chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There were none. patient was given second dose of RSV.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Pain in extremity, Product administered at inappropriate site, Sleep disorder
Clinical narrative: I was sitting in chart, MA giving shot was standing and immediately when she gave I could tell it was too high on my arm, very close to top of arm and way more painful than other shots. I hoped it would be ok, but I woke at 3am in a lot of pain in arm. Had to take ibuprofen and put on heat pad. I'm two weeks out and still cannot lay on that arm and still wake up with pain in my arm that feels like I just got the shot. an ache and pain lifting arm.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Mother brought patient to clinic for immunizations.  Did not remember he had them already.  Inadvertently given 2nd dose.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: New onset blurry vision to left eye the morning after vaccination
Age: 67.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus
Clinical narrative: Client in office 02/04/2025, given box of oral typhoid. On 02/10/2025 client self administered 1st dose oral typhoid on empty stomach. She states in approx 30-60 mins started itching to scalp which progressed to face and neck. She avoided scratching and states she had no redness or rash present. Post 3 hrs the itching started to decrease but states she still has itching ocassionally. She did not take anything to help with symptoms.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, Rash, Rash erythematous, Rash papular, Urticaria
Clinical narrative: Rash with slight, sporadic welt development to upper chest (approx. three inches below base of neck). Red, raised areas approx. 2-3 cm in diameter. The overall area is approx. 4-5 inches. Also, elevated temperature.
Age: 12.0
Sex: F
Vaccine: MENB, MMR, VARCEL
Symptoms: Dizziness, Injection site erythema, Visual impairment
Clinical narrative: Patient initially developed redness in her L arm at the injection site. She was seen at urgent care and given Keflex and Benadryl. She later developed lightheadedness and was seeing spots, but did not actually pass out. She was then evaluated at the emergency department for a syncopal episode. ED course was normal. Patient still had redness on her arm 1/31 when she was seen by the primary care doctor but no further syncopal episodes.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Sciatica
Clinical narrative: tingling all the way down right arm, even some sciatica on right side
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: The day after her vaccine, her hands turned purple.  No other symptoms and it went away within 12 hours.  We thought it was due to her Lupus issues.  It did happen after her second vaccine and since another patient reported this to me yesterday, we're submitting her details.
Age: 5.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: PATIENT WAS COMPLAINING OF ARM PAIN THE NEXT DAY BUT THAT WAS ALL
Age: 1.5
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No known adverse effect. Per medical chart,  dose given on 2/7/25 would make it 5th dose.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Cardiac monitoring, Computerised tomogram heart abnormal, Gastric emptying study
Clinical narrative: pt states after a month after being vaccinated he became lethargic and felt like he wasn't able to do the same jobs he was able to do in the past. Lower self esteem.  He would be nauseas in the morning and had high anxiety. He developed heart palpitations that would come and go. He in now being treated by cardiologist, Dr.. He was given medicine and had a calcium score test that was high. He may have to have an echo cardiogram. He has spiked protein in his blood. He is monitoring blood pressure and is wearing a heart monitor for 2 weeks. He continues with the other symptoms with the anxiety, being lethargic, and being nauseated. He saw a physiatrist and checked himself into a mental health clinic for a month. This did not help with his anxiety and he is resistant to the antidepressant medications he has been given so far. He has seen other doctors such as, gastro, endocrinologist, primary Dr., etc... but nobody can pinpoint why he is feeling like this. He no longer feels like life is worth living due to the way he is feeling. He went from going wide open to not being able to do much of anything and has lost quality of life.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Loss of personal independence in daily activities, Nausea, Palpitations, Quality of life decreased
Clinical narrative: pt states after a month after being vaccinated he became lethargic and felt like he wasn't able to do the same jobs he was able to do in the past. Lower self esteem.  He would be nauseas in the morning and had high anxiety. He developed heart palpitations that would come and go. He in now being treated by cardiologist, Dr.. He was given medicine and had a calcium score test that was high. He may have to have an echo cardiogram. He has spiked protein in his blood. He is monitoring blood pressure and is wearing a heart monitor for 2 weeks. He continues with the other symptoms with the anxiety, being lethargic, and being nauseated. He saw a physiatrist and checked himself into a mental health clinic for a month. This did not help with his anxiety and he is resistant to the antidepressant medications he has been given so far. He has seen other doctors such as, gastro, endocrinologist, primary Dr., etc... but nobody can pinpoint why he is feeling like this. He no longer feels like life is worth living due to the way he is feeling. He went from going wide open to not being able to do much of anything and has lost quality of life.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test positive, Self esteem decreased
Clinical narrative: pt states after a month after being vaccinated he became lethargic and felt like he wasn't able to do the same jobs he was able to do in the past. Lower self esteem.  He would be nauseas in the morning and had high anxiety. He developed heart palpitations that would come and go. He in now being treated by cardiologist, Dr.. He was given medicine and had a calcium score test that was high. He may have to have an echo cardiogram. He has spiked protein in his blood. He is monitoring blood pressure and is wearing a heart monitor for 2 weeks. He continues with the other symptoms with the anxiety, being lethargic, and being nauseated. He saw a physiatrist and checked himself into a mental health clinic for a month. This did not help with his anxiety and he is resistant to the antidepressant medications he has been given so far. He has seen other doctors such as, gastro, endocrinologist, primary Dr., etc... but nobody can pinpoint why he is feeling like this. He no longer feels like life is worth living due to the way he is feeling. He went from going wide open to not being able to do much of anything and has lost quality of life.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin disorder
Clinical narrative: The day after her vaccine, her hands turned purple.  no other symptoms and it went away within 12 hours.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Rt arm swelling and pain, can't move the arm. Given Ibuprofen and next day 3 day course of steroids and famotidine with complete resolution of symptoms.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: Shortly after her vaccine, her hands turned purple.  No other symptoms and it went away before she went to bed.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Chest X-ray, Human chorionic gonadotropin, International normalised ratio
Clinical narrative: syncope < 1 hour after vaccination .  In the evening developed parasthesias and intermittent muscle weakness that progressively worsened. Required hospital admission with neurology work up
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: Lumbar puncture, Magnetic resonance imaging, Metabolic function test, Muscular weakness, Paraesthesia
Clinical narrative: syncope < 1 hour after vaccination .  In the evening developed parasthesias and intermittent muscle weakness that progressively worsened. Required hospital admission with neurology work up
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: Prothrombin time, Red blood cell sedimentation rate, Respiratory viral panel, Syncope, Urine analysis
Clinical narrative: syncope < 1 hour after vaccination .  In the evening developed parasthesias and intermittent muscle weakness that progressively worsened. Required hospital admission with neurology work up
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient reported tingling in arm during the observation period.  She reported it feeling better about 15 minutes after first reporting it.  Was reported to pharmacy's nurse triage line.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Appendicectomy, Constipation, Ileocaecal resection, Intussusception, Lethargy
Clinical narrative: Adverse event was severe vomiting, lethargy, and no bowel movements. Sent to ER for evaluation and DX with intussusception, resulting in surgical ileocolonic resection and appendectomy.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Ultrasound scan, Vomiting
Clinical narrative: Adverse event was severe vomiting, lethargy, and no bowel movements. Sent to ER for evaluation and DX with intussusception, resulting in surgical ileocolonic resection and appendectomy.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Benign enlargement of the subarachnoid spaces, Fontanelle bulging, Ultrasound head abnormal
Clinical narrative: Transient Bulging Fontanelle noted the day after vaccines and resolved within 24 hours
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: syncope
Age: 73.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix to be administered to the patient.  Quadracel administered inadvertently. Manufacturer consulted- if DTaP administered to a person 11 years of age or older- count this dose as Tdap dose. No revaccination with Tdap required.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate decreased, Heart rate increased, Pain, Pallor
Clinical narrative: 2 hours after the vaccine was administered, the patient experienced an increase in Heart Rate to 140 bpm then a drop to 58 bpm.  She experienced light-headedness, had a fever of 101 degrees, had body aches, and was told she looked pale.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 2 hours after the vaccine was administered, the patient experienced an increase in Heart Rate to 140 bpm then a drop to 58 bpm.  She experienced light-headedness, had a fever of 101 degrees, had body aches, and was told she looked pale.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Injection site abscess, Injection site urticaria, Injection site warmth
Clinical narrative: Red warmth rash around the site of injection but also extending to involve majority of the RLE, hives like per picture
Age: 25.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Chest pain, Electrocardiogram, Lip swelling, Skin test, Tryptase
Clinical narrative: Patient states he got typhoid, anthrax, Japanese encephalitis, and yellow fever. He reports 10-15 minutes after getting the vaccines, his upper lip started swelling and he started to get some chest pain. He received  epinephrine via  a epi pen and then was taken by ambulance to Medical Center ER. Patient stated  his symptoms went away while he was at ER and denies any recurrence of symptoms. He stated that the site for the yellow fever vaccine was swollen and red all weekend and warm to the touch for about 4 days(vaccines administered Oct. 23, 2024); states it was the first time he received these specific vaccines. Patient reported he feels well today, Oct. 28, 2024, and has not had any reoccurrence in his symptoms.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arteriogram carotid, Blood test normal, Bone densitometry, Bone pain, Disturbance in attention
Clinical narrative: On May 5, 2023 I got the vaccine, everything was normal, that day I slept well, the next day I couldn't sleep, I woke up very sleepy, tired, with a headache, I couldn't concentrate, I went for a walk to be able to clear my head, but everything was the same, even if it happened to me for about 4 months, I don't remember when my hip and shoulder bones started to hurt, I took supplements at night to sleep, I went to see my doctor, I explained to him what I had, the bone pain was very strong, he did not understand what was happening to me, he sent me to do tests and x-rays and everything was fine, about 3 months passed the symptoms of headache, drowsiness and tiredness decreased a little, One day by carelessness I did not take the prostate pill in the afternoon I did not have bone pain, I told the doctor he changed the medicine about 5 times all of them caused bone pain, he recommended me to see the urologist I explained and I did not see the relationship of the pain with the medicine, he did an exam determined that I should stop taking the medication
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Sleep disorder
Clinical narrative: On May 5, 2023 I got the vaccine, everything was normal, that day I slept well, the next day I couldn't sleep, I woke up very sleepy, tired, with a headache, I couldn't concentrate, I went for a walk to be able to clear my head, but everything was the same, even if it happened to me for about 4 months, I don't remember when my hip and shoulder bones started to hurt, I took supplements at night to sleep, I went to see my doctor, I explained to him what I had, the bone pain was very strong, he did not understand what was happening to me, he sent me to do tests and x-rays and everything was fine, about 3 months passed the symptoms of headache, drowsiness and tiredness decreased a little, One day by carelessness I did not take the prostate pill in the afternoon I did not have bone pain, I told the doctor he changed the medicine about 5 times all of them caused bone pain, he recommended me to see the urologist I explained and I did not see the relationship of the pain with the medicine, he did an exam determined that I should stop taking the medication
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence, X-ray normal
Clinical narrative: On May 5, 2023 I got the vaccine, everything was normal, that day I slept well, the next day I couldn't sleep, I woke up very sleepy, tired, with a headache, I couldn't concentrate, I went for a walk to be able to clear my head, but everything was the same, even if it happened to me for about 4 months, I don't remember when my hip and shoulder bones started to hurt, I took supplements at night to sleep, I went to see my doctor, I explained to him what I had, the bone pain was very strong, he did not understand what was happening to me, he sent me to do tests and x-rays and everything was fine, about 3 months passed the symptoms of headache, drowsiness and tiredness decreased a little, One day by carelessness I did not take the prostate pill in the afternoon I did not have bone pain, I told the doctor he changed the medicine about 5 times all of them caused bone pain, he recommended me to see the urologist I explained and I did not see the relationship of the pain with the medicine, he did an exam determined that I should stop taking the medication
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: CSF test abnormal, Headache, Ophthalmic herpes zoster, Rash, Rash vesicular
Clinical narrative: Presumably healthy patient.  He received first vaccine against VZV at ~2 yrs on 12/21/2021 (Varivax - NDC 0006-4827-00) and second vaccine at ~4 yrs on 9/29/2023 (Proquad - NDC 0006-4171-01).  At age 5 yrs, he presented to Hospital w/ right-sided herpes zoster ophthalmicus.  Pt had a ~8-day prodrome of frontal HA and occasional emesis before developing a vesicular rash over his right CNV1 dermatome, which was present for ~2 days before admission.  Pt had normal mental status on presentation.  However, given his HA and emesis, LP was done w/ reassuring CSF indices, but VZV PCR was positive.  CSF was sent to lab for wild-type vs. vaccine strain VZV PCR, and it resulted + for vaccine strain, prompting this submission.  We will also do an immune work-up.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Varicella virus test positive, Vomiting
Clinical narrative: Presumably healthy patient.  He received first vaccine against VZV at ~2 yrs on 12/21/2021 (Varivax - NDC 0006-4827-00) and second vaccine at ~4 yrs on 9/29/2023 (Proquad - NDC 0006-4171-01).  At age 5 yrs, he presented to Hospital w/ right-sided herpes zoster ophthalmicus.  Pt had a ~8-day prodrome of frontal HA and occasional emesis before developing a vesicular rash over his right CNV1 dermatome, which was present for ~2 days before admission.  Pt had normal mental status on presentation.  However, given his HA and emesis, LP was done w/ reassuring CSF indices, but VZV PCR was positive.  CSF was sent to lab for wild-type vs. vaccine strain VZV PCR, and it resulted + for vaccine strain, prompting this submission.  We will also do an immune work-up.
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None reported
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient approached the pharmacy counter requesting RSV, flu, and Covid vaccines.  The patient did not mention receiving a previous RSV shot in April 2024.  There were no alerts in the pharmacy's que, nor was the prior RSV vaccine listed in the patient's vaccine record.  The patient received a second RSV vaccine, however, she did not experience any adverse effects.
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: She had swelling, redness, pain and bruising at the site of injection.  Later she developed some blisters surrounding the vaccine site and pain in her shoulder that limited her range of motion
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site vesicles, Mobility decreased
Clinical narrative: She had swelling, redness, pain and bruising at the site of injection.  Later she developed some blisters surrounding the vaccine site and pain in her shoulder that limited her range of motion
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Breast conserving surgery, Chemotherapy, Cytogenetic analysis, Mammogram
Clinical narrative: Triple Positive Right Breast Cancer (ICD and DCIS - HER2/ER/PR positive) diagnosed on 6/10/2024
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pathology test, Radiotherapy, Triple positive breast cancer, Ultrasound breast
Clinical narrative: Triple Positive Right Breast Cancer (ICD and DCIS - HER2/ER/PR positive) diagnosed on 6/10/2024
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dermatitis, Erythema, Pruritus, Pustule, Scab
Clinical narrative: Service member reports AEFI of dermatitis limited to the injection arm noted upon awakening day 1 after receipt of IIV 11/15/2023 (lot #AU1078A SEQ). He states the lesions were pruritic, painful, fixed, discrete, continued to enlarge over time, but new lesions didn?t develop, had some thin drainage when the ?popped?, ultimately scabbed and have left scarring; scattered erythematous pustules limited to the injection arm. Duration of lesions was about three weeks. Treatment was OTC topical antibiotic.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Scar, Secretion discharge, Skin lesion
Clinical narrative: Service member reports AEFI of dermatitis limited to the injection arm noted upon awakening day 1 after receipt of IIV 11/15/2023 (lot #AU1078A SEQ). He states the lesions were pruritic, painful, fixed, discrete, continued to enlarge over time, but new lesions didn?t develop, had some thin drainage when the ?popped?, ultimately scabbed and have left scarring; scattered erythematous pustules limited to the injection arm. Duration of lesions was about three weeks. Treatment was OTC topical antibiotic.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain, Amylase, C-reactive protein, Differential white blood cell count, Faecal calprotectin
Clinical narrative: Within a few days of receiving vaccines patient developed abd pain, vomiting, and a rash.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Full blood count, Lipase, Metabolic function test, Occult blood, Rash
Clinical narrative: Within a few days of receiving vaccines patient developed abd pain, vomiting, and a rash.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Red blood cell sedimentation rate, Vomiting
Clinical narrative: Within a few days of receiving vaccines patient developed abd pain, vomiting, and a rash.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No noted ADR, but pt received extra HBV does that was not indicated. Pt has had no adverse reactions at this time to any vaccines.
Age: 9.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: pt had 2 polio vaccines (age 4 and 9)   3rd dose given on 1/17/2025, vaccine was given 5 days too soon.  No treatment was needed, pt will have to return for 3rd vaccine
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt did not experience adverse event, however should not have received series at all. Pt received 2 doses (complete series) prior to age 50 with no immunocompromising condition. Pt does have hx of shingles. No ADR, pt doing well even now.
Age: 38.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Migraine, Mobility decreased, Vision blurred
Clinical narrative: Onset of 70 hour long migraine with complete blurred vision in left eye.  Proscribed Migraine medication management unsuccessful in reducing migraine symptoms.  Bedridden for the duration of the migraine, unable to attend work duties, unsafe to drive for treatment. Phone consultation with healthcare professional, recommended Urgent care or ER for migraine IV therapy, unable to comply with recommendation due to transportation issue and sole caregiver of young children.
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Asthenia, Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient wife reported her spouse symptoms about 2:33 pm today when I phoned her about her test results. Patient states after he got vaccine and was leaving the office on elevator he started feeling nausea. After he got home, he started having vomiting, watery diarrhea, chills, and weakness. Per MD He should rest and try to maintain good hydration. I have prescribed Zofran to help minimize the nausea. He can try over the counter Pepto-Bismol or Imodium to help the diarrhea. If he develops any pains, then Tylenol would be advised. If more serious symptoms develop then ER evaluation would be advised. Patient verbalized understanding.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Asthenia, Back pain, Coronary arterial stent insertion, Depressed mood
Clinical narrative: I got the shot and i felt really weird and not right and something wasnt right and i didnt have any energy and feeling down and nauseous and I thought that i had the flu. That feeling never went away, i started have pain in my arm and in my back and went in for the widow maker. The address for the doctor.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: I got the shot and i felt really weird and not right and something wasnt right and i didnt have any energy and feeling down and nauseous and I thought that i had the flu. That feeling never went away, i started have pain in my arm and in my back and went in for the widow maker. The address for the doctor.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: no adverse event
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Heart rate increased, Palpitations
Clinical narrative: Patient received Hep B vaccine (Engerix) around 12:05pm. at 12:16 pm patient presented to front desk staff complaining of headache and feeling like her heart was racing. Patient was brought back into clinic. BP checked at 12:18pm. BP-150/73 P-73; Advised patient that her BP was elevated but heart rate is normal. Patient complain of headache in right frontal lobe. Patient is here by herself and walked to clinic for appt. Offered to contact EMS. Patient declined for me to call  EMS. Stated that "she didnt want me to call EMS.". Asked patient how was she going to get home and patient stated that she may "call a taxi". Patient does not live far from the health dept.  Patient has only eaten a oatmeal pie today. Advised patient to eat when she gets home and take meds as ordered ny her physician. Advised patient if headache continues to call her doctor or EMS for evaluation. BP checked again at 12:23pm BP-146/72 P-71. Advised patient to wait an additional 15 mins in lobby before she leaves . Patient voices understanding.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site vesicles
Clinical narrative: Blister at injection site. Still present 1 month later.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had completed Hepatitis B series (3 shots) previously, a not needed fourth extra dose was administered. No symptoms after 24 hours from vaccination.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient got Hep B vaccine when she wanted a meningococcal vaccine, she had no reaction to the Hep b vaccine.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This serious case was reported by a physician via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown deltoid) and Influenza vaccine. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was unknown.   The reporter considered the bell's palsy to be related to Shingrix.     The company considered the bell's palsy to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 04-FEB-2025 The patient received Shingrix and Influenza vaccine at the same time and experienced bell's palsy. It was unknown if reporter considered the bell's palsy to be related to Influenza vaccine.; Sender's Comments: Bell's palsy is an unlisted event which is considered unrelated to GSK drug Shingrix.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This non-serious prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number ET475) for prophylaxis.   On 23-MAY-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 30 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Estimated Delivery/Due date: 07-AUG-2024  Pregnancy Details (Neonate 1):  Number of Fetuses/Neonates: 1 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 23-MAY-2024 The Nurse reported that a patient received Boostrix vaccine during pregnancy, which led to vaccine exposure during pregnancy. The reporter consented to follow up.   Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Lymph node pain, Mobility decreased, Nausea
Clinical narrative: lymph node in that arm hurts; can't raise my arm; diarrhea; nausea; mild headache; This non-serious case was reported by a consumer and described the occurrence of lymph node pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JAN-2025, the patient received Shingrix. On 15-JAN-2025, 1 days after receiving Shingrix, the patient experienced lymph node pain (Verbatim: lymph node in that arm hurts) and mobility decreased (Verbatim: can't raise my arm). In JAN-2025, the patient experienced diarrhea (Verbatim: diarrhea), nausea (Verbatim: nausea) and headache (Verbatim: mild headache). The outcome of the lymph node pain and mobility decreased were resolved and the outcome of the diarrhea, nausea and headache were not reported.   It was unknown if the reporter considered the lymph node pain, diarrhea, nausea, headache and mobility decreased to be related to Shingrix.     It was unknown if the company considered the lymph node pain, diarrhea, nausea, headache and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-JAN-2025 The reporter reported that patient got the vaccine a day before the reporting.  The day following armpit lymph node in that arm hurts, cannot raise his/her arm, diarrhea, nausea.  Mild headache but nothing compared to lymph pain.
Age: 46.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Bexsero to a a high-risk patient who is 46 years old; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 46-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo).   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero to a a high-risk patient who is 46 years old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JAN-2025  The physician reported that healthcare professional gave Bexsero to a a high-risk patient who was 46 years old which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain
Clinical narrative: Patient agonizing back pain and extremely painful; shoulder pains without the rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of back 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 back pain (Verbatim: Patient agonizing back pain and extremely painful) and shoulder pain (Verbatim: shoulder pains without the rash). The outcome of the back pain and shoulder pain were not reported.   It was unknown if the reporter considered the back pain and shoulder pain to be related to Shingles vaccine.     It was unknown if the company considered the back pain and shoulder pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that shingles was the form of same virus as chickenpox. The vaccine introduces a virus into your system in a small dose for the purpose of minimizing the effects if contract the illness but if had chickenpox, the virus was already introduced into body and no need for a vaccine. The patient had bad complications as extreme back pain and shoulder pains without rash from this vaccine since getting it five years ago from date of reporting. The reporter reported that virus lies dormant in body and rarely comes back in most cases but this was not the case with patient just info gave was told by physician. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got 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: still got 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: 28-JAN-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she had the shots and still got shingles. Patient believed it would have been worse if he/she did not had the shots. Patient indicated that it was horrible. Also, asked to pray to never get them again. The follow-up could not be possible as no contact details were available. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose of vaccine on an unknown date,was fine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the influenza-like symptoms was resolved (duration 24 hrs).   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-JAN-2025 This case was reported by a patient via interactive digital media. The patient had flu like symptoms for only 24 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: my arm is still very red  and swollen; my arm is still very red  and swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2025, the patient received Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: my arm is still very red  and swollen) and swelling arm (Verbatim: my arm is still very red  and swollen). The outcome of the erythema of extremities and swelling arm were not resolved.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.     It was unknown if the company considered the erythema of extremities and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-FEB-2025 This case was reported by a patient via (Shingrix GSK) interactive digital media. The reporter reported that a patient received Shingrix 3 days ago and patient arm was still very red and swollen.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling
Clinical narrative: redness rash; swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash 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 red rash (Verbatim: redness rash) and swelling (Verbatim: swelling). The outcome of the red rash and swelling were not resolved.   It was unknown if the reporter considered the red rash and swelling to be related to Shingrix.     It was unknown if the company considered the red rash and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-FEB-2025 The patient self-reported this case. The patient experienced the redness rash and swelling after receiving Shingrix vaccine and asked when will redness rash and swelling go away
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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, 6 weeks 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 was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 04-FEB-2025 This case was reported by a patient via interactive digital media. Patient had the shots and still got the shingles 6 weeks in and still hurting. The patient was asking for something which would helps him/her with the pain. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: it hurt like hell; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: it hurt like hell). The outcome of the pain was resolved.   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.   Additional Information: GSK receipt date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she got the shot of Shingrix vaccine and experienced it hurt like hell. The reporter reported that it would not wish that on anyone.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: pregnant accidentally received 1st dose; pregnant accidentally received a second dose; Live birth; received a second dose of Boostrix; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of live birth in a 28-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number DH382) for prophylaxis.   On 03-AUG-2023, the patient received the 2nd dose of Boostrix. In JUL-2023, the patient received the 1st dose of Boostrix. On 03-AUG-2023, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: received a second dose of Boostrix). The patient experienced live birth (Verbatim: Live birth). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant accidentally received 1st dose) and vaccine exposure during pregnancy (Verbatim: pregnant accidentally received a second dose). The outcome of the live birth, vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 30 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): Trimester unknown  Pregnancy Details (Neonate 1):  Actual Delivery Date:   Delivery Type: vaginal Pregnancy Outcome: Live neonate with no apparent congenital anomaly Birth Weight: 3270 grams (7lbs 3oz) Delivery Notes: The healthy baby was born at 38 weeks, 6 days gestation, baby's length was 48.3 centimeter (19 inches) and head circumference was 31.5 centimeter   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: 03-AUG-2023 The pharmacist reported that patient was 30 weeks pregnant when she accidentally received the second dose of Boostrix. The patient administered first dose of Boostrix (batch numer DH382) two weeks prior of second dose (July2023). The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.   Follow-up information received on 07-MAY-2024. A previous report was received because a pregnant women received a second Boostrix dose in error. The patient and her baby was discharged on postpartum day 1. Summary of changes: The patient's pregnancy details, event details and narrative were updated.   Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: pregnant patient received 2 doses of Boostrix approximately 14 days apart; pregnant patient received 2 doses of Boostrix approximately 14 days apart; pregnant patient received 2 doses of Boostrix approximately 14 days apart; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M4E4A, expiry date 05-OCT-2025) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 23-AUG-2023, the patient received Boostrix. On 09-AUG-2023, the patient received Boostrix. On 23-AUG-2023, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: pregnant patient received 2 doses of Boostrix approximately 14 days apart). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received 2 doses of Boostrix approximately 14 days apart) and vaccine exposure during pregnancy (Verbatim: pregnant patient received 2 doses of Boostrix approximately 14 days apart). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 29 Weeks Pregnancy Exposure (Boostrix): Trimester unknown Gestation time at first exposure (Boostrix): 27 Weeks Pregnancy Exposure (Boostrix): Trimester unknown Last Menstrual Period Date: 01-FEB-2023 Estimated Delivery/Due date: 08-NOV-2023  Pregnancy Details (Neonate 1):  Number of Fetuses/Neonates: 1 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date 25 August 2023: A registered nurse called in to report that a pregnant patient received 2 doses of Boostrix approximately 14 days apart and wished to know how to proceed. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. The patient received 2 doses of Boostrix approximately 14 days apart which led to extra dose administered and vaccine exposure during pregnancy.   Follow up information received on 22-Sep-2023. Summary of changes: The patient tab and narrative updated   Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type and narrative were updated.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: third trimester of pregnancy (28 weeks gestation), received Boostrix; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M4E4A, expiry date 05-OCT-2025) for prophylaxis.   On 11-DEC-2023, the patient received Boostrix. On 11-DEC-2023, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: third trimester of pregnancy (28 weeks gestation), received Boostrix). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 28 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Lost to follow up   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: 13-DEC-2023 A nurse reported that, the patient in her third trimester of pregnancy (28 weeks gestation), received Boostrix, which led to vaccine exposure during pregnancy. The date of last menstrual period and estimated delivery date were unknown. Nothing else was reported. The reporter consented to follow up.   Follow-up information received on 20-SEP-2024 and 17-OCT-2024 VAERS details were updated. This pregnancy case was now considered lost to follow-up.  Summary of Changes: FU Tracking memo in general tab updated, pregnancy outcome updated as lost to follow-up and narrative updated.   Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated.