chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Foetal heart rate normal, Full blood count normal, Haemorrhage in pregnancy, Ultrasound antenatal screen normal
Clinical narrative: At 34 weeks pregnant I started experiencing vaginal bleeding at 10:30 PM. I called the nurse hotline of my OB and they recommended I go to the emergency room. At the emergency room, they took the fetal heartbeat which was normal but due to continued bleeding, I was admitted for observation. I was in the hospital for 12 hours and bleeding subsided. I received a fetal ultrasound and no concerns were raised. The source of the bleeding was undetermined, but I was sent home and put on pelvic floor rest.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pediatric Moderna Covid Vaccine administered 12/3/24 given after the Beyond Use Date of 11/16/2024.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: 0.5 ml afluria given, should have been 0.25 ml.
Age: 10.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, Scratch, Underdose
Clinical narrative: Patient received HPV with no incident. Upon administration of Hep A vaccine, patient jumped and moved. Needle came out of arm and caused a scratch to the arm. Vaccine ran down patient's arm. Patient only received partial administration  of Hep A.
Age: 45.0
Sex: M
Vaccine: COVID19, IPV, MMR, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given 2nd dose of TDaP in one week. He previously received one dose on 12/4/24. He returned to pharmacy to get more vaccines and again requested TDaP. He filled out screening paperwork and marked that he had not received any vaccines in the last 4 weeks.  It was not discovered by the healthcare team until after he had received a dose again on 12/9/24. He was contacted on 12/10, and did not report any adverse effects at that time.
Age: 70.0
Sex: F
Vaccine: PNC20, TD, VARZOS
Symptoms: Cardiac pacemaker evaluation, Cardiac pacemaker insertion, Electrocardiogram, Heart rate decreased, Pyrexia
Clinical narrative: Fever of 104 for three days, did not urinate for four days, pulse of 30 and dropping when I got to Urgent Care four days after getting the vaccines. Emergency pacemaker put in.
Age: 70.0
Sex: F
Vaccine: PNC20, TD, VARZOS
Symptoms: Urinary retention
Clinical narrative: Fever of 104 for three days, did not urinate for four days, pulse of 30 and dropping when I got to Urgent Care four days after getting the vaccines. Emergency pacemaker put in.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pediatric Covid Moderna administered on 12/3/24 after the Beyond Use Date of 11/16/2024.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pediatric Moderna Covid Vaccine administered on 12/4/2024 after the Beyond Use Date of 11/16/2024.
Age: 1.5
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Respiratory syncytial virus infection
Clinical narrative: He has RSV. It's unrelated to the vaccines
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pediatric Moderna Covid vaccine administered on 12/10/2024 given after the Beyond Use Date of 11/16/2024.
Age: 16.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Headache, Pain, Pyrexia, Swelling face
Clinical narrative: Parent called the office to inform PCP that patient was noted to have facial swelling the same night as when she received vaccines.  The following morning, the facial swelling had significantly improved.  Also had fever, body aches, chills, headache (common side effects)
Age: 41.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt feeling dizzy/sweaty and faint ~15 minutes post vaccination with Flu and Covid. Pt also had Blood Pressure and Glucose POC ~5 minutes ago. Pt reports he has not eaten all day today and it is currently ~2 pm. Denies SOB/Rash/Itching/CP or any other sxs of allergic/anaphylactic rxn. Has had flu and covid vaccine in past with no problem. Reports that vaccines often make him feel this way. Pt was offered glucose tablets, declined. Patient was offered chocolates, ate a few and started feeling better. On site paramedics consulted, who evaluated patient. Patient had full symptomatic recovery, declined further medical care via ambulance.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Skin reaction, Urticaria
Clinical narrative: On the second day after the vaccine was administered, patient had hives on face, buttocks, foot and arm. Hives dissipated within a few hours but were concerning enough that we took her to pediatrician for evaluation. These hives have continued to reappear for short periods of time in the ensuing week since then. Patient had previously had extremely minor and extremely rare skin reactions after eating certain foods - only in the previous few months - but since this vaccine has regularly displayed reactions on her face and body after eating certain foods including almond butter, eggs and cherries.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU3, HEP, IPV, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: AE: Individual received an invalid dose of Moderna Covid-19 Vaccine age 6 mo-11 years rather than intended dose of Moderna Covid-19 Vaccine ages 12+. Treatment: Patient was notified of adverse event and scheduled to receive another dose of correct Moderna Vaccine. Outcomes: Patient reported bilateral sore arms where the five vaccines were administered but no other symptoms.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Death
Clinical narrative: UNKNOWN.
Age: 40.0
Sex: M
Vaccine: COVID19, FLU3, HEP, IPV, TDAP
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: AE: Individual received an invalid dose of Moderna Covid-19 Vaccine age 6 mo-11 years rather than intended dose of Moderna Covid-19 Vaccine ages 12+. Treatment: Patient was notified of adverse event and scheduled to receive another dose of correct Moderna Vaccine. Outcomes: Patient reported bilateral sore arms where the five vaccines were administered but no other symptoms.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt received flu vaccination and developed upper arm pain that has continued to linger.  Pt was seen in clinic 12/12/24 and continues to have mild pain in upper arm.  Denies pain in shoulder.  Pain limits range of motion of upper arm.  Pt was prescribed Diclofenac x 2 weeks and instructed to use a topical analgesic.  If no improvement in pain, will refer to physical therapy.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Pain
Clinical narrative: Injection site turned black/purple (bruise for three days) and soreness still present 12/5/24. Patient feels pain has changed since when she received vaccine, now radiating from shoulder down to arm and hand. Patient had consulted with primary care office in 10/2024 and was prescribed Duloxetine, but does not feel arm pain has significantly improved.
Age: 56.0
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Cough, Pyrexia
Clinical narrative: PATIENT'S WIFE STATE HE HAS FEVER AND COUGH STARTING THE NIGHT OF VACCINE AND CONTINUE UNTIL NOW WHICH IS 5 DAYS LATER.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal pain, Appendicitis, Body temperature increased, Computerised tomogram abdomen abnormal
Clinical narrative: On 10/01/2024 around 11:30 am I started to experience periumbilical cramping and discomfort. My smart watch showed my heart rate was 130 bpm. Once home I had muscle aches, more severe abdominal cramping, and a t-max of 100.6 that day. On 10/2/2024 my symptoms improved but I continued to have abdominal cramping. On 10/03/24 the abdominal cramping continued, and I ended up going to the emergency room late that night. I was given fluids, IV Toradol, and CT scan revealed I had uncomplicated acute appendicitis. A consult was placed for general surgery, and I opted to have a non-surgical treatment course. I was admitted under OBS and given IV fluids and antibiotics. My abdominal cramping resolved, and I was discharged home on a day course of PO Augmentin. I followed up with my primary care 10/25 and was symptom free at the time of the appointment. At the time of this entry, I have continued to be symptom free. I have no history of GI complications.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count, Metabolic function test, Myalgia, Scan with contrast abnormal, White blood cell count normal
Clinical narrative: On 10/01/2024 around 11:30 am I started to experience periumbilical cramping and discomfort. My smart watch showed my heart rate was 130 bpm. Once home I had muscle aches, more severe abdominal cramping, and a t-max of 100.6 that day. On 10/2/2024 my symptoms improved but I continued to have abdominal cramping. On 10/03/24 the abdominal cramping continued, and I ended up going to the emergency room late that night. I was given fluids, IV Toradol, and CT scan revealed I had uncomplicated acute appendicitis. A consult was placed for general surgery, and I opted to have a non-surgical treatment course. I was admitted under OBS and given IV fluids and antibiotics. My abdominal cramping resolved, and I was discharged home on a day course of PO Augmentin. I followed up with my primary care 10/25 and was symptom free at the time of the appointment. At the time of this entry, I have continued to be symptom free. I have no history of GI complications.
Age: 0.33
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse side effects to the patient, per MD "There are no real "side effects" from getting the flu shot before 6 months of age in terms of dangers to patient. Patient's immune system will not mount a vigorous response to the vaccine because of his age, so unfortunately this doesn't count towards his flu vaccines and he likely won't have protection for the next 2 months. If you want him to get the flu shot at his 6 month check up he will be eligible and then will need his second dose 1 month later for full protection. "
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given Fluad on 9/12/24 and again on 12/9/24
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Malaise, Nausea, Vomiting
Clinical narrative: Patient experienced headache, nausea, vomiting and general malaise. The patient reports that her symptoms did eventually resolve. She took tylenol for symptoms.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient experienced brief syncope after Tdap vaccination. Both patient and spouse (also present) told RPh that he has a history of fainting with vaccinations. Vaccine was administered with patient sitting on cushioned bench and spouse sitting next to him. When syncope occurred RPh ( and spouse ) helped support him in a reclined position. RPh requested Rx operations manager call 911, while RPh monitored pulse and breathing. Patient quickly regained responsiveness and requested that 911 operator cancel EMS dispatch. Operator insisted that patient verbally authorize EMS cancellation, and he responded "I'm good." Patient was provided electrolyte-containing beverage at his request. Patient later left with spouse in good condition and good spirits and under his own power. RPh counseled him to follow up with primary care physician at his earliest convenience.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lip swelling
Clinical narrative: Lip Swelling Around 2:30p the day I received the vaccine, my bottom lip (left side) began swelling, began to reduce around 4:30p and receded completely around 7p Around 6p, the right side of my bottom lip began swelling, receding around 10p Shortly there after the right side of my top lip began swelling, receding the following morning around 10a Upper Arm Swelling The day after the vaccine, my left arm (site of injection) began to swell. Size about 3-4 inches radially from the injection site. This slowly reduced to a pea sized area over a week. The hard pea sized area is still there at the injection site.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Cough, Viral test, X-ray
Clinical narrative: Cough
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hepatitis A vaccine given 5 months too soon
Age: 3.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: No adverse event
Clinical narrative: N/A pt had no adverse event.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pediatric Moderna Covid vaccine administered on 12/9/24 given after the Beyond Use Date of 11/16/2024.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: patinet had a lump and redness at the site of admin only. no hives, anaphylaxis, or itching.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: redness, hot and mild swelling that is localized
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received dose #2 of Heplisav-B 7 days prior to the 28-day minimum interval from dose #1. No adverse reactions are reported by patient. Patient was notified of timing error and an appointment to repeat dose #2 following the appropriate interval was made.
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: A 10 month old was given an extra dose of a Moderna vaccine. Her first Moderna vaccine was on 10/8/24, second dose 11/25/24 and the extra dose was given on 12/9/24. This error happened because the beyond use date was written down incorrectly on the vaccine that was given on 11/25/24. The clinic thought that the dose on 11/25/24 was expired so they had the patient come in for the repeat dose on 12/9/24. We then discovered that the vaccine given on 11/25/24 was potentially not expired. We are unable to 100% verify if it was expired because it is all hearsay.   I already contacted Moderna and they directed me to the CDC Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendices, References, and Previous Updates. If a higher than authorized dose is administered, the CDCs recommendation is to not repeat a dose. I also contacted the DOH nurses and they said "First, thank you for contacting us with your question about Moderna. Based on the information you provided in you email, you are right on track. There have been reports of patients receiving higher-than-authorized doses in the past, with no major side effects reported although the child may experience more pronounced side effects (like a soreness at the injections, site, etc.) Below is a link to a study on individuals that received extra doses of vaccine it was before COVID, but has good information on what could happen based on other vaccines: Is there any harm in administering extra-doses of vaccine to a person? Excess doses of vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2007-2017 -   Please be sure the incident is reported in VAERS - Report an Adverse Event as well. This is the tool they used for the study above. It is helpful for CDC to have this information so they can keep track of potential trends that may develop and respond, if needed."
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Balance disorder, Dysphagia, Dysstasia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: On Sunday 12/8, she felt achy. on Monday 12/9, her feet felt heavy and off balance, with a numb/wooden sensation. Weakness developed up her legs, eventually requiring her to use a quad cane. By 5pm on Monday, she could not get off the toilet due to leg weakness, and her husband had to assist her into a wheelchair, eventually calling EMS. Prior to presentation on 12/09, her hands started tingling.  While on admission on the floor on 12/10, while eating lunch, she experienced dysphagia with coughing and phlegm, leading her to stop eating, though she managed small sips of liquid. Transferred to ICU on 12/12 in AM and admitted with respiratory failure.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Immunoglobulin therapy, Intensive care, Limb discomfort, Muscular weakness, Pain
Clinical narrative: On Sunday 12/8, she felt achy. on Monday 12/9, her feet felt heavy and off balance, with a numb/wooden sensation. Weakness developed up her legs, eventually requiring her to use a quad cane. By 5pm on Monday, she could not get off the toilet due to leg weakness, and her husband had to assist her into a wheelchair, eventually calling EMS. Prior to presentation on 12/09, her hands started tingling.  While on admission on the floor on 12/10, while eating lunch, she experienced dysphagia with coughing and phlegm, leading her to stop eating, though she managed small sips of liquid. Transferred to ICU on 12/12 in AM and admitted with respiratory failure.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Paraesthesia, Productive cough, Respiratory failure, Walking aid user, Wheelchair user
Clinical narrative: On Sunday 12/8, she felt achy. on Monday 12/9, her feet felt heavy and off balance, with a numb/wooden sensation. Weakness developed up her legs, eventually requiring her to use a quad cane. By 5pm on Monday, she could not get off the toilet due to leg weakness, and her husband had to assist her into a wheelchair, eventually calling EMS. Prior to presentation on 12/09, her hands started tingling.  While on admission on the floor on 12/10, while eating lunch, she experienced dysphagia with coughing and phlegm, leading her to stop eating, though she managed small sips of liquid. Transferred to ICU on 12/12 in AM and admitted with respiratory failure.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, CSF protein increased, CSF white blood cell count negative, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: On Sunday 12/8, she felt achy. on Monday 12/9, her feet felt heavy and off balance, with a numb/wooden sensation. Weakness developed up her legs, eventually requiring her to use a quad cane. By 5pm on Monday, she could not get off the toilet due to leg weakness, and her husband had to assist her into a wheelchair, eventually calling EMS. Prior to presentation on 12/09, her hands started tingling.  While on admission on the floor on 12/10, while eating lunch, she experienced dysphagia with coughing and phlegm, leading her to stop eating, though she managed small sips of liquid. Transferred to ICU on 12/12 in AM and admitted with respiratory failure.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Immunoglobulin therapy, Intensive care
Clinical narrative: On Sunday 12/8, she felt achy. on Monday 12/9, her feet felt heavy and off balance, with a numb/wooden sensation. Weakness developed up her legs, eventually requiring her to use a quad cane. By 5pm on Monday, she could not get off the toilet due to leg weakness, and her husband had to assist her into a wheelchair, eventually calling EMS. Prior to presentation on 12/09, her hands started tingling.  While on admission on the floor on 12/10, while eating lunch, she experienced dysphagia with coughing and phlegm, leading her to stop eating, though she managed small sips of liquid. Transferred to ICU on 12/12 in AM and admitted with respiratory failure.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Per mom, patient developed "a large red swelling (which) feels hard almost like if you clench a muscle but continuous" at the injection site.
Sex: U
Vaccine: PNC21, TDAP
Symptoms: Infection
Clinical narrative: patient got an infection and needed medical attention and an antibiotic
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediatric Patient was administered a high dose Fluzone vaccine. No treatment was required per physician, advised to monitor patient for possible side affects.  Per patient guardian no adverse symptoms have not been experienced since injection was given.
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediatric Patient was administered a high dose Fluzone vaccine. No treatment was required per physician, advised to monitor patient for possible side affects.  Per patient guardian no adverse symptoms have not been experienced since injection was given.
Age: 54.0
Sex: F
Vaccine: COVID19, FLU3, TDAP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: PT came for Covid and TDaP shot.  Accidentally gave fluzone instead of TDap. Gave PT the  TDaP after realizing my mistake. PT had already received Fluzone on 10/15/24 prior to today.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: writer called Patient and explained the covid event that happened. He stated no side effects, and he is feeling fine. He was explained that he was welcome to come back and receive a full dose. Which he was not concerned about.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vial not diluted prior to administration.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site induration, Injection site inflammation, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Red painful rash, Inflammation, Induration on site of vaccination, left deltoid.
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vial not reconstituted with diluent prior to administering.
Age: 0.92
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AE; Physician calling to report multiple events of patients receiving their first PROQUAD dose prior to the age of 1 years old.  HCP specifically reported a patient born on 08/xx/2023 was administered a PROQUAD dose on 08/09/2024.  After probing for addi; This spontaneous report was received from physician and refers to a 11-month-old patient (unknown gender). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-AUG-2024, the patient received the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). No adverse event was reported (no adverse event).  This is one of 2 reports from the same reporter.; Sender's Comments:  US-009507513- 2411USA007544:
Sex: M
Vaccine: RVX
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This non-serious case was reported by a other health professional and described the occurrence of tinnitus in a 34-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 14-NOV-2024, the patient received RSV vaccine. On 14-NOV-2024, less than a day after receiving RSV vaccine, the patient experienced tinnitus (Verbatim: Tinnitus). The outcome of the tinnitus was not resolved.   It was unknown if the reporter considered the tinnitus to be related to RSV vaccine.     It was unknown if the company considered the tinnitus to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 14-NOV-2024 The reporter reported that the patient had received RSV vaccine and experienced tinnitus. The reporter asked that why would you add a high pitch sound to your commercial (Tinnitus).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Eczema
Clinical narrative: eczema flare; This non-serious case was reported by a consumer via call center representative and described the occurrence of eczema aggravated in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema.   On 05-NOV-2024, the patient received the 2nd dose of Shingrix. In NOV-2024, less than a week after receiving Shingrix, the patient experienced eczema aggravated (Verbatim: eczema flare). The patient was treated with prednisone. The outcome of the eczema aggravated was not resolved.   It was unknown if the reporter considered the eczema aggravated to be related to Shingrix.     It was unknown if the company considered the eczema aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-NOV-2024 The patient received second Shingrix shot on 5th November 2024. Due to a severe eczema flare, patient took 40 mg of Prednisone on 9th November 2024 and 10th November 2024. On day before reporting, on 11th November 2024 patient realized that this may impact body response to the vaccine. The patient stopped taking the prednisone. What patient wondering was if can still expect an adequate response to second Shingrix shot or if will had to repeat it.
Sex: U
Vaccine: RVX
Symptoms: Eye discharge, Gait disturbance
Clinical narrative: goop in my eye; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of eye discharge in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced eye discharge (Verbatim: goop in my eye). The outcome of the eye discharge was not reported.   It was unknown if the reporter considered the eye discharge to be related to RSV vaccine.     It was unknown if the company considered the eye discharge to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 12-NOV-2024 This case was reported by a patient via interactive digital media. The patient reported that due to RSV vaccine he/she had goop in eye, daughter thought a bite in others eye. Now the patient got problems walking seem forever. The patient got part in and they paid fortune for RSV. The company just want money. They did not give a crap about anybody stated patient. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Pyrexia
Clinical narrative: Fever; blisters; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever) and blister (Verbatim: blisters). The outcome of the fever and blister were not reported.   It was unknown if the reporter considered the fever and blister to be related to Shingrix.     It was unknown if the company considered the fever and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-NOV-2024 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available.
Age: 12.0
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: inadvertently given a single dose of Bexsero instead of a dose of Menveo; arm soreness; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 12-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On 14-NOV-2024, the patient received the 1st dose of Bexsero. On 14-NOV-2024, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: inadvertently given a single dose of Bexsero instead of a dose of Menveo). In NOV-2024, the patient experienced pain in arm (Verbatim: arm soreness). The outcome of the pain in arm was not reported and the outcome of the wrong vaccine administered was unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-NOV-2024 The patient was inadvertently given a single dose of Bexsero instead of a dose of Menveo, which led wrong vaccine administered. The side effect reported was arm soreness. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: ached all over; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of generalized aching in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Family history included shingles (mother had shingles).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced generalized aching (Verbatim: ached all over). The outcome of the generalized aching was not resolved.   It was unknown if the reporter considered the generalized aching to be related to Shingrix.     It was unknown if the company considered the generalized aching to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-NOV-2024 This case was reported by a patient via interactive digital media. Patient was the reporter Patient stated that he/she saw how his/her mother suffered. Her entire back was covered. That made decide him/her to get the vaccines.  After the first shot, he/she woke the next day felt like he/she had been hit by a bus. He/she ached all over and mentioned this to his/her physician's nurse and she said it was a good immune response. The same thing happened with the second one. He/she did not regret getting them at all. This case is linked with US2024AMR149652 (case is for same patient).; Sender's Comments:  US-GSK-US2024AMR149652:same patient US-GSK-US2024AMR149653:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: ached all over; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of generalized aching in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose of vaccine on an unknown date, for tolerance to 1st dose, refer case US2024AMR149370). Family history included shingles (mother had shingles).   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 generalized aching (Verbatim: ached all over). Rechallenge with Shingrix was positive. The outcome of the generalized aching was not resolved.   It was unknown if the reporter considered the generalized aching to be related to Shingrix.     It was unknown if the company considered the generalized aching to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-NOV-2024 This case was reported by a patient via interactive digital media. Patient was the reporter Patient stated that he/she saw how his/her mother suffered. Her entire back was covered. That made decide him/her to get the vaccines.  After the first shot, he/she woke the next day felt like he/she had been hit by a bus. He/she ached all over and mentioned this to his/her physician's nurse and she said it was a good immune response. The same thing happened with the second one. He/she did not regret getting them at all. This case is linked with US2024AMR149370 (case is for same patient).; Sender's Comments:  US-GSK-US2024AMR149370:same reporter, 1 st dose US-GSK-US2024AMR149653:same reporter, for Mother
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Extra dose administered
Clinical narrative: patient received a dose of Boostrix on Saturday and yesterday patient received another dose of Boostrix; Fluarix to a patient on Friday and another dose to the same patient last night; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 94j52, expiry date 30-JUN-2025) for prophylaxis.   Concomitant products included Influenza vaccine inact split 3v (Fluarix) and Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix).   On 11-NOV-2024, the patient received the 2nd dose of Boostrix and the 2nd dose of Fluarix 2024-2025 season. On 11-NOV-2024, an unknown time after receiving Boostrix and not applicable after receiving Fluarix 2024-2025 season, the patient experienced extra dose administered (Verbatim: patient received a dose of Boostrix on Saturday and yesterday patient received another dose of Boostrix) and extra dose administered (Verbatim: Fluarix to a patient on Friday and another dose to the same patient last night). The outcome of the extra dose administered 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: 12-NOV-2024 The patient received a dose of Boostrix on 09-November-2024 and another dose of Boostrix on 11-November-2024, which led extra dose administered. The patient received Fluarix 08-November-2024 and another dose on 11-November-2024, which led extra dose administered.
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: did not receive 3rd dose; 2nd dose received late; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) (batch number P9LT9) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix on 15th May 2022), Hepatitis B (received 1st dose on 16-JUN-1991), Hepatitis b vaccine (received 2nd dose on 27-AUG-1991) and Hepatitis b vaccine (received 3rd dose on 07-FEB-1992).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On 17-JUL-2022, the patient received the 2nd dose of Twinrix. On 17-JUL-2022, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: did not receive 3rd dose). The outcome of the incomplete course of vaccination and drug dose administration interval too long 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- 12-NOV-2024 The nurse stated that a patient who was also a Physician, got 3 Hepatitis B on 16th June 1991, 27th August 1991 and 07th February 1992. The patient also received 2 doses of Twinrix on 15th May 2022 and 17th July 2022. the patient received the 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. Till the time of reporting, the patient did not receive 3rd dose of Twinrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: Product Complaint; ran down patient's arm during administration; ran down patient's arm during administration/and had to be re-injected; incomplete dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of exposure via skin contact in a patient who received HBV (Engerix B) (batch number 5JX2E, expiry date 14-DEC-2026) for prophylaxis. This case was associated with a product complaint.   On 08-NOV-2024, the patient received Engerix B. On 08-NOV-2024, an unknown time after receiving Engerix B, the patient experienced exposure via skin contact (Verbatim: ran down patient's arm during administration), inadvertent exposure to vaccine (Verbatim: ran down patient's arm during administration/and had to be re-injected) and incomplete dose administered (Verbatim: incomplete dose administered). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the exposure via skin contact, inadvertent exposure to vaccine, incomplete dose administered 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: 12-NOV-2024 The complaint reported was that the Engerix-B ran down the patient's arm when they were injected, which led exposure via skin contact, inadvertent exposure to vaccine and incomplete dose administered. The patient had to be re-injected. The health care professional stated to the medical information agent that there was nothing wrong with the needle, but that the syringe might be cracked. The question asked-was the box or carton, or tray damaged upon receipt? If so, where? Reminder: If product was clearly damaged due to shipping, did not register complaint was there any evidence of leakage or product in box or carton (ex-wet PIL, liquid in box)? was there product still present in the syringe? Where was the crack or breakage observed on the syringe? If unable to attach needle, what gauge needle was been used? If report was for broken syringe hub tip, Did the syringe come broken or did it break when needle was been attached? Did the hub crack, break or shatter?
Sex: U
Vaccine: HEP
Symptoms: Syringe issue
Clinical narrative: Engerix-B leaked from the syringe during administration; Engerix-B leaked from the syringe during administration and had to be repeated; This non-serious case was reported by a other health professional via call center representative and described the occurrence of syringe leak in a patient who received HBV (Engerix B) for prophylaxis.   On 13-NOV-2024, the patient received Engerix B. On 13-NOV-2024, an unknown time after receiving Engerix B, the patient experienced syringe leak (Verbatim: Engerix-B leaked from the syringe during administration) and incomplete dose administered (Verbatim: Engerix-B leaked from the syringe during administration and had to be repeated). The outcome of the syringe leak and incomplete dose administered were unknown.   Additional Information: GSK Receipt Date: 13-NOV-2024 GSK Receipt Date: 13-NOV-2024 The healthcare professional reported that the Engerix-B leaked from the syringe during administration, which led to syringe leak and incomplete dose administered. The vaccine had to be repeated.  The patient had to be stucked a second time.  There was no product quality complaint related to this case.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidental administration of a dose of Kinrix in a patient 5 months of age.; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 702Y4, expiry date 22-AUG-2025) for prophylaxis.   On 14-NOV-2024, the patient received the 2nd dose of Kinrix. On 14-NOV-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidental administration of a dose of Kinrix in a patient 5 months of age.). The outcome of the inappropriate age at vaccine administration 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: 14-NOV-2024 The physician reported that there was an accidental administration of a dose of Kinrix in a patient of an inappropriate age, which led to inappropriate age at vaccine administration.   They reporter asked how to proceed now and mentioned that it was administered today (on the reporting day) and asked to remain anonymous. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: COVID19
Symptoms: Device breakage, No adverse event
Clinical narrative: had a vaccine that cracked. When the staff was applying the needle, the luer lock top part cracked; No adverse effect; This spontaneous case was reported by a non-health professional and describes the occurrence of DEVICE BREAKAGE (had a vaccine that cracked. When the staff was applying the needle, the luer lock top part cracked) and NO ADVERSE EVENT (No adverse effect) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043157) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3043157) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE BREAKAGE (had a vaccine that cracked. When the staff was applying the needle, the luer lock top part cracked) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE BREAKAGE (had a vaccine that cracked. When the staff was applying the needle, the luer lock top part cracked) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.            The product NDC was reported as 80777-110-01.  The Device problem code for Spikevax syringe include FDA code, code which include Device Damaged Prior to Use.   The device was malfunctioned, and the malfunction type was CIRM.  The reporter reported that the vaccine top part was cracked. When the staff applied the needle, the luer lock top part cracked. They had brought up the concern before that it felt flimsy when they applied the needle, so it was not a surprise that one of them cracked finally. Unfortunately, without knowing if plastic got into the liquid, the vaccine was discarded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Multiple sclerosis
Clinical narrative: I am diagnosed with Multiple Sclerosis; I've been on the Moderna and Pfizer vaccine as of 2020; I've been on the Moderna and Pfizer vaccine as of 2020; This spontaneous case was reported by a patient and describes the occurrence of MULTIPLE SCLEROSIS (I am diagnosed with Multiple Sclerosis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and Alprostadil (Caverject) for an unknown indication.    Concurrent medical conditions included Diabetes.   In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started Alprostadil (Caverject) (unknown route) at an unspecified dose. In 2020, the patient experienced COVID-19 IMMUNISATION (I've been on the Moderna and Pfizer vaccine as of 2020) and INTERCHANGE OF VACCINE PRODUCTS (I've been on the Moderna and Pfizer vaccine as of 2020). On 04-Dec-2024, the patient experienced MULTIPLE SCLEROSIS (I am diagnosed with Multiple Sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (I am diagnosed with Multiple Sclerosis), COVID-19 IMMUNISATION (I've been on the Moderna and Pfizer vaccine as of 2020) and INTERCHANGE OF VACCINE PRODUCTS (I've been on the Moderna and Pfizer vaccine as of 2020) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter.  It was reported that phone call was received for seeking assistance with caverject. During the call, it was stated, patient had been on the Moderna and Pfizer vaccine as of 2020, meant to take the shot, the penis shot, every single day. It was not for (inaudible) erection.   Treatment medication use information was not provided by reporter.; Reporter's Comments: The use of Co-suspect products Tozinameran  vaccine and Alprostadil remain as confounders for the event Multiple Sclerosis . The benefit -risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she usually gets arm soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (she usually gets arm soreness) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she usually gets arm soreness). At the time of the report, PAIN IN EXTREMITY (she usually gets arm soreness) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided.   This case was linked to MOD-2024-779018 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: previous vaccines she experienced fever and headache; previous vaccines she experienced fever and headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (previous vaccines she experienced fever and headache) and HEADACHE (previous vaccines she experienced fever and headache) in a 62-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (previous vaccines she experienced fever and headache) and HEADACHE (previous vaccines she experienced fever and headache). At the time of the report, PYREXIA (previous vaccines she experienced fever and headache) and HEADACHE (previous vaccines she experienced fever and headache) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.