chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: PNC21, PNC21, PNC21
Symptoms: Mechanical ventilation, Myalgia, Pain, Paralysis
Clinical narrative: 61yr old patient with history of gout (recent attack 4/18, patient took colchicine), HTN (baseline 120s/70s on amlodipine and lisinopril at home), and other comorbidities presented on 4/22 for check up with new concern for tinnitus. During visit, patient was prescribed to start rosuvastatin 10mg PO daily (# 850215666) due to risk of CAD. MD also ordered patient to receive Pneumococcal (PCV21) (>=19YRS) Vaccine (Capvaxive) (aka PCV21) [IMM6051] during visit. CMA administered Pneumococcal (PCV21 >=19yrs) vaccine (Capvaxive) LOT # Z005765 IM in patient's left deltoid. On 4/28, patient presented to Urgent Care with severe body aches and numbness (started in lower back and spread to hips, legs, shoulders, arms, neck and On 4/28, patient presented to Urgent Care with severe body aches and numbness (started in lower back and spread to hips, legs, shoulders, arms, neck and head). Pain described by "tingly" and accompanied by numbness in fingers and toes. Patient took acetaminophen without relief. Patient sent to ED for further management. Per H&P, patient reported receiving RSV vaccine on 4/24 (however, not listed within Immunizations,(redacted site name), nor state database). Patient admitted to ICU. Rosuvastatin held on admission however symptoms did not improve (CK levels normal). Patient later intubated 4/29 1550 due to acute respiratory failure. Patient given IVIG x 5 days. Concern for acute inflammatory demyelinating polyradiculoneuropathy (Guillan-Barre Syndrome), pending West Nile virus and heavy metals test. Per online service, myalgia (6-17%) listed as possible adverse reaction for Pneumococcal conjugate vaccine 21 valent as well as rosuvastatin. Team continues to manage symptoms.  Unable to identify cause of AIDP.  535587
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Patient said that after getting the vaccination she developed a rash around the injection site and said that rash was itchy, Said that the rash lasted for a few days and then went away. Patient said the Shingles Vaccination was the only thing she had gotten that day nothing else was new for her.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Epistaxis, Erythema, Feeling hot, Nasal congestion, Ocular hyperaemia
Clinical narrative: 3:15 Vaccine's given; Approximately 10 mins later Nose bleed, nasal congestion, then continued with Hives on arms, chest, back. Eyes blood shot, face red and warm.  Arrived at ER at 4:45p.  Per mom, pt given Benadryl, IV steroid.  Discharged home at 6p.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: 3:15 Vaccine's given; Approximately 10 mins later Nose bleed, nasal congestion, then continued with Hives on arms, chest, back. Eyes blood shot, face red and warm.  Arrived at ER at 4:45p.  Per mom, pt given Benadryl, IV steroid.  Discharged home at 6p.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Arthropod bite, Blister, Dermatitis, Dyspnoea, Gait inability
Clinical narrative: Developed rash on left leg 1-2 days after receiving Hep A vaccine. Rash spread to bilateral feet and included swelling and itching. Presented to urgent care on 5/11/2025. Diagnosed with bug bite and prescribed Keflex and prednisone. Unfortunately, I do not have the records at this time. Later that same day, he started to develop blisters on both feet and shortness of breath, so he went to the ED  Diagnosed with dermatitis and prescribed a steroid cream and given Benadryl. He only used the steroid cream once and washed it off because it caused pain. The swelling continued and caused enough pain that he was unable to walk for a time. Patient then presented here to his PCP's office on 5/14/2025 for an ED follow up, still with swelling and blisters on both feet. Patient finally took a turn for the better on 5/13/2025 and was able to walk and put on loose rainboots for his appointment on 5/14/2025. Patient instructed to complete course of prednisone and discontinue the Keflex prescribed by the hospital.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Pain, Pruritus, Rash, Swelling
Clinical narrative: Developed rash on left leg 1-2 days after receiving Hep A vaccine. Rash spread to bilateral feet and included swelling and itching. Presented to urgent care on 5/11/2025. Diagnosed with bug bite and prescribed Keflex and prednisone. Unfortunately, I do not have the records at this time. Later that same day, he started to develop blisters on both feet and shortness of breath, so he went to the ED  Diagnosed with dermatitis and prescribed a steroid cream and given Benadryl. He only used the steroid cream once and washed it off because it caused pain. The swelling continued and caused enough pain that he was unable to walk for a time. Patient then presented here to his PCP's office on 5/14/2025 for an ED follow up, still with swelling and blisters on both feet. Patient finally took a turn for the better on 5/13/2025 and was able to walk and put on loose rainboots for his appointment on 5/14/2025. Patient instructed to complete course of prednisone and discontinue the Keflex prescribed by the hospital.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: pt reported soreness and redness at injection site. reported back to clinic with symptoms, firm lump  under skin  2x3 inches , warm to touch, redness at lump site
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Diarrhoea, Gait disturbance, Muscle spasms
Clinical narrative: Four days of severe leg cramps around the knees making walking difficult. One loose stool 4 days after vaccine. Symptoms resolved.
Age: 1.25
Sex: F
Vaccine: HIBV, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Tdap given instead of Dtap.
Age: 0.83
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Rash morbilliform, Rhinorrhoea
Clinical narrative: Febrile seizure, followed by measles like rash, runny nose
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: VACCINE EXPIRED ON 05/13/2025
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error, Underdose
Clinical narrative: The patient did not receive the full dose of HIB the diluent was not added. Called and informed parents, and an appointment was made to get full vaccine.  My Practice leader also was informed of this event.
Age: 1.25
Sex: M
Vaccine: MMR, HIBV, MMR
Symptoms: Influenza virus test, Laboratory test, Pyrexia, Rash, Respiratory viral panel
Clinical narrative: Full body rash and fevers 12 days after the vaccine
Age: 1.25
Sex: M
Vaccine: MMR, HIBV, MMR
Symptoms: SARS-CoV-2 test
Clinical narrative: Full body rash and fevers 12 days after the vaccine
Age: 1.25
Sex: M
Vaccine: MMR, HIBV, MMR
Symptoms: Dermatitis diaper, Pyrexia, Rash morbilliform
Clinical narrative: Full body rash and fevers 12 days after the vaccine
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No adverse events
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Tinnitus
Clinical narrative: I developed tinnitus within a month of the first shot
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site red/painful/swollen/hot - patient experienced flu like symptoms (fever and fatigue)
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Site red/painful/swollen/hot - patient experienced flu like symptoms (fever and fatigue)
Age: 27.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Hyperhidrosis, Presyncope
Clinical narrative: Vasovagal reaction Patient did experience a vasovagal response after receiving immunizations. No LOC. Still conscious, alert to stimuli.  She was placed in supine position with feet elevated, cool towels applied to forehead.  Initial vital signs on evaluation included diaphoresis, alert, blood pressure 120/100, heart rate 58.  O2 98.  Patient was given apple juice, we were at bedside.  No syncopal.  Patient's blood pressure on discharge was 111/75, heart rate 89. Verbalized this has happened in the past.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Juvenile idiopathic arthritis, Laboratory test abnormal
Clinical narrative: Patient began having symptoms of JIA within 6 weeks of vaccination
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: Yf-Vax was mixed with Sterile water instead of Nacl
Age: 0.17
Sex: F
Vaccine: HIBV, PNC20
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomit. Vaccines given in the morning, fine throughout the day. Bottle fed the following morning and projectile vomited after. No symptoms or vomiting after.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received a dose on 04/17/2025: was not due for a second dose today/ No ill effects noted at this time
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was due for her second dose of HPV vaccine. When preparing the vaccine I grabbed MCV(menactra) instead of HPV and didn't realize the error until after giving the vaccine.  Patient received her first dose of MCV vaccine 02/21/2024. The patient showed no signs of reactions after receiving the erroneous vaccine. The patient and accompanying parent were informed by myself and provider who saw the patient today.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site mass
Clinical narrative: SMALL LUMP AT SITE OF INJECTION, BRUISING.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction, Injection site swelling, Rash, Rash pruritic, Swelling face
Clinical narrative: Seen last week for allergic reaction to Fe supplement Given IM benadryl in clinic, and prescribed benadryl, cetirizine and Epi-pen Was seen 2 days later, symptoms had improved, was given HPV Several hours later that day, on 5/7/25, developed swelling and itchy rash on left upper arm (site of HPV vaccine) and left side of face Seen at ER, no rash seen at time of visit, given oral benadryl Swelling and rash have since resolved Not taking benadryl or cetirizine currently Referred to Allergist- appt ready to be scheduled
Age: 83.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong patient received product
Clinical narrative: patient received a vaccination that was not meant to her - incorrect patient
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Diffuse urticaria shortly after event.  Loratadine given with improvement in symptoms.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Arthralgia, Magnetic resonance imaging, Mobility decreased, Tinnitus
Clinical narrative: Patient reports joint pain following initial Covid 19 vaccine. States pain has been consistent since first dose and mainly affects his knees and shoulders (difficult to raise arms overhead). Patient also reports a constant hum in one ear that does not resolve. Patient says he had vertigo symptoms in July of 2024 that led to a hospital admission.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Patient reports joint pain following initial Covid 19 vaccine. States pain has been consistent since first dose and mainly affects his knees and shoulders (difficult to raise arms overhead). Patient also reports a constant hum in one ear that does not resolve. Patient says he had vertigo symptoms in July of 2024 that led to a hospital admission.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Laboratory test, Musculoskeletal disorder, Paralysis
Clinical narrative: Patient states that 2 days after vaccines were given she went to the hospital. Her symptoms were : not able to lift her arms or move her arms or legs and was paralyzed. She was in the hospital from 1/25/2025 to 1/29/2025 then went back in on 04/24/2025 to 04/29/2025. She spoke with the doctors there and they would not listen to her. She then came into the pharmacy today 5/14/2025 and I was speaking with her and she was telling me her reactions she had to the vaccines and I spoke with my Pharmacy Manager, and the symptoms sounded like Guillian-Barre Syndrome and we advised her to reach out to her doctor and speak with them and let her know we will be submitting this VEARS reaction form.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: PT WAS TO GET MMR AND VARICELLA BUT WAS INADVERTLY GIVEN PROQUAD AND VARIVAX DUE TO THE SIMILAR LOOK OF VIALS OF PROQUAD AND MMR. UNKNOWN SYMPTOMS OF CHILD AT THIS TIME.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV9, TDAP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Per the manufacturer the patient should only have local reactions | per the provider the patient's guardian does not need to be notified
Age: 7.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Was informed on 4/24/25 by Pfizer that there was an error during shipping and shipment is no longer valid. Recalled patient, no adverse side effects reported.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Dyspnoea, Fatigue, Injection site erythema, Pain in extremity
Clinical narrative: pt says when she got the vaccine the pharmacist explained that she may have a few side effects but she starting feeling fatigued and her left arm was sore. She went to bed and woke up feverish. She had chills from the inside out, from head to toe. She started having a hard time breathing. She got her comforter and got back in bed but had to raise back up because she was still having a hard time breathing. About 8 the next morning, she woke up, she was a tired from not having a good nights sleep but she did feel better. No longer had fever or chills but she did notice some red spots around the injection site but had disappeared by the end of the day. She called her doctors office and spoke to the nurse and let them know about her symptoms. She feels like has recovered from all of the symptoms.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: pt says when she got the vaccine the pharmacist explained that she may have a few side effects but she starting feeling fatigued and her left arm was sore. She went to bed and woke up feverish. She had chills from the inside out, from head to toe. She started having a hard time breathing. She got her comforter and got back in bed but had to raise back up because she was still having a hard time breathing. About 8 the next morning, she woke up, she was a tired from not having a good nights sleep but she did feel better. No longer had fever or chills but she did notice some red spots around the injection site but had disappeared by the end of the day. She called her doctors office and spoke to the nurse and let them know about her symptoms. She feels like has recovered from all of the symptoms.
Age: 7.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: On 4/24/25 was notified by Pfizer that there was an error during shipment and shipment was no longer valid. Recalled patient, no adverse side effects reported.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: patient developed rash
Age: 46.0
Sex: M
Vaccine: CHIK
Symptoms: Fatigue, Headache, Heart rate increased, Influenza like illness, Myalgia
Clinical narrative: Felt flu-like symptoms, starting 2 days after the vaccine was received. Symptoms lasted 4-5 days - fatigue, muscle ache, headache, increased heart rate.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Tic, Tremor
Clinical narrative: Patient was given the TDAP during an ER visit because she cut herself and required stiches.  Due to Patient having weird tourette tic like symptoms after immunizations when she was younger, we requested strictly the tetanus - but she was given the full dtap. Her episodes have come back so we put her on a on a zeolite detox
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swelling, pain, and warm to touch at injection site
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Hello, (Email from on 05/13/25) Just some questions on patient (Questions and answers from PA-C who emailed back.) 1. Could you see the actual injection site?  If so, was placement correct? Yes, on my physical exam on 5/12/25 I could see where she received the injection as there was a small puncture mark still visible on her left lateral deltoid and that was the point of maximum tenderness.  2. What did the actual injection site look like? Besides the small puncture mark, there was no other visible abnormalities of the injection site (ie. No swelling, bruising, redness) 3. Pt was seen for shoulder/body injury on the 7th, seen at facility on the 8th for neck pain, then another facility on the 11th for shoulder pain, and then another facility on the 12th for left arm pain.  All re: shoulder, neck, upper back pain.  Adverse effect of vaccine???  Recommend not getting the MenB #2 of 2??? Per patient history she was knocked over by a friend on 5/7/25 which caused her to fall and hit her upper back/neck which she was evaluated for on 5/8/25. She did not complain of any shoulder or arm pain at that time. She received 2 immunizations, MEN B in the left deltoid and HPV dose #2 in the right deltoid, at the 5/8/25 OV. Patient reported some injection site tenderness of Left shoulder on Friday 5/9/25 to her parent and they decided to monitor. Patient reported that pain turned into numbness/tingling of her left arm as the day progressed on Friday, then it worsened on Saturday where she could barely move her left arm, so then parent took her to facility on 5/11/25 for evaluation. Patient stated they did not give her any clear answers and said she may have torn a muscle in her arm and told her to take OTC acetaminophen and ibuprofen as needed. Patient seen on 5/12/25 for worsening left arm pain/tingling and upon further history and progression of symptoms it was determined that symptoms were highly likely related to MEN B immunization on 5/8/25 as that was the immunization given in that arm. Patient denied doing any activity that would have injured her left arm or caused her to tear a muscle. Physical exam did not align with impingement syndrome from previous neck pain complaint and with maximum tenderness still at the injection site this provider determined this likely was a vaccine adverse effect. Patient had limited range of motion of left arm and pain with movement, facility gave her an arm sling to wear due to symptoms. Patient still wore arm sling on 5/12/25 and unable to move arm actively or passively without moderate pain. Per progression and severity of symptoms this provider recommended that patient not get MEN B dose #2.   I?m just making sure before I complete this VEARS Report and put an alert in the chart. Thanks.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dyspnoea, Flushing, Staring, Unresponsive to stimuli
Clinical narrative: After receiving the HPV in the right deltoid and meningococcal in the left deltoid vaccine the Pt was in sitting position and stated he needed some water and he couldn't breath very well and laid his head back on the bed. His face turned very flushed and he was starring off into space and not responding when asked if he was okay. I put the back of the bed all the way down and rolled him onto his left side. He was back alert once I got him onto  his side. The pt shook his head from side to side when asked if he was okay. I called another nurse into the room for assistance so I could stay with the pt and his mother. He was provided some water, fast sugar, an cold towels for his forehead. The pt mom states he passes out when he is very anxious and he had not ate today besides a coffee this morning. The patient has not had a reaction to the HPV shot before and this was his last dose. I stayed in the room with the patient until he stated he felt better and felt like he could breath and was ready to go home to eat. I walked to the car with the pt and mom. The pt was stable, walking without assist from vaccine room to car. Mom was advised to seek care from the ER if anything was to happen in the car or at home.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain
Clinical narrative: Pt received Adacel and states that same day started experiencing lower back pain
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Client was given the pediatric dose of Engerix B instead of adult dose.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: After administration of vaccinations, this RN noticed patient's vaccination history had updated to show patient received the above vaccinations on 5/6/25 at another office - this information was not available the day prior to the appt when the appt was prepped.  These vaccinations were intended to be the 1st set of vaccinations.  However, patient received an invalid dose of the vaccinations on 5/14/25. No immediate adverse reactions observed in office.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: No adverse reaction
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Extra dose of rotarix was given. EHR is set to recognize a 3-dose series of rotavirus vaccinations, not the 2-dose rotarix series. Nurse gave dose of rotarix thinking it was needed. Mother of patient was notified. Reviewed warning signs of adverse effects which may arise along with timeline.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site erythema, Paraesthesia
Clinical narrative: Patient called nurse line today reports redness at site of injection. reports the redness radiating down left arm since Monday 5/12/25.  Did admit to tingling in fingers of left hand. Denies any swelling, trouble breathing or or swallowing.  Patient instructed to take benedryl and ibuprofen, also instructed her to do cold compresses. Instructed patient to seek emergent care for any swelling, trouble breathing, etc. Patient voiced understanding and agreed to comply.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration, Mobility decreased, Oedema peripheral, Skin warm
Clinical narrative: Erythema, Edema, extremely hot, and hard from deltoid down to bicep, stopping at elbow. Unable to raise arm laterally and anteriorly. No fever at this time. Two days of ice, Benadryl and Motrin/Tylenol with worsening pain and swelling. MD seen on 5/14/25 given rx for keflex.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: HCP called to report a patient received an expired dose of GARDASIL 9. The product expired 02/14/2025 and was administered to one patient 04/28/2025. No side effects or symptoms have been reported, and product had not undergone a temperature excursio; HCP called to report a patient received an expired dose of GARDASIL 9. The product expired 02/14/2025 and was administered to one patient 04/28/2025. No side effects or symptoms have been reported, and product had not undergone a temperature excursio; This spontaneous report was received from a physician concerning a 12-year-old female patient.   The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 28-APR-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) ( lot number not reported, expiration date: 14-FEB-2025) 0.5 mL (0.5ml), (lot # was not reported) as prophylaxis. No side effects or symptoms have been reported and product had not undergone a temperature excursion. No additional information provided.  The operator of device was health professional.  Lot # is being requested and will be submitted if received.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a pediatric referring to a 4-year-old female patient. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On 03-MAR-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot#: Y000225, expiration date: 03-JAN-2026; dose and strength were not provided) subcutaneously in the left thigh; the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot#:Y011019, expiration date: 18-JUN-2026; dose and strength were not provided) subcutaneously in the left thigh. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, strength, and expiration date were not reported) for prophylaxis. On the same day, the patient was vaccinated with the fifth dose of Diphtheria vaccine toxoid ()+ Pertussis vaccine acellular (+) Tetanus vaccine toxoid (DTAP) (lot#: BCA20Cl, expiration date: 28-FEB-2026) intramuscularly in the right thigh; the forth dose of Polio vaccine inact (IPV) (lot#: BCA20Cl, expiration date: 17-NOV-2026) intramuscularly in the right thigh; and the forth dose of fluconazole (FLUZONE) (lot#: US4424A, expiration date: 30-JUN-2025) intramuscularly in the right thigh. A temperature excursion as a result of digital data logger at -9.8 C for 2 hours a minutes occurred to the vaccines mentioned above (product storage issue). No addition adverse events occurred (no adverse event).
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; patient was administered ROTATEQ during a temperature excursion.; This spontaneous report was received from an office manager concerning a patient of unspecified age and gender.   The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On 25-Apr-2025, during a temperature excursion of 0 degrees Celsius (C) for 1 hour 0 minutes and 0 seconds, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2088619 has been verified to be a valid batch lot number for Rotavirus Vaccine, Live, Oral, Pentavalent, expiration reported and confirmed as 09-Mar-2026) 1 dosage form (dosage regimen not reported) administered by oral route as prophylaxis (product storage error.)   There were no additional adverse events (AE) reported (no adverse event). There were no additional details reported.
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; HCP calling to report T/E. VFC data logger was off. HCP could not provide any temperature and time information to further evaluate GARADSIL 9. HCP did state GARDASIL 9 was administered. See T/E case# 02799358.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 28-APR-2025, a temperature excursion occurred. On an unspecified date in 2025, the patient was vaccinated with an improper storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), lot #Y012508; which has been verified to be valid, expiration date reported and upon internal validation establish as 01-JAN-2027 (strength, dose number, exact quantity volume, route and anatomical site of administration were not provided) administered for prophylaxis (Improper storage of product in use).  It was also reported that the data logger was off so the reporter could not provide any temperature and time information to further evaluate the vaccine. No previous temperature excursion. No additional adverse event reported (No adverse event).
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: HCP reported that the patient has not received her third dose of the GARDASIL vaccine and has not completed her vaccination series.; No additional AE; This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   In 2021, the patient received the first two doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, route, strength, lot # and expiration date were not reported) for prophylaxis. The patient has not received her third dose of the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccine and has not completed her vaccination series (Inappropriate schedule of product administered). No additional adverse event was reported.  Lot# is being requested and will be submitted if received.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Inbound call from HBP calling to report administration of VAQTA that was expired. Caller states a medical assistant accidently administered the dose on 13-MAY-2025 and expired on 11-MAY-2025; This spontaneous report was received from a consumer or other non-health professional and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported.   On 13-MAY-2025, the patient was vaccinated accidently with an expired dose of Hepatitis A Vaccine, Inactivated Injection (VAQTA) injection, dose reported as 0.5 mL (conflicting information) administered as prophylaxis (lot number X026485 has been verified to be a valid lot number for [hepatitis a vaccine, inactivated injection], expiration date reported and established as 11-May-2025) (expired product administered) (strength, dose number, route of administration, vaccination scheme frequency and anatomical site of application were not provided).  No additional adverse events were reported (No adverse event).
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; Nurse reported that a patient received expired PEDVAX HIB on 5/13/2025.  No additional AEs were reported, no further information provided. No PQC.; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 13-MAY-2025, the patient was vaccinated with an expired dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) administered as the first dose for prophylaxis (lot number reported as W028532, which has been verified as valid, expiration date reported and validated as 09-MAY-2025) (strength, dose, route of administration, and anatomical site of injection were not reported) (Expired product administered).  No additional events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Peripheral swelling
Clinical narrative: patient received Shingrix subcutaneous instead of intramuscular; Arm red; Arm swollen; This non-serious case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a female patient who received Herpes zoster (Shingrix) (batch number 4479Y) for prophylaxis.   In JAN-2025, the patient received the 1st dose of Shingrix (subcutaneous, left deltoid). In JAN-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: patient received Shingrix subcutaneous instead of intramuscular). On an unknown date, the patient experienced erythema of extremities (Verbatim: Arm red) and swelling arm (Verbatim: Arm swollen). The outcome of the intramuscular formulation administered by other route was not applicable and the outcome of the erythema of extremities and swelling arm were resolved (duration 3 weeks).   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.     It was unknown if the company considered the erythema of extremities and swelling arm to be related to Shingrix.   Additional Information: GSK receipt date: 30-APR-2025 The nurse reported that the patient received 1stdose of Shingrix subcutaneous instead of intramuscular which led to, intramuscular formulation administered by other route. The patient said her arm was red and swollen for three weeks but did not seek medical attention.  She informed the practice of it when she returned for her 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: a big red circle rash at the injection site; Redness; "it is hot, hard and swollen; "it is hot, hard and swollen ( at injection site); "it is hot, hard and swollen ( at injection site); Sore throat; it was extremely itchy yesterday; soreness and pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of sore throat in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-APR-2025, the patient received Shingrix (intramuscular, right arm) .5 ml. On 28-APR-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness and pain at the injection site). On 30-APR-2025, the patient experienced injection site itching (Verbatim: it was extremely itchy yesterday). On 01-MAY-2025, the patient experienced sore throat (Verbatim: Sore throat). On an unknown date, the patient experienced injection site rash (Verbatim: a big red circle rash at the injection site), injection site erythema (Verbatim: Redness), injection site swelling (Verbatim: "it is hot, hard and swollen), injection site warmth (Verbatim: "it is hot, hard and swollen ( at injection site)) and injection site induration (Verbatim: "it is hot, hard and swollen ( at injection site)). The outcome of the sore throat, injection site erythema and injection site pain were not resolved and the outcome of the injection site rash, injection site itching, injection site swelling, injection site warmth and injection site induration were resolving.   It was unknown if the reporter considered the sore throat, injection site rash, injection site erythema, injection site pain, injection site itching, injection site swelling, injection site warmth and injection site induration to be related to Shingrix.     It was unknown if the company considered the sore throat, injection site rash, injection site erythema, injection site pain, injection site itching, injection site swelling, injection site warmth and injection site induration to be related to Shingrix.   Additional Information: GSK Receipt Date 01-MAY-2025: It was reported that the patient received the 1st dose of Shingrix in her right arm on April 28th, 2025, at a local pharmacy.  She reports she has "a big red circle rash at the injection site". She reports, "it is hot, hard and swollen."  The patient reports soreness and pain at the injection site. The patient reports "it was extremely itchy yesterday, but it is getting better".  The patient reports the symptoms have improved but the pain, redness, and soreness are still present. The patient reports, "on the reporting day I have a sore throat, asked is this related to the vaccine. The patient was referred to HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Oropharyngeal pain, Rash erythematous
Clinical narrative: a big red circle rash at the injection site; Redness; "it is hot, hard and swollen; "it is hot, hard and swollen ( at injection site); "it is hot, hard and swollen ( at injection site); Sore throat; it was extremely itchy yesterday; soreness and pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of sore throat in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-APR-2025, the patient received Shingrix (intramuscular, right arm) .5 ml. On 28-APR-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness and pain at the injection site). On 30-APR-2025, the patient experienced injection site itching (Verbatim: it was extremely itchy yesterday). On 01-MAY-2025, the patient experienced sore throat (Verbatim: Sore throat). On an unknown date, the patient experienced injection site rash (Verbatim: a big red circle rash at the injection site), injection site erythema (Verbatim: Redness), injection site swelling (Verbatim: "it is hot, hard and swollen), injection site warmth (Verbatim: "it is hot, hard and swollen ( at injection site)) and injection site induration (Verbatim: "it is hot, hard and swollen ( at injection site)). The outcome of the sore throat, injection site erythema and injection site pain were not resolved and the outcome of the injection site rash, injection site itching, injection site swelling, injection site warmth and injection site induration were resolving.   It was unknown if the reporter considered the sore throat, injection site rash, injection site erythema, injection site pain, injection site itching, injection site swelling, injection site warmth and injection site induration to be related to Shingrix.     It was unknown if the company considered the sore throat, injection site rash, injection site erythema, injection site pain, injection site itching, injection site swelling, injection site warmth and injection site induration to be related to Shingrix.   Additional Information: GSK Receipt Date 01-MAY-2025: It was reported that the patient received the 1st dose of Shingrix in her right arm on April 28th, 2025, at a local pharmacy.  She reports she has "a big red circle rash at the injection site". She reports, "it is hot, hard and swollen."  The patient reports soreness and pain at the injection site. The patient reports "it was extremely itchy yesterday, but it is getting better".  The patient reports the symptoms have improved but the pain, redness, and soreness are still present. The patient reports, "on the reporting day I have a sore throat, asked is this related to the vaccine. The patient was referred to HCP.
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: partial dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a patient who received Herpes zoster (Shingrix) (batch number 99d52, expiry date 25-MAR-2027) for prophylaxis.   On 09-MAY-2025, the patient received Shingrix. On 09-MAY-2025, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: partial dose). The outcome of the accidental underdose was not applicable.   Additional Information: GSK Receipt Date: 09-MAY-2025 The pharmacist reported that a patient received a partial dose of Shingrix on the day of reporting due to an issue with the needle during administration, which led to accidental underdose. There was no product quality complaint.
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: Muscle weakness both hips, both knees, both shoulders; joint pain in both hips, both knees, both shoulders; This non-serious case was reported by a consumer and described the occurrence of muscle weakness in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9SB34) for prophylaxis.   On 22-APR-2025, the patient received Arexvy .5 ml. On 25-APR-2025, 3 days after receiving Arexvy, the patient experienced muscle weakness (Verbatim: Muscle weakness both hips, both knees, both shoulders) and joint pain (Verbatim: joint pain in both hips, both knees, both shoulders). The outcome of the muscle weakness and joint pain were not resolved.   It was unknown if the reporter considered the muscle weakness and joint pain to be related to Arexvy.     It was unknown if the company considered the muscle weakness and joint pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-MAY-2025 Patient experienced muscle weakness and joint pain in both hips, both knees and both Shoulders after Arexvy administration.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: the pharmacy injected him first with the Adjuvant suspension by itself without reconstituting with the Antigen vial; the pharmacy injected him first with the Adjuvant suspension by itself without reconstituting with the Antigen vial; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a male 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 inappropriate preparation of medication (Verbatim: the pharmacy injected him first with the Adjuvant suspension by itself without reconstituting with the Antigen vial) and inappropriate dose of vaccine administered (Verbatim: the pharmacy injected him first with the Adjuvant suspension by itself without reconstituting with the Antigen vial). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 12-MAY-2025 The reporter reported that while getting the Shingrix vaccine, the pharmacy injected him first with the adjuvant suspension by itself without reconstituting with the antigen vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacy then noted the mistake and administered him the reconstituted vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination failure, Zoster sine herpete
Clinical narrative: Suspected vaccination failure; Subclincal shingles; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a elderly male 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: Subclincal shingles). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was resolved.   The reporter considered the vaccination failure and zoster sine herpete to be related to Shingrix.     The company considered the vaccination failure and zoster sine herpete to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2025 The reporter reported that patient received Shingrix vaccine and experienced subclincal shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles 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.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; small shingles outbreak on my lower back; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: small shingles outbreak on my lower back). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 29-APR-2025 This case was reported by the patient via (Shingrix Chatbot) interactive digital media. The patient was fully vaccinated against shingles, yet he/she just recently had a small shingles outbreak on lower back. The reporter wanted to know if he/she should consider getting the Shingrix vaccine and booster again. This case was considered as suspected vaccination failure as details regarding time to onset for shingles 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: have been to the Urgent Care And ER twice this week in severe psin; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced pain (Verbatim: have been to the Urgent Care And ER twice this week in severe psin). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date 01-MAY-2025: This case was reported by a patient via interactive digital media. The patient received 2 shot series Shingle vaccine, 2 years today, 4/30 and have been to the Urgent Care and emergency care twice this week in severe pain. It's going on 3 weeks now.