chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Incorrect dose administered
Clinical narrative: Patient was give an adult does (0.5 ml) of Moderna covid vaccine rather than the 0.25 ml dose that should have been given due to her age.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Asthenia
Clinical narrative: Patient experienced a slight increase in body temp (99 F.) the day following the vaccinations. He also felt weakness come on. He has recovered since then.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Dizziness, Electrocardiogram abnormal, Heart rate increased, Tachycardia
Clinical narrative: New onset runs of tachycardia either SVT atrial fibrillation. Heart rate up to 165, typically 140s, 4-5 episodes. First 10/16/23. 5th episode 11/5 and associated with severe dizziness leading to an ER visit and new diagnosis of atrial fibrillation., starting diltiazem, and referral to cardiology.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Troponin normal
Clinical narrative: New onset runs of tachycardia either SVT atrial fibrillation. Heart rate up to 165, typically 140s, 4-5 episodes. First 10/16/23. 5th episode 11/5 and associated with severe dizziness leading to an ER visit and new diagnosis of atrial fibrillation., starting diltiazem, and referral to cardiology.
Age: 46.0
Sex: F
Vaccine: HEPA, PNC20
Symptoms: Asthenia, Chest discomfort, Dizziness, Rash, Rash erythematous
Clinical narrative: Patient received her Hep A and PCV 20 vaccine on 09/11/23. On 09/13/23, patient called the clinic and reported that she has large raised welts, hives, and pink bumps all over her body, neck, facial area, and was feeling itchy. The patient also felt dizzy and weak. Patient also awoke to a mild sensation of heaviness in her chest area. Patient was advised to go to the Emergency Department for further medical evaluation and plan was discussed with the doctor.
Age: 46.0
Sex: F
Vaccine: HEPA, PNC20
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Patient received her Hep A and PCV 20 vaccine on 09/11/23. On 09/13/23, patient called the clinic and reported that she has large raised welts, hives, and pink bumps all over her body, neck, facial area, and was feeling itchy. The patient also felt dizzy and weak. Patient also awoke to a mild sensation of heaviness in her chest area. Patient was advised to go to the Emergency Department for further medical evaluation and plan was discussed with the doctor.
Age: 92.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event known. Patient had already received a dose of Fluad on 8/29/2023 at same pharmacy. This was not discovered until after receiving the second dose on 9/16/2023.
Age: 76.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Fatigue, Hypotonia, Influenza like illness
Clinical narrative: Patient experienced symptoms for 3 days following shot. She complained of extreme fatigue, body limp, and stayed in bed for a long time with extreme flu like symptoms She has chronic fatigue syndrome but she says that this was unlike what she had ever experienced
Age: 77.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Abdominal pain, Chest tube insertion, Computerised tomogram abdomen abnormal, Condition aggravated, Diaphragmatic hernia
Clinical narrative: 11/3 HS: Patient with abrupt abd pain. Went to ER next morning where a CT done. Patient's diaphragmatic hernia used to just contain a small amount of fat, now on CT today shows herniated segment of colon coming through hernia with concern for bowel obstruction. Transferred to larger hospital to have surgery to repair hernia. At time of this report, it is 11/5 & patient is inpatient recovering from surgery with left sided chest tube, dilaudid PCA, IV medications while waiting for bowels to wake up.
Age: 77.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Hernia repair, Surgery
Clinical narrative: 11/3 HS: Patient with abrupt abd pain. Went to ER next morning where a CT done. Patient's diaphragmatic hernia used to just contain a small amount of fat, now on CT today shows herniated segment of colon coming through hernia with concern for bowel obstruction. Transferred to larger hospital to have surgery to repair hernia. At time of this report, it is 11/5 & patient is inpatient recovering from surgery with left sided chest tube, dilaudid PCA, IV medications while waiting for bowels to wake up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric dose was administered instead of the adult dose. The patient is not experiencing any adverse side effects.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: PATIENT STATED THEY STARTING HAVING REDNESS AT SITE OF INJECTION STARTING ON 10/31/23.
Age: 16.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Vomiting
Clinical narrative: Post meningococcal and MMR vaccines, pt verbalized dizziness and nausea, then proceeded to vomit twice. Observed pt looking pale and diaphoretic. VS initiated, legs elevated on chair, ice packs, water, and lollipop provided. Pt was reassessed after 10 minutes, pt still appeared pale and diaphoretic, pt was carefully moved to the sofa with another RN. RN Observed VS and color normalized after lying down.  Pt was moved to observation for continue monitoring.  At 2:50pm, Pt verbalized symptoms fully resolved, pt left observation in stable conditions with parent. Education and teaching provided to pt and parent.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site haemorrhage, Product administered at inappropriate site
Clinical narrative: 11/29/22 covid shot: Patient said bruised at the injection site and about a week later, a little bit of blood came out of the bruise. She did not follow up with the doctor. She has frozen shoulder currently and has had in her left arm for about 2 years, where she cannot lift up her arm high. She said that she thought the male pharmacist hit the bone, he was standing while giving the shot, and she thought he did the shot too high.
Age: 12.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Cold sweat, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Patient complained of lightheadedness, clammy skin, sweating, and headache. I had patient sit, gave him a sugary drink, and a cool compress for his neck. He felt better in about 5 minutes
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave patient Flu vaccine when she presented to clinic for Covid vaccine.  (She had had her flu vaccine last week). The flu vaccine given was indicated for 65 years and older.
Age: 78.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Patient stated low grade fever flu-like symptoms for 72 hours.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT STATES THEY STARTED HAVING REDNESS AND ITCHINESS AT SITE OF INJECTION STARTING IN THE MORNING ON 11/5.
Age: 79.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Injection site reaction, Rash macular, Rash pruritic
Clinical narrative: Patient reported a splotchy itchy rash on right arm about 8x4 inches when asked to see other arm to compare he showed another rash 2X2 over both deltoid regions. Given hydrocortisone 1% topically told to use 3-4 times daily over areas and Loratadine 10mg to take 1 daily. Follow up performed 11/3/23 patient was less itchy but both rashes were still prevalent.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema, Eye swelling, Lip swelling, Swelling, Throat tightness
Clinical narrative: The following morning approximately 24 hours after injection I woke up with some throat tightness and angio edema. Eyes and lips swollen. I also experienced mild swelling throughout body.  My husband and I both work in healthcare since I did not have any difficulty breathing I was able to take my normal daily dose of Zyrtec plus Prilosec, Benadryl and some prednisone I have on hand for reactions. I did not seek medical attention as I have known allergy to shellfish and have the medications on hand at home. If the reaction did not subside after a medications I would have used an epipen and gone to the ED.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram abnormal, Loss of consciousness, Presyncope, Seizure like phenomena
Clinical narrative: Patient was playing Basketball approximately two hours after vaccination. His friend stated during the seizure-like episode that he had passed out while playing basketball a month ago and almost once before. Once taken to the hospital there was a report of an abnormal EKG. He has been admitted for monitoring.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Pityriasis rubra pilaris
Clinical narrative: Pityriasis Rubra Pilaris Ten days later
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Nausea
Clinical narrative: five minutes after receiving immunization pt reported flushing, lightheadedness, dizziness and mild nausea.  Pt's blood pressure was 135/65 and heartrate 65 bpm. Pt remained seated for 15 minutes before she said she felt well enough to stand up. Pt went home and pharmacist called pt 4 hours later. Pt reported feeling back to normal within one hour except for a mild headache.
Age: 61.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient came in on 11/5/23 and reports they had an adverse reaction to possibly the arexvy vaccine recieved on 10/18/23. Patient reports they experienced some local injection site reactions on the same evening of 10/18/23. On 10/19/23, patient reports it was red, hot to the touch and raised slightly and it was slightly bigger than previously. On 10/20/23, patient reports that the reaction was from the deltoid muscle to the elbow and had wrapped around three-quarters around. Patient the was given bactrim DS for 7 days for cellulitis starting on 10/20/23. On 10/22/23, patient reports relief and reduction in size of reaction. Patient reported no fever nor any systemic symptoms for the duration.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient stated large area of swelling on right arm. The area also became warm to the touch as well. This reaction started about 24 hours after the vaccine was administered. Patient states she has never had a reaction like this in the past to any vaccination.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: Vasovagel syncope
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, hardening and hot to touch at injection site.   No treatment given, still present today. Redness is a bit larger. Still warm to touch and hardening is about the same.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Craniocerebral injury, Syncope
Clinical narrative: Syncopal event led to severe traumatic brain injury
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypotension, Syncope
Clinical narrative: Dad came to pharmacy and asked us to call 911.  Patient fainted as they were heading down to look at the squish mellows.   She had just gotten her flu shot.  Dad brought her back to pharmacy area and she was sitting in the chair and was alert and able to communicate.    EMT arrived and check her vitals.  O2 and HR within normal limits, bp on the lower side (~70).  Dad received shot first, and patient said it did make her nervous getting the shot after seeing that.  Dad and patient did not feel need to go to the hospital and went home after EMT left.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lacrimation increased, Syncope
Clinical narrative: Someone came to pharmacy to let us know someone fainted.  I asked them to call 911 while I headed to that direction.  The patient, was on her way to the pharmacy.  Her face was red and her eyes were watery.  Sat her down and asked her what happened and she said she just fainted and am feeling fine now.  EMT came and took her vitals.  All were within normal range (BP, O2, HR).  She said she has fainted in the past before when she got both the covid and the flu shot together (a few hours late).  She elected not to go to hospital and her roommate and friend came to pick her up and will keep a watch on her.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Loss of personal independence in daily activities, Pruritus, Skin test negative, Sleep disorder
Clinical narrative: Developed extreme chronic urticaria which lasted approximately one year. Intense hives and itching  would randomly occur all over the body at random spots and last for approximately 30 minutes to 2 hours in each spot. Urticaria would prevent sleep and normal daily functioning. Allergy medicines would temporarily alleviate symptoms and prevent urticaria but would require daily intake. Multiple steroid shots had little effect on alleviating urticaria symptoms.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Urticaria chronic
Clinical narrative: Developed extreme chronic urticaria which lasted approximately one year. Intense hives and itching  would randomly occur all over the body at random spots and last for approximately 30 minutes to 2 hours in each spot. Urticaria would prevent sleep and normal daily functioning. Allergy medicines would temporarily alleviate symptoms and prevent urticaria but would require daily intake. Multiple steroid shots had little effect on alleviating urticaria symptoms.
Age: 75.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Wrong product administered
Clinical narrative: Pt was only expecting flu vaccine and received covid vaccine instead. Was then given flu vaccine after mistake discovered.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Condition aggravated, Dizziness, Heart rate irregular
Clinical narrative: Dizziness, weakness, pounding heartbeat, more-than-usual pain in left arm, pain in neck, nausea, and  chills and fever for several hours. All symptoms ceased in a few hours except fever which decreased but remained for three days.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Palpitations
Clinical narrative: Dizziness, weakness, pounding heartbeat, more-than-usual pain in left arm, pain in neck, nausea, and  chills and fever for several hours. All symptoms ceased in a few hours except fever which decreased but remained for three days.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Dizziness, weakness, pounding heartbeat, more-than-usual pain in left arm, pain in neck, nausea, and  chills and fever for several hours. All symptoms ceased in a few hours except fever which decreased but remained for three days.
Age: 85.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: Technician injected adjuvant suspension only for Arexvy vaccine. Patient received correct dose again on the same day. Did not experience redness or painful arms on vaccine arm.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Dysphagia, Rash, Swollen tongue
Clinical narrative: she felt like she had Urinary tract infection; tongue swelling; unable to swallow; rash; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of urinary tract infection in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EA4RB, expiry date 04-FEB-2025) for prophylaxis.   On 25-OCT-2023 15:00, the patient received Arexvy (intramuscular). On 26-OCT-2023, 1 days after receiving Arexvy, the patient experienced urinary tract infection (Verbatim: she felt like she had Urinary tract infection), swollen tongue (Verbatim: tongue swelling), unable to swallow (Verbatim: unable to swallow) and rash (Verbatim: rash). The patient was treated with macrobid (nos) (Macrobid), steroids nos (Steroids) and prednisone. The outcome of the urinary tract infection, swollen tongue, unable to swallow and rash were unknown.   It was unknown if the reporter considered the urinary tract infection, swollen tongue, unable to swallow and rash to be related to Arexvy.     It was unknown if the company considered the urinary tract infection, swollen tongue, unable to swallow and rash to be related to Arexvy.   Additional Information: GSK Receipt Date : 27-OCT-2023 The reporter stated that patient received Arexvy on Wednesday and on Thursday, she said she felt like she had urinary tract infection and had a supply of Macrobid which she took at 4pm. At 7pm that night she developed tongue swelling, she was not able to swallow, and developed a rash and went to the ER. The ER gave her steroids and discharged her on prednisone this morning. The reporter was not sure if she was admitted or if she remained in ER. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Dysphagia, Rash, Swollen tongue, Urinary tract infection
Clinical narrative: she felt like she had Urinary tract infection; tongue swelling; unable to swallow; rash; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of urinary tract infection in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EA4RB, expiry date 04-FEB-2025) for prophylaxis.   On 25-OCT-2023 15:00, the patient received Arexvy (intramuscular). On 26-OCT-2023, 1 days after receiving Arexvy, the patient experienced urinary tract infection (Verbatim: she felt like she had Urinary tract infection), swollen tongue (Verbatim: tongue swelling), unable to swallow (Verbatim: unable to swallow) and rash (Verbatim: rash). The patient was treated with macrobid (nos) (Macrobid), steroids nos (Steroids) and prednisone. The outcome of the urinary tract infection, swollen tongue, unable to swallow and rash were unknown.   It was unknown if the reporter considered the urinary tract infection, swollen tongue, unable to swallow and rash to be related to Arexvy.     It was unknown if the company considered the urinary tract infection, swollen tongue, unable to swallow and rash to be related to Arexvy.   Additional Information: GSK Receipt Date : 27-OCT-2023 The reporter stated that patient received Arexvy on Wednesday and on Thursday, she said she felt like she had urinary tract infection and had a supply of Macrobid which she took at 4pm. At 7pm that night she developed tongue swelling, she was not able to swallow, and developed a rash and went to the ER. The ER gave her steroids and discharged her on prednisone this morning. The reporter was not sure if she was admitted or if she remained in ER. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Low Platelet count; Immune thrombocytopenia; This serious case was reported by a pharmacist via call center representative and described the occurrence of immune thrombocytopenia in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 10M752F) for prophylaxis.   On 10-OCT-2023, the patient received Arexvy. In OCT-2023, 10 days after receiving Arexvy, the patient experienced immune thrombocytopenia (Verbatim: Immune thrombocytopenia) (serious criteria GSK medically significant). On 20-OCT-2023, the patient experienced platelet count low (Verbatim: Low Platelet count). The outcome of the immune thrombocytopenia and platelet count low were unknown.   It was unknown if the reporter considered the immune thrombocytopenia and platelet count low to be related to Arexvy.   It was unknown if the company considered the immune thrombocytopenia and platelet count low to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 The reporter called to inquire that any data available of any other patients having this type of reaction. The reporter reported a patient received an Arexvy vaccine and 10 days later experienced an immune thrombocytopenia.  On 20th October 2023, they ran labs and it showed very low platelet counts. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Immune thrombocytopenia, Platelet count decreased
Clinical narrative: Low Platelet count; Immune thrombocytopenia; This serious case was reported by a pharmacist via call center representative and described the occurrence of immune thrombocytopenia in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 10M752F) for prophylaxis.   On 10-OCT-2023, the patient received Arexvy. In OCT-2023, 10 days after receiving Arexvy, the patient experienced immune thrombocytopenia (Verbatim: Immune thrombocytopenia) (serious criteria GSK medically significant). On 20-OCT-2023, the patient experienced platelet count low (Verbatim: Low Platelet count). The outcome of the immune thrombocytopenia and platelet count low were unknown.   It was unknown if the reporter considered the immune thrombocytopenia and platelet count low to be related to Arexvy.   It was unknown if the company considered the immune thrombocytopenia and platelet count low to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 The reporter called to inquire that any data available of any other patients having this type of reaction. The reporter reported a patient received an Arexvy vaccine and 10 days later experienced an immune thrombocytopenia.  On 20th October 2023, they ran labs and it showed very low platelet counts. The reporter did not consent to follow-up.
Sex: M
Vaccine: RV5
Symptoms: Endotracheal intubation, Foreign body aspiration, Product administered to patient of inappropriate age, Respiratory failure
Clinical narrative: Respiratory decompensation approximately 8-12 hours after administration of first dose of ROTATEQ.; The patient aspirated on the ROTATEQ; Inappropriate age at vaccine administration; This spontaneous report was received from a pharmacist and refers to a 3-month-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter (Inappropriate age at vaccine administration) (lot number 1947634 has been verified to be a valid lot number, expiration date reported and validated as 05-MAY-2024), administered orally for prophylaxis.  He was given the vaccine; however, the patient was intubated, and it was believed that the patient aspirated on rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (aspiration) on that day. Then, on that same date (reported as 8-12 hour after vaccination), the patient experienced respiratory decompensation (respiratory failure). The patient was already hospitalized when the events occurred. At the reporting time, the outcome of the events was unknown.   The causal relationship between the events and the suspect vaccine was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Cant use muscles in right arm; Swelling right arm; Right arm Pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injected limb mobility decreased (Verbatim: Cant use muscles in right arm), swelling arm (Verbatim: Swelling right arm) and pain in arm (Verbatim: Right arm Pain). The outcome of the injected limb mobility decreased, swelling arm and pain in arm were not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, swelling arm and pain in arm to be related to Shingrix.     It was unknown if the company considered the injected limb mobility decreased, swelling arm and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 27-OCT-2023 The reporter was the patient. The patient experienced pain and swelling in her right arm and could not use her muscles. The patient was not forthcoming to elaborate on the adverse event.  No further information was given during this phone call.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received a dose of Boostrix by accident; a patient of 6 years and 7 months of age received a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7, expiry date 06-DEC-2025) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: received a dose of Boostrix by accident) and inappropriate age at vaccine administration (Verbatim: a patient of 6 years and 7 months of age received a dose of Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 27-Oct-2023 A medical assistant called to inform that the patient was supposed to receive a DTaP dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Boostrix accidently instead of DTap at an inappropriate age , which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had to re start the Shingrix series if more than 6 months have elapsed since the first dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose a year ago or so).   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: had to re start the Shingrix series if more than 6 months have elapsed since the first dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Oct-2023 A physician mentioned that patient was older than 80 years. The reporter called to ask if a patient had to re start the Shingrix series if more than 6 months have elapsed since the first dose. The reporter consented to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received a second dose of Arexvy today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75BS5, expiry date 28-JAN-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 27-OCT-2023, the patient received the 2nd dose of Arexvy. On 27-OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received a second dose of Arexvy today). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 27-Oct-2023 The registered pharmacist reported that the patient received first dose of Arexvy a little over 2 months ago in August. The reporter consented to follow-up. This is 1 of 2 inked patients reported by the same reporter for different patient. The patient received second dose of Arexvy on the day of reporting, which led to extra dose administered.; Sender's Comments:  US-GSK-US2023149471:2nd patient
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received a second dose of Arexvy today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 83-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75BS5, expiry date 28-JAN-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 27-OCT-2023, the patient received the 2nd dose of Arexvy. On 27-OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received a second dose of Arexvy today). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 27-Oct-2023 The registered pharmacist reported that the patient received first dose of Arexvy a little over 2 months ago in August. The reporter consented to follow-up. This is 2 of 2 inked patients reported by the same reporter for different patient. The patient received second dose of Arexvy on the day of reporting, which led to extra dose administered.; Sender's Comments:  US-GSK-US2023149472:2nd patient
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 35 weeks pregnant lady was administered Arevy; 35 weeks pregnant lady was administered Arevy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number t3m4m, expiry date 05-MAR-2025) for prophylaxis.   On 26-OCT-2023, the patient received Arexvy. On 26-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 35 weeks pregnant lady was administered Arevy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 35 weeks pregnant lady was administered Arevy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 30-Oct-2023 The reporter consented to follow-up. An pregnant patient received a dose of Arexvy at an inappropriate age, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: inadvertently administered the Arexvy diluent only without the lyophilized component; inadvertently administered the Arexvy diluent only without the lyophilized component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number B945F, expiry date 01-FEB-2025) for prophylaxis.   On 26-OCT-2023, the patient received Arexvy. On 26-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered the Arexvy diluent only without the lyophilized component) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Arexvy diluent only without the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 30-Oct-2023 Clinic operations manager called to inquired that when the patient could come back for a full dose of the Arexvy. The reporter did not consent to follow-up. The patient was inadvertently administered the Arexvy diluent only without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: pregnant patient received a dose of Arexvy; inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7942H, expiry date 02-MAR-2025) for prophylaxis.   On 27-OCT-2023, the patient received Arexvy. On 27-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received a dose of Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 31-Oct-2023 The reporter noted that the patient was approximately 32 weeks along in her pregnancy.  No additional information was provided. The reporter consented to follow-up. A pregnant patient received a dose of Arexvy at an inappropriate age, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received an extra dose of Arexvy; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 30-OCT-2023, the patient received the 2nd dose of Arexvy (intramuscular, left deltoid). On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received an extra dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 31-Oct-2023 The reporter stated that he has had no symptoms at all since receiving his second Arexvy vaccine. The patient received second dose of Arexvy, which led to extra dose administered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: 11/4/23 fever  99.3 . 11/5/23  awoke with severe sharp headache . Required taking Tylenol about every 6 hours. All  joints ache even with taking Tylenol.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Extra dose administered, Mobility decreased
Clinical narrative: Hardly lift her left arm; asymptomatic after receiving extra erroneous dose of Bexero vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of mobility decreased in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On 23-OCT-2023, the patient received Bexsero (intramuscular). On 23-OCT-2023, not applicable after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: asymptomatic after receiving extra erroneous dose of Bexero vaccine). On an unknown date, the patient experienced mobility decreased (Verbatim: Hardly lift her left arm). The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). The outcome of the mobility decreased was resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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 23 Oct 2023: The reporter consented to follow up. The HCP reported that patient could hardly lift her left arm 1 day after vaccination with 2nd dose of BEXSERO. The patient took Tylenol and Advil 12 hours afterwards the symptom resolved (within the day). The Patient was asymptomatic after receiving extra erroneous dose of Bexero vaccine, which led to extra dose administered. The reporter consented to follow up.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC20, RV1
Symptoms: Wrong product administered
Clinical narrative: PATIENT CAME IN TO MEDICAL GROUP ON 11/03/2023 TO RECEIVE 2 MONTH OLD VACCINES. DR ORDERED FOR THE FOLLOWING VACCINE TO BE ADMINISTERED: ROTARIX, HEP B, PENTACEL, AND PREVENAR 13. ALL VACCINES WERE GIVEN EXCEPT PREVENAR 13. PREVENAR 20 WAS GIVEN BY MISTAKE. OUTCOME: DR REVIEWED THE CDC GUIDELINES AND THE PATIENT WILL BE OKAY. OFFICE MANAGER: SPOKE WITH PATIENT'S MOTHER: TO UPDATE HER ON THE INCORRECT VACCINE THAT WAS GIVEN AND TO PROVIDE INSTRUCTION BY DR.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: LOCAL REDNESS/SWELLING/WARM
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose amount of Moderna 23/24 6m-11 given on 10/25/23. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother contacted expressed understanding. Instructions provided to monitor patient for additional or prolonged side effects with call back number for Nursing Supervisor. Mother informed that subsequent dose may still be administered at the recommended interval. Additionally, a message sent to patient's PCP informing them of error.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Mechanical urticaria
Clinical narrative: 3 days after the vaccine developed dermographic urticaria which has persisted daily for 9 months.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose amount of Moderna 23/24 6m-11 given on 10/24/2023. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother expressed understanding. Instructions provided to monitor patient for additional or prolonged side effects with call back number for Nursing Supervisor. Additionally, a message sent to patient's PCP informing them of error. Father called to request a letter containing information about the administered dose in order to contact the CDC and ascertain whether any additional precautions are necessary.
Age: 34.0
Sex: M
Vaccine: FLUA4, TDAP
Symptoms: Brain fog, Fatigue, Injection site pain, Lethargy, Pain in extremity
Clinical narrative: Severe pain at injection site in right arm. Beginning at 5 hours post injection continuing >48 hours after injection Slight pain in left arm. Beginning at 7 hours post injection continuing >48 hours after injection Fatigue Brain Fog Lethargy
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Outgoing call to patient's mother to discuss incorrect dose amount of Moderna 23/24 6m-11 given on 10/25/23. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother expressed understanding and indicated patient had mild side effects this morning which they treated with a dose of Tylenol and patient was able to attend school. Instructions provided to monitor patient for additional or prolonged side effects and contact clinic with any concerns. Additionally, a message sent to patient's PCP informing them of error.
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Outgoing call to patient's mother to discuss incorrect dose amount of Moderna 23/24 6m-11 given on 10/24/2023. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother expressed understanding. Instructions provided to monitor patient for additional or prolonged side effects with call back number for Nursing Supervisor. Additionally, a message sent to patient's PCP informing them of error. Father called to request a letter containing information about the administered dose in order to contact the CDC and ascertain whether any additional precautions are necessary.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given Hep A vaccine too soon. Date of Hep A vaccine should have been 11/12/2023 or after.
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Outgoing call to patient's mother to discuss incorrect dose amount of Moderna 23/24 6m-11 given on 10/24/2023. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother expressed understanding. Instructions provided to monitor patient for additional or prolonged side effects with call back number for Nursing Supervisor. Additionally, a message sent to patient's PCP informing them of error.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Outgoing call to patient's father to discuss incorrect dose amount of Moderna 23/24 6m-11 given on 10/25/23. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's father expressed understanding. Instructions provided to monitor patient for additional or prolonged side effects with call back number for Nursing Supervisor. A message sent to patient's PCP informing them of error. Patient is being seen by pediatrician, Dr, on 11/1 for knee pain (~ 3 weeks according to appointment notes). Message sent to Dr informing of medication error as well. Inbound call from the mother, who had additional inquiries regarding the recent incident. She is seeking information about the follow-up procedures following the error, as well as any reporting protocols in place for vaccine-related mistakes. During the conversation, the mother was educated about the Vaccine Adverse Event Reporting System (VAERS) and expressed a desire to know if there are mechanisms in place to ensure that the process has been successfully concluded. To provide reassurance and document the interaction, the mother will receive a confirmation email from VAERS forwarded to her once the process is finalized.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: Discussed with patient's mother that incorrect dose amount of Moderna 23/24 6m-11 given on 10/25/23. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother expressed understanding and indicated patient had mild fever the day following immunization, but is doing well. Instructions provided to monitor patient for additional or prolonged side effects and contact clinic with any concerns. Additionally, a message sent to patient's PCP informing them of error.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Right axilla lymph node swelling and pain.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Computerised tomogram, Headache, Paraesthesia, Paraesthesia oral, Vision blurred
Clinical narrative: Cloudy vision, headache, sleepiness in left arm and mouth since 7pm.