chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Eye discharge, Eye pain, Ocular hyperaemia, Swelling of eyelid, Vision blurred
Clinical narrative: 04/25/2025 patient sent a portal message that on 04/24/2025 she started with severe pain in both eyes, redness, and production of mucous. Had a lot of pain and blurry vision. both eyes swollen shut.  Went to see OD
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pain, Scab, Secretion discharge
Clinical narrative: he says he developed bubbling blisters on his feet between his toes and the edges of his ankles and soles of his feet. They will pop and ooze and then dry up. He tried everything. Its kind of like a poison. These have migrated to his bottom side (buttocks and outer thighs) They come out in long painful swirls.  This has continued for four years. His doctors have looked at them but do not know what they are or how to treat them. He is going to ask his doctors to send him to a specialist for treatment.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis
Clinical narrative: Pt previously had pfizer vaccinations, last dose 5/2022 - okay with moderna. given 1105 pt waited in clinic for 15min with no issues then left. at 1130 came back reporting excessive sweating and light dizziness. states she did not eat yet today but had coffee and water. pt brought in to clinic, vitals normal, blood glucose normal. pt drank water and after 3-4min pt felt normal again. husband was called to clinic to drive her. patient stated she felt full symptom resolution and was okay to leave. advised to fu with er if symptoms reoccur and to fu with her pcp.
Age: 48.0
Sex: M
Vaccine: FLU3, HEP, MMR, TDAP, VARCEL
Symptoms: Hyperhidrosis, Hyporesponsive to stimuli, Pallor
Clinical narrative: Client experienced a 10 second episode of decrease responsiveness, pallor and diaphoresis 3 minutes after receiving vaccine. Vital signs remained stable.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: i was told to call mother to apologize for the incorrect vaccine. just got extra tetanus vaccine but no harm as per the Dr.
Age: 56.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Erythema, Injection site erythema, Skin warm
Clinical narrative: erythema around injection site started day of vaccine, now 6 days post vaccination redness has spread down the entire arm & is warm to touch. denies fever, chills. no drainage, no pain, no itching.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: 30 minutes past injection time, the donor stated that she felt nauseous and lightheaded. Donor asked for an emesis bag, vomited in the bag. Donor then stated that she felt better and left under own volition. Medical staff was unable to perform any vitals or post immunization reaction treatment due to the donor leaving.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Scratch, Underdose
Clinical narrative: Patient moved unexpectedly. Mom thought she had her, but patient was a lot stronger, so she moved in the process of getting vaccine. did not receive full dose. Did sustain superficial scratch from the needle. Band-Aid applied to area. Provider notified to assess.
Age: 53.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Pt received HPV vaccine on 03/20/2025. Provider was informed about pt receiving vaccine at 3/20/25 visit by nursing manager on 03/20/2025. Pt was contacted after visit that date and care giver was informed about the event with no further questions. On 3/28/25, received message pt had a question about the vaccine. Spoke with pt about the HPV vaccine event. Pt was informed provider was informed about this immunization being given by RN Manager and from safety aspect provider has no concerns regarding the patient receiving the vaccine; provider stated that the vaccine just isn't as effective due to patient's age. Pt verbalized understanding. Pt states her arm feels sore from vaccine but denies any other concerns. Pt was informed she may feel sore as this is an intramuscular injection and can have some soreness for a few days. Pt was informed RN spoke with caregiver as well about it. Pt expressed understanding and had no other further questions at the end of the call.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Feeling cold, Headache, Pyrexia, Rash macular
Clinical narrative: Patient experienced fever, chills, and headache for 1 week since vaccination. Also developed red blotchy patches on the arm of the injection.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blindness, Syncope
Clinical narrative: 4/28/25 Patient received TDAP, HPV, and Menquadfi vaccines. Patient and mother was at checkout window when event occurred at approximately 1:32pm. Mom stated that she needed help because patient was fainting. office Supervisor called code blue at 1:32 pm. RN got a chair for patient and helped lower her to sit in chair. Mom stated that she said she could not see and started to faint. Someone retrieved the ammonia smelling stuff. Patient opened her eyes while sitting in chair.  Someone completed blood pressure and I placed pulse ox on patient. vitals at 1:35 pm were blood pressure of 70/52, pulse 75, spo2 97%.  Someone retrieved water for patient. They also give patient a wet and cool napkin to place on her head.  Vitals at 1:40pm were blood pressure of 94/58, pulse 82, spo2 98%. Patient stated that she was feeling better. mom was given information about fainting and vaccines. Mom states that patient faints often. Mom and patient was escorted out to vehicle by someone.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia, Peripheral swelling
Clinical narrative: The patient experience some tingling and said her hand swelled up some later that day. Her arm started to bruise as well around the site. The swelling in hand subsided and has gone away entirely but there is some bruising around the site. Her shoulder area feels fine and not painful . But still tender in the bruised area which has yellowed some since last week.
Age: 54.0
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Severe muscle aches and low-grade fever for 36 hours after vaccine.  Low grade fever for following 2 nights.  Redness in arm below injection site that was red, itchy, and warm.  Improved over the next 3 days.
Age: 54.0
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Severe muscle aches and low-grade fever for 36 hours after vaccine.  Low grade fever for following 2 nights.  Redness in arm below injection site that was red, itchy, and warm.  Improved over the next 3 days.
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: full body rash that required doctor visits and treatment
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness
Clinical narrative: I had no symptoms after the vaccine. And then all of a sudden after to vaccine i felt light headed drying dishes ]. Someone took my blood pressure and it was not what it should be i went a saw my heart doctor and i found out a  Afib
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cough, Decreased activity, Decreased appetite, Erythema
Clinical narrative: Day 1 started with localized redness, increased in size on day 2 with difficulty walking which became refusal to bear weight by day 5. Developed fever to 103, runny nose and dry cough, chills, lethargy, vomiting from da2-5. Currently still symptomatic. Seen on 04/28/2025 with presence of Otitis media, redness 6 cm with underlying induration of very tender 10 to 12 cm diameter. Decreased activity and lethargy, decreased appetite throughtout
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Induration, Lethargy, Otitis media, Pyrexia
Clinical narrative: Day 1 started with localized redness, increased in size on day 2 with difficulty walking which became refusal to bear weight by day 5. Developed fever to 103, runny nose and dry cough, chills, lethargy, vomiting from da2-5. Currently still symptomatic. Seen on 04/28/2025 with presence of Otitis media, redness 6 cm with underlying induration of very tender 10 to 12 cm diameter. Decreased activity and lethargy, decreased appetite throughtout
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Rhinorrhoea, Tenderness, Vomiting, Weight bearing difficulty
Clinical narrative: Day 1 started with localized redness, increased in size on day 2 with difficulty walking which became refusal to bear weight by day 5. Developed fever to 103, runny nose and dry cough, chills, lethargy, vomiting from da2-5. Currently still symptomatic. Seen on 04/28/2025 with presence of Otitis media, redness 6 cm with underlying induration of very tender 10 to 12 cm diameter. Decreased activity and lethargy, decreased appetite throughtout
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Laboratory test
Clinical narrative: Heart failure
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event to report. Patient was inadvertently given a 3rd dose of Hepatitis A vaccine that was not needed.
Age: 40.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received duplicate vaccines.  Patient received Tdap, flu, and covid 11/19/24. Patient didn't state he had these and it wasn't pulling up in system right away. After vaccines were given 04/28/25, nurse went to document and noticed vaccines needed to be reconciled. Then it was updated in system and showed patient had the same vaccines 11/19/24. Patient was called and informed of the situation.
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left Arm became red from injection site to elbow and was warm to the touch.
Age: 25.0
Sex: M
Vaccine: COVID19, TYP, YF
Symptoms: Limb discomfort, Pain, Tenderness
Clinical narrative: Patient reports the following: on Tuesday (4/22/25) 1 day after vaccination felt achy and tired, and on Wednesday (4/23/25) 2 days after vaccines noticed tenderness under left arm when applying deodorant. Called on Friday (4/25/25) 4 days after vaccines to discuss symptoms. Also notes discomfort in the underarm area when raising or extending left arm. Not getting worse, but noticeable. No enlarged lymph nodes on palpation of the area per patient. No fever or other systemic symptoms. Assessment - Symptoms are consistent with lymphadenopathy under the left arm following 2 vaccinations, including covid vaccine to the left arm. Rxn has been reported in 15% of vaccinations and usually resolves within 1 week. Asked patient to monitor, hydrate, and treat symptoms with pain reliever as needed, and to report back on 4/28/25 (monday) on progress and to seek medical care if symptoms worsen.         Followed up with patient on 4/28/25 who self described 30% improvement in symptoms under his left arm. Only painful if lifts arm and extends over his head. Pt spoke with his primary care Dr who is not overly concerned, MD told pt most likely swollen lymph gland from vaccine and to make appt if no further improvement in a few days. Pt taking 1 advil per day for pain. I told pt to check in with us in a few days (Wednesday 4/30/25)
Age: 3.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Given Kinrix at 3y 9m old and manufacturer specifies to be given from 4y-6y. Medication error, no signs or symptoms of adverse reaction from patient.
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Patient reported to pharmacy on 04/28/2025, and stated that she has redness, swelling, felt feverish for several days after the injection on the 16th of April.  Patient self treated and stated things settled down over the course of 5 to 7 days, never obtained medical or pharmacy assessment during time of reaction.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; a patient received improperly stored vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On 25-Mar-2025, the patient was vaccinated with 1 dose of improperly stored vaccine of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y014436, expiration date: 22-Feb-2026), diluted with sterile diluent (MERCK STERILE DILUENT), administered as prophylaxis (dose, strength, and route of administration) (improper storage of product in use). The vaccine was exposed to temperature excursion (Temperature: 14.92 F, Time frame: 1 hour 40 minutes) on an unknown date. There was no previous temperature excursion. No adverse event was reported (no adverse event).
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; a patient who was inadvertently administered GARDASIL 9 at less than the indicated age; This spontaneous report was received from a physician and refers to 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.    On 15-Mar-2024, the patient was inadvertently vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) 0.5 mL (valid lot #X005579, expiration date: 30-Nov-2024) (route of administration was not provided) for prophylaxis at less than the indicated age (product administered to patient of inappropriate age). No additional adverse event (AE) was reported.
Sex: F
Vaccine: BCG
Symptoms: Poor quality product administered, Product preparation error
Clinical narrative: poor quality product administered; HCP states that they did not receive any DILUENT with the orders and do not have lot and expiration dates for the DILUENT they used to reconstitute; This spontaneous report was received from a health care professional (HCP) and refers to a female  patient of unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient started therapy with bacille Calmette-Guerin (TICE BCG LIVE) for an unknown indication.   On 13-Feb-2025, the patient had poor quality product administered (Poor quality product administered); 2 lots were reported: lot #Y011796, expiration date: 03-Jul-2025 and lot #y017668 expiration date: 23-OCT-2025. Upon receipt of the bacille Calmette-Guerin (TICE BCG LIVE) they found that the powder in all the vials was "as hard as a rock and stuck to the bottom of the vials", color was cream white. They reconstituted and administered 3 of them. HCP states that they did not receive any diluent with the orders and do not have lot and expiration dates for the diluent they used to reconstitute (Product preparation error).   No further information provided.
Vaccine: MMR
Symptoms: Contraindication to vaccination
Clinical narrative: HCP calling to state that they gave the MMR-II vaccine to an individual who has Multiple Sclerosis and has an unspecified autoimmune disease. After administering the MMR-II they were told the patient is also immunocompromised. HCP did not provide fur; they gave the MMR-II vaccine to an individual who has Multiple Sclerosis and has an unspecified autoimmune disease; This spontaneous report was received from a pharmacist and refers to a 36-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included multiple sclerosis, and an unspecified autoimmune disease. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) solution for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis (Contraindicated product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not reported).  The reporter stated that after administering measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) they were told the patient was also immunocompromised. The outcome of the event was not reported.  The causal relationship between the event and the suspect vaccine reconstituted with the suspect sterile diluent (MERCK STERILE DILUENT) was not provided.  Upon internal review, the event of immunocompromised was determined to be medically significant.
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The HCP reports that a patient was administered MMR II today that occurred in a temperature excursion. The DILUENT used to reconstitute the vaccine lot/exp is unknown. No other information is available surrounding this case. This ca; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml, lot #Y012439, expiration date: 16-Jul-2026 (strength, dose number, route, and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). The temperature excursion was: 11°C, Time frame: 1 hour 0 minutes 0 seconds and it was unknown if  There was a previous temperature excursion. No adverse event reported.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: She received one dose 7/2007 and the second dose 9/2007; This spontaneous report was received from a Physician Assistant on 24-Apr-2025 and refers to a currently 29-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   In 2007, the patient was vaccinated with 2 doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) for prophylaxis, first dose in July 2007, second dose in September 2007 (strength, dose, route, lot # and expiration date were not reported) (Inappropriate schedule of product administration).   Lot # is being requested and will be submitted if received.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported patient received an expired dose of VAQTA.  No additional AEs or PQC reported.; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 24-Apr-2025, the patient received the hepatitis A vaccine, Inactivated Injection (VAQTA) 1 mL, lot #X024966 administered by Intramuscular route for prophylaxis, which was expired on 23-Mar-2025 (Expired product administered). No adverse event was reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Provider requesting information on administering a second dose of GARDASIL 9 to a patient. She states that the patient received their first dose 2/21/2020 when she was 13 years old. She is now requesting to finish the series. No additional AE, no PQC; No additional AE; This spontaneous report has been received from a physician regarding a female patient of unknown age.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 21-FEB-2020, when the patient was 13 years old, she was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  The patient is now requesting to finish the series, and the healthcare provider requested information on administering the second dose (Inappropriate schedule of product administration). No additional adverse event was reported.
Sex: F
Vaccine: RSV
Symptoms: Encephalitis
Clinical narrative: encephalitis; This serious case was reported by a other health professional and described the occurrence of encephalitis in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 04-OCT-2024, the patient received Arexvy. On 27-NOV-2024, 54 days after receiving Arexvy, the patient experienced encephalitis (Verbatim: encephalitis) (serious criteria hospitalization and GSK medically significant). On 10-JAN-2025, the outcome of the encephalitis was resolved (duration 1 month 14 days).   It was unknown if the reporter considered the encephalitis to be related to Arexvy.     The company considered the encephalitis to be unrelated to Arexvy.   Additional Information: GSK receipt date: 22-APR-2025 The reporter reported that the extensive work up in hospital and after the hospital. On high-dose steroids for about 8 weeks. On the day of reporting in the office patient was fully recovered. The reporter reported that the patient complete work up without another diagnosis. The patient was in hospital for encephalitis unspecified to unspecified. The expiry date of Arexy was unknown.; Sender's Comments: Encephalitis is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: About a month after the 2nd shot I developed Bell's palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (got the 2 shingles shots about 6 months apart).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: About a month after the 2nd shot I developed Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was resolved (duration 6 weeks).   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.     The company considered the bell's palsy to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 20-APR-2025 This case was reported by a patient via interactive digital media.  Patient stated that he/she got the 2 shingles shots about 6 months apart and about a month after the 2nd shot he/she developed bell's palsy. Patient stated that he/she was thankful, it went away after about 6 weeks, but indicated that it was worth getting the shots.; Sender's Comments: Bell's palsy is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: shivering; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included depression and suicidal ideation. Family history included shingles (Patient father had Shingles in the past).   In FEB-2022, the patient received the 1st dose of Shingrix. In FEB-2022, less than a day after receiving Shingrix, the patient experienced shivering (Verbatim: shivering). The outcome of the shivering was resolved (duration 1 day).   It was unknown if the reporter considered the shivering to be related to Shingrix.     It was unknown if the company considered the shivering to be related to Shingrix.   Linked case(s) involving the same patient:  US2024137579   Additional Information: GSK Receipt Date: 23-APR-2025 The patient added that she also experienced shivering with dose one Shingrix.  The shivering started within 24 hours of receiving vaccine and resolved in a day.; Sender's Comments:  US-GSK-US2024137579:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Blisters on nose and on back; This non-serious case was reported by a nurse via sales rep and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3334Y) for prophylaxis.   On 03-APR-2025, the patient received the 1st dose of Shingrix (unknown deltoid). On 03-APR-2025, less than a day after receiving Shingrix, the patient experienced blister (Verbatim: Blisters on nose and on back). The outcome of the blister was unknown.   The reporter considered the blister to be related to Shingrix.     The company considered the blister to be related to Shingrix.   Additional Information: GSK receipt date: 17-APR-2025 The patient experienced blisters on nose and on her back.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Inappropriate schedule of product administration, Mobility decreased
Clinical narrative: sore arm; Swollen arm; red arm; warm arm; Fever; Chills; body ache; Headache; she cannot move her arm well; late dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine in July of last year).   On 14-APR-2025, the patient received the 2nd dose of Shingrix. In APR-2025, less than a week after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm), swelling arm (Verbatim: Swollen arm), erythema of extremities (Verbatim: red arm), skin warm (Verbatim: warm arm), fever (Verbatim: Fever), chills (Verbatim: Chills), general body pain (Verbatim: body ache), headache (Verbatim: Headache), mobility decreased (Verbatim: she cannot move her arm well) and drug dose administration interval too long (Verbatim: late dose). The outcome of the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, headache and mobility decreased were unknown and the outcome of the general body pain was resolved and the outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, general body pain, headache and mobility decreased to be related to Shingrix.  It was unknown if the company considered the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, general body pain, headache and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2025 The patient received her second dose of Shingrix on Monday. She stated that after her dose, she experienced a sore, swollen, red, warm arm, fever, chills, body ache and headache. She also states that she cannot move her arm well. She received her first dose of Shingrix in July of last year which led to drug dose administration interval too long. Other Conditions were reported as unknown.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: sore arm; Swollen arm; red arm; warm arm; Fever; Chills; body ache; Headache; she cannot move her arm well; late dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine in July of last year).   On 14-APR-2025, the patient received the 2nd dose of Shingrix. In APR-2025, less than a week after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm), swelling arm (Verbatim: Swollen arm), erythema of extremities (Verbatim: red arm), skin warm (Verbatim: warm arm), fever (Verbatim: Fever), chills (Verbatim: Chills), general body pain (Verbatim: body ache), headache (Verbatim: Headache), mobility decreased (Verbatim: she cannot move her arm well) and drug dose administration interval too long (Verbatim: late dose). The outcome of the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, headache and mobility decreased were unknown and the outcome of the general body pain was resolved and the outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, general body pain, headache and mobility decreased to be related to Shingrix.  It was unknown if the company considered the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, general body pain, headache and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2025 The patient received her second dose of Shingrix on Monday. She stated that after her dose, she experienced a sore, swollen, red, warm arm, fever, chills, body ache and headache. She also states that she cannot move her arm well. She received her first dose of Shingrix in July of last year which led to drug dose administration interval too long. Other Conditions were reported as unknown.
Sex: F
Vaccine: RSV
Symptoms: Computerised tomogram normal, Dizziness, Laboratory test normal, Magnetic resonance imaging normal, Vestibular function test normal
Clinical narrative: Got dizzy; This non-serious case was reported by a consumer and described the occurrence of dizziness in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number H2522, expiry date APR-2025) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included lisinopril dihydrate (Lisinopril).   On 06-SEP-2023, the patient received Arexvy. On 06-SEP-2023, 1 hr after receiving Arexvy, the patient experienced dizziness (Verbatim: Got dizzy). The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to Arexvy.     It was unknown if the company considered the dizziness to be related to Arexvy.   Additional Information: GSK receipt date: 22-APR-2025 The patient got dizzy one hour after Arexvy shot and had continued dizziness even till the time of reporting. She had seen a neurologist for Computerized Tomogram scan and Magnetic resonance imaging which were negative and an inner ear specialist with vestibular testing etc, all were negative. The reporter asked about how many reported cases had continued dizziness and when do the reproter expect this to subside. The symptom was not treated.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: patient given MMR(Priorix) that was frozen prior to reconstitution; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 38-year-old female patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis.   Concomitant products included Priorix.   On 10-MAR-2025, the patient received Priorix (subcutaneous) .5 ml. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: patient given MMR(Priorix) that was frozen prior to reconstitution). The outcome of the incorrect storage of drug 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: 15-APR-2025 Reporter stated that patient given MMR (Priorix) that was frozen prior to reconstitution, which led to incorrect storage of drug. This case is 1 of 6 cases reported by same reporter.
Vaccine: VARZOS
Symptoms: Pain, Product use in unapproved indication
Clinical narrative: shot was rough; doctor told me to get the shot because of my allergies; 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, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot was rough) and drug use for unapproved indication (Verbatim: doctor told me to get the shot because of my allergies). The outcome of the pain was not reported and the outcome of the drug use for unapproved indication was not applicable.   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: 18-APR-2025 This case was reported by a patient via interactive digital media.  Patient stated that his/her doctor told to get the shot, because of allergies, which led to drug use for unapproved indication. Patient reported that shot was rough but he/she made it.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I hurt on the first one too; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine headache (since child).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: I hurt on the first one too). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:US2025048282   Additional Information: GSK Receipt Date: 21-APR-2025 The reporter was hurt on the first one too. For tolerance of 2nd dose of Shingrix, refer case US2025048282.; Sender's Comments:  US-GSK-US2025048282:Same patient/Diffrent dose
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of the Shingles vaccine 5 years ago and got second in february; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included varicella zoster vaccine (Patient received first dose 5 years ago).   In FEB-2025, the patient received the 2nd dose of Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: first dose of the Shingles vaccine 5 years ago and got second in february). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 20-APR-2025 This case was reported by a patient via interactive digital media. Patient had a first dose of the shingles vaccine about 5 years ago, and got second dose in February. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. This case is one of the multiple linked cases.; Sender's Comments:  US-GSK-US2025AMR048644:same reporter different patient US-GSK-US2025AMR048648:same reporter different patient US-GSK-US2025AMR048653:same reporter different patient US-GSK-US2025AMR048658:same reporter different patient US-GSK-US2025AMR048644:same reporter different patient US-GSK-US2025AMR048648:same reporter different patient
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered She stated they received a dose of Pediarix, and IPOL, so they essentially received 2 doses of the polio vaccine; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of overdose in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included Polio vaccine inact (Ipv) (batch number W1C741M, expiry date 17-NOV-2025) for prophylaxis.   On 11-MAR-2025, the patient received Pediarix and Ipv (intramuscular) .5 ml. On 11-MAR-2025, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Extra dose administered She stated they received a dose of Pediarix, and IPOL, so they essentially received 2 doses of the polio vaccine). The outcome of the overdose 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: 21-APR-2025 The health care professional reported that a patient received a dose Pediarix and IPV (VERO) [IPOL] received, so they essentially received 2 doses of the polio vaccine with no adverse event. The patient's past medical history, medical treatments, vaccinations and family history were not provided.  On 11-Mar-2025, the patient received an unknown dose of suspect IPV (VERO) [IPOL] via Intramuscular route in unknown administration site for vaccine dose schedule due and received an unknown dose of suspect diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid not produced by Sanofi Pasteur with (Unknown strength, formulation, lot and expiry date), via unknown route in unknown administration site for Prophylactic vaccination (Immunisation), so they essentially received 2 doses of the polio vaccine with no adverse event (extra dose administered) (latency same day), which led to overdose. The nurse was asked for additional adverse event information, and she agreed to it initially and when she was asked for the initials and date of birth of the patient she asked if this goes back to the patient.  Then she declined to provide additional information at the time of her call and states that she would fill out any paperwork that was sent to her.
Vaccine: RVX
Symptoms: Cough
Clinical narrative: still have the cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: still have the cough). The outcome of the cough was not resolved.   It was unknown if the reporter considered the cough to be related to RSV vaccine.     It was unknown if the company considered the cough to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient did had RSV vaccine and it helped and wasn't so severe but still had the cough and was still coughing but if didn't get the vaccine, sure it would be worse.
Sex: F
Vaccine: MENB
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Pain in arm; she is unable to continue daily activities; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   In APR-2025, the patient received the 1st dose of Bexsero (left arm). In APR-2025, an unknown time after receiving Bexsero, the patient experienced pain in arm (Verbatim: Pain in arm) and activities of daily living impaired (Verbatim: she is unable to continue daily activities). The outcome of the pain in arm and activities of daily living impaired were not reported.   It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the pain in arm and activities of daily living impaired to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-APR-2025 Physician called to report that she has a 17.5-year-old female patient who received her first dose of Bexsero last week.  Since then, the patient has had severe arm pain to the point where she is unable to continue daily activities. Patient stated that she was aware this is a side effect listed in the package insert but it is more severe than she has heard of in any patient and requested that report the incident. She would like any follow up and guidance of how to assist the patient.
Vaccine: VARZOS
Symptoms: Back pain, Fall, Pain in extremity
Clinical narrative: arm was very sore all week; I fell off my couch; hurt my back badly; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In APR-2025, the patient received Shingles vaccine. In APR-2025, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm was very sore all week), fall (Verbatim: I fell off my couch) and back pain (Verbatim: hurt my back badly). The outcome of the pain in arm was resolved and the outcome of the fall and back pain were not reported.   It was unknown if the reporter considered the pain in arm, fall and back pain to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, fall and back pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself Patient had gotten the vaccine a week before, and his/her arm had been very sore all week.  The other night, he/she had fallen off his/her couch and hurt his/her back badly, even though he/she had not been drinking.
Vaccine: VARZOS
Symptoms: Oral herpes zoster, Oral pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I developed shingles in my mouth; 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, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and oral herpes zoster (Verbatim: I developed shingles in my mouth). The outcome of the vaccination failure and oral herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and oral herpes zoster 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 oral herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Two months after patient had gotten the vaccine, he/she developed shingles in his/her mouth.  Little was more painful than having massive ulcers in his/her gums and palate. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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 clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: got shingles from the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles from the vaccine). The outcome of the shingles was not reported.   The reporter considered the shingles to be related to Shingles vaccine.     The company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 The patient got shingles from the vaccine. Then she was so sick she did not get the second half.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the vaccine for shingles and got the shingles 10 days after that; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got the vaccine for shingles and got the shingles 10 days after that). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. Reporter had a friend that got the vaccine for shingles and got the shingles 10 days after that.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; 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: shingles). 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: 22-APR-2025 This case was reported by a patient via interactive digital media. Patient got the vaccine and still got them (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 Shingles vaccine.