chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Respiratory symptom
Clinical narrative: Patient's symptoms has been going on for 9 days at the time of admission Chest x-ray no acute findings on admission Pulmonary evaluated patient Received ceftriaxone and Levaquin to cover any superimposed bacterial pneumonia Received IV dexamethasone Received nebulizer treatment
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Body temperature increased, COVID-19, COVID-19 pneumonia, Computerised tomogram head normal, Dehydration
Clinical narrative: unwitnessed fall with suspicion of head trauma as the patient had some nasal bleeding unknown of the patient is on blood thinner or not.   Upon arrival to ED, patient was septic, tachycardic with heart rate around 114 beats per minute, febrile up to 38.7 C with otherwise normal blood pressure saturating 93% on room air.  Tested positive for COVID.  Noncontrast CT head no acute findings. admit as a case of sepsis secondary to COVID-19 pneumonia in a demented patient complicated by lactic acidosis, hypomagnesemia, dehydration/volume depletion.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Epistaxis, Fall, Head injury, Hypomagnesaemia, Hypovolaemia
Clinical narrative: unwitnessed fall with suspicion of head trauma as the patient had some nasal bleeding unknown of the patient is on blood thinner or not.   Upon arrival to ED, patient was septic, tachycardic with heart rate around 114 beats per minute, febrile up to 38.7 C with otherwise normal blood pressure saturating 93% on room air.  Tested positive for COVID.  Noncontrast CT head no acute findings. admit as a case of sepsis secondary to COVID-19 pneumonia in a demented patient complicated by lactic acidosis, hypomagnesemia, dehydration/volume depletion.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Lactic acidosis, SARS-CoV-2 test positive, Sepsis, Tachycardia
Clinical narrative: unwitnessed fall with suspicion of head trauma as the patient had some nasal bleeding unknown of the patient is on blood thinner or not.   Upon arrival to ED, patient was septic, tachycardic with heart rate around 114 beats per minute, febrile up to 38.7 C with otherwise normal blood pressure saturating 93% on room air.  Tested positive for COVID.  Noncontrast CT head no acute findings. admit as a case of sepsis secondary to COVID-19 pneumonia in a demented patient complicated by lactic acidosis, hypomagnesemia, dehydration/volume depletion.
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray normal, Pyrexia
Clinical narrative: COVID 19 infection  SIRS criteria not met on admission. CXR was unremarkable. Patient without oxygen requirement. No indications for COVID-19 specific therapy.  Will continue supportive care for now Tylenol PRN fever
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 12/27/2021  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Skin warm, Swelling
Clinical narrative: MAJOR SWELLING, WARM TO TOUCH--  NO TREATMENT, RESOLVED WITHIN 48 HOURS.
Age: 14.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Dizziness, Hypoaesthesia, Visual impairment
Clinical narrative: On 08/09/2023. Patient was vaccinated by RN for Measles, Mumps, Rubella(MMR), Polio, and Varicella. RN completed pre-screening of contraindications/precautions related to vaccine administration and patient medical history. Patient's Mother no history of adverse reactions with vaccines . No allergies or history of immune system problems/previous health conditions. Patient was vaccinated for varicella vaccine administered in Left arm subcutaneously and 2 minutes post-vaccine reported of numbness of ears, dizziness, and seeing of visual spots. Vaccine administered on both arms subcutaneously varicella on left arm measles mumps and rubella and polio on right arm. Patient was assisted to floor with yoga mat, patient is given juice and energy bar, and no further symptoms reported. Continued to monitor client while on yoga mat with legs elevated. Patient instructed to move legs and feet for blood circulation. Patient's vitals assessed at 1140 respirations: 16/min Blood pressure: 96/61 mmHg. Oxygen: 98% heart rate: 49 bpm. 1145 patient denies throat discomfort, or headache. Respirations: 18 Heart rate is 50 bpm Oxygen: 97% blood pressure: 91/63 mmHg. 1150 patient denies headache, no visual impairment, patient denies dizziness. Does not feel throat discomfort Respirations: 18 Heart rate: 53 Oxygen: 97% Blood pressure: 96/59mmHg. 1155 patient denies headache, dizziness, throat discomfort. Parents request and consent for remaining two vaccines, polio and MMR to be administered today. RN administered these two vaccines into client's right arm subcutaneously. Client did not have any further syncope symptoms. Client was observed for an additional 10 minutes post vaccination. Parents were educated on th signs and symptoms to watch for over the next few hours. Final set of Vitals taken standing: Respirations: 18 Heart rate: 68 bpm oxygen: 100% blood pressure: 102/66 mmHg. RN recommended following up  with a primary health care provider and seeking urgent or emergency services if needed as well as importance of providing hydration and nutrition prior to vaccine and maintaining a seated position post-vaccination. Patient left in care of mother, able to ambulate with an even/steady gait.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Pateint received vaccine after BUD
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pateint received vaccine after BUD
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 3/1/2022  &  7/27/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt. received pediatric dose instead of adult dose - no adverse event. Adult dose was provided 8/9/23.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Symptom recurrence
Clinical narrative: PERIPHERAL NEUROPATHY 2/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock, Hypersensitivity
Clinical narrative: ANAPHYLACTIC SHOCK, INIT ALLERGIC REACTION, SUBSEQ
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, INIT
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Incorrect dose administered
Clinical narrative: The patient was given 0.2 ML's of the gray cap formulation instead of 0.2 ML's of the orange cap formulation. After talking with the patient's guardian today, the guardian stated the patient only had a mild headache the day of (8/9/23). I advised the guardian to keep an eye on the patient and I watch out for any alarming side effects. I also let them know that as of now that this shot still counts as the patient's full series.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin reaction
Clinical narrative: 4 yr old male seen back in clinic for skin reaction on his R thigh . Pt was seen in clinic on 09Aug for his 4 yr well visit and received MMRV and Kinrix vaccines. The Kinrix (DTaP-IPV) was given in the R thigh, MMRV was given in the L thigh. Pt developed a small area of redness around the injection site the following day however this AM the area became significantly larger. Area is red , raised and warm. not itchy, pt does not c/o pain. He is walking normally, and maintaining normal activity , jumping and running not affected. He has not had fevers, no swelling of his R leg. no other skin rashes , no other illness symptoms.  He has never had a reaction to vaccines previously other than fevers.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction, simply received Flu vaccine instead of Tdap, as patient had requested to receive flu vaccine at a later date.  No symptoms or complaints.  reporting due to administration error.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Breathing-related sleep disorder
Clinical narrative: BREATHING RELATED SLEEP DISORDER 5/2/2023 OBSERVATION AND EVALUATION FOR SUSPECTED CONDITION
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MILD
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: I26.99 ACUTE PULMONARY EMBOLISM 3/27/2023 ACUTE PULMONARY EMBOLISM
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 3/13/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Alcohol use
Clinical narrative: ETOH cardiomyopathy. Medical condition is ongoing and chronic. Listed in medical history. Contributing factors include HTN, hyperlipidemia, cardiomyopathy. Subject admitted heavy ETOH consumption. Followed up with cardiologist.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Coagulopathy, Hypotension, Hypoxia
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE HYPOTENSION CHRONIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA 2/27/2022,  3/14/2022,  3/29/2022,  3/31/2022,  4/7/2022,  4/15/2022,  4/26/2022,  5/16/2022,  5/17/2022,  5/25/2022,  5/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, Symptom recurrence
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE HYPOTENSION CHRONIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA 2/27/2022,  3/14/2022,  3/29/2022,  3/31/2022,  4/7/2022,  4/15/2022,  4/26/2022,  5/16/2022,  5/17/2022,  5/25/2022,  5/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardioversion, Sinus rhythm
Clinical narrative: Atrial fibrillation. Chronic AF controlled with carvedilol and lisinopril. Cardioversion performed. Converted back to NSR.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle and joint pain
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Pericarditis
Clinical narrative: I30.9 ACUTE PERICARDITIS, UNSPECIFIED 4/11/2023 AUTOIMMUNE THYROIDITIS
Age: 41.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Injection site swelling
Clinical narrative: included: Muscle & joint soreness, fever/chills, nausea, diarrhea, headache, lethargy, irritability, & swelling @ the injection site that turned swollen & welted.  Member reports symptoms subsided. reported via  database system. on 8/11/23.
Age: 41.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Irritability, Lethargy, Myalgia, Nausea
Clinical narrative: included: Muscle & joint soreness, fever/chills, nausea, diarrhea, headache, lethargy, irritability, & swelling @ the injection site that turned swollen & welted.  Member reports symptoms subsided. reported via  database system. on 8/11/23.
Age: 41.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: included: Muscle & joint soreness, fever/chills, nausea, diarrhea, headache, lethargy, irritability, & swelling @ the injection site that turned swollen & welted.  Member reports symptoms subsided. reported via  database system. on 8/11/23.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Skin laceration, Syncope
Clinical narrative: patient fainted about 5 minutes after receiving the vaccine. First aid was administered with only a small laceration in the left eyebrow
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: This RN administered the CWY portion of the vaccine and did not mix it with the A portion.  No adverse reaction to the vaccine. Just incorrect administration of the vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety,
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pain, Pain of skin, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Skin localized pain, tenderness with erythema, induration, and warmth to vaccination area. Treatment : Start Cephalexin Suspension Reconstituted
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Vaccination site warmth
Clinical narrative: Skin localized pain, tenderness with erythema, induration, and warmth to vaccination area. Treatment : Start Cephalexin Suspension Reconstituted
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphonia
Clinical narrative: In summary, the vaccines haven't stolen my vocal power completely, but the second administration of the Moderna shot and the Pfizer-BIONTech shots seemed to be hard on my thyroidal/esophageal organs, whichever organs, tissue and muscles involves a singing voice. It seems that it reset my vocal power to a time of my voice while it was developing. Also, on 6/4/2021 it could've been the combination of the vaccine, some cheap, powdery sugar-free candy and dehydration from walking a distance from dowtown to the Pharmacy. As for the Pfizer vaccine, it seems to be effective, but again, without the presence of any questionable consumables, it took a toll on my vocal power. It's restoring, but it's almost as if my voice has been stolen.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 11.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Given in error to 11 year old child
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: App. 15 minutes after immunizations were given, patient broke out in hives all over body. No respiratory symptoms or distress. No facial swelling or mouth swelling. Benadryl (Diphenhydramine 12.5mg/5ml) in the amount of 4 ml was given to the baby by mouth and the hives went away with 15-20 minutes.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Gait disturbance, Monoplegia, Nerve conduction studies, Walking aid user
Clinical narrative: 15 days After vaccination, patient is unable to walk comfortably (partial paralysis of left leg) went from walking with cane to needing a walker.  Prescriber thinks may be Guillain barre syndrome but has not officially diagnosed in chart.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood glucose normal, Electrocardiogram normal, Fall, Head injury, Headache
Clinical narrative: Shots at 1210 PM. She was not nervous and was very conversant and cooperative. She had eaten breakfast. Mom and pt. walked out and showed her paperwork to office staff. Pt. fainted and fell backwards hitting head on floor. No bleeding. Complains of headache. Temp 96.1, B/P 130/60, O2 sat 99%, P 65. EMS called and arrived at 1020.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Shots at 1210 PM. She was not nervous and was very conversant and cooperative. She had eaten breakfast. Mom and pt. walked out and showed her paperwork to office staff. Pt. fainted and fell backwards hitting head on floor. No bleeding. Complains of headache. Temp 96.1, B/P 130/60, O2 sat 99%, P 65. EMS called and arrived at 1020.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports injection site reaction of the left arm, below the site of injection. symptoms included: redness, swelling, warm to the touch and a hardness in the area of discomfort. the pain subsided over the next few days, but the redness remained when she came to the pharmacy to discuss the reaction.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyskinesia, Heart rate increased, Lethargy, Pain, Syncope
Clinical narrative: Within minutes of receiving 2 vaccines my 12 year old fainted and started jerking. She came to fairly quickly but had a very rapid heart rate and they had to keep checking her blood pressure. She had to stay lying down for quite a while. Afterwards she was very sore and lethargic the rest of the afternoon.
Age: 28.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Expired product administered, Pain in extremity, Wrong product administered
Clinical narrative: 1) Patient received an expired Hep A vaccine. Expired 6/17/23. Hep A was administered 7/6/23.  2) RN intended to administer Hepatitis B shot. Patient received wrong medication. She received the Meningitis B shot.  Patient c/o sore arm.  Patient came back to the public health clinic 7/18/23 and received an up to date Hep A and Hep B vaccine at no charge.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient given Tdap but needed PCV20.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received a 2nd dose of Pfizer bivalent 11 months after 1st dose, patient was not eligible for 2nd dose at time of administration.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Measles - like rash, low grade fever for about 5 days onset and then self-resolved.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: HEADACHE,  FEVER, CHILL, NAUSEA, VOMITING, BODY ACHES, FATIGUE
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: HEADACHE,  FEVER, CHILL, NAUSEA, VOMITING, BODY ACHES, FATIGUE
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 0.92
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE REACTION. Child was behind on vaccines and came for a 9month visit at 11 months old. Had only received 1 other set of vaccines in their life. Vaccines were ordered correctly in the room for pt to receive Pediarix, Hib, and pcv15. The lab tech also administered a second dose of Rota. Vaccine was ordered after the mistake was made and documented. Parent was notified of all info including the risks
Age: 0.92
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5, RV1
Symptoms: Decreased appetite, Diarrhoea, Irritability, Nausea, Pyrexia
Clinical narrative: NO ADVERSE REACTION. Child was behind on vaccines and came for a 9month visit at 11 months old. Had only received 1 other set of vaccines in their life. Vaccines were ordered correctly in the room for pt to receive Pediarix, Hib, and pcv15. The lab tech also administered a second dose of Rota. Vaccine was ordered after the mistake was made and documented. Parent was notified of all info including the risks
Age: 0.92
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5, RV1
Symptoms: Somnolence
Clinical narrative: NO ADVERSE REACTION. Child was behind on vaccines and came for a 9month visit at 11 months old. Had only received 1 other set of vaccines in their life. Vaccines were ordered correctly in the room for pt to receive Pediarix, Hib, and pcv15. The lab tech also administered a second dose of Rota. Vaccine was ordered after the mistake was made and documented. Parent was notified of all info including the risks
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. See original AE case 02429442 which did not include un; This spontaneous report was received from Consumer and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-JUL-2023, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1968385, expiration date: 22-MAY-2024, administered orally for prophylaxis (strength was not provided).   ; Sender's Comments:  US-009507513-2307USA009885:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. See original AE case 02429442 which did not include un; This spontaneous report was received from a customer and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 07-JUL-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1968385, expiration date: 22-MAY-2024, administered orally for prophylaxis (strength was not provided) after temperature excursion (20-JUN-2023: 34.9F for 6 hours 34 minutes 0 seconds, 03-JUL-2023: 51.4 F for 7 hours 33 minutes 0 seconds, 04-JUL-2023: 51.1F for 24 hours 0 minutes 0 seconds, 05-JUL-2023: 50.7F for 9 hours 27 minutes 0 seconds; time frame: 34.9F for 6 hours 34 minutes 0 seconds; 51.4 F for 7 hours 33 minutes 0 seconds; 51.1F for 24 hours 0 minutes 0 seconds; 50.7F for 9 hours 27 minutes 0 seconds; no previous temperature excursion). No additional information.; Sender's Comments:  US-009507513-2307USA009885:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored administered ROTATEQ; This spontaneous report was received from a customer (reported also as "other") and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JUN-2023, the patient was vaccinated with improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, administered orally, lot # reported and confirmed as: 1968385, expiration date reported and confirmed as: 22-MAY-2024 from prophylaxis. Temperature excursion details: 34.9 degree Fahrenheit for 6 hours 34 minutes (20-JUN-2023); no previous temperature excursion.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009292:02429442
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored administered ROTATEQ; This spontaneous report was received from a customer (reported also as "other") and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUL-2023, the patient was vaccinated with improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, administered orally, lot # reported and confirmed as: 1968385, expiration date reported and confirmed as: 22-MAY-2024 from prophylaxis. Temperature excursion details: 34.9 degree Fahrenheit for 6 hours 34 minutes (20-JUN-2023); 51.4 degree Fahrenheit for 7 hours 33 minutes (03-JUL-2023); 51.1 degree Fahrenheit for 24 hours (04-JUL-2023); 50.7 degree Fahrenheit for 9 hours 27 minutes (05-JUL-2023); no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009292:02429442
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Incorrect product storage; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 12-JUL-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) (lot # X002292, expiration date reported as 21-JUN-2024, however upon internal validation established as 21-JUL-2024, 1 dose; strength, route were not reported) for prophylaxis (product storage error). Temperature excursion was 6.93 F for 1 Hour 13 Minutes 0 Seconds. Previous temperature excursion was 52.01 F for 2 hours 6 minutes 0 seconds; 9.74 F for 4 hours 34 minutes 0 seconds. No additional adverse event was reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; No additional AE; This spontaneous report was received from a nurse refers to a 4-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 21-FEB-2019, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided). On 16-MAY-2019, the patient was vaccinated with second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration and no adverse event).; Sender's Comments:  US-009507513-2307USA009252: US-009507513-2307USA011295:
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of vaccine administered; No additional AE; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 13-DEC-2018, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). 21-FEB-2019, the patient was vaccinated with second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration and no adverse event).; Sender's Comments:  US-009507513-2307USA010113: US-009507513-2307USA009252:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; PROQUAD that was inadvertently administered to a patient after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 01-AUG-2023, the patient was inadvertently vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5ml/once, recombinant Human albumin (rHA) lot # X011980 with expiration date 19-JUL-2024, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. It was stated that the vaccine was exposed to a temperature of -2.2°C for 5 hours and 57 minutes. No previous temperature excursions were reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no AE; The medical assistant is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 08-AUG-2023, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (1 dosage form, lot #w017819 was valid for formulation pre-filled syringe, expiration date 27-DEC-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  The suspect vaccine experienced a temperature excursion of 18.8 degrees Celsius for 9 hours. No additional adverse events (AEs)were reported (No adverse event). No further information was provided. There was no previous excursion.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Medical assistant reported that a 4 year old patient inadvertently received 4th dose (w038864  7/16/2025) of RECOMBIVAX.  The medical assistant did not provide the lot numbers for the previous 3 doses of RECOMBIVAX.   No additional AEs were reported.; No additional AEs were reported.; This spontaneous report was received from Other Health Professional and refers to a 4-year-old patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 dose, lot #W038864, expiration date: 16-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced Medical assistant reported that a 4 year old patient inadvertently received 4th dose of RECOMBIVAX. The medical assistant did not provide the lot numbers for the previous 3 doses of RECOMBIVAX. No additional AEs were reported. No further information provided. No PQC.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired dose of GARDASIL 9 was administered.; This spontaneous report has been received from a medical assistant, regarding a patient of unknow age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 09-AUG-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, at a dose of 0.5 milliliters intramuscularly in the deltoid (unspecified) as prophylaxis (lot number: 1780867, which was determined to be valid as syringe formulation, with an expiration date on 08-AUG-2023) (Expired product administered).  No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Neuropathy; Tingling in feet and legs; Pain in legs; This serious case was reported by a nurse via sales rep and described the occurrence of neuropathy in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), tingling of extremity (Verbatim: Tingling in feet and legs) and leg pain (Verbatim: Pain in legs). The outcome of the neuropathy, tingling of extremity and leg pain were unknown.   It was unknown if the reporter considered the neuropathy, tingling of extremity and leg pain to be related to Shingrix.     It was unknown if the company considered the neuropathy, tingling of extremity and leg pain to be related to Shingrix.   Additional Information: GSK Receipt date: 04-AUG-2023 The reporter informed GSK representative that a patient received Shingrix vaccine and since January the patients had experiencing neuropathy, tingling in feet and legs, also pain in legs.  The reporter consented to follow up. This case had been link with US2023106293, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023106293:Same reporter, different patient, same events
Sex: U
Vaccine: VARZOS
Symptoms: Depression, Fear, Limb discomfort, Pain, Skin ulcer
Clinical narrative: hand discomfort/It snows at the moment with my 3 fingers of the hand; Intense pain; depression; Sores; Fear; This serious case was reported by a consumer and described the occurrence of limb discomfort in a patient who received Herpes zoster (Shingrix) (batch number GR375, expiry date 28-MAY-2024) for prophylaxis.   On 30-OCT-2019, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced limb discomfort (Verbatim: hand discomfort/It snows at the moment with my 3 fingers of the hand) (serious criteria hospitalization), pain (Verbatim: Intense pain) (serious criteria hospitalization), depression (Verbatim: depression) (serious criteria hospitalization), skin ulcer (Verbatim: Sores) (serious criteria hospitalization) and fear (Verbatim: Fear) (serious criteria hospitalization). The patient was treated with analgesic, nos (Pain Medication) and ambiguous medication nos (Cortisone (Nos)). The outcome of the limb discomfort, pain, depression and skin ulcer were not resolved and the outcome of the fear was not reported.   It was unknown if the reporter considered the limb discomfort, pain, depression, skin ulcer and fear to be related to Shingrix.  It was unknown if the company considered the limb discomfort, pain, depression, skin ulcer and fear to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-AUG-2023 It showed at the moment with his/her 3 fingers of beeping hand.  The patient affected and one on the left hand and felt like a bicero when his/her fingers and the internal dox flowed through his/her whole body and toes, frightening Ansages, Without savir what farges, intense pains.  The reporter stated that left the hospital and doctor said two days of 1 Side effects and everything would be fine but unfortunately it was not. The patient experienced sores and depression. They had Satin commission, the patient was clear and already knew.  The varis berection / exchanges of remedies and it had been 2 months and still. In the morning as the patient lunch, the patient began to feel uncomfortable in his leg, hand (who fears Vaccine), hand (passed at night he/she feared a medication because his/her deco was a lot of docx (middle finger), at he/she hours of the morning, he/she called his/her husband because the dose she was unbearable, intense.  The patient had felt nothing and we were in the hospital where he/she was medicated. The reporter stated that he/she need cortisone the almost until gone. The reporter stated that he/she felt like animal in his/her finger.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Post herpetic neuralgia, Rash
Clinical narrative: ash developed in same arm and about my back and upper chest/all on the same side as that 2nd injection; Skin tenderness/all on the same side as that 2nd injection; ash developed in same arm and about my back and upper chest/all on the same side as that 2nd injection; Post herpetic neuralgia; diagnosed as shingles; This non-serious case was reported by a consumer and described the occurrence of injection site rash in a 62-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 03-JUL-2023, the patient received the 2nd dose of Shingles vaccine (right deltoid). On 07-JUL-2023, 4 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: diagnosed as shingles). In AUG-2023, the patient experienced post herpetic neuralgia (Verbatim: Post herpetic neuralgia). On an unknown date, the patient experienced injection site rash (Verbatim: ash developed in same arm and about my back and upper chest/all on the same side as that 2nd injection), injection site tenderness (Verbatim: Skin tenderness/all on the same side as that 2nd injection) and rash (Verbatim: ash developed in same arm and about my back and upper chest/all on the same side as that 2nd injection). The patient was treated with gabapentin and paracetamol (Tylenol). On 04-AUG-2023, the outcome of the shingles was not resolved. The outcome of the injection site rash and rash were resolving and the outcome of the injection site tenderness and post herpetic neuralgia were not reported.   It was unknown if the reporter considered the injection site rash, injection site tenderness, shingles, post herpetic neuralgia and rash to be related to Shingles vaccine.     It was unknown if the company considered the injection site rash, injection site tenderness, shingles, post herpetic neuralgia and rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 4-Aug-2023 This report was submitted via the online direct entry reporting system. The patient received the 2nd injection and had skin tenderness developed 72 hours later under that arm. Rash developed in same arm and about her back and upper chest. All adverse event occurred on the same side as that 2nd injection.  The physician diagnosed as shingles and treated the patient as such.  Rash is healing but the patient had severe post herpetic neuralgia and was concerned that it would last a long time.  The patient was convinced the vaccine gave her shingles. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Epistaxis
Clinical narrative: Bleeding nose; This non-serious case was reported by a consumer and described the occurrence of epistaxis in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced epistaxis (Verbatim: Bleeding nose). In AUG-2023, the outcome of the epistaxis was resolved.   It was unknown if the reporter considered the epistaxis to be related to Shingrix.     It was unknown if the company considered the epistaxis to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-AUG-2023 The reporter stated that the symptoms were treated. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: feeling bad; Mild fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: feeling bad) and fever (Verbatim: Mild fever). The outcome of the feeling bad and fever were resolved (duration 1 day).   It was unknown if the reporter considered the feeling bad and fever to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad and fever to be related to Shingles vaccine.   Additional Information: GSK receipt date:02-AUG-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had finished 2 shot of vaccine.  The second shot he/she was feeling bad for the following day.  The patient had mild fever and was fine the next morning. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I forgot to get the second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th January 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I forgot to get the second shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-AUG-2023 This case was reported by a consumer via (Shingrix GSK) interactive digital media. The patient forgot to get the second shot of Shingrix before 6 months or 9th July 2023 but he/she did have that okay. The CDC had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the do not need to restart the vaccine series. However, the efficacy of alternative dosing regimens had not been evaluated. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: she administered the shot a fair amount squirted out of the needle; a portion of the vaccine actually made it into my arm/ the vaccine squirted out of the needle and ran down my arm; portion of the vaccine actually made it into my arm/ the vaccine squirted out of the needle and ran down my arm; This non-serious case was reported by a consumer and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: she administered the shot a fair amount squirted out of the needle), exposure via skin contact (Verbatim: a portion of the vaccine actually made it into my arm/ the vaccine squirted out of the needle and ran down my arm) and inadvertent exposure to vaccine (Verbatim: portion of the vaccine actually made it into my arm/ the vaccine squirted out of the needle and ran down my arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK receipt date: 5-Aug-2023 and 7-Aug-2023 The patient went to get first dose of the Shingrix vaccine for shingles.  The pharmacist apparently failed to ensure that the needle was screwed on tightly and when she administered the shot a fair amount squirted out of the needle and down the patient's arm, so only a portion of the vaccine actually made it into her arm.  There was no way to know how much of the vaccine went into the arm and how much was lost when the vaccine squirted out of the needle and ran down the arm.  The pharmacist wanted to gave a second injection of the vaccine immediately, but the physician and the medical adviser said not to allow her to do that. They advised to wait before receiving more vaccine and to contact the manufacturer for guidance on what to do now.  The patient was reaching out and hoping that someone can provide advice on what to do now that she had received only some unknown portion of the first dose or someone could at GlaxoSmithKline please advise. The patient called and provided consent and contact information for her health care professional. The pharmacist apparently failed to ensure that the needle was screwed on tightly and when she administered the shot a fair amount squirted out of the needle and down the patient's arm, so only a portion of the vaccine actually made it into her arm, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine.
Sex: U
Vaccine: FLU4
Symptoms: Intercepted product storage error
Clinical narrative: the medication refrigerator was out of range for the time span of 15 minutes; This non-serious case was reported by a consumer and described the occurrence of intercepted product storage error in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   On an unknown date, the patient did not receive Fluarix Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced intercepted product storage error (Verbatim: the medication refrigerator was out of range for the time span of 15 minutes). The outcome of the intercepted product storage error 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: 04-AUG-2023 The reporter was inquiring about the viability of his/her supply of Fluarix Quadrivalent vaccine. The reporter's practice lost power and the medication refrigerator was out of range for the time span of 15 minutes. The temperature reached 46.184 degree F. The reporter asked would these vaccines still be able to be utilized. The Fluarix Quadrivalent vaccine stored above recommended temperature, which led to intercepted product storage error.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Extra dose administered, Vomiting
Clinical narrative: extra dose administered; felt sick to his stomach half an hour ago; experiencing vomiting; This non-serious case was reported by a consumer via call center representative and described the occurrence of vomiting in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of neoplasm malignant (the patient had a full course of Shingrix and got cancer in 2021, He also had a breakout of shingles earlier this year, for the tolerance of previous dose refer case - US2023105254 ).   On 01-AUG-2023, the patient received the 3rd dose of Shingrix. On 02-AUG-2023, 1 days after receiving Shingrix, the patient experienced upset stomach (Verbatim: felt sick to his stomach half an hour ago). In AUG-2023, the patient experienced vomiting (Verbatim: experiencing vomiting). On an unknown date, the patient experienced extra dose administered (Verbatim: extra dose administered). The outcome of the vomiting and extra dose administered were unknown and the outcome of the upset stomach was not reported.   It was unknown if the reporter considered the vomiting and upset stomach to be related to Shingrix.     It was unknown if the company considered the vomiting and upset stomach to be related to Shingrix.   Linked case(s) involving the same patient:  US2023105254   Additional Information: GSK Receipt Date: 02-AUG-2023 The patient self-reported this case. The patient received one dose of Shingrix yesterday. The reporter stated that he experiencing vomiting in the middle of the night and felt sick to his stomach half an hour ago. The reporter consented to follow up. The patient was given 3rd dose of Shingrix, which led to extra dose administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023105254:Same reporter (original case)