chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumovax 23 given in 01/2021 but was not logged into the immunization registry.  Patient was seen by his provider on 6/18/25 and they recommended him to receive Prevnar 20 that day.   They sent him to the pharmacy and it was administered 6 months early.  Patient was called and informed of the early administration and has no concerns.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Headache, Pyrexia, Rash
Clinical narrative: Following vaccination, a full-body rash developed as well as a fever > 100 F, headache, and eventually anaphylaxis requiring hospitalization.
Vaccine: HPVX
Symptoms: Paralysis
Clinical narrative: paralyzed; This serious case was reported by a consumer and described the occurrence of paralysis in a patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, an unknown time after receiving HPV vaccine, the patient experienced paralysis (Verbatim: paralyzed) (serious criteria GSK medically significant). The outcome of the paralysis was not reported.   It was unknown if the reporter considered the paralysis to be related to HPV vaccine.     The company considered the paralysis to be unrelated to HPV vaccine.   Additional Information: GSK receipt date: 03-JUL-2025 The reporter heard about a person who was paralyzed by HPV shot; Sender's Comments: A case of Paralysis, an unknown date after receiving HPV vaccine, patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received US-GSK-US2025AMR084861:Same reporter
Age: 40.0
Sex: M
Vaccine: HPV9, VARZOS
Symptoms: Mobility decreased
Clinical narrative: cannot move arm
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Patient immediately felt lightheaded after vaccine. She walked to checkout after a few minutes and fainted. We had patient sit for about 20 minutes gave her water, crackers, and a popsicle. We checked her BP.  She stated she felt better and mother agreed to go home.
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Breast pain, Lymph node pain, Pain in extremity
Clinical narrative: PT came into the pharmacy on 07/10/25, and stated that she had a lot of pain in the arm, which travelled to the lymph nodes and breast. At this point, she was feeling much better, but she also reported it to her doctor.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient reported 24 hours after getting vaccinated that she developed a large, itchy rash on her back. It got bad enough to warrant a trip to urgent care.
Age: 0.2
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Blood glucose normal, Electrocardiogram normal, Haemoglobin normal, Hyporesponsive to stimuli, Pallor
Clinical narrative: Abnormal breathing, pallor and decreased tone with decreased responsiveness x10 minutes. Brought to the ED and observed.
Age: 0.2
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Respiration abnormal
Clinical narrative: Abnormal breathing, pallor and decreased tone with decreased responsiveness x10 minutes. Brought to the ED and observed.
Age: 1.33
Sex: F
Vaccine: HIBV, PNC20, UNK
Symptoms: Febrile convulsion, Injection site bruising, Injection site erythema
Clinical narrative: Febrile seizure that lasted 4 minutes. Red and bruised at injection site.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Cellulitis at injection site (Left Deltoid). Warm, erythematous, painful welp formed within 24 hours of injection. Warmth and erythema spread with poorly defined borders down to antecubital region. Augmentin started. Ongoing treatment.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Cellulitis at injection site (Left Deltoid). Warm, erythematous, painful welp formed within 24 hours of injection. Warmth and erythema spread with poorly defined borders down to antecubital region. Augmentin started. Ongoing treatment.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Very swollen area of injection, warm to the touch and she states it feels like a deep bruise. She has been using a pain reliever and icing it.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Patient states she was unable to move her arm for over 3 days and had pain radiating to her back and neck. She states now which is 10 days after vaccine administration she is feeling a little better and can lift her arm but her neck is a little stiff and her reach is limited. Patient was counseled to follow up with primary doctor if symptoms worsen and to apply cold compress to arm in addition to using OTC analgesics.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient states she was unable to move her arm for over 3 days and had pain radiating to her back and neck. She states now which is 10 days after vaccine administration she is feeling a little better and can lift her arm but her neck is a little stiff and her reach is limited. Patient was counseled to follow up with primary doctor if symptoms worsen and to apply cold compress to arm in addition to using OTC analgesics.
Age: 1.0
Sex: M
Vaccine: DTPPVHBHPB, PNC20, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaxelis administered in error by staff, last dose administered 4/03/2025 - administered too soon - patient was supposed to only have Varicella/Prevnar at visit and return at later date for additional vaccination. Error made at administration providing incorrect immunization resulting in additional dose to patient. Without further c/o vaccine reaction from patient/mom.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity, Restless arm syndrome
Clinical narrative: Chronic pain in my arm now since I got the shot.  Restless arm feeling, loss of strength and loss of motion in arm
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Exposure during pregnancy, Injection site pain, Mobility decreased
Clinical narrative: Chronic pain in my arm now since I got the shot.  Restless arm feeling, loss of strength and loss of motion in arm
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site erythema, Injection site infection, Injection site warmth, Limb discomfort
Clinical narrative: Start heavy arm some pain then 2nd day red on injection site hot on the site the redness got bigger inflammation in the arm achy and hotter.  Bruising started 5 days after the injection. Pain in the arm for 2 weeks. The pain still there and bruise is slowly getting better.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Start heavy arm some pain then 2nd day red on injection site hot on the site the redness got bigger inflammation in the arm achy and hotter.  Bruising started 5 days after the injection. Pain in the arm for 2 weeks. The pain still there and bruise is slowly getting better.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: pt got vaccine and then after a few minutes he lost consciousnesses. after only a few seconds he regained consciousnesses and was able to speak and tell me his name. he mentioned he had not eaten at all that day. the pt has lost consciousnesses before at school but never after a vaccine. after several minutes pt was able to walk and was feeling better after a snack
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: I was pregnant at time of vaccine and my baby was born with two birth defects. Duane syndrome type 1 in her left eye which is incurable. And also webbed toes on both feet.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received an  additional RSV vaccine
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: The patient initially experienced pain at the injection site for the first few days. Subsequently, the pain migrated to the forearm. While the pain at the injection site has subsided, the patient continues to report forearm pain and difficulty grasping objects with her hand.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Sore arm, no other side effects, pt received a dose on 10/7/2023. pt was not supposed to receive another dose on 7/12/25
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Hives all over body starting 11 days after the vaccine lasting several days and may last longer. I have been taking Allegera and Benadryl to control it, neither of which are helping. Have developed dermatographism. Hives are extremely itchy and red. Appear all over body, disappearing and reappearing. Have had three prior covid vaccines, none of which caused this.
Age: 75.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: PATIENT IS HAVING PAIN AT THE INJECTION SITE IN LEFT ARM SINCE THE VACCINATION WAS ADMINISTERED. SHE COMPLAINS OF LIMITED MOVEMENT IN THAT ARM. SHE DESCRIBE THE PAIN AS IT IS BETWEEN NERVE AND BONE. AND SOMETIMES THE PAIN IS AT THE SCALE OF 10 (ON 1-10 SCALE). SHE ALSO STATES THAT PAIN IS GETTING WORSE AND INJECTION  SITE IS PAINFUL TO TOUCH. SHE STATES THAT SHE TAKES IBUPROFEN FOR THE PAIN, BUT IT ONLY HELPS FOR A SHORT DURATION. PATIENT WAS RECOMMENDED TO MAKE APPOINTMENT WITH HER PRESCRIBER. I CALLED AND LEFT MESSAGE WITH HER DOCTOR'S OFFICE AS WELL AND INFORMED ABOUT THE SITUATION.  LATER TODAY PATIENT CONFIRMED SHE HAD MADE APPOINTMENT WITH HER DOCTOR TODAY.
Age: 91.0
Sex: M
Vaccine: PNC20
Symptoms: No adverse event
Clinical narrative: A second dose of Prevnar-20 was administered upon patient request. First dose was given in 2023. Patient experienced no adverse effect from the second vaccination.
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Dyspnoea, Feeling abnormal, Pain in extremity
Clinical narrative: Patient called to inform the pharmacy she already received the pneumonia vaccine in November 2024 and believed she was having an allergic reaction. She stated her arm was sore, she felt bad, and she was short of breath the evening of 7/12/25.  She stated she was taking Benadryl and pain relievers to help with the reaction. Pharmacist explained ibuprofen or Tylenol will help with pain and Benadryl with swelling, but any shortness of breath is a medical emergency and she would need to be seen if she was experiencing that.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient called Sunday (7.13) to report a 4 inch raised rash by the injection site. Patient states it is itchy and burns. I counseled patient to use OTC measures for the itching and pain. She had already taken famotidine before calling.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: A patient was given a shingrix vaccine but he had already finished the two dose series, in fact this was a fourth dose according to database which was checked later when we thought we were giving him a second dose.
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Hard lump about 1  inch in diameter where vaccine administered for 2-3 days. Currently hot to touch and redness that seems to be spreading toward elbow. advised to ice, take Benadryl or other antihistamine, and to seek either regular PCP or urgent care.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram neck normal, Computerised tomogram thorax normal, Dysphonia, Laryngoscopy abnormal
Clinical narrative: Hoarseness  onset 6/14/25. No response to antibiotic and prednisone.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vocal cord paralysis
Clinical narrative: Hoarseness  onset 6/14/25. No response to antibiotic and prednisone.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Headache, Swelling
Clinical narrative: Swelling, joint pain, headaches
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Discomfort, Pain, Swelling, Tenderness
Clinical narrative: patient presented with a baseball size bruise, slight swelling, tenderness, and mild/moderate pain. Profound Bruising and patient was in discomfort and wanted to ensure we were aware.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Malaise
Clinical narrative: Patient came to the pharmacy to ask what to do with the redness and swelling in her arm. She received the Prevnar 20 vaccine on 7/10/25 and felt sick on the 11th and 12th and still has redness and swelling today 7/13. Upon inspection of the right upper arm, the injection site appears red with about 1 inch margins around the injection site. Patient stated she feels 'ok' today, but still has redness and itching on her arm which appears to be worsening.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: DISCOVERED VACCINE WAS EXPIRED POST ADMINISTRATION; PATIENT AWARE; WILL CONTACT GSK TO DETERMINE WHETHER PATIENT NEEDS TO BE RE-VACCINATED
Age: 67.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash below area of injection that occurred 2 days after immunization given.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Pain at injection site; Heat at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included lisinopril dihydrate (Lisinopril).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 30-JUN-2025, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: Heat at injection site). On an unknown date, the patient experienced injection site pain (Verbatim: Pain at injection site). The patient was treated with diclofenac sodium (Salonpas). The outcome of the injection site pain and injection site warmth were not resolved.   It was unknown if the reporter considered the injection site pain and injection site warmth to be related to Shingrix.     It was unknown if the company considered the injection site pain and injection site warmth to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUL-2025 The patient stated she received the vaccine approximately 18 weeks ago. As soon as she received the vaccination the injection was very painful, and the pain had not resolved. The patient had reported this twice to her pharmacy and examined twice by a Primary Care Professional.   The patient stated she was told to put a Salonpas patch on the area and she had been doing that.   She had blood work done yesterday by her Primary Care Professional to understand what the problem was may be.   When examined yesterday the Health Care Professional stated she could feel heat at the injection site.   The patient stated her Primary Care Professional told her when she was vaccinated the needle may have hit her bone. The patient mentioned she has hypertension and was prescribed Lisinopril (dose not disclosed) to be taken as needed for elevated blood pressure.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes at the location of her left collar bone and left upper arm; felt pain after the injection.; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) (batch number 99D52, expiry date 25-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date).   On 29-JUN-2025, the patient received the 2nd dose of Shingrix (left arm) .5 ml. On 29-JUN-2025, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: felt pain after the injection.). On 01-JUL-2025, the patient experienced swollen lymph nodes (Verbatim: swollen lymph nodes at the location of her left collar bone and left upper arm). The outcome of the pain in arm was resolving and the outcome of the swollen lymph nodes was not resolved.   It was unknown if the reporter considered the pain in arm and swollen lymph nodes to be related to Shingrix.     It was unknown if the company considered the pain in arm and swollen lymph nodes to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUL-2025 The reporter was the patient who received her 2nd dose of Shingrix on the 29th of June 2025 in her left arm.  The reporter stated that she immediately felt pain after the injection.  The pain was still ongoing, but it was not as severe as it was before.  The reporter stated that yesterday the 1st of July 2025 she noticed swollen lymph nodes at the location of her left collar bone and left upper arm.  The reporter did not want to give her date of birth and states she was an adult over the age of 50 years old.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: she has not been well; not received her second dose yet;  This non-serious case was reported by a consumer via call center representative and described the occurrence of unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer (diagnosed pre Shingrix vaccination).   On 04-NOV-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced unwell (Verbatim: she has not been well) and incomplete course of vaccination (Verbatim: not received her second dose yet). The outcome of the unwell was not resolved and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the unwell to be related to Shingrix.     It was unknown if the company considered the unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JUL-2025 The patient stated that she received the first dose of Shingrix on 04 November 2024 and had not received her second dose, yet which led to incomplete course of vaccination. The patient mentioned that she had not been well due to having cancer and receiving treatment (Cancer was diagnosed pre Shingrix).
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the first dose of Shingrix vaccine back on 17 May 2023/Late 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 68-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17-MAY-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: had the first dose of Shingrix vaccine back on 17 May 2023/Late second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 01-JUL-2025 and 07-JUL-2025 She wanted to know if it was needed to restart the wholes series or just administer a booster dose.  Health Care Provider confirmed that the patient got the shot on a different facility and no Expiration date nor Lot number were available for doing a follow-up. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd 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 adult female patient who did not receive HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (on 16-AUG-2024 1st dose received).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   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: 02-JUL-2025 The patient got the 1st dose of Twinrix and she came in (at the time of reporting) today to get the 2nd dose. Till the time of reporting the patient had not received the second dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient got an extra dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient got an extra dose of Shingrix). The outcome of the extra dose administered was not applicable.   Additional Information: GSK receipt date: 02-JUL-2025 The pharmacist reported that a patient got an extra dose of Shingrix because it wasn't in the registry which led to extra dose administration.
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: A 34 years old female patient received a pediatric dose of Havrix; A 34 years old female patient received a pediatric dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 34-year-old female patient who received HAV (Havrix pediatric) (batch number Y014446, expiry date 01-FEB-2026) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: A 34 years old female patient received a pediatric dose of Havrix) and adult use of a child product (Verbatim: A 34 years old female patient received a pediatric dose of Havrix). The outcome of the underdose and adult use of a child product were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:07-Jul-2025 A Medical Assistant called to report that they administered a pediatric dose of Havrix to a 34 years old female patient, which led to underdose and adult use of a child product. The reporter asked what were the next steps to follow and when did the patient had to receive the adult dose. The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Neck mass
Clinical narrative: 5 Localized raised large red bumps on right side of neck under jawline in lymph node area; Initial information received on 10-Jul-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional).  This case involves 21 years old female patient who had 5 localized raised large red bumps on right side of neck under jawline in lymph node area after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Jul-2025, the patient received a dose of 1 DF (total) (dosage form) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection (lot U8232AA) (strength and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation).  On 10-Jul-2025, the patient developed 5 localized raised large red bumps on right side of neck under jawline in lymph node area (rash erythematous) (Ltency: 2 days).  Action taken was not applicable.  The patient was treated with Diphenhydramine hydrochloride (Benadryl) for Rash erythematous.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
Vaccine: PNC15
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: HCP stated that a 2 month old patient did not receive a full dose of  the VAXNEUVANCE vaccine. HCP stated that the patient may have received 0.1 to 0.2 mLs of the VAXNEUVANCE dose.; HCP reported that the needle came out during the administration of the vaccine and the patient did not  receive the full dose of the VANEUVANCE.; HCP reported that the needle came out during the administration of the vaccine; No additional AE; This spontaneous report was received from a medical assistant and refers to a 2-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) administered for prophylaxis (strength, dosage, lot # and expiration date, route and anatomical site of administration were not reported).  Due to the needle came out during the administration of the vaccine (needle issue; poor quality device used) the patient did not receive a full dose of the vaccine; the patient may have received 0.1 to 0.2 mL (underdose). No additional adverse events (No adverse event). Reporter provided limited pertinent information and demographic data.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 16 y.o male with 4cm x 4cm area of warmth, tenderness, erythema & induration over left deltoid about 72 hrs after Bexsero was given. Will treat with 10 day Cephalexin course due to secondary Cellulitis
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: not symptomatic; administration of GARDASIL-9 to a 4-month-old patient; This spontaneous report was received from a nurse and refers to a 4-month-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-Jul-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y012865, expiration date: 10-Oct-2026), administered for prophylaxis by a healthcare profession (strength, dose, and route were not reported) (Product administered to patient of inappropriate age). The patient was not symptomatic (No adverse event).
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: have received Gardasil 9 beyond age indication; No additional AE; This spontaneous report was received from a nurse via company employee and referred to an Elderly (age reported as 70s) patient of unknown gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient received Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) (strength, formulation, dose, route, lot # and expiration date were not reported) for prophylaxis beyond age indication (Product administered to patient of inappropriate age). No additional event was reported.
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: have received Gardasil 9 beyond age indication; No additional AE; This spontaneous report was received from a nurse via company employee and referred to an adult (age reported as 50s) patient of unknown gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient received human papillomavirus 9-valent vaccine, recombinant (GARDASIL9) (strength, formulation, dose, route, lot # and expiration date were not reported) for prophylaxis beyond age indication (Product administered to patient of inappropriate age). No additional event was reported. This is one of 2 reports from the same reporter.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no symptoms reported; Consumer received her second dose of GARDASIL 9 in May of 2025.; This spontaneous report was received from a 26-year-old female patient and refers to herself.   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 in August 2023, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, administered for prophylaxis (strength, dose, route, lot #, and expiration date were not reported). On an unknown date in May 2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Inappropriate schedule of product administration). It was first identified by the patient and pharmacist on 08-Jul-2025. No symptoms were reported (No adverse event).  Lot# is being requested and will be submitted if received.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: a small rash with no open lesions across his back at the belt line; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2025, the patient received the 1st dose of Shingrix (intramuscular). On 27-JUN-2025, 64 days after receiving Shingrix, the patient experienced rash (Verbatim: a small rash with no open lesions across his back at the belt line). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUL-2025 The patient called to ask if he should receive his 2nd dose of Shingrix. He described a small rash with no open lesions across his back at the belt line.  It crosses the midline.  This report was being submitted with minimal information. No additional information is known.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got them;  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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got them). 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 Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and still got them (shingles). It was more mild than most he/she guesses.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: My 17 year old daughter received one dose on June 23 and the second dose today on July 7; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On 07-JUL-2025, the patient received the 2nd dose of Bexsero. On 07-JUL-2025, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: My 17 year old daughter received one dose on June 23 and the second dose today on July 7). The outcome of the drug dose administration interval too short was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-JUL-2025 The reporter reported that the patient received one dose of Bexsero vaccine on June 23 and the second dose today on July 7 as directed by our provider, which led to drug dose administration interval too short. The reporter was ask this was correct dosage, according to what reporter seeing on the site it looks like it should have been 6 months apart.
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: patient received a dose of Kinrix instead of Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (Patient has 2 previous doses of Pediarix) and Pediarix (Patient has 2 previous doses of Pediarix).   On an unknown date, the patient received Kinrix and Pediarix. On an unknown date, an unknown time after receiving Kinrix and Pediarix, the patient experienced wrong vaccine administered (Verbatim: patient received a dose of Kinrix instead of Pediarix). The outcome of the wrong vaccine administered was not applicable.   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: 30-JUN-2025 Other reported that they administered a dose of Kinrix to a female patient who was 2 years old instead of Pediarix, which led to wrong vaccine administered. Do they need to revaccinate? What are the next steps? Any safety information available? Patient had 2 previous doses of Pediarix.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I got my first shingrix shot in 2019 and second in 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first Shingrix shot in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I got my first shingrix shot in 2019 and second in 2025). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 30-JUN-2025 Reporter stated that patient got first Shingrix shot in 2019 and second in 2025, which led to drug dose administration interval too long. Also asked if they need another one or not.
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: Priorix was reconstituted using DTaP IPV liquid (component of Pentacel); Priorix was reconstituted using DTaP IPV liquid (component of Pentacel)/Reconstitution with a different diluent;  This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Priorix was reconstituted using DTaP IPV liquid (component of Pentacel)) and inappropriate dose of vaccine administered (Verbatim: Priorix was reconstituted using DTaP IPV liquid (component of Pentacel)/Reconstitution with a different diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   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: 01-JUL-2025 The reporter mentioned that Priorix was reconstituted using DTaP-IPV liquid (component of Pentacel) which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered The pharmacist enquired if they have any information on safety and stability when Priorix was reconstituted with anything else other than the provided diluent.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old female patient who received HAB (Twinrix) (batch number M4B34, expiry date 28-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 19-NOV-2024 with batch number 2553X and lot expiry 25-SEP-2026).   On 08-JUL-2025, the patient received the 2nd dose of Twinrix. On 08-JUL-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long was not applicable.   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: 09-JUL-2025 The pharmacist asked what was the recommended time interval between dose two and three of Twinrix taking into account that the second dose was given late, which led to drug dose administration interval too long. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: PNC20
Symptoms: Hyperhidrosis, Injection site pain, Pyrexia, Sleep disorder
Clinical narrative: fever/started having 102 F (38.9 C) fever; I couldn't sleep; sweating; pain at injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: 002191.  A 57-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 09Jul2025 at 09:00 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 09Jul2025, outcome "unknown", described as "I couldn't sleep"; VACCINATION SITE PAIN (non-serious) with onset 09Jul2025, outcome "not recovered", described as "pain at injection site"; HYPERHIDROSIS (non-serious) with onset 09Jul2025, outcome "unknown", described as "sweating"; PYREXIA (non-serious) with onset 09Jul2025 at 21:00, outcome "not recovered", described as "fever/started having 102 F (38.9 C) fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient had fever after getting the shot of Prevnar 20 and is asking if fever is normal after getting it. She received Prevnar 20 yesterday (09Jul2025) at ~9am and at 9pm, she started having 102 F (38.9 C) fever that was unbearable. She couldn't sleep and took Tylenol at midnight. Besides the fever, she was sweating and had pain at injection site. She felt better after 2 hours and pain was reduced. The next morning morning, the fever is bearable and under control but there is still pain at the injection site, it still hurts.      No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Respiratory disorder
Clinical narrative: Still having adverse effects and bad symptoms of your vaccine; Still having all the symptoms of Covid-19; Still having adverse effects and bad symptoms of your vaccine; Still having all the symptoms of Covid-19; Respiratory issues; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Still having adverse effects and bad symptoms of your vaccine; Still having all the symptoms of Covid-19"; RESPIRATORY DISORDER (non-serious), outcome "not recovered", described as "Respiratory issues". Clinical course: Consumer stated, "I wanted to see where, it's been a while and I have been like, I have got into the research and medicine myself and I am still experiencing many symptoms of adverse effect of vaccine, and I wanted to see if you still have like trials open. Maybe if I could be part of your research of any reports being done that were mistakenly made or, because I am still having, like I said, adverse effects and bad symptoms of your vaccine and still having respiratory issues and all the symptoms of Covid-19." When probed to clarify if consumer took the Pfizer Covid-19 Vaccine, consumer stated, "I had the Pfizer and I am still having all the symptoms of Covid-19." When paraphrased the concern, consumer stated, "Yes, what's available? Who could I report it to? Where do I report it to and if I could speak with someone in person about the symptoms. Do you have a clinic to welcome the people who were affected from vaccine or where it did not work, and I am still having Covid-19 symptoms."  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: ill with tremors and basically crippled now; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EW0175) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (disability), outcome "not recovered", described as "ill with tremors and basically crippled now".
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations, Specialist consultation
Clinical narrative: an increased heartrate; palpitations; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 2, single (Lot number: EW0181) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE; BATCH/LOT NUMBER: EW0181), administration date: 04Jul2021, for Covid-19 immunisation. The following information was reported: HEART RATE INCREASED (non-serious) with onset 14Aug2021, outcome "not recovered", described as "an increased heartrate"; PALPITATIONS (non-serious) with onset 14Aug2021, outcome "not recovered". The events "an increased heartrate" and "palpitations" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate increased, palpitations. Additional information: A few days after receiving the 2nd of the 3 Pfizer COVID-19 vaccines, reporter said he experienced an increased heartrate and palpitations during rest.  Over next several years, these same symptoms would happen on occasion. Reporter saw a Cardiologist this past month to get it checked.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500141443 same patient/events, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations, Specialist consultation
Clinical narrative: an increased heartrate; palpitations; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE; BATCH/LOT NUMBER: EW0181), administration date: 04Jul2021, for Immunisation; comirnaty (DOSE 2, SINGLE; BATCH/LOT NUMBER: EW0181), administration date: 11Aug2021, for Immunisation, reaction(s): "Heart rate increased", "Palpitations". The following information was reported: HEART RATE INCREASED (non-serious), outcome "not recovered", described as "an increased heartrate"; PALPITATIONS (non-serious), outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate increased, palpitations. Additional information: A few days after receiving the 2nd of the 3 Pfizer COVID-19 vaccines, reporter said he experienced an increased heartrate and palpitations during rest.  Over next several years, these same symptoms would happen on occasion. Reporter saw a Cardiologist this past month to get it checked.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500141424 same patient/events, different dose;