chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Muscle twitching, Seizure, Tic
Clinical narrative: tics and twitching on L side starting 2 days after vaccinations, found to have ischemic R MCA with associated symptomatic seizures
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Encopresis, Gastrointestinal disorder, Loss of personal independence in daily activities, Melaena
Clinical narrative: The morning after the vaccine, my daughter developed explosive, tarry diarrhea.  This lasted approximately one month and would not go away.  It resulted in a loss of work for the month for me as she couldn't go to childcare.  I took her to the hospital and they were of little help.  Subsequently, over the following year and years after, my daughter developed encopresis that did not respond to treatment.  At age 12, she is just now starting to grow out of it.  Prior to the vaccine, she had no problem with bowel movements, or issues with the size of her bowel movements - however post vaccine that began to change, and over time developed into a significant challenge with encopresis -numerous tests, etc.  As her parent, I feel strongly that the long term issues with her colon began with the adverse reaction to the MMR vaccine, which was almost immediate.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth, Myalgia
Clinical narrative: Bruise about 1.5 inches in diameter at injection site and red warm patch on lower upper arm (not connected to bruise, about 1.5 inches lower than bruise). Patient says she had a low fever on 2nd day after vaccine and a lot of muscle aches. She now feels fine. The red patch on the harm is slightly warm and she says it feels a little itchy. It wraps 3/4 way around her arm and its about 2-3 inches wide. She came into pharmacy today to show us. She will report to her doctor is it starts to get worse.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: Bruise about 1.5 inches in diameter at injection site and red warm patch on lower upper arm (not connected to bruise, about 1.5 inches lower than bruise). Patient says she had a low fever on 2nd day after vaccine and a lot of muscle aches. She now feels fine. The red patch on the harm is slightly warm and she says it feels a little itchy. It wraps 3/4 way around her arm and its about 2-3 inches wide. She came into pharmacy today to show us. She will report to her doctor is it starts to get worse.
Age: 23.0
Sex: F
Vaccine: COVID19, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Malaise, Pain, Pruritus, Rash macular, Skin warm
Clinical narrative: Please note: Sterile Diluent with Varivax was Merck 1946079; Diluent with MMR was Merck 196007.On 7/30, a 23 yo female and her uncle walked in to Public Health. They needed vaccines for an appt with immigration and had driven from (PRIVACY) as no one else could help them. Female immigrated from (PRIVACY).  I chose to assist.  The female needed six vaccines to be compliant. We discussed risks & benefits. At public health, when persons have no vaccine records or need catch-up, we often give four plus vaccines.  The client needed: Tdap IPOL-Polio Varivax Hep. B C-19 MMR The client decided to do all the vaccines. I do remember the conversation of possible side effects and the uncle asking me if ok to do all. No history of vaccine reactions reported.  Vaccines were administered Left IM Hep B, C-19; Left SQ MMR Right IM Tdap, IPOL; Right SQ Varivax  Self-care post vaccines was reviewed and we have giveaway reusable ice packs that we offer that I always explain the use of and provided.   Yesterday, Uncle texted. See picture attached. He wrote she had the vaccines and felt unwell the next days. Three days ago, per his report, she developed a red spot on her arm with warmth and tenderness. They had gone to (privacy), 8/12 but left as (privacy) wanted to do blood test and uninsured.  Yesterday, things seemed worse, additional red spot on back, achy, itchy and trouble breathing.   With the red arm area, I suspected cellulitis or bruising from the image examination. I worked to try to get them to (privacy) and if that did not work, I was going to attempt a clinic connect(free (privacy) one time visit).  (privacy) interacted and the family accessed (privacy).  From what I can gather from today, the client was directed to pick up a medicine from pharmacy. (privacy) attempting to get information on this.   I am looking back at the VAR and I am not sure I can identify anything practice-wise I did that may have caused this. The number of injections was many but they were adequately spaced and we do give 4+ vaccine frequently in our public health clinic when catch-up vaccine schedules and needs are identified.   It is unknown if there was any application of products that irritated the injection site. Anaphylaxis seems late and although not improbable, unlikely.  I did think of the Moderna arm we experienced initially in the pandemic but this was a Pfizer product. The vial itself was close to the beyond use date but was still within the time of use(BUD 8/7/24).  I did consult Dr. medical consultant. He concurred not anaphylaxis but agrees more information is/was needed to fully discern.  At this time, client is recovering with less symptoms reported.   A county incident was submitted.
Age: 23.0
Sex: F
Vaccine: COVID19, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Tenderness
Clinical narrative: Please note: Sterile Diluent with Varivax was Merck 1946079; Diluent with MMR was Merck 196007.On 7/30, a 23 yo female and her uncle walked in to Public Health. They needed vaccines for an appt with immigration and had driven from (PRIVACY) as no one else could help them. Female immigrated from (PRIVACY).  I chose to assist.  The female needed six vaccines to be compliant. We discussed risks & benefits. At public health, when persons have no vaccine records or need catch-up, we often give four plus vaccines.  The client needed: Tdap IPOL-Polio Varivax Hep. B C-19 MMR The client decided to do all the vaccines. I do remember the conversation of possible side effects and the uncle asking me if ok to do all. No history of vaccine reactions reported.  Vaccines were administered Left IM Hep B, C-19; Left SQ MMR Right IM Tdap, IPOL; Right SQ Varivax  Self-care post vaccines was reviewed and we have giveaway reusable ice packs that we offer that I always explain the use of and provided.   Yesterday, Uncle texted. See picture attached. He wrote she had the vaccines and felt unwell the next days. Three days ago, per his report, she developed a red spot on her arm with warmth and tenderness. They had gone to (privacy), 8/12 but left as (privacy) wanted to do blood test and uninsured.  Yesterday, things seemed worse, additional red spot on back, achy, itchy and trouble breathing.   With the red arm area, I suspected cellulitis or bruising from the image examination. I worked to try to get them to (privacy) and if that did not work, I was going to attempt a clinic connect(free (privacy) one time visit).  (privacy) interacted and the family accessed (privacy).  From what I can gather from today, the client was directed to pick up a medicine from pharmacy. (privacy) attempting to get information on this.   I am looking back at the VAR and I am not sure I can identify anything practice-wise I did that may have caused this. The number of injections was many but they were adequately spaced and we do give 4+ vaccine frequently in our public health clinic when catch-up vaccine schedules and needs are identified.   It is unknown if there was any application of products that irritated the injection site. Anaphylaxis seems late and although not improbable, unlikely.  I did think of the Moderna arm we experienced initially in the pandemic but this was a Pfizer product. The vial itself was close to the beyond use date but was still within the time of use(BUD 8/7/24).  I did consult Dr. medical consultant. He concurred not anaphylaxis but agrees more information is/was needed to fully discern.  At this time, client is recovering with less symptoms reported.   A county incident was submitted.
Age: 67.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt came in and asked for an RSV vaccine today. I noticed the patient had already received it previously, and told him he didn't need another. I looked into it a bit further, and noticed he'd actually received 2 doses already, one on 11/14/2023 and one on 3/28/2024.  To my knowledge, patient had no adverse events.
Age: 3.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, IPV, MMR, PNC13, VARCEL
Symptoms: Dysstasia, Extra dose administered, Mobility decreased, Pain
Clinical narrative: Patient received Vaxelis vaccine containing DTaP, IPV, HepB, Hib along with a separate dose of IPOL on the same day (8/13/2024). Spoke with patient's mother on 8/14/2024 at 2:00PM CST, mother states patient reports "lots of pain with difficulty standing and raising arms and body aches" and fever of 37.6 celcius. Last dose of paracetamol given at 5:00AM CST.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site urticaria
Clinical narrative: Hives at site of injection and discontinuous and distal to the site of injection.
Age: 21.0
Sex: M
Vaccine: COVID19-2, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a dose of boostrix and covid-19 after they just received a dose of each on 6-27-24. No adverse event reported by patient but vaccines were given outside of the recommended dosing interval.
Age: 9.0
Sex: F
Vaccine: HEPA, IPV, MMRV, TDAP
Symptoms: Injection site erythema, Injection site reaction, Musculoskeletal pain, Peripheral swelling, Pyrexia
Clinical narrative: My patient was nine years old, going into the third grade, and had missed her kindergarten shots. She and her mother presented to clinic on a Friday requesting vaccines. She needed her tetanus, polio, MMR, varicella, and hepatitis A vaccines. The mother was agreeable to all vaccines and accepted the combination shot for MMR/varicella (per protocol, able to give up until age 12). The child tolerated all vaccines. The mother called Monday morning to inform me the child had a reaction to the MMR/varicella vaccine. She stated "her fever spiked at 101.4 on Saturday, she did not have a rash but her arm was swollen, had a welt on the back of it, and was red. She also complained of left shoulder blade pain. I took her to Urgent Care and they recommended continuing tylenol and calling the health department." Informed child's mother on Monday that redness and swelling are common with vaccines, especially the live combo vaccine. Fever can also occur. It is unknown at this time where the left shoulder blade pain originated; mother stated the child did not have a rash and her father told her to sleep with her arm above her head. Encouraged mother to continue using tylenol if child was febrile and she could use a cold pack as needed. She stated the provider at the urgent care also told her her symptoms could last up to two weeks but should resolve on their own. I called the mother later in the week to determine if the symptoms were resolving; she stated the child no longer had a fever, the welt on her arm had gone down some, but the arm still had redness at the site. I encouraged her to continue to monitor for improvement and to call/ return to our clinic as needed.
Age: 9.0
Sex: F
Vaccine: HEPA, IPV, MMRV, TDAP
Symptoms: Urticaria
Clinical narrative: My patient was nine years old, going into the third grade, and had missed her kindergarten shots. She and her mother presented to clinic on a Friday requesting vaccines. She needed her tetanus, polio, MMR, varicella, and hepatitis A vaccines. The mother was agreeable to all vaccines and accepted the combination shot for MMR/varicella (per protocol, able to give up until age 12). The child tolerated all vaccines. The mother called Monday morning to inform me the child had a reaction to the MMR/varicella vaccine. She stated "her fever spiked at 101.4 on Saturday, she did not have a rash but her arm was swollen, had a welt on the back of it, and was red. She also complained of left shoulder blade pain. I took her to Urgent Care and they recommended continuing tylenol and calling the health department." Informed child's mother on Monday that redness and swelling are common with vaccines, especially the live combo vaccine. Fever can also occur. It is unknown at this time where the left shoulder blade pain originated; mother stated the child did not have a rash and her father told her to sleep with her arm above her head. Encouraged mother to continue using tylenol if child was febrile and she could use a cold pack as needed. She stated the provider at the urgent care also told her her symptoms could last up to two weeks but should resolve on their own. I called the mother later in the week to determine if the symptoms were resolving; she stated the child no longer had a fever, the welt on her arm had gone down some, but the arm still had redness at the site. I encouraged her to continue to monitor for improvement and to call/ return to our clinic as needed.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Neck pain
Clinical narrative: Muscle soreness, patchy, thick, red swelling at injection site for the evening off and 2 days after injection ,  upper arm pain radiating to back of neck.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Rash, Skin hypertrophy
Clinical narrative: Muscle soreness, patchy, thick, red swelling at injection site for the evening off and 2 days after injection ,  upper arm pain radiating to back of neck.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient was given a dose of TDaP on 8/14, not realizing that the patient had received a dose on 8/12.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacture
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: N/a
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Product availability issue
Clinical narrative: Provider ordered Engerix Hep x2 SHF and while waiting for the provider to come out the next patient's room to let him know that he needed to change it to Prehevbrio cause we did not have Engerix SHF. I went ahead and pulled two Prehevbrio's Hep B SHF and administered to the patient while waiting for Provider to change it. Provider did change it but then let me know that the Prehevbrio he only needed one dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Contusion, Epistaxis, Injection site discolouration, Injection site erythema
Clinical narrative: Location: Left; Onset: 08/13/2024; Quality: Worsening  Patient was seen on 08/12/2024 in the office for follow up after puncture wound with a metal rake over the weekend. Had been started on keflex by urgent care. Since he was 4 years old and needed Tetanus vaccination anyways, Kinrix and Proquad were given. GM reports that they were given in the L upper thigh. Patient had a little swelling around both puncture wounds in the morning and then this continued to get worse with swelling, warmth and erythema and pain. Now somewhat indurated and dusky in appearance. Low grade temp started 08/13/2024 after noon. No V/D. Normal PO and UOP. No oozing or drainage from R foot wound. Also with nose bleeds intermittently over the past 2 months. ROS Otherwise unremarkable. Skin: ABNORMAL inspection: Area of about 7.5cm x 7.5cm of erythema with induration of about 4cm around puncture wound and mild erythema and warmth around 2nd puncture wound, no streaking down leg; Puncture wound on bottom of R foot is stable with no drainage, but mild bruising around entry point of rake. Normal palpation: good skin turgor.   Plan: Decadron 10mg given PO x 1. Will use Zyrtec daily and will apply ice to area with compress. dexamethasone sodium phosphate vial 10 mg/mL. Bactrim ordered to replace Keflex                                                                                                                                                                        .                                                                                                                                                                                                                                                                                                                                      Medications: Dispense: 1 (one)   Give 1mL PO x 1 stat   Start date: 08/14/2024  Administered in office   cetirizine solution, oral 5 mg/5 mL  Dispense: 300 (three hundred) milliliter  Take 5 mL by mouth once a day as needed   Start date: 08/14/2024                                                                                                                                                                                                                                                                                                                     .                                                                                                                                                                                                          sulfamethoxazole-trimethoprim suspension, oral (final dose form) 200-40 mg/5 mL  Dispense: 200 (two hundred) milliliter  Take 10 mL by mouth twice a day for 10 days  Calc on 1st component (SMZ) = 20 mg/kg/dose (12 mL = 480 mg)  Start date: 08/14/2024  End date: 08/24/2024
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Location: Left; Onset: 08/13/2024; Quality: Worsening  Patient was seen on 08/12/2024 in the office for follow up after puncture wound with a metal rake over the weekend. Had been started on keflex by urgent care. Since he was 4 years old and needed Tetanus vaccination anyways, Kinrix and Proquad were given. GM reports that they were given in the L upper thigh. Patient had a little swelling around both puncture wounds in the morning and then this continued to get worse with swelling, warmth and erythema and pain. Now somewhat indurated and dusky in appearance. Low grade temp started 08/13/2024 after noon. No V/D. Normal PO and UOP. No oozing or drainage from R foot wound. Also with nose bleeds intermittently over the past 2 months. ROS Otherwise unremarkable. Skin: ABNORMAL inspection: Area of about 7.5cm x 7.5cm of erythema with induration of about 4cm around puncture wound and mild erythema and warmth around 2nd puncture wound, no streaking down leg; Puncture wound on bottom of R foot is stable with no drainage, but mild bruising around entry point of rake. Normal palpation: good skin turgor.   Plan: Decadron 10mg given PO x 1. Will use Zyrtec daily and will apply ice to area with compress. dexamethasone sodium phosphate vial 10 mg/mL. Bactrim ordered to replace Keflex                                                                                                                                                                        .                                                                                                                                                                                                                                                                                                                                      Medications: Dispense: 1 (one)   Give 1mL PO x 1 stat   Start date: 08/14/2024  Administered in office   cetirizine solution, oral 5 mg/5 mL  Dispense: 300 (three hundred) milliliter  Take 5 mL by mouth once a day as needed   Start date: 08/14/2024                                                                                                                                                                                                                                                                                                                     .                                                                                                                                                                                                          sulfamethoxazole-trimethoprim suspension, oral (final dose form) 200-40 mg/5 mL  Dispense: 200 (two hundred) milliliter  Take 10 mL by mouth twice a day for 10 days  Calc on 1st component (SMZ) = 20 mg/kg/dose (12 mL = 480 mg)  Start date: 08/14/2024  End date: 08/24/2024
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Area of induration and redness measuring 13.5 cm x 9 cm, area warm and tender to the touch. Area became sore and red starting within a few hours after the vaccine was administered. Area of redness and induration continued to spread and became more tender by the following day.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Same day that vaccines were administered, she developed Red, hard, stiff, area to left arm.  She also had some discomfort.  Mom knew that this could be a "normal" reaction, so just watched it. By 2 days later, the red, hard, swelling had spread to include the area from shoulder to elbow. Also, pain increased to the point she was "babying" her arm.  Mom said she had a similar reaction in her thigh when she received her 18 month vaccines--red, hard and swollen area that eventually "sloughed" off and oozed "fluids".  Denies any reaction when she received her kindergarten vaccines.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Same day that vaccines were administered, she developed Red, hard, stiff, area to left arm.  She also had some discomfort.  Mom knew that this could be a "normal" reaction, so just watched it. By 2 days later, the red, hard, swelling had spread to include the area from shoulder to elbow. Also, pain increased to the point she was "babying" her arm.  Mom said she had a similar reaction in her thigh when she received her 18 month vaccines--red, hard and swollen area that eventually "sloughed" off and oozed "fluids".  Denies any reaction when she received her kindergarten vaccines.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered outside the timeframe recommended by the manufacturer
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest discomfort, Cold sweat, Nausea, Pallor
Clinical narrative: Appx 10 mins after immunization administration and while speaking with patient about education topics during monitoring, patient became nauseated and pale. Patient reported she had not eaten all day. Patient then transferred to bed and feet elevated. Patient became clammy and had tightness to chest. Remained alert and oriented. Offered a fruit snack and water, ingested without complication. Father at bedside reported that patient had a previous incident unrelated to vaccines similar to this and had gone to emergency room where she was told it was a reaction related to anxiety. Patient was then recovered without further complaint and able to ambulate with father to personal vehicle. Encouraged father to seek emergent care if condition worsens.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain
Clinical narrative: Noted onset of erythema, induration, and pain within 24 hours of vaccine administration.  No trouble breathing. No facial swelling.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; temperature excursion of ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-APR-2024, a temperature excursion occurred to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for 3 days 23 hours (also reported as 72 hours) with temperature: 74.4F hours (also reported as minimum: 39.03 degrees Fahrenheit (F) and maximum 74.84 F). No previous temperature excursion.  On 26-JUN-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #X015245, expiration date: 22-NOV-2024, administered orally for prophylaxis (strength and dose were not provided) (Product storage error). Operator of device was health professional. No additional adverse event (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA009835: US-009507513-2407USA012955: US-009507513-2407USA012957: US-009507513-2407USA012958: US-009507513-2407USA013125: US-009507513-2407USA013127: US-009507513-2407USA013298: US-009507513-2407USA013327: US-009507513-2407USA013069:
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Rash, Scab
Clinical narrative: Granddaughter developed a full body rash that is now scabbing over.; was afraid it was measles; Granddaughter developed a full body rash that is now scabbing over.; Baby also had a 103 degree fever; Grandma is worried the baby's immune system is suppressed now too; her 1 year old baby granddaughter had a reaction to her 2nd dose of MMR II; This spontaneous report was received from the patient's granddaughter via a company representative and referred to an 1-year-old female patient.  The patient's medical history, historical drugs, known allergies, additional concurrent conditions, nor concomitant therapies were reported.   On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, albumin status, lot #, expiry date, anatomical location of injection, and route of administration were not provided). In addition, it was stated that the patient had not have a reaction to the first dose. On an unspecified date in 2024, The patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, as prophylaxis (route of administration reported as 'injection') (strength, albumin status, lot #, expiry date, and anatomical location of injection were not provided) (Inappropriate age at vaccine administration).   However, the reporter stated that the patient had a reaction to the second dose of the suspect vaccine, as possibly on Friday 02-AUG-2024, developed a full body rash (Rash) that since an unspecified date in August 2024 (reported as now) was scabbing (Scab) over. The reporter was concerned as the patient's mother was on an injectable (unspecified) for psoriasis, that suppressed the immune system, and was currently breast feeding her (part of familial history), so she was worried that now the baby's immune system was suppressed to (onset: unspecified date in 2024) and was now afraid that it was measles (onset: possibly on Friday 02-AUG-2024). Therefore, the patient had been to the pediatrician for treatment (it was not specified if therapy for the events had indeed been started), and they stated that it was just a rash. In addition, on an unspecified date in August 2024, the patient also had a 103 degree (unspecified) fever (Pyrexia). At the time of this report, the outcome of the events had not been provided.  The reporter considered the reactions of rash, scab, and measles to be related to the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The causal relationship between immunosuppression and pyrexia was not reported. Upon internal review, the event of immunosuppression was considered to e medically significant.
Sex: M
Vaccine: MMRV
Symptoms: Death, Disseminated varicella zoster virus infection, Skin culture, Skin lesion, Viral test
Clinical narrative: disseminated varicella zoster virus infection; This spontaneous report was received from a physician via company representative and refers to a male child with unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location and route of administration were not provided).  On an unknown date, the patient succumbed to disseminated varicella zoster virus (VZV) infection. It was unknown whether the autopsy was done. The patient's care team was curious if the virus that caused his infection was wild-type or vaccine-derived VZV.  The patient's care team was requesting polymerase chain reaction (PCR) testing. 2 samples of lesion swab in viral transport medium and viral culture (mixture of cell maintenance medium, antimicrobial agents, and human/nonhuman primate cells) would be sent to company for test in the week of 12-AUG-2024.   The causal relationship between the event disseminated varicella zoster virus infection and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.  The action taken with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not applicable.  Upon internal review, the event disseminated varicella zoster virus infection was determined to be medically significant.  Lot# is being requested and will be submitted if received.; Reported Cause(s) of Death: Disseminated varicella zoster virus infection
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: 17 year old boy fainted; This spontaneous report was received from a nurse via field based employee (FBE) and refers to a 17-year-old male patient. His concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not provided.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, anatomical location, route of administration, lot # and expiry date were not provided) as a prophylaxis.  On an unknown date, after receiving his first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination, he fainted. No other information was provided.  The outcome of the event was unknown. It was unknown if patient sought any medical attention, received treatment for the event or had any laboratory diagnostics performed.  The causal relationship between the event and the suspect vaccine was not provided.   Upon internal review, the event of faint was determined to be medically significant.  Lot # is being requested and will be submitted if received.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE/No PQC.; Pharmacist called to report that a 16 year old patient was inadvertently administered an adult dose of VAQTA.  No symptoms reported.  Consent to correspond provided.   No additional AE/No PQC.; This spontaneous report was received from a pharmacist and refers to a 16-year-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant mediations was provided.  On 25-MAY-2024 the patient was inadvertently vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # X006702 and expiration date 01-OCT-2024, 1 milliliter for prophylaxis (dose number, route and site of administration were not provided) (accidental overdose). No additional adverse event and product quality complaint was reported (no adverse event).
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; HCP called to report a TE for PROQUAD where one patient received the product after improperly stored; This spontaneous report was received from a registered nurse (RN) referring to a 5-year-old male patient. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.   On 05-AUG-2024, while the patient was 5-year-old, he was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), at a dose of 0.5 ml for prophylaxis (route of administration, vaccination scheme frequency, anatomical location were not provided; valid  lot number Y004996  with an expiration date of  26-AUG-2025, albumin status: rHA).The administered dose of the vaccine experienced a temperature excursion (product storage error). It was not reported if the information was recorded by a data logger or not. There was no adverse effect reported.
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported/ No additional AE; patient inadvertently received both MMR II and PROQUAD at the same time instead of MMR II and VARIVAX; patient inadvertently received both MMR II and PROQUAD at the same time instead of MMR II and VARIVAX; This spontaneous report has been received from a nurse concerning to a female patient (age reported as: 12-15 month). The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 10-AUG-2024, the patient inadvertently was vaccinated with both measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection at the same time instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (specific doses, routes and anatomical locations of administration, lot numbers and expiration dates were not provided), both as prophylaxis (wrong product administered/ accidental overdose). No adverse effects were reported. No additional adverse event.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Scoliosis, Syncope
Clinical narrative: Fainting; Scoliosis; This serious case was reported by a consumer and described the occurrence of fainting in a 11-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 09-AUG-2024, the patient received the 1st dose of Meningococcal B vaccine. On 09-AUG-2024, less than a day after receiving Meningococcal B vaccine, the patient experienced fainting (Verbatim: Fainting) (serious criteria GSK medically significant) and scoliosis (Verbatim: Scoliosis). The outcome of the fainting was not resolved and the outcome of the scoliosis was not reported.   It was unknown if the reporter considered the fainting and scoliosis to be related to Meningococcal B vaccine.     The company considered the fainting to be related to Meningococcal B vaccine. It was unknown if the company considered the scoliosis to be related to Meningococcal B vaccine.   Additional Information: GSK Receipt Date: 09-AUG-2024 The patient self-reported this case for herself. The patient received Meningitis B vaccine and experienced fainting and scoliosis.; Sender's Comments: Syncope is a listed event which is considered related to GSK vaccine Meningococcal B vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Continued outbreaks of shingles post vaccination; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Continued outbreaks of shingles post vaccination). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-AUG-2024 The reporter was alerted to this by a former GlaxoSmithKline colleague that her brother-in-law had an issue with shingles prior to vaccination.  The reporter reported that, the patient received Shingrix and continued outbreaks of shingles post vaccination. The continued outbreaks of shingles post vaccination were reported as worsened.  The reporter did not know which dose of the vaccine was this. The patient had been vaccinated and outbreaks of shingles were continuing.  The reporter asked if you get shingles and then you already had the vaccine it was horrible.  The reporter asked you can get shingles again and again. The patient had shingles twice and he had been on the back had the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: RVX
Symptoms: Flatulence, Irritability
Clinical narrative: Irritable/fussy; Gassy; This non-serious case was reported by a nurse via sales rep and described the occurrence of irritability in a male patient who received Rotavirus vaccine (batch number 5F7L2) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced irritability (Verbatim: Irritable/fussy) and gas (Verbatim: Gassy). The outcome of the irritability was not resolved and the outcome of the gas was not reported.   The reporter considered the irritability and gas to be related to Rotavirus vaccine.     The company considered the irritability and gas to be related to Rotavirus vaccine.   Additional Information: GSK Receipt Date: 05-AUG-2024 The patient had symptoms of irritability, fussy, gassy. The patient did not spit up any vaccine. This case was linked with US2024AMR097672 and US2024AMR097673 for the same reporter.; Sender's Comments:  US-GSK-US2024AMR097672:Male patient US-GSK-US2024AMR097673:Female patient
Sex: M
Vaccine: RVX
Symptoms: Flatulence, Irritability
Clinical narrative: Irritable/fussy; Gassy; This non-serious case was reported by a nurse via sales rep and described the occurrence of irritability in a male patient who received Rotavirus vaccine (batch number 5F7L2) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced irritability (Verbatim: Irritable/fussy) and gas (Verbatim: Gassy). The outcome of the irritability was not resolved and the outcome of the gas was not reported.   The reporter considered the irritability and gas to be related to Rotavirus vaccine.     The company considered the irritability and gas to be related to Rotavirus vaccine.   Additional Information: GSK Receipt Date: 05-AUG-2024 The patient had symptoms of irritability, fussy, gassy did not spit up any vaccine. This case was linked with US2024097507 and US2024AMR097673 for the same reporter.; Sender's Comments:  US-GSK-US2024AMR097673:Female patient US-GSK-US2024097507:Male patient
Sex: F
Vaccine: RVX
Symptoms: Flatulence, Irritability
Clinical narrative: Irritable/fussy; Gassy; This non-serious case was reported by a nurse via sales rep and described the occurrence of irritability in a infant female patient who received Rotavirus vaccine (batch number 5F7L2) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced irritability (Verbatim: Irritable/fussy) and gas (Verbatim: Gassy). The outcome of the irritability was not resolved and the outcome of the gas was not reported.   The reporter considered the irritability and gas to be related to Rotavirus vaccine.     The company considered the irritability and gas to be related to Rotavirus vaccine.   Additional Information: GSK Receipt Date: 05-AUG-2024 The patient had symptoms of irritability, fussy, gassy did not spit up any vaccine. This case was linked with US2024097507 and US2024AMR097672 for the same reporter.; Sender's Comments:  US-GSK-US2024097507:Male patient US-GSK-US2024AMR097672:Male patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix several years ago, never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose several years ago).   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: received the first dose of Shingrix several years ago, never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-AUG-2024 The pharmacist consultant reported that a patient received the first dose of Shingrix several years ago and never received the second dose, which led to incomplete course of vaccination. The reporter had no patient demographics.  The reporter had no information about the Shingrix dose such as expiry or route or location of administration or date of administration
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Product administration error, Underdose
Clinical narrative: Maladministration of Havrix Pediatric dose to an adult patient.; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 46-year-old female patient who received HAV (Havrix 720) (batch number BM4R5, expiry date 24-APR-2026) for prophylaxis.   On 04-AUG-2024, the patient received Havrix 720. On 04-AUG-2024, an unknown time after receiving Havrix 720, the patient experienced adult use of a child product (Verbatim: Maladministration of Havrix Pediatric dose to an adult patient.) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose 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: 05-AUG-2024 The pharmacist reported maladministration of Havrix pediatric dose to an adult patient. The reporter reported administered a 720 EL.U instead of an 1440 EL.U adult dose, which led underdose and adult use of a child product. The reporter needs to know what was the advise to the patient since it was an immigration related issue. The reporter consented to follow up.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Vasovagal syncope after trying to get up from exam table several minutes after the immunization was administered. The episode was brief per patient's mother. Mother helped patient lie back down on the exam table and prevented injury. No associated shaking/abnormal body movements. She was A&O and answering questions appropriately after the event. She was ultimately able to get up again after resting several more minutes and left the clinic with her mother.
Age: 34.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Erythema, Lip pruritus, Pruritus
Clinical narrative: About 15 minutes after administration of vaccine, individual c/o itchiness to upper chest, and slightly to lips, no difficulty breathing. She appeared with redness to upper chest. She recalled happening prior, but does not remember details as to why it happened. She would stay in observation for 20 more minutes. After  the 20 minutes, stated she felt better and left clinic. She was explained s/s of anaphylactic reactions, and to immediate medical help if noticed.
Age: 68.0
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given a 3rd dose of Bexsero. He had already had 2 doses.  Attempted to contact patient via phone after left clinic to inform of this but unable to get of hold of patient until the following day. Spoke with pt via phone on 8/8/24. Pt denied any c/o's at this time or noticeable side effects.  medical provider, Dr.,  contacted to report.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Pain in extremity
Clinical narrative: Localized pain, tingling and numbness traveling down injection site in left deltoid to forearm and digits
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Localized pain, tingling and numbness traveling down injection site in left deltoid to forearm and digits
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood pressure decreased, Dizziness, Eye movement disorder, Nausea, Syncope
Clinical narrative: Mom said as they were leaving the store, patient felt nauseous. Then after getting in the car she felt dizzy. When the mom was pulling out of the parking lot the patient fainted. Mom stopped the car and tried to get the patient to respond but she did not. Her eyes had rolled back. Mom called 911. They checked out the patient and found that her blood pressure had dropped but other vitals were fine.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: Mom said as they were leaving the store, patient felt nauseous. Then after getting in the car she felt dizzy. When the mom was pulling out of the parking lot the patient fainted. Mom stopped the car and tried to get the patient to respond but she did not. Her eyes had rolled back. Mom called 911. They checked out the patient and found that her blood pressure had dropped but other vitals were fine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness & soreness at injection site