chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: TDAP
Symptoms: Bursitis, Injection site pain, Product administered at inappropriate site, Ultrasound joint
Clinical narrative: On December 3, 2024 I received a tetanus vaccination where the needle was inserted too high on my shoulder and was later diagnosed to have hit my bursa sac. I thought the technician was prepping an injection location too high on my shoulder but didn't say anything. The vaccination itself was uneventful but within 2 days. I had near constant pain in the L shoulder around the injection site. Icing and Advil/Alleve did not resolve the issue. I met with Nurse Practitioner on December 10, and she referred me to Dr. who I saw on December 17. He gave me ultrasound and suggested a cortisone shot but I declined on the grounds that I did not want anymore needles in my shoulder. He referred me to another Dr for further treatment. I saw Dr. on December 18. He used ultrasound to diagnos bursitis and suggested a cortisone shot. I declined the shot. He prescribed Meloxicam (Mobic) which I took for almost 3 weeks as the pain symptoms subsided. After about 6 weeks I felt my left shoulder had been relieved of pain and was back to normal.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Loss of consciousness, Pyrexia
Clinical narrative: 1/13 chills in afternoon 1/14 Low grade fever all day 1/15 About 5 am - woke to soaking wet nightgown, hair was wet, ringing in my ears - stood up to go to bathroom and ringing increased ten fold - passed out. Then throwing up + diarrhea. Finally stopped about 6:15 am
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Tinnitus, Vomiting
Clinical narrative: 1/13 chills in afternoon 1/14 Low grade fever all day 1/15 About 5 am - woke to soaking wet nightgown, hair was wet, ringing in my ears - stood up to go to bathroom and ringing increased ten fold - passed out. Then throwing up + diarrhea. Finally stopped about 6:15 am
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Infant irritability, Pyrexia, Somnolence
Clinical narrative: Fever of 101, increased fussiness, sleepy
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria, Rash, Urticaria
Clinical narrative: Patient returned to clinic at 3 pm following DTaP/Polio and MMR/Varicella vaccinations reaction. Left arm site where DTaP/Polio was given was severely red and had hives present. Chest, behind ears and hands had some minor hives. benadryl (12.5/5) 7 ml given in office. Patient observed for 2 hours with minor improvement in rash. No difficulty breathing, O2 95%, no vomiting, no diarrhea. Patient's mother confirms epipen (up to date) in care. Informed of anaphlyaxis sx, if appears to give epipen and call 911. Mother understood and left office with child.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Nausea, Pallor, Vomiting
Clinical narrative: Patient became pale and nauseous, patient had 1 episode of emesis and had to sit down. Patient was given apple juice and crackers, 0940 BP was taken with results being 80s over 40s. Pulse oximeter was placed for monitoring purposes. 0942 BP taken 100/62, patient stated they felt better. 0952 BP taken again 100/62 SPO2 98-100%, HR sustained in 90s-100s. Patient stated they felt much better.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient was given Gardasil vaccine on 1/29/25 by error  .Patient had already received the Gardasil vaccine series on 7/18/20 & 8/3/19
Age: 35.0
Sex: F
Vaccine: PNC20
Symptoms: No adverse event, Vaccination error
Clinical narrative: Pt inadvertently received Prevnar 20 vaccine. No adverse side effects noted.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient reports muscle soreness that started 1 day post vaccine and has persisted for over 2 months.  Patient says that she still feels some muscle pain and that it "comes and goes", especially with movement.
Age: 38.0
Sex: M
Vaccine: FLU3, MMR, TD, VARCEL
Symptoms: Abdominal distension, Asthenia, Blood test normal, Diarrhoea, Disturbance in attention
Clinical narrative: No immediate symptoms following immunization, it was weeks later he felt extremely sick. Couldn't wake up and had weakness, diarrhea, bloating, and dizziness. Unable to concentrate and fatigue followed. Gut issues persist to this day.
Age: 38.0
Sex: M
Vaccine: FLU3, MMR, TD, VARCEL
Symptoms: Dizziness, Fatigue, Malaise
Clinical narrative: No immediate symptoms following immunization, it was weeks later he felt extremely sick. Couldn't wake up and had weakness, diarrhea, bloating, and dizziness. Unable to concentrate and fatigue followed. Gut issues persist to this day.
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: None- covid vaccine expired 1/23/25 (10 weeks in refrigerator) and was administered 2/1/25
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Malaise, Myalgia, Nausea
Clinical narrative: myalgias, chills, malaise. nausea (no vomiting), abdominal cramping and 1 large loose stool and subsequent syncopal episode felt to be a vagal reaction. symptomatic treatment, recovered in 2 days
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: myalgias, chills, malaise. nausea (no vomiting), abdominal cramping and 1 large loose stool and subsequent syncopal episode felt to be a vagal reaction. symptomatic treatment, recovered in 2 days
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient admitted 1/29. Expired 2/1
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Abdominal pain, Arthralgia, C-reactive protein, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: The vaccine that caused the autoimmune response was Capvaxive but that was not available as a choice above so I selected other vaccine.   Within 24 hours I had severe pain in the shoulders/upper arms and waist.  I initially went to a neurologist who diagnosed my problem as Polymyalgia Rhumatica (PMR).  This was confirmed today 2/3/25 by a Rhumatologist.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Red blood cell sedimentation rate
Clinical narrative: The vaccine that caused the autoimmune response was Capvaxive but that was not available as a choice above so I selected other vaccine.   Within 24 hours I had severe pain in the shoulders/upper arms and waist.  I initially went to a neurologist who diagnosed my problem as Polymyalgia Rhumatica (PMR).  This was confirmed today 2/3/25 by a Rhumatologist.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram thorax, Differential white blood cell count, Feeling hot, Flushing, Full blood count
Clinical narrative: 3 days after vaccine developed severe and frequent headaches. Then on day 5 developed intermittent stinging sensation (pins and needles) on the entire left side of his body as well as warmth and flushing on the the left side of his face. These sensations lasted for a couple weeks.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Liver function test, Paraesthesia, Scan with contrast
Clinical narrative: 3 days after vaccine developed severe and frequent headaches. Then on day 5 developed intermittent stinging sensation (pins and needles) on the entire left side of his body as well as warmth and flushing on the the left side of his face. These sensations lasted for a couple weeks.
Age: 68.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: Patient expresses that they noticed a large red rash at the site of injection the day following immunization. Over the course of the next few days, the rash spread from the injection site to a full body rash. The patient denies any other symptoms such as difficulty breathing or painful rash sites. The patient returned to the pharmacy on January 27th, 2025 to discuss this event and says the rash was gone when they returned.   The patient claims they experience similar full body rashes when exposed to respiratory illnesses. The patient did not express that they treated the rash with any medication or seek medical treatment.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Infant irritability, Pyrexia, Swelling, Urticaria, Vomiting
Clinical narrative: Reported to me by mother that approx. 6 hours later, child developed high fever, hives, bumps that looked similar to chicken pox, neck started to swell, fussy and vomiting.
Age: 87.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Immediate post-injection reaction, Nausea, Walking aid user
Clinical narrative: Nausea immediately following vaccine which lasted at least 20 minutes.  Followed by immediate pain in right knee which accelerated during the day, requiring a cane and avoidance of walking.  Pain was intense.  Went to bed and approximately 7 hours later was able to walk normally with no pain.  Anticipated reaction regarding joint pain needs to be emphasized under "possible side effects.  It was very alarming!
Age: 87.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Back pain, Full blood count normal, Gait inability, Mobility decreased
Clinical narrative: Nausea immediately following vaccine which lasted at least 20 minutes.  Followed by immediate pain in right knee which accelerated during the day, requiring a cane and avoidance of walking.  Pain was intense.  Went to bed and approximately 7 hours later was able to walk normally with no pain.  Anticipated reaction regarding joint pain needs to be emphasized under "possible side effects.  It was very alarming!
Age: 87.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: Nausea immediately following vaccine which lasted at least 20 minutes.  Followed by immediate pain in right knee which accelerated during the day, requiring a cane and avoidance of walking.  Pain was intense.  Went to bed and approximately 7 hours later was able to walk normally with no pain.  Anticipated reaction regarding joint pain needs to be emphasized under "possible side effects.  It was very alarming!
Age: 56.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT REPORTS REDNESS, SWELLING, WARMTH, PAIN AND EXTREME ITCHING TO IMMUNIZATION SITE
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Client received Covid vaccine that was thawed over the allowable time frame.  No adverse events reported. Phone call was made to parents to recommend a repeat vaccine per CDC guidelines.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Unevaluable event
Clinical narrative: Patient reports going to the hospital after receiving the two vaccines in the same arm.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epilepsy, Focal dyscognitive seizures, Generalised tonic-clonic seizure, Pain, Pyrexia
Clinical narrative: I took my first dose on 09/11/2021 at a store while still on work travel. I took My second somewhere else. I took the vaccine and came home sick with a fever and body aches for multiple days. I began to having tonic clonic seizures on December 7 and was medicated then began having complex partial seizures until medicine was balanced. I am now diagnosed epileptic. I have seen multiple other individuals who are saying similar things. This was a life changing condition.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin burning sensation, Swelling face
Clinical narrative: Swelling, redness and burning to the face 2 days after vaccine. Continues through today. Improvement in swelling, but redness and minimal swelling continues. Denies any involvement of mouth or throat.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Cardiac monitoring
Clinical narrative: A few weeks after my second covid vaccine I began having Atrial Fibrillation  episodes. ( I took the first dose on May 13, 2021 at the same store; Pfizer EW0168)  I saw a cardiologist who had me monitored for several weeks.  He diagnosed me with Afib somewhere around September 2021.  While I previously did have arrythmia (well-controlled through a small dosage of metoprolol) I had never had Afib before I took the Covid vaccine.  I continued having Afib episodes approximately every 5-6 weeks, each lasting 24-36 hours, until June 2023, when I had an episode that lasted 5 days.  I went to the ER after the first 2 days and they encouraged me to follow up with my cardiologist.  He encouraged me to be cardioverted, but my Afib episode ended on its own.  However, I did begin taking Multaq, an anti-arrythmic medicated to control the Afib, which it did quite well, but caused some unpleasant side effects.  In April 2023 I received an ablation by a different cardiologist (by this time we had moved to Texas.)  After the ablation, as of this date, I have had no more episodes of Afib.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diplegia, Muscular weakness, Tremor
Clinical narrative: A few hours after injection, patient had severe shaking chills and reports BL leg paralysis. Symptoms lasted until the next morning. Legs still had some weakness but she returned to her baseline the next day.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: No verification prompted pharmacist to notify her that patient had received Prevnar 20 previously. First dose was not listed in system.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A Tdap was given to the patient when it should have been a Dtap
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient got two vaccines one in 2023 one in 2025 this should be a one time only vaccine
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Of the Series, dose 2 of COVID vaccine given earlier than due at nursing visit.
Age: 1.67
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: As vaccine was being administered some of the vaccine leaked out
Age: 58.0
Sex: M
Vaccine: FLU3, PNC21, TDAP, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: The patient came into the pharmacy and stated that in two outer fingers on his left hand have numbness since the date of the vaccine.  He had not had it evaluated by a doctor and I recommended him to do that.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received a second dose of flulaval (influenza vaccine) there was no observed immediate side effects. We contacted the patient again the next day on 1/31/2025 and RN assessment was done via telephone, the patient has no delayed reaction nor any side effects from the Flulaval that was given.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral infarction, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging head, Ultrasound head
Clinical narrative: Cerebral infarction Stroke on October 23, 2024.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Fever, Chills, loose stools, Retching from the bowels during diarrhea, Sore throat, running nose, Brain fog, Muscle Fatigue and Soreness especially around joints, Malaise, lightheaded or dizzy. Extreme tiredness, especially after physical activity. Problems with taste and smell.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle fatigue, Myalgia, Oropharyngeal pain, Parosmia
Clinical narrative: Fever, Chills, loose stools, Retching from the bowels during diarrhea, Sore throat, running nose, Brain fog, Muscle Fatigue and Soreness especially around joints, Malaise, lightheaded or dizzy. Extreme tiredness, especially after physical activity. Problems with taste and smell.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Retching, Rhinorrhoea, Taste disorder
Clinical narrative: Fever, Chills, loose stools, Retching from the bowels during diarrhea, Sore throat, running nose, Brain fog, Muscle Fatigue and Soreness especially around joints, Malaise, lightheaded or dizzy. Extreme tiredness, especially after physical activity. Problems with taste and smell.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autonomic nervous system imbalance, Postural orthostatic tachycardia syndrome
Clinical narrative: I was diagnosed with  POTS/ autonomic dysfunction 6/2024 by my rheumatologist Dr, PCP Dr,  neurologist Dr and functional medicine and physiatrist Dr  and cardiologist Dr
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Congenital cystic kidney disease, Dyslipidaemia, Gene mutation identification test positive, Hypertension, Laboratory test
Clinical narrative: At this time,  I developed both symptoms of nonhereditary ADKPD and Psoriatic plaques which further developed into Psoriatic Arthritis. After further genetic testing, it was found that ADPKD was not inherited, but a sporadic mutation & a very fast progressive form of the disease. - the Nephrologist confirmed that this was a very rare form of the disease. I had developed hypertension, severe edema, and dyslipidemia. My kidney function declined to less than 40% within 6 months.  The Psoriasis was also a very fast progressive form of the disease, one that was very unusual according to the Rheumatologist. I had skin plaques all over the extensor surfaces of my body.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oedema, Psoriasis, Psoriatic arthropathy, Renal impairment, Ultrasound kidney
Clinical narrative: At this time,  I developed both symptoms of nonhereditary ADKPD and Psoriatic plaques which further developed into Psoriatic Arthritis. After further genetic testing, it was found that ADPKD was not inherited, but a sporadic mutation & a very fast progressive form of the disease. - the Nephrologist confirmed that this was a very rare form of the disease. I had developed hypertension, severe edema, and dyslipidemia. My kidney function declined to less than 40% within 6 months.  The Psoriasis was also a very fast progressive form of the disease, one that was very unusual according to the Rheumatologist. I had skin plaques all over the extensor surfaces of my body.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Haematochezia, Influenza, Pyrexia
Clinical narrative: Mom reported - flu symptoms, mild fever, blood in stool
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Haematochezia, Influenza, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Mom reported at the site of injection a raised painful red circle rash, roughly 3". Flu symptoms, mild fever, blood in stool
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Mom reported at the site of injection a raised painful red circle rash, roughly 3". Flu symptoms, mild fever, blood in stool
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Pyrexia
Clinical narrative: fever initially along with feeling disoriented, fever resolved and now feels disoriented and like he is not in his own body
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Vaccine was not thawed properly before administration. Vaccine was thawed for 20-30 minutes before administration.  No reports of adverse side effects.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Miosis, Vision blurred
Clinical narrative: Blurred vision, constricted pupils, brief diarrhea
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased, Hyperhidrosis, Loss of consciousness
Clinical narrative: Extremely rapid heart beat, severe chest pain, extreme sweating, loosing consciousness
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia, Rash, Skin warm
Clinical narrative: Pt states she began having flu like symptoms on Friday evening. Pt had been advised this was a normal reaction. Pt states she ran a low grade fever that resolved. This was followed by a rash noted on Saturday Morning at 8:00 A.M. while showering. Rash is hot to touch and 7cm in diameter.  Still present on 2/3/25 but seems to be improving per pt.
Age: 88.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered wrong RSV immunization
Age: 21.0
Sex: F
Vaccine: MENB, TDAP, TYP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt verbalized feeling lightheaded shortly after receiving all 3 vaccinations. Followed by loss of consciousness for approximately 30 seconds. Pt was moved to exam table to lay down.  Snack provided. 4PM BP 98/58, HR 65, O2 99%.  4:06PM BP 101/61. 4:12PM BP 95/60. 4:21PM 113/78. Pt reported feeling much improved, declined ongoing lightheadedness. Pt ambulated safely out of clinic.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Depressed level of consciousness, Fluid intake reduced, Hyporesponsive to stimuli, Lethargy, Seizure
Clinical narrative: hypotonic seizure, decreased arousal, decreased fluid intake, decreased responsiveness to stimuli, lethargy
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Limb injury, Product administered at inappropriate site
Clinical narrative: Shot was injected too high into the shoulder causing injury. Pain and limited use of shoulder have been ongoing for almost 5 months.
Age: 66.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Acne, Allergy test, Condition aggravated, Dyspepsia, Formication
Clinical narrative: October 19th, 2024: Initial Symptom 15 minutes post vaccination, felt a high amount of stomach acid entering stomach. On or About 3 days post vaccine, continued having severe stomach acids and burning even after taking medication. A few days after taking the vaccine, I started getting bumps on my scalp and sporadic scattered pimples on my face and buttotocks. Started developing hives and a rash on my right arm. Went to Urgent Care and was prescribed sucralfate three times a day. As days passed, I started getting hives and spotty rashes in different areas of the body. Went to the dermatologist, they prescribed clindamycin topical lotion for scalp, also, ketoconazole 2% Shampoo, Mometasone Furoate 0.1% Soln. I had to return for three follow-up visits since symptoms did not improve. Dermatologist did not respond as to specifically why. Returned to the Urgent Care two weeks after. They stated that most likely it was a possible allergic reaction and received a cortisone injection. There after improve somewhat but continued developing new spotty rashes. Went to the ER and they could not do anything, there after I went back to urgent care for the 3rd time, they gave me a third shot of cortizone. Continued having sensitive skin and the feeling of insects crawling on my skin, cannot sleep at night.
Age: 66.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Hyperchlorhydria, Hypersensitivity, Laboratory test, Rash, Rash macular
Clinical narrative: October 19th, 2024: Initial Symptom 15 minutes post vaccination, felt a high amount of stomach acid entering stomach. On or About 3 days post vaccine, continued having severe stomach acids and burning even after taking medication. A few days after taking the vaccine, I started getting bumps on my scalp and sporadic scattered pimples on my face and buttotocks. Started developing hives and a rash on my right arm. Went to Urgent Care and was prescribed sucralfate three times a day. As days passed, I started getting hives and spotty rashes in different areas of the body. Went to the dermatologist, they prescribed clindamycin topical lotion for scalp, also, ketoconazole 2% Shampoo, Mometasone Furoate 0.1% Soln. I had to return for three follow-up visits since symptoms did not improve. Dermatologist did not respond as to specifically why. Returned to the Urgent Care two weeks after. They stated that most likely it was a possible allergic reaction and received a cortisone injection. There after improve somewhat but continued developing new spotty rashes. Went to the ER and they could not do anything, there after I went back to urgent care for the 3rd time, they gave me a third shot of cortizone. Continued having sensitive skin and the feeling of insects crawling on my skin, cannot sleep at night.
Age: 66.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Sensitive skin, Skin disorder, Sleep disorder, Urticaria
Clinical narrative: October 19th, 2024: Initial Symptom 15 minutes post vaccination, felt a high amount of stomach acid entering stomach. On or About 3 days post vaccine, continued having severe stomach acids and burning even after taking medication. A few days after taking the vaccine, I started getting bumps on my scalp and sporadic scattered pimples on my face and buttotocks. Started developing hives and a rash on my right arm. Went to Urgent Care and was prescribed sucralfate three times a day. As days passed, I started getting hives and spotty rashes in different areas of the body. Went to the dermatologist, they prescribed clindamycin topical lotion for scalp, also, ketoconazole 2% Shampoo, Mometasone Furoate 0.1% Soln. I had to return for three follow-up visits since symptoms did not improve. Dermatologist did not respond as to specifically why. Returned to the Urgent Care two weeks after. They stated that most likely it was a possible allergic reaction and received a cortisone injection. There after improve somewhat but continued developing new spotty rashes. Went to the ER and they could not do anything, there after I went back to urgent care for the 3rd time, they gave me a third shot of cortizone. Continued having sensitive skin and the feeling of insects crawling on my skin, cannot sleep at night.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Pt was to be administered influenza vaccine. Medical assistant notified provider that incorrect vaccine was administered. Tuberculin PPD skin test 0.5mL was administered intramuscularly. No immediate reaction was observed. Provider spoke with pt at 12:15pm, and pt continued to experience no symptoms. Pt denies any injection site reaction as well. Spoke with CDC who referred me to TB control office for the state. Will follow up in 24 and 48 hours as well per the guidance of regional TB manager.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Arm felt like it was breaking it hurt so bad, nausea. Took Ibuprofen. Still having soreness, weakness, not able to move arm because of pain.  Today could move arm slightly better than before.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received Menveo and TDaP after having received them in September of last year.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Dizziness, Dysstasia, Gait inability, Headache, Mobility decreased
Clinical narrative: Dizziness, altered vision, immobility,  shaking, headache, inability to dial phone, couldn't stand or walk. onset approximately 12 to 15 hours post vaccination and continued for approx. 3 hours
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Tremor, Visual impairment
Clinical narrative: Dizziness, altered vision, immobility,  shaking, headache, inability to dial phone, couldn't stand or walk. onset approximately 12 to 15 hours post vaccination and continued for approx. 3 hours
Age: 58.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP reported administering GARDASIL 9 to a 58 year old female.; No additional AE/PQC; This spontaneous report was received from nurse practitioner and refers to a 58-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient received the dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No adverse event was reported.   No follow up was required.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose May-2024 and Second Dose in Nov-2024; Initial report received on 27-Dec-2024.    A pharmacist reported that a 28-year-old female (race, ethnicity not reported) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received the second dose six months later.    No medical history or concomitant medications were reported.    In May-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLIAV-B (lot #, expiration date, NDC #, site and route not reported).    In Nov-2024, approximately six months after receiving HEPLISAV-B, the patient received the second dose of HEPLISAV-B.    No adverse reactions were reported.  The reporter declined to provided further information.       Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient Received Second Dose of Heplisav-B a Couple of Weeks Later Than One Month After First Dose; Initial report received on 27-Dec-20.  A quality assurance specialist reported that a patient (age, gender, race, ethnicity not reported) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization a couple of weeks later than one month after the first.  Medical history was reported as an allergy to penicillin.    No concomitant medications were reported.    On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported).    On an unknown date, a couple of weeks later than one month after the first dose, the patient received dose 2 of HEPLISAV-B (NDC # 43528-002-01, lot #, expiration date, site and route not reported).    No further adverse effects were reported.   No other information was available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Asked for TB Test But was Given IM HEPLISAV-B Instead; Initial report received on 30-Dec-2024.  A pharmacist reported that a 20-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization instead of receiving a tuberculosis (TB) test.  Medical history included an allergy to penicillin.    No concomitant medications were reported.     On 23-Nov-2024, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 944920, expiration date 04-Dec-2026, and NDC 43528-0003-05) intramuscularly in the left arm.  The patient came in and asked for a TB test but was given HEPLISAV-B vaccine instead in error. The pharmacist told the patient to return in a month. The patient thought he was returning to have his TB test read. The patient has previously received a three-dose hepatitis B vaccine series as a child. No further adverse effects were reported.   Per the reporter, no other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: A one time loss of muscle control trying to get out of bed and needed help to get back up; This non-serious case was reported by a consumer and described the occurrence of muscle weakness in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included general symptom. Concomitant products included acetylsalicylic acid (Aspirin).   On an unknown date, the patient received Shingles vaccine. In AUG-2024, an unknown time after receiving Shingles vaccine, the patient experienced muscle weakness (Verbatim: A one time loss of muscle control trying to get out of bed and needed help to get back up). The outcome of the muscle weakness was resolved.   It was unknown if the reporter considered the muscle weakness to be related to Shingles vaccine.     It was unknown if the company considered the muscle weakness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JAN-2025 The patient self-reported this case for herself. The patient experienced a onetime loss of muscle control when trying to get out of bed and needed help to get back up. The symptoms were not treated.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP called and reported 6 month old patient was given HAVRIX HEP A; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: HCP called and reported 6 month old patient was given HAVRIX HEP A). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 07-JAN-2025 The health care professional reported that 6 month old patient was given Havrix Hepatitis A vaccine, which led to inappropriate age at vaccine administration. No symptoms or side effects reported.  No additional adverse event/no product quality complaint.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles twice). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-JAN-2025 This case was reported by a patient via interactive digital media. The patient said that the vaccine did not work for shingles. He/she got shingles twice with a vaccination garbage. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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 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-JAN-2025 This case was reported by a patient via interactive digital media. The patient had shingles vaccine two years in a row and now had shingles and the medicine was awful. 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 and Shingrix dose 2.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received the shingles vaccine, still get shingles three times a year/ suspected vaccination failure; still get shingles three times a year; 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: received the shingles vaccine, still get shingles three times a year/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still get shingles three times a year). 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: 26-JAN-2025 This case was reported by the patient via interactive digital media. Patient received the shingles vaccine and  still gets shingles three times a year. Patient was asking what can the patient do? 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. The follow-up could not be possible as no contact details were available.; 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; aunt vaccinated and has had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: aunt vaccinated and has had 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: 29-JAN-2025 The case was received from the consumer via interactive digital media. Reporter reported that his/her aunt vaccinated and she has had shingles.  Reporter believed the vaccine lessened the pain though. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. This is 1 of 3 linked cases reported by the same reporter for different patients.; 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. US-GSK-US2025AMR013183:same reporter different patient US-GSK-US2025AMR013181:same reporter different patient
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder; Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number G97Y2, expiry date 15-NOV-2026) for prophylaxis.   On 04-JAN-2025, the patient received the 1st dose of Shingrix. On 04-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that who received Shingrix adjuvant alone without the powder as a Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2025001102, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2025001102:Same reporter/Different aptient
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Maladministration in a 18 year old patient instead of a BOOSTRIX dose; Inappropriate schedule of vaccine (INFANRIX three dose schedule); Underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (received Boostrix vaccine in 2014).   On 03-JAN-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 03-JAN-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Maladministration in a 18 year old patient instead of a BOOSTRIX dose), adult use of a child product (Verbatim: Inappropriate schedule of vaccine (INFANRIX three dose schedule)) and underdose (Verbatim: Underdose). The outcome of the wrong vaccine administered, adult use of a child product and underdose were 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: 06-JAN-2025 The healthcare professional reported that an eighteen year old patient was administered with a Infanrix instead of a Boostrix vaccine, wrong vaccine administered, adult use of a child product and underdose. Last Boostrix vaccination was on 2014.  The reporter reactively also mentioned this same patient received a three dose series schedule.
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: liquid portion inadvertently administered; liquid portion inadvertently administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 22-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A) for prophylaxis.   On 08-JAN-2025, the patient received the 1st dose of Menveo. On 08-JAN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: liquid portion inadvertently administered) and inappropriate dose of vaccine administered (Verbatim: liquid portion inadvertently administered). The action taken with Menveo was unknown. The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist called and reported that they had a Menveo vaccine, which was supposed to be given and the nurse only gave 1 component of it the liquid portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Reporter called to ask if they could reconstitute the powder for the Men A with just sterile diluent and given properly.  It was asked to the HCP if the patient only received the liquid portion and she replied as they provide both vials, but the powder was expired, and the liquid was not, so the nurse decided just to give the liquid component. Based on her answer, it seemed that the HCP only administered the liquid portion of the Menveo vaccine.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose given to adult; pediatric dose given to adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 57-year-old male patient who received HBV (Engerix B pediatric) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 09-JAN-2025, the patient received Engerix B pediatric. On 09-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose given to adult) and accidental underdose (Verbatim: pediatric dose given to adult). The outcome of the adult use of a child product and accidental underdose were 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: 09-JAN-2025 Patient was accidentally given a pediatric dose of Engerix-B, which led to adult use of a child product and accidental underdose.