chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: RN drew up undiluted pediatric pfizer covid vaccine and it was administered - equivalent of 3 doses.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Patient received two doses of DTAP
Age: 72.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Peripheral swelling
Clinical narrative: 2 weeks after administration, patient woke with swelling and redness in hands, around all MCP's.  This was temporary, and labs did not show any infection or significant underlying inflammatory condition.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: MOD 6m-11yrs was accidentally administered to an adult. - No known adverse effects.
Age: 1.33
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given a Hepatitis B fourth dose and no MMR first dose
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered. Once documenting expiration date error was found. Doctor was informed and patient was notified.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: 2nd vaccination of COVID series given 3/12/21 (first given 2/19/21), and patient come to emergency department on 5/24/21 with "two days of light headedness, chest pain, shortness of breath, and palpitations" however states that has had this previously. This has since resolved and underwent a cardiac work-up with preexisting cardiac stents, ruled out acute cardiac event though noted with new palpitations that was medically managed.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Palpitations, Scan myocardial perfusion
Clinical narrative: 2nd vaccination of COVID series given 3/12/21 (first given 2/19/21), and patient come to emergency department on 5/24/21 with "two days of light headedness, chest pain, shortness of breath, and palpitations" however states that has had this previously. This has since resolved and underwent a cardiac work-up with preexisting cardiac stents, ruled out acute cardiac event though noted with new palpitations that was medically managed.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose was administered inadvertently 18 days after the 1st dose of Menquadfi and 2nd dose of the HPV was given. The pharmaceutical companies were contacted.  There hasn't been any reported adverse events at the time this report is made
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles appearing rash to chest. Given valtrex and oral steroids
Age: 12.0
Sex: F
Vaccine: RAB
Symptoms: Antinuclear antibody negative, Balance disorder, Blood creatine phosphokinase normal, C-reactive protein normal, Decreased vibratory sense
Clinical narrative: Patient was revaccinated on 3/20 with RIG due to not receiving RIG on 3/19 at R calf (site of scratch from fox's tooth). Received 2nd dose of Rabies vaccine on 3/22, and 3rd rabies vaccine on 3/26/25. 4th shot on 4/2/25.  On 3/31 started with bilateral leg weakness and reported inability to run. Legs felt achy and off blance. On 4/17 unable to participate in a fire drill due to leg pain and weakness. Due to ongoing symptoms was seen in the ED on 4/25 where she was noted to have more of an antalgic gait rather than weakness and intact/full strength bilaterally that became limited due to discomfort. Reflexes were intact and symmetric. Mild vibration sense deficiet distally  noted in toe compared to ankle. MRI of entire spine and brain was unremarkable. Admitted to the hospital from 4/25-4/28 and during this time retained full strength. Genetic testing was obtained due to concerns for possible CMT. Abnormal gait not sugestive of weakness or cerebellar abnormalities but appeared to be more functional as she showed improvement on repetition.
Age: 12.0
Sex: F
Vaccine: RAB
Symptoms: Differential white blood cell count normal, Exercise tolerance decreased, Full blood count normal, Gait disturbance, Genetic testing
Clinical narrative: Patient was revaccinated on 3/20 with RIG due to not receiving RIG on 3/19 at R calf (site of scratch from fox's tooth). Received 2nd dose of Rabies vaccine on 3/22, and 3rd rabies vaccine on 3/26/25. 4th shot on 4/2/25.  On 3/31 started with bilateral leg weakness and reported inability to run. Legs felt achy and off blance. On 4/17 unable to participate in a fire drill due to leg pain and weakness. Due to ongoing symptoms was seen in the ED on 4/25 where she was noted to have more of an antalgic gait rather than weakness and intact/full strength bilaterally that became limited due to discomfort. Reflexes were intact and symmetric. Mild vibration sense deficiet distally  noted in toe compared to ankle. MRI of entire spine and brain was unremarkable. Admitted to the hospital from 4/25-4/28 and during this time retained full strength. Genetic testing was obtained due to concerns for possible CMT. Abnormal gait not sugestive of weakness or cerebellar abnormalities but appeared to be more functional as she showed improvement on repetition.
Age: 12.0
Sex: F
Vaccine: RAB
Symptoms: Glycosylated haemoglobin normal, Limb discomfort, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal
Clinical narrative: Patient was revaccinated on 3/20 with RIG due to not receiving RIG on 3/19 at R calf (site of scratch from fox's tooth). Received 2nd dose of Rabies vaccine on 3/22, and 3rd rabies vaccine on 3/26/25. 4th shot on 4/2/25.  On 3/31 started with bilateral leg weakness and reported inability to run. Legs felt achy and off blance. On 4/17 unable to participate in a fire drill due to leg pain and weakness. Due to ongoing symptoms was seen in the ED on 4/25 where she was noted to have more of an antalgic gait rather than weakness and intact/full strength bilaterally that became limited due to discomfort. Reflexes were intact and symmetric. Mild vibration sense deficiet distally  noted in toe compared to ankle. MRI of entire spine and brain was unremarkable. Admitted to the hospital from 4/25-4/28 and during this time retained full strength. Genetic testing was obtained due to concerns for possible CMT. Abnormal gait not sugestive of weakness or cerebellar abnormalities but appeared to be more functional as she showed improvement on repetition.
Age: 12.0
Sex: F
Vaccine: RAB
Symptoms: Metabolic function test normal, Muscular weakness, Pain in extremity, Red blood cell sedimentation rate normal, Reflex test normal
Clinical narrative: Patient was revaccinated on 3/20 with RIG due to not receiving RIG on 3/19 at R calf (site of scratch from fox's tooth). Received 2nd dose of Rabies vaccine on 3/22, and 3rd rabies vaccine on 3/26/25. 4th shot on 4/2/25.  On 3/31 started with bilateral leg weakness and reported inability to run. Legs felt achy and off blance. On 4/17 unable to participate in a fire drill due to leg pain and weakness. Due to ongoing symptoms was seen in the ED on 4/25 where she was noted to have more of an antalgic gait rather than weakness and intact/full strength bilaterally that became limited due to discomfort. Reflexes were intact and symmetric. Mild vibration sense deficiet distally  noted in toe compared to ankle. MRI of entire spine and brain was unremarkable. Admitted to the hospital from 4/25-4/28 and during this time retained full strength. Genetic testing was obtained due to concerns for possible CMT. Abnormal gait not sugestive of weakness or cerebellar abnormalities but appeared to be more functional as she showed improvement on repetition.
Age: 12.0
Sex: F
Vaccine: RAB
Symptoms: Thyroid function test normal, Urine analysis normal
Clinical narrative: Patient was revaccinated on 3/20 with RIG due to not receiving RIG on 3/19 at R calf (site of scratch from fox's tooth). Received 2nd dose of Rabies vaccine on 3/22, and 3rd rabies vaccine on 3/26/25. 4th shot on 4/2/25.  On 3/31 started with bilateral leg weakness and reported inability to run. Legs felt achy and off blance. On 4/17 unable to participate in a fire drill due to leg pain and weakness. Due to ongoing symptoms was seen in the ED on 4/25 where she was noted to have more of an antalgic gait rather than weakness and intact/full strength bilaterally that became limited due to discomfort. Reflexes were intact and symmetric. Mild vibration sense deficiet distally  noted in toe compared to ankle. MRI of entire spine and brain was unremarkable. Admitted to the hospital from 4/25-4/28 and during this time retained full strength. Genetic testing was obtained due to concerns for possible CMT. Abnormal gait not sugestive of weakness or cerebellar abnormalities but appeared to be more functional as she showed improvement on repetition.
Age: 52.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient seen 5/16 (4 days after vaccines administered)  started noticing rash to her left upper arm 5/13. Notes rash is progressively worsening. The affected area is on her left shoulder, characterized by redness, induration, and pain, described as itchy and similar to the sensation of being hit. This is the first time she has experienced such a reaction to a vaccine, although she had a mild reaction to the second COVID vaccine, which was not as severe. She has previously received the shingles vaccine without any issues.
Age: 87.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Injection site swelling
Clinical narrative: Patient called the pharmacy the day after  receiving the vaccines. Patient stated their right arm (where patient received Capvaxive vaccine) has a "swollen goose egg" where the vaccine was given. Patient states the swelling started a few hours after getting the vaccine.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site mass
Clinical narrative: there is a lump at the vaccination site and my left hand pinky and ring fingers have been numb and tingling since the vaccination. No treatment has been sought yet.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Pain
Clinical narrative: patient described full body hurting, especially her left shoulder and chilling beginning roughly 8 hours after injection.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Antinuclear antibody negative, Antinuclear antibody positive, Arthralgia, Immunoassay, Muscular weakness
Clinical narrative: Within 2 hours of receiving RSV vaccine began having R shoulder and cervical spine sharp/arthritic pain that worsened in severity over the day. Awoke next morning with R arm weakness, finally to the ER 5/9/25 where he was admitted for "possible vaccine related acute arthritis". Given IV steroids, transitioned to oral steroids prior to discharge when symptoms drastically improved, walking independently in hall.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Parvovirus B19 test negative, Spinal pain
Clinical narrative: Within 2 hours of receiving RSV vaccine began having R shoulder and cervical spine sharp/arthritic pain that worsened in severity over the day. Awoke next morning with R arm weakness, finally to the ER 5/9/25 where he was admitted for "possible vaccine related acute arthritis". Given IV steroids, transitioned to oral steroids prior to discharge when symptoms drastically improved, walking independently in hall.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2 month vaccine on 5-03-25 prior to being released from hospital and was given the same vaccines in office again 5-16-25
Age: 22.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Prior to the vaccination, the patient stated that he sometimes gets lightheaded after vaccinations. At approximately 2:45pm, the patient received both the covid and the flu vaccination. After the vaccination, the patient fainted while sitting in the chair and was assisted to the floor. He appeared to lose consciousness for around 30 seconds. At 2:50pm, he regained consciousness, with a BP of 120/68. At 3:00pm, his BP was 110/70. Nurse continued to monitor patient, as he drank some apple juice and water, and sat down for 15 additional minutes. After resting, patient stated he was "feeling fine".
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Electroencephalogram, Febrile convulsion
Clinical narrative: complex febrile seizure on 5/16/2025. seizure lasted 20 minutes
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired BioEntech vaccine 04/26/2025 given on 05/20/2025. Ni ill effects described at the time of administration
Age: 62.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle and joint soreness in the arm/shoulder
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills and Headache
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Sudden death
Clinical narrative: sudden death within 24 hours
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, C-reactive protein, Differential white blood cell count, Fatigue, Full blood count
Clinical narrative: With a few days I started having pins and needles in my thighs and round me hips.  After about a week of feeling it, I broke out in hives/rash, which was diagnosed by my primary doctor as shingles on 10/15/2025.  Since there I have developed multiple health issues.  Today I struggle with chronic fatigue, and constant body pains.  Even laying down to sleep is painful
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Rash, Red blood cell sedimentation rate, Urticaria
Clinical narrative: With a few days I started having pins and needles in my thighs and round me hips.  After about a week of feeling it, I broke out in hives/rash, which was diagnosed by my primary doctor as shingles on 10/15/2025.  Since there I have developed multiple health issues.  Today I struggle with chronic fatigue, and constant body pains.  Even laying down to sleep is painful
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Nausea, Pyrexia
Clinical narrative: NAUSEA, STOMACH PAIN, FEVER, CHILLS
Age: 78.0
Sex: F
Vaccine: PNC21
Symptoms: Pruritus, Skin warm
Clinical narrative: ITCHY AND WARM TO THE TOUCH.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Constipation, Diarrhoea, Headache, Pyrexia
Clinical narrative: SEVERE vomiting, fever, chills, constipation with diarrhea, pounding headache
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: SEVERE vomiting, fever, chills, constipation with diarrhea, pounding headache
Age: 58.0
Sex: F
Vaccine: PNC21, TDAP, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient received Adacel, Capvaxive, and 1st dose of Shingrix. Within about 2 minutes of completing vaccine administration, patient complained of severe sharp pain in her back. She sat on the bench for a few minutes outside of the pharmacy. We took her blood pressure and pulse and those numbers appeared normal. Patient complained of no swelling or trouble breathing. She said her lips and cheeks were a little "tingly". Patient remained seated on the bench by the pharmacy for about 30 minutes. Her back pain significantly improved. She did say her lips still felt "tingly". Recommended patient to get otc benadryl to help with possible allergic reaction. Gave the patient 2 tablets of ibuprofen from my personal bottle. Patient left with her husband. Told them to go to ER if patient has trouble breathing.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site irritation, Pain, Pyrexia
Clinical narrative: received Capvaxive vaccine and developed fever, body aches, irritation at injection, physical exhaustion, headache the evening after she got the vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Oedema peripheral, Pain
Clinical narrative: Starting 5/20/25 evening: - Intermittent chest pain Shooting Pain - Radiates from her right side to her left side Swelling - Significant swelling in her armpits                                                                                                                                                                                                                      treating with: tylenol and ibuprofen - minimal relief
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Peripheral swelling
Clinical narrative: Localized swelling with induration approximately 15cm x 14cm right thigh started 24hrs after vaccination. Started as quarter sized & enlarged to triple size over night.
Age: 68.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Intraocular pressure increased
Clinical narrative: A patient reported experiencing an increase in eye pressure, describing the sensation as if her eyes were "popping out." She sought medical attention and was prescribed multipe eye drops to alleviate the pressure. While the exact timeline was unclear, the patient began her eye drop prescription approximately two months after receiving her vaccination. The patient beliees her eye issues are linked to receiving two vaccines simultaneously, caliming that pharmacist "forced" or "promoted" her to get both at the same time. 12/30/2024 simbrinza 02/18/2025 latanoprost, dorzolamide 04/15/2025 loteprednol 05/02/2025 brimonidine
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient is not experiencing any adverse effects
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Eye movement disorder, Hyporesponsive to stimuli, Immediate post-injection reaction, Pallor, Respiratory arrest
Clinical narrative: Child had an episode immediately following vaccinations consisting of decreased responsiveness, pallor, "eyes rolled back". Mom reported "not breathing". Mom reported episode lasted 10 seconds, MA reported a few seconds.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Nausea, Syncope, Vision blurred
Clinical narrative: The teenager while walking in the hallway after been vaccinated experienced a brief episode of syncope while standing. The event was preceded by lightheadedness, nausea, and blurred vision. The episode lasted for approximately 1 minute, and he regained consciousness spontaneously without any confusion or disorientation. The patient denies any similar episodes in the past. The child is on fasting today because of willingness to do lab work; he is active teenager, no history of exertion chest pain, palpitations. FH is non-contributory. Vitals taken and were stable, and patient was observed for 30 mins.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: A child dose was given instead of an adult does.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The Havrix vaccine was provided 5 days to early, ( 1 day too early with the 4 day grace period.)
Age: 1.25
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Injection site reaction, Rash erythematous, Rash macular, Rash papular
Clinical narrative: Red raised rash-target like- appeared to the upper left thigh around the injection site after injection, within 5 minutes patients face/cheeks/back of neck became red and blotchy.  Parent gave oral Tylenol within 1-2 minutes of administering vaccines.  Oral Benadryl was administered within 30 minutes of the reaction.  Rash began decreasing within 30 minutes of vaccine administration.  Provider observed patient, vitals remained stable.   Parent felt comfortable leaving facility within 40 -minutes of reaction
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Death
Clinical narrative: Death
Age: 0.25
Sex: F
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: Varicella vaccine was given by mistake instead of Vaxelis.
Age: 93.0
Sex: M
Vaccine: RSV
Symptoms: Computerised tomogram head, Full blood count, Guillain-Barre syndrome, Lumbar puncture, Metabolic function test
Clinical narrative: Progressive bilateral lower limb weakness the day after his vaccine.  Presented to the ER and diagnosed with  Guillian Barre syndrome.
Age: 93.0
Sex: M
Vaccine: RSV
Symptoms: Muscular weakness
Clinical narrative: Progressive bilateral lower limb weakness the day after his vaccine.  Presented to the ER and diagnosed with  Guillian Barre syndrome.
Age: 21.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given IM rather than subcutaneous; no known adverse patient reaction related to administration site error
Age: 31.0
Sex: F
Vaccine: HEPAB, HPV9, TDAP, VARCEL
Symptoms: Genital erythema, Pruritus, Vulvovaginal swelling
Clinical narrative: Patient called and stated she was itching all over. No injection site reaction, redness or swelling. Patient states she was especially itchy and red on her hands and neck. She also stated her labia was red and swollen. This reaction occurred after the patient left the pharmacy several hours later.
Age: 60.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient inadvertently received a pediatric formulation of the Hepatitis A vaccine. Patient was administered a 0.5 mL pediatric dose of the Hepatitis A vaccine. In consultation with the nurse, it was determined that the appropriate course of action was to administer an additional 0.5 mL of the pediatric formulation on the same day to complete the standard 1.0 mL adult dose. The patient returned on same day 5/20/25 for second 0.5 ml pediatric dose and has been advised to return in six months for the second 1.0 mL adult dose to complete the vaccination series.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Arthralgia, Limb injury, Pain
Clinical narrative: shoulder injury related to vaccine administration. Extreme pain in shoulder joint of right arm throbbing down to elbow. referral placed for steroid joint injection for treatment.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: shoulder injury related to vaccine administration. Extreme pain in shoulder joint of right arm throbbing down to elbow. referral placed for steroid joint injection for treatment.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Arthralgia, Limb injury, Pain
Clinical narrative: Patient described normal injection site pain turned to abnormal injection site pain on day three after receiving vaccines.  Swelling, tenderness, warm to touch, and range of motion issues.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient described normal injection site pain turned to abnormal injection site pain on day three after receiving vaccines.  Swelling, tenderness, warm to touch, and range of motion issues.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, RSV, RSV
Symptoms: Cellulitis
Clinical narrative: Pt seen in PCP office today after vaccine reaction from administration at pharmacy. Upon exam it was determined patient had cellulitis and antibiotics were presribed by APRN who saw patient.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report expired administration of GARDASIL-9 on 05/03/2025. The product was expired on 02/14/2025 with no TEs. No symptoms reported on behalf of patient. Supported outcome delivered verbally per memo. Case number provided. Received cons; This spontaneous report was received from a Pharmacist and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant therapies were not provided.   On 03-MAY-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) suspension for injection, lot #X019863, expiration date: 14-FEB-2025, administered by unknown route for prophylaxis (dose and strength were not provided) (Expired product administered). No additional AE. At the reporting time, the outcome of the events was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) was not reported but established to be as not applicable.
Age: 40.0
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed no symptoms or side effects; VARIVAX administered on 5/12/2025 that expired on 4/19/2025; This spontaneous report was received from a nurse and refers to a 40-year-old patient of unknown gender.   The patient's medical history, concurrent conditions or concomitant therapies were not reported.   On 12-MAY-2025, the patient was vaccinated with expired varicella virus vaccine live (oka-merck) (VARIVAX) injection at a dose of 0.5 mL, administered once, lot #X011425, expiration date: 19-APR-2025 (route of administration and anatomical location were not reported) for prophylaxis (Expired product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiry date were not reported). No temperature excursion history. No symptoms or side effects were confirmed (No adverse event).
Age: 11.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Headache, Lymphadenopathy, Oropharyngeal pain, Rash
Clinical narrative: she starting having swollen lymph nodes, sore throat, headache and a rash on her belly. Caller advised she took her daughter to the HCP on 04/25/2025 and she had EpsteinBarr and tested positive for mono.; This spontaneous report was received from a consumer and refers to a 11-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-Apr-2025, the patient (her daughter) received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 mL injection in the arm (lot #Y009782, expiration date: 23-May-2026) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). Operator of device was reported as lay user/patient.  On 24-Apr-2025 and 25-Apr-2025, the patient started having swollen lymph nodes, sore throat, headache and a rash on her belly. She took her daughter to the HCP on 25-Apr-2025 and she had Epstein-Barr and tested positive for "mono" (Epstein-Barr virus test positive). The reporter advised her daughter's lymph nodes had went down but they were still enlarged and she was tired and fatigue. At the reporting time, the patient had not recovered from the event. The action taken was not applicable.   The causal relationship between the event, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and reconstituted suspect sterile diluent  was not reported.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; inadvertently administered a dose of expired VAQTA on 05/14/2025; This spontaneous report was received from a Registered Nurse on 15-MAY-2025 and refers to a patient of unknown age and gender.   The patient's medical history concurrent conditions and concomitant therapies were not reported.   On 14-MAY-2025, the patient was vaccinated with and expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), (lot #X024966, expiration date: 23-MAR-2025) (dose number, anatomical location and route of administration were not mentioned) for prophylaxis, Caller confirmed the product had no history of temperature excursion. No additional adverse event reported.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: Gardasil 9 used as treatment for eyelid and facial cutaneous warts;   This literature marketed report was received from the authors as stated above and refers to A 9-year-old immunocompetent boy with history of asthma, obesity, nonalcoholic fatty liver disease, and sleep apnea, on daily albuterol, cetirizine, and fluticasone.  On an unknown date, reported as "for the previous year", the family had noted growths in the skin of the patient's face, including both eyelids. The family reported that the lesions were getting progressively larger, leading to significant discomfort and disfigurement for the patient, resulting in social withdrawal and low self-esteem. The family also stated they tried treating the lesions with over-the-counter topical ointments (moisturizers and steroids), which had been unsuccessful. On an unspecified date, the patient presented at the medical institution with eyelid lesions. On examination, the patient's visual acuity was 20/25 In the right eye and 20/30 in the left eye. There were multiple flesh-colored, hyperkeratotic papules with irregular, "cauliflower-like" surface of various sizes on the upper and lower eyelids of both eyes, forehead, and nasal bridge as well as on the index finger of the right hand. All lesions were clinically suggestive of cutaneous viral warts. The patient's conjunctiva was not involved, and the remainder of the ocular examination was unremarkable. Given the location and multiplicity of lesions, HPV vaccination was recommended. Therefore, on an unknown date, 5 days after visit, the patient received the first and single dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) (route, anatomical location lot # and expiration date were not reported) for cutaneous viral warts (Off label use).  All lesions completely resolved 2 weeks after this single dose of vaccine. On the 2-month follow-up visit, the patient did not have any new complaints. Visual acuity was stable at 20/25 in both eyes, and no recurrence was observed.  Although spontaneous resolution of cutaneous warts may occur, the temporal association between the vaccination and the resolution of the lesions was striking, suggesting a possible causal relationship. It has been demonstrated that younger individuals generate higher titers of HPV-specific B and T cells following vaccination, which likely results in a stronger immune response capable of clearing HPV-related cutaneous lesions.
Sex: F
Vaccine: TTOX, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Sensory disturbance, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and TETANUS VACCINE for prophylaxis.   The patient's past medical history included shingles (she had shingles prior to receiving the vaccine in 2013 or 2014).   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix (unknown arm) and TETANUS VACCINE (unknown arm). In APR-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved with sequelae.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-MAY-2025 and 14-MAY-2025 The patient reported that she had 2 doses of Shingrix (2 to 6 months apart) back in 2019 and the last month she had nerve sensory discomfort and a rash on left side of back.  She went to her health care professional and was diagnosed with shingles and antiviral medication for 10 days.  She stated that the rash was gone but she was still having sensory issues in her back. At the beginning she delayed going to the doctor because she was already vaccinated and she thought the 2 doses of Shingrix are enough for lifetime protection. Caller also mentioned she got a Tetanus vaccine (unknown brand, lot number or expiration date) at the same time (but different arm) than the first Shingrix shot, and she forgot to gave that information to the prior agent from GlaxoSmithKline response center.  It was unknown if the reporter considered the vaccination failure and shingles to be related to Tetanus vaccine. This case was considered as suspected vaccination failure as details regarding laboratory test confirming 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 laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and 2)
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Muscular weakness, Peripheral swelling, Pyrexia
Clinical narrative: Tenderness in arm; Redness in arm; swelling in arm; Fever; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-MAY-2025 08:15, the patient received the 2nd dose of Shingrix. On 06-MAY-2025, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: Tenderness in arm), erythema of extremities (Verbatim: Redness in arm), swelling arm (Verbatim: swelling in arm) and fever (Verbatim: Fever). The patient was treated with paracetamol (Tylenol). On 11-MAY-2025, the outcome of the pain in arm, erythema of extremities, swelling arm and fever were resolved (duration 5 days).   The reporter considered the pain in arm, erythema of extremities, swelling arm and fever to be related to Shingrix.     The company considered the pain in arm, erythema of extremities, swelling arm and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-MAY-2025 The nurse reported that the patient received the second dose of Shingrix and shortly after receiving this second dose, she experienced tenderness in arm and started to run a fever.   She took a few Tylenol and the fever resolved and the redness, swelling and tenderness of arm continued for 4 to 5 days then resolved.   She shared that she applied an ice pack to her arm which helped and had previously reported an adverse event with her first dose of Shingrix which had discouraged her from receiving the second dose until now.  The reaction with this second dose not as strong at the first one.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never receiving the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine in 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never receiving the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 14-MAY-2025 The reporter had received the first dose of Shingrix in 2022 but never got the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Insomnia, Pyrexia
Clinical narrative: Mild fever; extremely HOT/feeling like I'm baking inside a; insomnia; This non-serious case was reported by a consumer and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for vaccination.   Concomitant products included verapamil hydrochloride (Verapamil).   On 09-MAY-2025, the patient received Shingrix. On 09-MAY-2025, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Mild fever) and feeling hot (Verbatim: extremely HOT/feeling like I'm baking inside a). In MAY-2025, the patient experienced insomnia (Verbatim: insomnia). On 11-MAY-2025, the outcome of the fever was resolved (duration 2 days). The outcome of the insomnia and feeling hot were not resolved.   It was unknown if the reporter considered the fever, insomnia and feeling hot to be related to Shingrix.     It was unknown if the company considered the fever, insomnia and feeling hot to be related to Shingrix.   Additional Information: GSK receipt date: 15-MAY-2025 The patient feels like baking inside a side effect. The patient also have insomnia which might be because patient was hot.  No fever since Sunday. Asked how long will this feeling last. Mild fever and extremely hot .
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: Adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 15-MAY-2025 Other HCP reported that Adjuvant was given without being mixed with the active ingredient. Reporter asked MA to call medical line and report the incident. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: just got a second vaccine on 5/6/2025; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 05-OCT-2023).   On 06-MAY-2025, the patient received the 2nd dose of Shingrix. On 06-MAY-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: just got a second vaccine on 5/6/2025). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 16-MAY-2025 The patient self-reported this case for herself. The reporter had her first shingles vaccine on but forgot to get a second dose.  The reporter just got a second vaccine. The reporter asked was the vaccine still effective or were these dosages too far apart, does she need to have another vaccine within 6 months of this last does for it to be effective. The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; Patient stated that he contracted shingles after taking both vaccinations.; This serious case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2020, the patient received the 2nd dose of Shingrix. In DEC-2019, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient stated that he contracted shingles after taking both vaccinations.). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 19-MAY-2025 The patient stated that he contracted shingles after taking both vaccinations. No other information provided. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: I AM ALLERGIC TO IT SHOULD BE ON MY RECORDS THERE; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy 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 allergy (Verbatim: I AM ALLERGIC TO IT SHOULD BE ON MY RECORDS THERE). The outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Shingles vaccine.     It was unknown if the company considered the allergy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 07-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she was allergic to it should be on his/her records there.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: I am getting sicker and sicker; Tired of being sick; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of sickness 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 sickness (Verbatim: I am getting sicker and sicker; Tired of being sick). The outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK receipt date: 14-MAY-2025 Consumer stated that he/she had called in before about the adverse reactions from the Pfizer booster vaccine (Name of the booster vaccine was not available over the call, hence captured as Unspecified Booster Vaccine) and looked like the patient was getting sicker and sicker, was tired of being sick. Consumer was requested to contact Pfizer Drug Safety as consumer voice was breaking and offered with the number of Pfizer Drug Safety. Further probing could not be done as the consumer hung up the call abruptly. Thus, product details (LOT number, NDC number, UPC number and expiration date),  purchase details and other details were unknown.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; breakout; 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: breakout). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 10 days).   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: 14-MAY-2025 This case was reported by a patient via interactive digital media. Reporter was just sharing his/her experience.  The vaccine had been 95 percent effective, but he/she was among the 5 percent for whom it did not fully prevent illness.  His/her breakout had lasted about 10 days.  He/she had known others without the vaccine who had suffered much worse cases.  He/she had not regretted getting the vaccine, everyone had their own opinion on it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got the shingles very painful; 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 the shingles very painful). 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: 13-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and still got the shingles very painful. 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.