chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: I had a stroke the day after receiving the vaccine while I was having a kidney stone pushed out at Hospital.  I was in the hospital for a week.  I went to rehab and was there for 5 months trying to regain my left side mobility.  Vision is now permanently impaired and my left arm is still wonky and my left leg is still having issues.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Blood gases, Blood grouping, C-reactive protein, Cardio-respiratory arrest, Full blood count
Clinical narrative: 09/13/23 2300 arrived to emergency department  09/14/2023 0815 code started, chest compressions, epinephrine x 10 throughout code, plasmalyte, calcium chloride, plasma and packed RBC administered 09/14/2023 0930 code ended
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Procalcitonin, Red blood cell sedimentation rate, Red blood cell transfusion, Resuscitation, Transfusion
Clinical narrative: 09/13/23 2300 arrived to emergency department  09/14/2023 0815 code started, chest compressions, epinephrine x 10 throughout code, plasmalyte, calcium chloride, plasma and packed RBC administered 09/14/2023 0930 code ended
Age: 78.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Urticaria
Clinical narrative: Patient developed hives within 24 hours of receiving  the vaccine and sought medical attention. Patient had received flu vaccines in the past without any reactions so doctor attributed it to the RSV vaccine
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Listless
Clinical narrative: He got his vaccine when he was picking up a prescription, and he got it, then went home and had dinner around 6:00.  He then felt light headed and dizzy.  He started to get a slight headache, which he never gets.  He took a couple of Tylenol and sat down and watched TV and he dozed off ,which was odd as well.  He woke up and felt real tired and listless, which is unusual for him.  He was thinking it might be a AE to the vaccine.  Yesterday he felt a little better, and today he is feeling better and the headache is about gone, and more energetic and a little more energy.  He had no energy prior to that and going up steps he was tired out and his legs felt weak.  Today he has been able to go outside and do yard work and mow the grass.
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Muscular weakness
Clinical narrative: He got his vaccine when he was picking up a prescription, and he got it, then went home and had dinner around 6:00.  He then felt light headed and dizzy.  He started to get a slight headache, which he never gets.  He took a couple of Tylenol and sat down and watched TV and he dozed off ,which was odd as well.  He woke up and felt real tired and listless, which is unusual for him.  He was thinking it might be a AE to the vaccine.  Yesterday he felt a little better, and today he is feeling better and the headache is about gone, and more energetic and a little more energy.  He had no energy prior to that and going up steps he was tired out and his legs felt weak.  Today he has been able to go outside and do yard work and mow the grass.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Blister, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm became swollen and red, painful and hot to the touch, with tiny blisters forming. Patient took Benadryl with no relief. She was planning to try Hydrocortisone and an ice pack as well as reach out to her physician for a possible steroid.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Nausea, Diarrhea, Muscle Aches, Headache, Joint Pain, Ringing in Ears, Tiredness - last 4 days
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Nausea, Tinnitus
Clinical narrative: Nausea, Diarrhea, Muscle Aches, Headache, Joint Pain, Ringing in Ears, Tiredness - last 4 days
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Erythema, Flushing
Clinical narrative: Immediate flushing, red face, hard time breathing, chest pressure , dizziness.   Pharmacist gave Benadryl tablet.  Symptoms eased after a few minutes.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction
Clinical narrative: Immediate flushing, red face, hard time breathing, chest pressure , dizziness.   Pharmacist gave Benadryl tablet.  Symptoms eased after a few minutes.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Autoimmune disorder, Blindness
Clinical narrative: auto immune problem, lost voice and sight
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Malaise, Nausea, Rash, Spider vein
Clinical narrative: Patient reported  purple "spider spots" on her legs and in patches. Purple bruising appearing on her. "Intense rash" She reports she was "very nauseas and sick feeling to where I couldn't do much but just be at rest the next day" (it lasted another 48  hours). Patient reports that she did take Benadryl, and over the counter anti-itch gel.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt came to clinic for vaccines 8/1/23. Pt birthdate was incorrectly entered into system. RN verified birthdate and corrected it in system but did not recalculate pt age. Tdap was given instead of Dtap. Pt mother made aware. Pt to clinic 9/14/23 and given correct vaccines per age and guidelines.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: sore arm first day, red and swelling. 2nd say,  sore joints, muscle aches, fever and swollen , red and hot injection site. 3 day to now , swollen, hot to the touch injection site.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia, Pain in extremity, Pyrexia, Swelling
Clinical narrative: sore arm first day, red and swelling. 2nd say,  sore joints, muscle aches, fever and swollen , red and hot injection site. 3 day to now , swollen, hot to the touch injection site.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Feeling of body temperature change, Flushing, Headache
Clinical narrative: Employee received vaccine prior to end of shift. Upon follow up by staff, employee denied symptoms of any form. Employee went home and began experiencing episodes of facial flushing, extreme warmth and extreme cold, as well as a headache. Employee states they laid down and after resting  for an estimated 2 hours, symptoms had resolved. Employee denies any known changes in environment or routine with the exception of vaccine. Employee denies seeking medical care for complications following  initial outcome.
Age: 57.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Patient experienced swelling in the arm 2 weeks after the vaccine then 4 weeks after the vaccine patient experienced swelling in the back of the neck.  Patient was told by the doctor that will go down over time.  Patient used massage to help go down,
Age: 83.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash, Rash pruritic
Clinical narrative: Two days after vaccination, patient noticed itchiness which spread into a rash covering the entire trunk and extremities.  Patient had to seek medical attention at an urgent care and received a prescription for steroids and Benadryl.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Patient states once he received the  Influenza vaccine at the onsite clinic on 9/14/23 , he states he developed shortness of breath, diarrhea, chills, nausea and vomiting, and he was diaphoretic. Patient states the exact same thing happened to him last year.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Patient states once he received the  Influenza vaccine at the onsite clinic on 9/14/23 , he states he developed shortness of breath, diarrhea, chills, nausea and vomiting, and he was diaphoretic. Patient states the exact same thing happened to him last year.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Received Fluzone instead of high dose flu vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Patient requested to be given covid 19 Bivalent vaccine d/t to his comorbidities, LVN informed patient that new covid 19 vaccine would be out soon. At the time I was not aware that the Bivalent was no longer authorized being that I administered the vaccine 9/12/23 at 448 pm and then I received an email stating the Bivalent was no longer authorized since 09/11/23. I received that specific email 9/12/23 at 7pm.
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Skin swelling
Clinical narrative: breathing problems 2 raised skin areas of arm and shoulder
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Brain fog, Cardiac monitoring normal, Confusional state, Dizziness
Clinical narrative: Dizziness, brain fog, confusion, headaches, unstable gait and blurred vision.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram abnormal, Gait disturbance, Headache, Hydrocephalus, Loss of consciousness
Clinical narrative: Dizziness, brain fog, confusion, headaches, unstable gait and blurred vision.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Seizure, Sleep study, Tilt table test positive, Vision blurred
Clinical narrative: Dizziness, brain fog, confusion, headaches, unstable gait and blurred vision.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Presyncope, Syncope
Clinical narrative: pt was given Menveo in office. Pt waited the 15 minutes. Stated she was fine and left with her mother.  When pt was walking to their car, pt became faint and passed out. Rapid response was called. ER provider, 3 RNs, 2 ER Techs, Respiratory therapist came to pt within 3-5 minutes. Pt was evaluated by the ER provider and was determined that d/t pt had not eaten since the afternoon of the day before she had a vasal Vagle occurrence.  Pt was given juice, banana, and a candy bar.  Pt was doing better after 20-30 minutes and allowed to go home with her mother. Mother did refuse to go to ER with daughter. Reminded to return to ER if s/s returned. Mother voiced understanding.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy salivary gland, Oral discomfort, Salivary gland adenoma, Ultrasound scan
Clinical narrative: Development of an Adenoma in the salivary gland, first being noticed as a notable growth in June of 2022. As the tumor is not causing any discomfort, unless it grows further, it has been decided to not extract it.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Axillary pain, Breast pain, Lymphadenopathy, Neck pain
Clinical narrative: 2 Days after the vaccine, I fell asleep on the couch and when I wen to get up, the whole underarm area of my left arm was in excrutiating pain! For the next 2 days I iced it and went to off-hours clinic and they triaged me and said to come back the next day if it was still bad. I didnt go. My lymph nodes were swollen and sore in my left side of my neck. The pain was out of this world! 11 out of 10! It started to ease up by 9/10. each day after it subsided a little more til I didnt need the ice packs. All the pain was localized in my underarm and toward the breast area.
Age: 4.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Reaction. Pt to come to clinic on 9/19/2023 for DTap vaccine.
Age: 65.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Fatigue, Paraesthesia, Pyrexia
Clinical narrative: Pt describes tingling, high fever (103 degrees) and fatigue
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 1.33
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AEs or PQC reported; Caller reports PROQUAD and VARIVAX were inadvertently administered at the same office visit to a 16 month old; This spontaneous report was received from a registered nurse and refers to a 16-month-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, historical drugs and concomitant therapies were not reported.  On 29-AUG-2023, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #X011980 rHA, expiration date: 19-JUL-2024, administered intramuscularly for prophylaxis (strength was not provided); and with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #X006980, expiration date: 07-MAR-2025, administered intramuscularly for prophylaxis (strength was not provided) (accidental overdose.)  No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; the patient was administered an expired dose of VARIVAX; Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 30-AUG-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #u024220, expiration date: 04-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided). No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No related effects noted; initial TE; new short date exp. date 7/19/2023; This spontaneous report was received from a non-medical healthcare worker referring to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, Concomitant therapies and historical drugs were not reported.  On 06-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, single dose, lot #W031815, expiration date: 05-OCT-2024, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided). Due to the previous temperature excursion for 1 hour 22 minutes (product storage error), new short expiration date date was 19-JUL-2023 (expired vaccine used). No related effects noted (no adverse event).  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA002813:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Contraceptive implant, Cyst rupture, Dizziness, Dysstasia, Loss of consciousness
Clinical narrative: cyst then ruptured into patient's lung; sore throat; birth control implant; put on a birth control pill; POTS; cyst in the back of their throat; This spontaneous report was received from a nurse via a company staff referring to an approximately 13-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were unknown.   On an unknown date in 2019 (also reported as "at age 13"), the patient completed the vaccination of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date (reported as "shortly after"), the patient developed a sore throat that persisted on and off for about a year. Since an unknown date in 2020 (reported as "the following year"), the patient developed a cyst in the back of their throat (tonsillar cyst). On an unknown date, the cyst then ruptured into patient's lung and was hospitalized for 4 days. On an unknown date in 2022 (reported as "one year ago"), the patient started struggling standing up, experiencing dizziness and at times passing out. On an unknown date in March 2023 (reported as "6 months ago"), the patient was diagnosed with postural tachycardia syndrome (POTS) and was put on a birth control pill (oral contraception) as well as a birth control implant (contraceptive implant). It was unknown if the patient sought medical attention or treatment was given. The outcome of the events above was not reported.  The causal relationship between the events above and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Oral contraception, Oropharyngeal pain, Postural orthostatic tachycardia syndrome, Tonsillar cyst
Clinical narrative: cyst then ruptured into patient's lung; sore throat; birth control implant; put on a birth control pill; POTS; cyst in the back of their throat; This spontaneous report was received from a nurse via a company staff referring to an approximately 13-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were unknown.   On an unknown date in 2019 (also reported as "at age 13"), the patient completed the vaccination of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date (reported as "shortly after"), the patient developed a sore throat that persisted on and off for about a year. Since an unknown date in 2020 (reported as "the following year"), the patient developed a cyst in the back of their throat (tonsillar cyst). On an unknown date, the cyst then ruptured into patient's lung and was hospitalized for 4 days. On an unknown date in 2022 (reported as "one year ago"), the patient started struggling standing up, experiencing dizziness and at times passing out. On an unknown date in March 2023 (reported as "6 months ago"), the patient was diagnosed with postural tachycardia syndrome (POTS) and was put on a birth control pill (oral contraception) as well as a birth control implant (contraceptive implant). It was unknown if the patient sought medical attention or treatment was given. The outcome of the events above was not reported.  The causal relationship between the events above and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
Sex: F
Vaccine: PNC15
Symptoms: Accident at work, Scratch, Syringe issue
Clinical narrative: The HCP who administered the vaccine got a "little scratch" on her right hand due to the breakage of the syringe while administering the injection; The HCP who administered the vaccine got a "little scratch" on her right hand due to the breakage of the syringe while administering the injection; the plastic part by the plunger of the VAXNEUVANCE syringe was broken off on the circular ring while administering the vaccine; This spontaneous report was received from an registered nurse and refers to a 27-year-old non-pregnant female who refers to herself.  The patient's concurrent conditions included drug reaction/allergy to amoxicillin and erythromycin. The patient's medical history and concomitant therapies were not reported.  On 08-SEP-2023, the plastic part by the plunger of the 15v conj vaccine (crm197) (VAXNEUVANCE) (lot #X019197, expiration date: 30-AUG-2025) syringe was broken off on the circular ring while administering the vaccine. The nurse who administered the vaccine got a "little scratch" on her right hand due to the breakage of the syringe while administering the injection (scratch, Injury associated with device, Syringe broken ). There was no vaccine exposure to the skin. The vaccine with the product quality issue was administered to the patient (captured in MARRS # 2309USA004099). Sample was not available for retrieval as it was discarded prior to the call.  The nurse sought medical attention but did not receive treatment for the event. On 11-SEP-2023, the nurse recovered from little scratch.  The relatedness between the event of little scratch and 15v conj vaccine (crm197) (VAXNEUVANCE) was not provided.  This is one of two reports received from the same source. ; Sender's Comments:  US-009507513-2309USA004099:MSD
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE; we gave a 18month old her 2nd Hep A shot today. Her first one was at her 12 month appointment on 3/16/23. So we are early about 4 Days; This spontaneous report was received from other health professional and refers to an 18-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-MAR-2023, the patient was vaccinated with her first dose of hepatitis a vaccine, inactivated (manufacturer unknown) administered for prophylaxis (dose, anatomical location, lot #, expiry date, and route of administration were not provided). On 12-SEP-2023, the patient was vaccinated with her second dose of hepatitis a vaccine, inactivated (manufacturer unknown) administered for prophylaxis (dose, anatomical location, lot #, expiry date, and route of administration were not provided), so they were early about 4 Days (Inappropriate schedule of product administration). No other adverse events (AE) experienced (No adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE.; patient given PNEUMOVAX23 expiration 8/18/2023; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 12-SEP-2023, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot #U035117, expiration date: 18-AUG-2023, administered for prophylaxis (anatomical location, and route of administration were not provided) (expired product administered). There were no adverse events reported (no adverse event).
Age: 0.33
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects reported; HCP calling to report GARDASIL 9 was inadvertently administered to a 4 month old patient. No side effects reported.; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of unknown gender. No medical history, concurrent conditions nor concomitant medications were reported.  On 28-AUG-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (0.5 mL, lot # W026977 has been verified to be a valid lot number for formulation pre-filled syringe, expiration date 04-JAN-2025) for prophylaxis (Inappropriate age at vaccine administration). No side effects reported. No additional adverse event (AE)/ product quality complaint (PQC) (No adverse event).
Age: 0.33
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: No side effects reported; HCP calling to report GARDASIL 9 was inadvertently administered to a 4 month old patient. No side effects reported.; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of unknown gender. No medical history, concurrent conditions nor concomitant medications were reported.  On 28-AUG-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (0.5 mL, lot # W026977 has been verified to be a valid lot number for formulation pre-filled syringe, expiration date 04-JAN-2025) for prophylaxis (Inappropriate age at vaccine administration). No side effects reported. No additional adverse event (AE)/ product quality complaint (PQC) (No adverse event).
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant and Received Heplisav-B; Initial report received on 26-May-2023.  A physician's assistant reported that a female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient is pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (route, site, lot #, expiration date were not reported, and NDC # 43528-002-01).   On an unspecified date, after having been vaccinated with HEPLISAV-B, the patient was noted to have been pregnant when she was vaccinated.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: His arm was red/swollen; Red arm; red with white welts; This non-serious case was reported by a consumer and described the occurrence of welts in a 8-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2023-2024 season) (batch number FC22G) for prophylaxis.   On 06-SEP-2023, the patient received the 1st dose of FluLaval Tetra 2023-2024 season (right arm). On 07-SEP-2023, 1 days after receiving FluLaval Tetra 2023-2024 season, the patient experienced welts (Verbatim: red with white welts). On 07-SEP-2023 06:00, the patient experienced swelling arm (Verbatim: His arm was red/swollen) and erythema of extremities (Verbatim: Red arm).The outcome of the welts, swelling arm and erythema of extremities were not resolved.   The reporter considered the welts, swelling arm and erythema of extremities to be related to FluLaval Tetra 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.   The company considered the welts, swelling arm and erythema of extremities to be related to FluLaval Tetra 2023-2024 season and Flulaval Tetra 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: 07-SEP-2023 This report was submitted via the online direct entry reporting system.  The patient had FluLaval tetra 2023-2024 approximately noon. No previous injection site reactions had been experienced. The patient's arm was red/swollen at 6am and had gotten worse as of 4pm on the same day (7th September 2023). The patient was not having any primary disease. The patient was not having any no complicating disease. This was not related to existing case.
Sex: F
Vaccine: RSV
Symptoms: Injection site rash
Clinical narrative: had a slight rash on her arm around the site of injection; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site rash in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site rash (Verbatim: had a slight rash on her arm around the site of injection).  The outcome of the injection site rash was not reported.   It was unknown if the reporter considered the injection site rash to be related to Arexvy.     It was unknown if the company considered the injection site rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-SEP-2023 The healthcare professional mentioned that her Mother got Arexvy the other day and had a slight rash on her arm around the site of injection. The reporter did not consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injected limb mobility decreased, Myalgia, Oral herpes
Clinical narrative: Severe herpes on chin/ 3 spots on chin; severe Cold sores; limited mobility in the injected arm; muscle pain; localized pain; This non-serious case was reported by a physician via call center representative and described the occurrence of herpes zoster in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores.   On 01-SEP-2023, the patient received the 1st dose of Shingrix (unknown arm). In SEP-2023, 2 days after receiving Shingrix, the patient experienced herpes zoster (Verbatim: Severe herpes on chin/ 3 spots on chin), cold sores (Verbatim: severe Cold sores), injected limb mobility decreased (Verbatim: limited mobility in the injected arm), muscle pain (Verbatim: muscle pain) and pain localized (Verbatim: localized pain).  The outcome of the herpes zoster was not resolved and the outcome of the cold sores, injected limb mobility decreased, muscle pain and pain localized were not reported.   It was unknown if the reporter considered the herpes zoster, cold sores, injected limb mobility decreased, muscle pain and pain localized to be related to Shingrix.     It was unknown if the company considered the herpes zoster, cold sores, injected limb mobility decreased, muscle pain and pain localized to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-SEP-2023  The wife of the patient reported that the patient received the first dose of Shingrix and experienced localized pain, muscle pain, and limited mobility in the injected arm. Two days after receiving the vaccine, the patient experienced severe herpes on his chin. There were currently 3 spots on his chin. The day of reporting was the first day a new sore did not appear. The patient had from time to time, experienced cold sores in the past, but this time it was more severe. The reporter gave permission to call back for further details. The patient was also a Medical Doctor.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Severe herpes on chin/ 3 spots on chin; severe Cold sores; limited mobility in the injected arm; muscle pain; localized pain; This non-serious case was reported by a physician via call center representative and described the occurrence of herpes zoster in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores.   On 01-SEP-2023, the patient received the 1st dose of Shingrix (unknown arm). In SEP-2023, 2 days after receiving Shingrix, the patient experienced herpes zoster (Verbatim: Severe herpes on chin/ 3 spots on chin), cold sores (Verbatim: severe Cold sores), injected limb mobility decreased (Verbatim: limited mobility in the injected arm), muscle pain (Verbatim: muscle pain) and pain localized (Verbatim: localized pain).  The outcome of the herpes zoster was not resolved and the outcome of the cold sores, injected limb mobility decreased, muscle pain and pain localized were not reported.   It was unknown if the reporter considered the herpes zoster, cold sores, injected limb mobility decreased, muscle pain and pain localized to be related to Shingrix.     It was unknown if the company considered the herpes zoster, cold sores, injected limb mobility decreased, muscle pain and pain localized to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-SEP-2023  The wife of the patient reported that the patient received the first dose of Shingrix and experienced localized pain, muscle pain, and limited mobility in the injected arm. Two days after receiving the vaccine, the patient experienced severe herpes on his chin. There were currently 3 spots on his chin. The day of reporting was the first day a new sore did not appear. The patient had from time to time, experienced cold sores in the past, but this time it was more severe. The reporter gave permission to call back for further details. The patient was also a Medical Doctor.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: patient received both pentacel and pediarix on same day; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concomitant products included PENTACEL VACCINE (DTAP-HIB-IPV), ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).   On 01-AUG-2023, the patient received Pediarix. On 01-AUG-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: patient received both pentacel and pediarix on same day).  The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Sept-2023 The patient's past medical history, medical treatments, vaccinations and family history were not provided. Information on the batch number was requested. The nurse reported that the patient had not required any treatment for the event, reports that the patient had not required any emergency room or physician visits. The patient received Pediarix and Pentacel on the same day, which led to overdose.
Sex: U
Vaccine: RSV
Symptoms: Incorrect dose administered
Clinical narrative: Difficult to withdraw 0.5 ml accurately/it is impossible to get full 0.5 ml in a syringe without inverting vial too many times which slows the whole process; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: Difficult to withdraw 0.5 ml accurately/it is impossible to get full 0.5 ml in a syringe without inverting vial too many times which slows the whole process).  The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 6-Sept-2023 The case was received from the consumer via (Open field AE monitoring) interactive digital media. The reporter reported that difficult to withdraw 0.5 ml accurately and reporter felt that some reconstituted vaccine get trapped by internal edges of the rubber stopper and it was impossible to get full 0.5 ml in a syringe without inverting vial too many times which slows the whole process, which led to incomplete dose administered.
Sex: U
Vaccine: FLUX, UNK
Symptoms: Immunisation reaction, Urticaria
Clinical narrative: hives head to waist; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of generalized urticaria in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   On 08-SEP-2023, the patient received RSV vaccine and FLU VACCINE (NAME UNKNOWN). On 10-SEP-2023, 2 days after receiving RSV vaccine and FLU VACCINE (NAME UNKNOWN), the patient experienced generalized urticaria (Verbatim: hives head to waist).  The outcome of the generalized urticaria was not reported.   It was unknown if the reporter considered the generalized urticaria to be related to RSV vaccine.     It was unknown if the company considered the generalized urticaria to be related to RSV vaccine.   Additional Information: GSK receipt date: 10-SEP-2023 This case was reported the patient via interactive digital media. The patient got the RSV and flu vaccine on Friday.  The patient had all of the side effects.  Today (on the day of reporting) the patient woke up with hives head to waist.  The patient still beat the hospital though. It was unknown if the reporter considered the generalized urticaria to be related to Flu vaccine. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: DTAP
Symptoms: Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: administering Infanrix but the vial just cracked in her hands; vial just cracked in her hands; administering Infanrix but the vial just cracked in her hands/cracked vial of Infanrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of occupational exposure while administering product in a patient who received DTPa (Infanrix) (batch number 253J4, expiry date 07-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced occupational exposure while administering product (Verbatim: administering Infanrix but the vial just cracked in her hands), exposure via skin contact (Verbatim: vial just cracked in her hands) and pharmaceutical product complaint (Verbatim: administering Infanrix but the vial just cracked in her hands/cracked vial of Infanrix).  The outcome of the occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 06-SEP-2023  The reporter reported via call to medical information department that a nurse was administering Infanrix, but the vial just cracked in her hands. The GSK Sales Representative had pictures of this vial. The reporter consented to follow up. The reporter reported that nurse was administering Infanrix, but the vial just cracked in her hands, which led to occupational exposure while administering product and exposure via skin contact.
Sex: M
Vaccine: VARZOS
Symptoms: Splenectomy
Clinical narrative: Patient has since had a splenectomy after 2 Shingrix doses; This non-serious case was reported by a other health professional via sales rep and described the occurrence of splenectomy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   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 splenectomy (Verbatim: splenectomy).  The outcome of the splenectomy was unknown.   It was unknown if the reporter considered the splenectomy to be related to Shingrix.     It was unknown if the company considered the splenectomy to be related to Shingrix.   Additional Information: GSK receipt date: 07-SEP-2023 Medical information department received The patient received both doses of Shingrix.  The patient since had a splenectomy. The reporter was  wondering if the patient should receive an additional dose (or doses) to provide post-splenectomy protection against shingles. The reporter consented to follow up.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: about a 3 year-old female patient who received Kinrix; about a 3 year-old female patient who received Kinrix/ extra dose of IPV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included IPV (last IPV dose was administered in February 2021).   On 07-SEP-2023, the patient received Kinrix. On 07-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: about a 3 year-old female patient who received Kinrix) and extra dose administered (Verbatim: about a 3 year-old female patient who received Kinrix/ extra dose of IPV).The outcome of the inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-SEP-2023 The reporter called to ask for information about a 3 year-old female patient who received Kinrix, which led to inappropriate age at vaccine administration. The reporter mentioned that Dtap dose was ok, however, the patient received an extra dose of IPV, which led to extra dose administered. The reporter asked how to proceed with this patient. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Myalgia, Oral herpes, Skin lesion
Clinical narrative: herpes simplex on the lower lips; redness; fatigue; muscle pain; lesions; This non-serious case was reported by a physician via call center representative and described the occurrence of herpes simplex labialis in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-SEP-2023, the patient received the 1st dose of Shingrix. On 03-SEP-2023, 2 days after receiving Shingrix, the patient experienced herpes simplex labialis (Verbatim: herpes simplex on the lower lips), erythema (Verbatim: redness), fatigue (Verbatim: fatigue), muscle pain (Verbatim: muscle pain) and skin lesion (Verbatim: lesions).  The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the herpes simplex labialis, erythema, fatigue, muscle pain and skin lesion were not resolved.   It was unknown if the reporter considered the herpes simplex labialis, erythema, fatigue, muscle pain and skin lesion to be related to Shingrix.     It was unknown if the company considered the herpes simplex labialis, erythema, fatigue, muscle pain and skin lesion to be related to Shingrix.   Additional Information: GSK receipt date: 07-SEP-2023 The physician was the patient himself had his first dose of Shingrix and after 3 days he developed herpes simplex on the lower lips, he developed more lesions and had to start Valtrex.  He waited 4 to 5 days and lesions are getting worse . He also had systemic symptoms like muscle pain, fatigue and redness. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: If patient misses 2nd dose of Shringrix within 6 months; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   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: If patient misses 2nd dose of Shringrix within 6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 07-SEP-2023 The reporter enquired that if patient had missed 2nd dose of Shringrix within 6 months, should they start series again or get only the 2nd dose. Adverse event (AE) was conservatively documented did not speak with the Health Care Provider, so please follow up with the Sales Representative for more information.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: COULD NOT WALK FOR 3 DAYS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis.  The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced could not walk for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk for 3 days. This report was non-serious.
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Previously administered products included for Product used for unknown indication: Covid-19 vaccine (two vaccines). Past adverse reactions to the above products included COVID-19 with Covid-19 vaccine.   On 12-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.            Concomitant medication not reported.   She had the initial two vaccines, then she ended up with COVID and was treated, and her last Moderna COVID-19 bivalent vaccine was on 12 Sept 2022. Last week, she was in contact with someone who may have tested positive last night 10 Sep 2023. She did not have any symptoms or fever. She was hoping that she was protected. She was hoping that she wasn't protected when she saw her. She had a stroke and was not able to have transportation to the hospital. She took the flu vaccine on the same day that she took the Moderna bivalent vaccine on 12 Sep 2022. Her doctor said it was ok.  Company comment:  This spontaneous case concerns an adult female patient, with no relevant medical history reported, who received a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine (reported as third dose of her COVID  19 vaccination schedule), and experienced the unexpected, serious (medically significant) AESI of cerebrovascular accident. Latency cannot be properly assessed since exact onset date was not provided. No further clinical details were provided for medical reviewing. Co-suspect product includes Influenza vaccine which was administered on the same day as mRNA  1273.222. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.