-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) in error simultaneously (exact doses, sites of vaccination, routes of administration, lot numbers and expiration dates were not reported) for prophylaxis (overdose). The reporter wanted to know about any vaccine adverse interactions. No additional adverse events (AEs) were reported (no adverse events).
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; the patient first dose of ROTAVIRUS vaccine was ROTARIX and today the patient received their second dose of the series as ROTATEQ; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine live oral 1v (ROTARIX) instead of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (interchange of vaccine products). On 10-APR-2023, the patient was vaccinated with the second dose of the series as rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called in to report a patient was prescribed PNEUMOVAX 23, and received an expired dose. HCP wanted to know of any adverse effects of receiving expired dose of vaccine. MIR on 02368968. No additional AE/PQC.; This spontaneous report was received from a nurse, referring to a 4-year-old patient with unknown gender. The patient's concomitant therapy, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 10-APR-2023, the patient was prescribed pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number U027357 has been verified to be a valid lot number, expiration date was reported as 25-MAR-2023, 0.5 milligram (mg) /x1 only, route and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event (AE) reported (no adverse event). The reporter wanted to know of any adverse effects of receiving expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive, Product use in unapproved indication
Clinical narrative: no additional adverse event reported; Product use in unapproved indication; Nurse practitioner reported patient received a dose of GARDASIL 9 on Apr 10, 2023 and then later on the same day patient found out that she was pregnant. Pregnancy Gestation or LMP: Unknown by nurse practitioner. Nurse practitioner stated patient has; This spontaneous report was received from nurse practicioner and refers to a 24-year-old female.  The patient's medical history included papanicolaou smear abnormal. The patient's concurrent conditions included mildasthma. Concomitant therapies were not reported.  On 10-APR-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, lot #U019412, expiration date: 30-OCT-2023, administered intramuscularly for smear cervix abnormal and papilloma viral infection (strength was not provided) (product use in unapproved indication).  On an unknown date (also reported as: last week), pregnancy test was negative. On unknown date, nurse practitioner reported that on 10-APR-2023, patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On the same day, patient found out that she was pregnant (maternal exposure druring pregnancy). Pregnancy Gestation or LMP: Unknown by nurse practitioner. Nurse practitioner stated patient has irregular periods and did not think it was possible to get pregnant. No further information provided. No additional AE reported. No PQC reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient is not exhibiting any signs/symptoms of adverse event; Expired GARDASIL 9 (expiration date 04/09/2023) was administered today to patient; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On 11-APR-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (2nd dose) lot number T036444 with expiration date on 09-APR-2023 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The patient was not exhibiting any signs/symptoms of adverse event.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No temp excursions and no symptomatic side effects reported by patient. No additional AE details or PQC; Inbound call from HCP stating that an expired PNEUMOVAX 23 was inadvertently administered past it's expiration date; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-MAR-2023, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (dosage regimen, and route of administration were not provided), lot #U026796, expiration date: 28-JAN-2023, administered as prophylaxis (expired product administered). No temperature excursions and no symptomatic side effects were reported by patient (No adverse event).
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was administered intramuscularly instead of subcutaneous; Case reference number US-BN-2022-001792 is a spontaneous case report initially received on 05-Aug-2022 from a health care professional via Communication and concerns one patient of unknown age.  The patients' relevant medical history and concomitant medications were not reported.  On 05-Aug-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) administered subcutaneously (explicitly coded as 'Inappropriate route of vaccination') at an unreported dose, or anatomical site for unknown indication.   At the time of this report, no further information was provided.   Additional information received on 08-Aug-2022 included local BN case ID.; Reporter's Comments: A patient of unknown age was vaccinated with Jynneos vaccine, administered subcutaneously which is considered as inappropriate route of vaccination, at an unreported dose, or anatomical site for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, no further information was provided. The patients' relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age was vaccinated with Jynneos vaccine, administered subcutaneously which is considered as inappropriate route of vaccination, at an unreported dose, or anatomical site for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, no further information was provided. The patients' relevant medical history and concomitant medications were not reported. Causal relationship is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shot and Had shingles/Suspected Vaccination Failure; Shingles in left eye; Shingles, mild case in forehead and hair; Very painful; Headache was terrible; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot and Had shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in left eye) (serious criteria GSK medically significant), shingles (Verbatim: Shingles, mild case in forehead and hair), pain (Verbatim: Very painful) and headache (Verbatim: Headache was terrible). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles, pain and headache were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, pain and headache to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles, pain and headache to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 The case  was received from the patient via  interactive digital media. The patient had shingles last year and it was very painful and had a mild case in the left eye, forehead and in his/her hair. The patient stated that headache was terrible and headache 2 weeks before broke out.  The patient had the Shingle shot and booster. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Near death experience
Clinical narrative: Vx nearly killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a bad case of shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: Vx nearly killed me) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported.   The reporter considered the near death experience to be related to Shingles vaccine.   The company considered the near death experience to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles vaccine later to prevent another breakout of shingles.  The reporter stated that the shingles vaccine nearly killed him/her so it was need to know there were risks. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2 months in shingles after vaccinated/ suspected vaccination failure; Shingles; 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: 2 months in shingles after vaccinated/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 2 months).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he or she experienced shingles for two months after received shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had shot still got shingles/suspected vaccination failure; shingles; sharp pain; 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: had shot still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: sharp pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not recovered/resolved.   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: 25-Mar-2023 and 27-Mar-2023 The case was received from the patient via interactive digital media. The patient had the shot and still got the shingles. The patient still feels the sharp pain occasionally. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Was vaccinated and got Shingles/Suspected vaccination failure; Shingles; 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: Was vaccinated and got Shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-APR-2023 This case was reported by a doctor's patient via interactive digital media. The patient was vaccinated with shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR053044, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR053044:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had vacccine got them/suspected vaccination failure; got them; 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: had vacccine got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that it was very true, he/she had the shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Pruritus, Scar
Clinical narrative: Got the shot years ago now got shingles/ suspected vaccination failure; Shingles on back; Very painful; Itchy; My back is all scarred; Awful; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot years ago now got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on back), pain (Verbatim: Very painful), pruritus (Verbatim: Itchy), scar (Verbatim: My back is all scarred) and feels awful (Verbatim: Awful). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not reported and the outcome of the scar and feels awful were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus, scar and feels awful to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, pruritus, scar and feels awful to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine years ago and now experienced shingles. The patient stated that it was very painful, itchy and now shingles on his or her back and it was now all scarred which was never had prior to having shingles and it was awful. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.