chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Ultrasound Doppler normal
Clinical narrative: Patient was awakened in the night with left upper arm pain, redness and warmth. Pain worsened over the next 2 days and she was seen at clinic for evaluation on 10/31/2023. She rated her pain as a 7-8 out of 10 that was worse with ROM, pain was interfering with her ability to work and sleep. She was prescribed a Medrol Dosepak and Norco 7.5/325 for pain. She was seen ER on November first with c/o 10/10 pain in her left arm; she had a venous doppler US of her left arm, a CBC, CMP and EKG that were all found to be normal; she was prescribed Gabapentin to take in addition to the steroid and pain medications prescribed. As, of 11/3/2023 she was still experiencing sever pain in her arm; the redness had improved, but the arm continued to be warm
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AFTER BUD
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Induration, Mobility decreased, Nodule, Pain in extremity
Clinical narrative: hard nodule, bruising all up and down arm , pain , trouble moving arm
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Balance disorder, Blood glucose normal, Confusional state, Loss of consciousness, Petechiae
Clinical narrative: At home several hours later patient was found unconscious on the floor of his room. He roused with stimulation, but was confused and unsteady. When EMT got there he had stable vital signs and normal blood sugar, and was returning to baseline. When I spoke with mom a couple hours after that he seemed completely fine, other than a petechial rash around his right eye. There were no witnesses to him losing consciousness, it is unclear if this was syncope, or if he had had a seizure and was post-ictal.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Rash
Clinical narrative: At home several hours later patient was found unconscious on the floor of his room. He roused with stimulation, but was confused and unsteady. When EMT got there he had stable vital signs and normal blood sugar, and was returning to baseline. When I spoke with mom a couple hours after that he seemed completely fine, other than a petechial rash around his right eye. There were no witnesses to him losing consciousness, it is unclear if this was syncope, or if he had had a seizure and was post-ictal.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Vertigo
Clinical narrative: This was (spikevax) Moderna.  Patient did not elaborate but mentioned allergic reaction including "head spinning"
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Laboratory test, Swelling face, Vomiting
Clinical narrative: This was (spikevax) Moderna.  Patient did not elaborate but mentioned allergic reaction including "head spinning"
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Vertigo
Clinical narrative: swollen face, vomiting, breathing issues
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Laboratory test, Swelling face, Vomiting
Clinical narrative: swollen face, vomiting, breathing issues
Age: 29.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Bursitis, Injection site pain, Pain
Clinical narrative: Received Flu vaccine on 9/27/2023 as an employee through Occupational Health.  Begin having pain that evening.  Was seen after approx 1 month for continued  left shoulder pain.  Reports diagnosed with subacromial bursitis.
Age: 29.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Arthralgia, Bursitis, Pain
Clinical narrative: Received Flu vaccine on 9/27/2023 as an employee through Occupational Health.  Begin having pain that evening.  Was seen after approx 1 month for continued  left shoulder pain.  Reports diagnosed with subacromial bursitis.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient had no issues, the only problem was she isn't 65 and she didn't need the high dose.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was mistakenly given high dose flu vaccine at age 64 and 10 months. No adverse reaction noted.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Large welt like, red,and warm area 1 week after vaccination
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt is age 35 years old and received a Fluzone HD vaccine.  No reaction at this time.  Pt notified by NP.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Erythema, Pain, Swelling
Clinical narrative: Patient called to report that the right arm she received her Varivax vaccine on 11/2/23  is Itchy, has a red bump, she has body aches, headache and has become short of breath.  Since she reported shortness of breath, I encouraged her to go to the Emergency Room.  She verbalized agreement and understanding.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Thirst
Clinical narrative: chills, thirsty, shivering
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Right low arm/hand rash the next day after vaccination
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Disorientation, Fall, Head injury, Pallor
Clinical narrative: 15 year old female vaccinated with influenza vaccine (Fluarix). Patient 5 to 10 minutes after vaccination fell and hit her head. She was pale, conscious, and disoriented for approximately 2 to 3 minutes. Patient mom and patient reported not fainting in the past with vaccinations. Patient and patient mom reported patient ate approximately 2 hours before vaccination. Vital signs taken while patient was lying down BP was 100/62 and pulse 66bpm. 2 minutes later vital signs were taken with patient sitting and were BP 107/81 and pulse 108 bpm. 2 minutes later vital signs were taken with patient standing up, BP was 111/74 and pulse 84 bpm. Patient denied pain, nausea/vomitting , dizziness, and was alert and oriented to name, place, situation, and time. Patient was given juice and snack and she drank and ate them. Patient's mom denied EMS services and was instructed to monitor patient for signs of concussion and seek medical attention . Patient mom verbalized understanding and patient was observed leaving the clinic with a steady gait accompanied by mother.
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site mass
Clinical narrative: At 3:28pm, flu vaccine was administered IM in patient's left deltoid. Bleeding was immediately noted from injection site, and within 10 seconds of administration, a lump began forming under the injection site and reached approximately 1.5cm in diameter. Patient at that time denied symptoms of anaphylaxis and was awake, alert and engaging appropriately in conversation. Light pressure was held to site to control the bleeding and second RN was called to assist. Within 1 minute of lump forming, it decreased in size and area of redness approximately 3cm in diameter around the injection site was noted. Bleeding stopped and gauze and a bandaid was applied. Cold pack was held to area for 20 minutes while RN continuously monitored patient. The only symptoms patient noted was feeling "a bit funny in my head" but she noted she had a bit of a headache prior. She sipped on approximately 12oz water during this time as well. Approximately 15 minutes after vaccine was administered, redness around injection site resolved and no further discoloration was noted at the injection site. Patient continued to deny symptoms of anaphylaxis (SOB, tongue/throat swelling, difficulty swallowing/talking, dizziness, feeling faint) and no change in level of consciousness was noted. Patient was advised to go to the ER if she or her husband who was accompanying her today notice any of the symptoms listed above.
Age: 41.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pyrexia
Clinical narrative: mild fever
Age: 41.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: mild fever
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site urticaria
Clinical narrative: Employee received Flu vaccine 0n 10/26/23. On 10/28/23 he noted one hive around the injection site.  On 10-31-23 he noted 4-5 hives around injection site and contacted Employee Health where he got the vaccine.  RN talked with the Chief Medical Officer who is over Employee Health.  Employee took Benadryl at home after work and on 11/3/23 he stated the hives disappeared after the Benadryl.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Cough, Drooling, Fall, Loss of consciousness
Clinical narrative: 16 hours post vaccine child standing, went pale, coughed a "weird" cough, fell forward to the ground and was unconscious for few seconds, started shaking and drooling and was incontinent of urine. Once stood up he vomited in the hallway at school. EMT was called and examined child  O2 was around 90, no fever noted. Parent took child to Pediatrician. Child temp was at 101.2, Dr had him drink Gatorade in which he vomited. Took about 30 minutes at Pediatricians prior to going home.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Tremor, Urinary incontinence, Vomiting
Clinical narrative: 16 hours post vaccine child standing, went pale, coughed a "weird" cough, fell forward to the ground and was unconscious for few seconds, started shaking and drooling and was incontinent of urine. Once stood up he vomited in the hallway at school. EMT was called and examined child  O2 was around 90, no fever noted. Parent took child to Pediatrician. Child temp was at 101.2, Dr had him drink Gatorade in which he vomited. Took about 30 minutes at Pediatricians prior to going home.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Blood test, Cardiac ablation, Chest X-ray
Clinical narrative: Day of vaccine - cold chills withing hours, followed by 103-106 body fever and only 99 forehead fever, flu like symptoms for 3 days. Within a month from the vaccine started experiencing mild nausea and motion sickness while driving to work, and eyesight focusing issues. Symptoms were mild enough, didn't go to doctor. Saw an eye doctor in 2022 and found no issues. Symptoms continued to get worse and be more consistent (motion sickness and nausea). Starting summer 2022 until Jan 2023 started experiencing "pulled muscle feeling" in the back, lats and chest with pain and shortness of breath. Thought it was due to workouts. Pain worsened in Jan/Feb 2023, diagnosed with irregular heartbeats and 31% PVC. Had heart ablation in April 2023 with no prior family history of heart issues. Since then, continued having worse, debilitating motion sickness, nausea during drivers and flights. Also started having anxiety, claustrophobia, tinitus and headaches. Continued having dizziness, eye focusing issues, body shakes for no reason. Seeing various specialists (GI, neurologist, ENT) with no answers and no treatment.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Claustrophobia, Computerised tomogram, Dizziness
Clinical narrative: Day of vaccine - cold chills withing hours, followed by 103-106 body fever and only 99 forehead fever, flu like symptoms for 3 days. Within a month from the vaccine started experiencing mild nausea and motion sickness while driving to work, and eyesight focusing issues. Symptoms were mild enough, didn't go to doctor. Saw an eye doctor in 2022 and found no issues. Symptoms continued to get worse and be more consistent (motion sickness and nausea). Starting summer 2022 until Jan 2023 started experiencing "pulled muscle feeling" in the back, lats and chest with pain and shortness of breath. Thought it was due to workouts. Pain worsened in Jan/Feb 2023, diagnosed with irregular heartbeats and 31% PVC. Had heart ablation in April 2023 with no prior family history of heart issues. Since then, continued having worse, debilitating motion sickness, nausea during drivers and flights. Also started having anxiety, claustrophobia, tinitus and headaches. Continued having dizziness, eye focusing issues, body shakes for no reason. Seeing various specialists (GI, neurologist, ENT) with no answers and no treatment.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram ambulatory, Headache, Heart rate irregular, Influenza like illness
Clinical narrative: Day of vaccine - cold chills withing hours, followed by 103-106 body fever and only 99 forehead fever, flu like symptoms for 3 days. Within a month from the vaccine started experiencing mild nausea and motion sickness while driving to work, and eyesight focusing issues. Symptoms were mild enough, didn't go to doctor. Saw an eye doctor in 2022 and found no issues. Symptoms continued to get worse and be more consistent (motion sickness and nausea). Starting summer 2022 until Jan 2023 started experiencing "pulled muscle feeling" in the back, lats and chest with pain and shortness of breath. Thought it was due to workouts. Pain worsened in Jan/Feb 2023, diagnosed with irregular heartbeats and 31% PVC. Had heart ablation in April 2023 with no prior family history of heart issues. Since then, continued having worse, debilitating motion sickness, nausea during drivers and flights. Also started having anxiety, claustrophobia, tinitus and headaches. Continued having dizziness, eye focusing issues, body shakes for no reason. Seeing various specialists (GI, neurologist, ENT) with no answers and no treatment.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Motion sickness, Muscle discomfort, Myalgia, Nausea
Clinical narrative: Day of vaccine - cold chills withing hours, followed by 103-106 body fever and only 99 forehead fever, flu like symptoms for 3 days. Within a month from the vaccine started experiencing mild nausea and motion sickness while driving to work, and eyesight focusing issues. Symptoms were mild enough, didn't go to doctor. Saw an eye doctor in 2022 and found no issues. Symptoms continued to get worse and be more consistent (motion sickness and nausea). Starting summer 2022 until Jan 2023 started experiencing "pulled muscle feeling" in the back, lats and chest with pain and shortness of breath. Thought it was due to workouts. Pain worsened in Jan/Feb 2023, diagnosed with irregular heartbeats and 31% PVC. Had heart ablation in April 2023 with no prior family history of heart issues. Since then, continued having worse, debilitating motion sickness, nausea during drivers and flights. Also started having anxiety, claustrophobia, tinitus and headaches. Continued having dizziness, eye focusing issues, body shakes for no reason. Seeing various specialists (GI, neurologist, ENT) with no answers and no treatment.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus, Tremor, Ultrasound biliary tract, Ultrasound scan
Clinical narrative: Day of vaccine - cold chills withing hours, followed by 103-106 body fever and only 99 forehead fever, flu like symptoms for 3 days. Within a month from the vaccine started experiencing mild nausea and motion sickness while driving to work, and eyesight focusing issues. Symptoms were mild enough, didn't go to doctor. Saw an eye doctor in 2022 and found no issues. Symptoms continued to get worse and be more consistent (motion sickness and nausea). Starting summer 2022 until Jan 2023 started experiencing "pulled muscle feeling" in the back, lats and chest with pain and shortness of breath. Thought it was due to workouts. Pain worsened in Jan/Feb 2023, diagnosed with irregular heartbeats and 31% PVC. Had heart ablation in April 2023 with no prior family history of heart issues. Since then, continued having worse, debilitating motion sickness, nausea during drivers and flights. Also started having anxiety, claustrophobia, tinitus and headaches. Continued having dizziness, eye focusing issues, body shakes for no reason. Seeing various specialists (GI, neurologist, ENT) with no answers and no treatment.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles, Vision blurred
Clinical narrative: Day of vaccine - cold chills withing hours, followed by 103-106 body fever and only 99 forehead fever, flu like symptoms for 3 days. Within a month from the vaccine started experiencing mild nausea and motion sickness while driving to work, and eyesight focusing issues. Symptoms were mild enough, didn't go to doctor. Saw an eye doctor in 2022 and found no issues. Symptoms continued to get worse and be more consistent (motion sickness and nausea). Starting summer 2022 until Jan 2023 started experiencing "pulled muscle feeling" in the back, lats and chest with pain and shortness of breath. Thought it was due to workouts. Pain worsened in Jan/Feb 2023, diagnosed with irregular heartbeats and 31% PVC. Had heart ablation in April 2023 with no prior family history of heart issues. Since then, continued having worse, debilitating motion sickness, nausea during drivers and flights. Also started having anxiety, claustrophobia, tinitus and headaches. Continued having dizziness, eye focusing issues, body shakes for no reason. Seeing various specialists (GI, neurologist, ENT) with no answers and no treatment.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site mass, Injection site nodule
Clinical narrative: Patient had vaccine given in left deltoid. He started to bleed after injection was given.  CMA noticed that patient was starting to have a small bump at injection site. Bleeding continued for 15 seconds. Bump started to become more noticeable as patient sat in chair. He did not have any other complaints, no pain at site. When injection site was felt, golf sized ball/knot was noticed at site of injection.   FNP notified. She listened to patient's breathing. BP checked 134/90. Patient coherent, no complaints. Patient was advised to take benadryl, tylenol, and ibuprofen.
Age: 1.25
Sex: F
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: Area of injection was bruised and resulted in rash.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Apathy, Asthenia, Fatigue, Lethargy, Vaccination site erythema
Clinical narrative: Lethargic, apathetic, Weakness, fatigue the morning after vaccination. 4 inch diameter erythema around vaccine site, tender to the touch and firm to pressure.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: Lethargic, apathetic, Weakness, fatigue the morning after vaccination. 4 inch diameter erythema around vaccine site, tender to the touch and firm to pressure.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Temperature excursion for PROQUAD, administered to patient; This spontaneous report was received from a registered nurse concerning a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), lot number X007358 with expiration date 08-SEP-2024 for prophylaxis (dose, administration route and anatomical location were not reported).  The administered dose had previous excursion of -14°C to -10°C (-13.8 C) for 0 hours 26 minutes and an additional one of -14°C to -10°C (-13.0 C) for 0 hours 18 minutes (improper storage of product in use).  At the reporting time, the patient's outcome was unknown.; Sender's Comments:  US-009507513-2310USA001447:Case # 02485005
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Nurse reported 4-month-old twins received first dose of ROTATEQ; This spontaneous report was received from a registered nurse, referring to a 4-months-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 05-OCT-2023, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, administered orally, lot # reported as X001085 with expiration date on 01-NOV-2024), for prophylaxis (inappropriate schedule of product administration).  Lot number X001085 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2310USA001641:
Age: 0.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; 2-month-old patient received VARIVAX in error; This spontaneous report was received from a physician assistant concerning a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 12-OCT-2023, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot number X006983 with expiration date internally validated as 07-MAR-2025 for prophylaxis (anatomical location and route of administration were not reported) (product administered to patient of inappropriate age). No adverse events reported.  At the reporting time, the patient's outcome was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE/no PQC.; HCP reported patient received PROQUAD and VARIVAX concomitantly in error.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-OCT-2023, the patient received measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, 1 dose, valid lot #X011982, expiration date: 22-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, 1 dose, valid lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided) concomitantly in error (Accidental overdose). No additional adverse event was reported (No adverse event).
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Gait inability, Joint swelling, Pyrexia, Rash
Clinical narrative: stopped walking; had a high fever; rash; joint swelling; stopped forming speech for about 1 month; hypersensitivity reaction to MMR-II; This spontaneous report was received from a consumer and refers to a male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On unknown date, the patient gad a hypersensitivity reaction to the vaccine after receiving first dose. The reporter stated that the patient stopped walking, had high fever, rash, joint swelling and stopped forming speech for about 1 month after receiving that first dose on unknown date. At the time of reporting, the outcome of the events were not known.  The reporter considered hypersensitivity reaction to MMR-II to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The causal relationship between the rest of adverse events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; The medical assistant is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX  (w032370  4/19/2025) Temperature: 37.2F; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 19-SEP-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as prophylaxis (lot number: w032370, which was determined to be valid, with an expiration date on 10-OCT-2024) (strength, dose, scheme, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of 37.2 degrees Fahrenheit for 18 hours. No previous temperature excursion was reported.   No additional adverse event was provided.
Age: 1.33
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administration error, Syringe issue, Tremor, Underdose
Clinical narrative: Infant flinched; Some of the vaccine leaked from the syringe, resulting in the infant receiving less than the full dose; HCP called to report that during administration of MMR II, an infant flinched and some of the vaccine leaked from the syringe; This spontaneous report has been received from a pharmacy student, concerning a 16-month-old patient (reported as "infant" [conflicting information]) of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) injection, dose frequency: 0.5 ml, administered as prophylaxis (lot number W029539 was verified to be valid, expiration date not reported but upon internal validation was established as 15-SEP-2024) (route of administration and anatomical location were not provided). However, during the administration of the vaccine, the patient flinched (Tremor) (It was mentioned that "no adverse effects were reported" [conflicting information]) and some of the vaccine leaked from the syringe (Product administration error), resulting in the patient receiving less than the full dose (Underdose). The reporter asked about the validity of the dose being less than indicated in the prescribing info, and had questions about revaccination.  The outcome of the event of flinching and its causal relationship with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) was not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer called back about a temperature excursion case stating they just ran a report and found out that 1 patient was administered 1 dose of MMR II that was involved in multiple excursions prior to being administered.; This spontaneous report was received from a certified medical assistant and refers to a patient of unspecified age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-OCT-2023, the patient was vaccinated with improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) 1 dose, lot # W012118, expiration date 24-DEC-2023 (exact dose, route of administration and anatomical location were not provided). Administered dose of vaccine experienced temperature excursion of 12 degrees Celsius for 7 hours. Previous temperature excursions were reported as 1.6 degrees Celsius for 1 hour and 12 degrees Celsius for 7 hours. No additional adverse event was reported.
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: HCP called to report an infant who vomited after receiving a full dose of ROTATEQ. Patient received their first dose of ROTATEQ on 01NOV2023 and "vomited a few seconds later." No additional AE/PQC.; This spontaneous report was received from a nurse and refers to an 8-week-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2023, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, administered orally for immunisation (strength, lot #, and expiry date were not provided).  On 01-NOV-2023, the patient experienced HCP called to report an infant who vomited after receiving a full dose of ROTATEQ (a few seconds after). On 01-NOV-2023, the patient recovered from the event.   The causal relationship between adverse event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccinated in 2018 (unsure of exact date)/Contracted Shingles Diagnosed on 29 October 2023/Suspected Vaccination failure; Vaccinated in 2018 (unsure of exact date)/Contracted Shingles Diagnosed on 29 October 2023; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 29-OCT-2023, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Vaccinated in 2018 (unsure of exact date)/Contracted Shingles Diagnosed on 29 October 2023/Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Vaccinated in 2018 (unsure of exact date)/Contracted Shingles Diagnosed on 29 October 2023). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-OCT-2023 The case was reported by patient's father. The patient was vaccinated in 2018. On 29 October 2023 patient was diagnosed with shingles. The exact date of vaccination was unsure. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter agreed to follow up from GSK.
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: 101 degree fever; This non-serious case was reported by a consumer and described the occurrence of fever in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number KD424) for prophylaxis.   On 23-OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: 101 degree fever). The outcome of the fever was not resolved.   It was unknown if the reporter considered the fever to be related to Arexvy.     It was unknown if the company considered the fever to be related to Arexvy.   Additional Information: GSK receipt date: 24-OCT-2023 The patient had 101 degree fever. The reporter consented to follow up.
Sex: F
Vaccine: RVX
Symptoms: Induration, Mass, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Swelling arm; very sore arm; large red circle; itching; hard lump; soreness; discolored itching circle; This non-serious case was reported by a consumer and described the occurrence of swelling arm in a 82-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included diabetes, blood pressure and copd.   On 19-OCT-2023, the patient received RSV vaccine. In OCT-2023, an unknown time after receiving RSV vaccine, the patient experienced erythema (Verbatim: large red circle), pruritus (Verbatim: itching), mass (Verbatim: hard lump), pain (Verbatim: soreness) and skin discoloration (Verbatim: discolored itching circle). On 19-OCT-2023, the patient experienced swelling arm (Verbatim: Swelling arm) and pain in arm (Verbatim: very sore arm). The outcome of the swelling arm, pain in arm, pruritus, pain and skin discoloration were not resolved and the outcome of the erythema and mass were not reported.   It was unknown if the reporter considered the swelling arm, pain in arm, erythema, pruritus, mass, pain and skin discoloration to be related to RSV vaccine.     It was unknown if the company considered the swelling arm, pain in arm, erythema, pruritus, mass, pain and skin discoloration to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-OCT-2023 The patient used too many to list other products which were ongoing Since the rsv vaccine the arm had a large red circle and kept itching constantly.  First came hard lump and soreness now (at the time of reporting) discolored itching circle about 1-2inch diameter.  The reporter asked if it was normal. The reporter consented to follow up.
Sex: F
Vaccine: RVX
Symptoms: Skin discolouration, Skin reaction
Clinical narrative: Swelling arm; very sore arm; large red circle; itching; hard lump; soreness; discolored itching circle; This non-serious case was reported by a consumer and described the occurrence of swelling arm in a 82-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included diabetes, blood pressure and copd.   On 19-OCT-2023, the patient received RSV vaccine. In OCT-2023, an unknown time after receiving RSV vaccine, the patient experienced erythema (Verbatim: large red circle), pruritus (Verbatim: itching), mass (Verbatim: hard lump), pain (Verbatim: soreness) and skin discoloration (Verbatim: discolored itching circle). On 19-OCT-2023, the patient experienced swelling arm (Verbatim: Swelling arm) and pain in arm (Verbatim: very sore arm). The outcome of the swelling arm, pain in arm, pruritus, pain and skin discoloration were not resolved and the outcome of the erythema and mass were not reported.   It was unknown if the reporter considered the swelling arm, pain in arm, erythema, pruritus, mass, pain and skin discoloration to be related to RSV vaccine.     It was unknown if the company considered the swelling arm, pain in arm, erythema, pruritus, mass, pain and skin discoloration to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-OCT-2023 The patient used too many to list other products which were ongoing Since the rsv vaccine the arm had a large red circle and kept itching constantly.  First came hard lump and soreness now (at the time of reporting) discolored itching circle about 1-2inch diameter.  The reporter asked if it was normal. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Nausea
Clinical narrative: pain in injection site for days after; chills; nausea; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-OCT-2023, the patient received Shingrix. On 23-OCT-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain in injection site for days after), chills (Verbatim: chills) and nausea (Verbatim: nausea). The outcome of the injection site pain, chills and nausea were not resolved.   It was unknown if the reporter considered the injection site pain, chills and nausea to be related to Shingrix.     It was unknown if the company considered the injection site pain, chills and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2023 This report was submitted via the online direct entry reporting system. The patient self-reported this case. The patient received Shingrix and had chills, nausea and pain in injection site for days after. The patient did not receive any other products. The reporter asked to specify to pharmacists on how to give this shot. The reporter read online that it made a difference on how it was administered, but he could not find out how it was supposed to be given because he was not a doctor. The symptoms were not treated. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased
Clinical narrative: difficulty moving the shoulder; This non-serious case was reported by a physician via sales rep and described the occurrence of mobility decreased in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced mobility decreased (Verbatim: difficulty moving the shoulder). The outcome of the mobility decreased was resolved (duration 8 weeks).   It was unknown if the reporter considered the mobility decreased to be related to Arexvy.     It was unknown if the company considered the mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-OCT-2023 A GSK MSL Field Representative reported that a physician stated in his office that 3 female patients (no distinguishing factors provided), all received the Arexvy vaccine, and had difficulty moving the shoulder the vaccine was administered in for 6 to 8 weeks after administration. The GSK MSL Field Representative did not have any further information about this event, nor any information about lot/expiry or date of administration. The reporter consented to follow up. This case is linked with US2023AMR152006, same reporter.; Sender's Comments:  US-GSK-US2023AMR149219:3rd FEMALE PATIENT US-GSK-US2023AMR152006:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of Shingrix given earlier than the 2-6 month interval; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number F4LV5, expiry date 27-SEP-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 19-OCT-2023, the patient received the 2nd dose of Shingrix (left deltoid) .5 ml. On 19-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose of Shingrix given earlier than the 2-6 month interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2023 HCP called to report the maladministration of a 2nd dose of Shingrix given earlier than the 2 to 6 month interval. The patient received the 1st dose of Shingrix on 2nd October 2023. The 2nd dose was given 3 weeks after, on 19th October 2023 which led to shortening of vaccinations schedule. The HCP reported that the patient did not have any events following administration and had left the office before the maladministration was known. The reporter agrees to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: almost missed my second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: almost missed my second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 The patient stated that he/she almost missed the second dose of the shingles shot. The patient was expecting to receive an email much sooner, however, his/her pharmacist reminded that it was due. The patient thanked goodness for that because the vaccine put him/her out of commission for a day and he/she did not have a day to spare during the next 2 weeks. The patient suggested to email people much sooner as the email should have been sent in July. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: extreme pain in the arm; her entire shoulder in pain; limited range of motion; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   Previously administered products included Bexsero (1st dose received on an unknown date.).   On 06-SEP-2023, the patient received the 2nd dose of Bexsero (left arm) .5 ml. On 07-SEP-2023, 1 days after receiving Bexsero, the patient experienced pain in arm (Verbatim: extreme pain in the arm), shoulder pain (Verbatim: her entire shoulder in pain) and mobility decreased (Verbatim: limited range of motion). The patient was treated with ibuprofen. The outcome of the pain in arm, shoulder pain and mobility decreased were not resolved.   The reporter considered the pain in arm, shoulder pain and mobility decreased to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the pain in arm, shoulder pain and mobility decreased to be possibly 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 - 25-OCT-2023 It was stated that the patient received 2nd dose of Bexsero and on the day of the visit did not had any other complaints, nor did she receive any other vaccines during the visit.  The day after receiving vaccine she reported feeling extreme pain and decreased range of motion in the arm where the vaccine was administered. The patient went back to the clinic complaining of her entire shoulder in pain with limited range of motion. The patient was not prescribed a prescription medication, but the patient's notes said that the patient was advised to continue ibuprofen and alternate heat and ice. Within the Note, there was no mention of the adverse event resolving. When asked, the healthcare professional thought that the adverse event was very likely due to the vaccine administration, given the temporal association. This case is linked with US2023AMR148956, same reporter.; Sender's Comments:  US-GSK-US2023AMR148956:Same reporter, Different patient
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in arm; decreased range of motion in the arm; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   Previously administered products included Bexsero (1st dose received on 9th February 2023.). Additional patient notes included patient did not had a history of arm pain.   On 16-OCT-2023, the patient received the 1st dose of Bexsero (left arm) .5 ml. In OCT-2023, 1 week after receiving Bexsero, the patient experienced pain in arm (Verbatim: Pain in arm) and mobility decreased (Verbatim: decreased range of motion in the arm). The outcome of the pain in arm and mobility decreased were not resolved.   The reporter considered the pain in arm and mobility decreased to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the pain in arm and mobility decreased to be possibly 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: 25-OCT-2023 It was stated that the patient received 2nd dose of Bexsero and on the day of the visit did not had any other complaints, nor did she receive any other vaccines during the visit.  The healthcare professional did not know when the adverse event began following vaccination, but said one week later, the patient called complaining of arm pain and decreased range of motion. The patient made an appointment to see the physician on 26 october 2023. The adverse event had not resolved. When asked, the healthcare professional said she thought this adverse event was likely due to the vaccine and would categorize it as moderate severity since it had lasted so long. The patient did not had a history of arm pain. This case was linked to US2023AMR148934, same reporter.; Sender's Comments:  US-GSK-US2023AMR148934:Same reporter different patient
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Arexvy Vaccine not reconstituted but administered; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Arexvy Vaccine not reconstituted but administered) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 Arexvy vaccine not reconstituted but administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Influenza like illness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: arm soreness; mild influenza like symptoms; less arm stiffness; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: arm soreness), influenza-like symptoms (Verbatim: mild influenza like symptoms) and limbs stiffness (Verbatim: less arm stiffness). The outcome of the pain in arm, influenza-like symptoms and limbs stiffness were not reported.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms and limbs stiffness to be related to Arexvy.     It was unknown if the company considered the pain in arm, influenza-like symptoms and limbs stiffness to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-OCT-2023 The HCP (health care professional) stated, the patients have been doing well on Arexvy.  They were mainly experienced arm soreness and mild influenza like symptoms.  Her patients in general have less arm stiffness than Influenza vaccines. The follow-up could not be possible as no contact details were available.