chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Rash erythematous
Clinical narrative: present with redness below site of injection and  itching sensation, present to office today with progression slightly red cheeks, and larger erythematous rash ,
Age: 75.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second RSV vaccine on 7/17/24 by mistake. Patient had previously had the RSV vaccine administered on 12/05/23.  Pt did not report any additional adverse reactions.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Contusion, Erythema, Fatigue, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient reports the development of 4 dots on his right arm in the bicep and triceps region.  The dots are described as red, bruise-like in appearance, fingertip sized. Patient reports they are not raised and are not causing any pain.  The symptoms were noticed on 7/24/2024 following a tdap vaccination on 7/16/2024. Patient also reports he experienced unusual fatigue on 7/24/2024.  When asked about symptoms immediately after the vaccine, patient reported only soreness at the injection site (which was on the left arm).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 75.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Erythema, Extra dose administered, Peripheral swelling, Skin warm
Clinical narrative: Patient received a second RSV vaccine on 7/17/24 by mistake. Patient had previously had the RSV vaccine administered on 12/05/23.  Pt also reported her arm was red, warm, and swollen.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 66.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue, Single component of a two-component product administered
Clinical narrative: Patient received only one of the two vials of Menveo. Administered C,Y,W-135 portion that was not reconstituted with A portion.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on arms, legs and torso.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Delirium, Dementia, Herpes zoster, Impaired work ability
Clinical narrative: He got his vaccine, he had vomiting, shaking, extreme delirium, dementia like his head would not get straight, nausea and then the pain.  He had 4-5 sites in the middle of back that stretched out about 2 feet and was so painful that if somebody put ice on his back or cream he would cry out in pain.  The area is from the center of his back and has 4 spots have broken up and pushing into the muslces in his back and then spreads out like a "christmas tree", all the way down the sides to his buttocks.  He cannot wear a short and cannot stand anything touching it and sensitive to hot and cold.  He went to the ER clinic at Medical Center. They informed him that he had shingles, and gave him creams and antiviral medication Valacyclovir, and was given triamcinolone.  He went to the hospital today, the same one and they wanted to give  him some pain medicine, Tramadol which he informed him that it would not take care of that.  They did not give him a steroid to relieve the inflammation of his back but would not give him one.  He was prescribed another prescription that he has not picked up yet, as he just got home from the hospital.   He did not have any blood work or anything.  He got his first Shingrix vaccine on 5/26/24 and started breaking out and getting sores on his back which he did not realize it was from the vaccine.  Then 60 days later he got the 2nd vaccine and then 2-3 days later he started getting reactions and realized it had to be from the vaccine.  He has no other health problems.   He is having extreme headaches, throwing up, severe back pain and brain fog, and the feelings on his back and on top of his skin.  He is also having vertigo symptoms.   He has not been able to work for the past 2 months since these symptoms started.  He is now on Medical Leave and works in IT and has had to use all his PT and sick leave.   He is really disappointed that this has happened to him as this has hurt his family financially and he trusted the industry to protect him is why he took the vaccine.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Tenderness, Tremor, Vomiting
Clinical narrative: He got his vaccine, he had vomiting, shaking, extreme delirium, dementia like his head would not get straight, nausea and then the pain.  He had 4-5 sites in the middle of back that stretched out about 2 feet and was so painful that if somebody put ice on his back or cream he would cry out in pain.  The area is from the center of his back and has 4 spots have broken up and pushing into the muslces in his back and then spreads out like a "christmas tree", all the way down the sides to his buttocks.  He cannot wear a short and cannot stand anything touching it and sensitive to hot and cold.  He went to the ER clinic at Medical Center. They informed him that he had shingles, and gave him creams and antiviral medication Valacyclovir, and was given triamcinolone.  He went to the hospital today, the same one and they wanted to give  him some pain medicine, Tramadol which he informed him that it would not take care of that.  They did not give him a steroid to relieve the inflammation of his back but would not give him one.  He was prescribed another prescription that he has not picked up yet, as he just got home from the hospital.   He did not have any blood work or anything.  He got his first Shingrix vaccine on 5/26/24 and started breaking out and getting sores on his back which he did not realize it was from the vaccine.  Then 60 days later he got the 2nd vaccine and then 2-3 days later he started getting reactions and realized it had to be from the vaccine.  He has no other health problems.   He is having extreme headaches, throwing up, severe back pain and brain fog, and the feelings on his back and on top of his skin.  He is also having vertigo symptoms.   He has not been able to work for the past 2 months since these symptoms started.  He is now on Medical Leave and works in IT and has had to use all his PT and sick leave.   He is really disappointed that this has happened to him as this has hurt his family financially and he trusted the industry to protect him is why he took the vaccine.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Herpes zoster, Impaired work ability, Lethargy, Pain
Clinical narrative: He got his vaccine, he had vomiting, shaking, extreme delirium, dementia like his head would not get straight, nausea and then the pain.  He had 4-5 sites in the middle of back that stretched out about 2 feet and was so painful that if somebody put ice on his back or cream he would cry out in pain.  The area is from the center of his back and has 4 spots have broken up and pushing into the muslces in his back and then spreads out like a "christmas tree", all the way down the sides to his buttocks.  He cannot wear a short and cannot stand anything touching it and sensitive to hot and cold.  He went to the ER clinic at Medical Center. They informed him that he had shingles, and gave him creams and antiviral medication Valacyclovir, and was given triamcinolone.  He went to the hospital today, the same one and they wanted to give  him some pain medicine, Tramadol which he informed him that it would not take care of that.  They did not give him a steroid to relieve the inflammation of his back but would not give him one.  He was prescribed another prescription that he has not picked up yet, as he just got home from the hospital.   He did not have any blood work or anything.  He got his first Shingrix vaccine on 5/26/24 and started breaking out and getting sores on his back which he did not realize it was from the vaccine.  Then 60 days later he got the 2nd vaccine and then 2-3 days later he started getting reactions and realized it had to be from the vaccine.  He has no other health problems.   He is having extreme headaches, throwing up, severe back pain and brain fog, and the feelings on his back and on top of his skin.  He is also having vertigo symptoms.   He has not been able to work for the past 2 months since these symptoms started.  He is now on Medical Leave and works in IT and has had to use all his PT and sick leave.   He is really disappointed that this has happened to him as this has hurt his family financially and he trusted the industry to protect him is why he took the vaccine.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Allergy to vaccine, Lip swelling, Urticaria
Clinical narrative: patient developed hives and swelling up upper lip following PPSV23 vaccine . He was given benadryl a couple minutes after symptoms occured,  symptoms improved after 10 mins. Vitals remained stable and he did not have any respiratory concerns. He was monitored for about 45 minutes after vaccination and discharged home with strict return precautions in case hives, swelling, vomiting, wheezing, or difficulty breathing occur - PPSV23 added to allergy list
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Blood glucose normal, Disorientation, Loss of consciousness, Myoclonus, Unresponsive to stimuli
Clinical narrative: Pt was given the vaccines, while sitting in chair, pt suddenly became unresponsive, muscle jerking noted, prtslowly started to be more responsive,  disorientation noted, pt states that "everything suddenly went black" pt stated he does not remember what happened. Mother stated he has no history of physical illness, stated pt did not eat very well prior to coming to clinic, and pts room remains hot and he wears long sleeve shirts, she also stated that pt had stayed up late the night before and had barely woken up when coming to get vaccines.  Once pt was more alert and orientated, refreshments and snacks were offered, Multiple attempts at getting a blood pressure to left arm without success. after drinking a sports drink and eating some chips BP obtained to right arm at 134/73 with a pulse at 63.  cbg obtained and was 131.  Pt is a track athlete. Pt and family encouraged to follow up with primary.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO Adverse Reactions when spoke to grandmoter
Age: 24.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects noted. pt got extra dose of MMR and Hep B when he was already fully vaccinated for it.
Age: 69.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site pain, Tremor
Clinical narrative: THE DAY AFTER THE PATIENT RECEIVED THE ABOVE NAMED VACCINES, SHE STARTED EXPERIENCING SIDE EFFECTS. SHE EXPERIENCED CHILLS, SHAKING AND TIREDNESS. SHE TOOK ONE OF HER PERCOCET AND HAD SOME RELIEF. SHE SLEPT MOST OF THAT DAY. UPON WAKING TODAY, SHE HAD LESS SHAKING AND WEAKNESS AND NO CHILLS.  THE SITE OF HER PREVNAR-20 IS THE MOST SORE. I TOLD THE PATIENT TO CONTINUE TO MONITOR SYMPTOMS AND SEEK MEDICAL ATTENTION IF NEEDED.  I TOLD HER THAT IT WAS A GOOD SIGN THAT THE SYMPTOMS WERE IMPROVING. WE WILL CONTINUE TO CHECK IN WITH THE PATIENT VIA PHONE TO MONITOR HER PROGRESS.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Pt received 3rd dose of Meningococcal when this should of been MenB
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Patient experienced localized redness to injection site. MD ordered Benadryl PO and cold pack. patient was under RN supervisor for 15 minutes. Patient was alert and oriented. redness got smaller after 15 minutes. Mom was instructed to continue with OTC medications, cold pack at home. Mother was instructed to take patient to ER if swelling or wheezing occur.
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: patient was given hepatitis A (havarix) pediatric dose
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Guillain-Barre syndrome, Muscle fatigue
Clinical narrative: Patient was vaccinated at clinic as he was due for shingles injection on 4/2/24,  Patient was diagnosed with GBS within 8 weeks og vaccine, Patient messaged provider 7/19 to address concerns of needing extra assistance while ambulating with muscle fatigue, patient seen in clinic and in hospital on 7/23
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Mother reported on the same day after receiving vaccines on 7/23/24 she noted a small red spot on patient's left thigh where Varicella vaccine was administered. Spot is hard, warm to touch.  As of 8:58pm on 7/24/24, spot was now the size of tennis ball and itchy. Mom administered ibuprofen at 9:00pm.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site infection, Joint swelling, Localised infection, Skin warm
Clinical narrative: Infection of injection site and shoulder. Patient presented with redness, swelling and warm to touch to left shoulder. Patient sent to emergency room and given antibiotics.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Hypotonia, Lethargy, Pyrexia
Clinical narrative: high fever, lethargy and hypotonia resulting in ER admission
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred.  The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Asthma, Condition aggravated, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 1 hour; swelling at injection site, warm; pain, redness at injection site, asthma attack,
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Injection site warmth
Clinical narrative: Within 1 hour; swelling at injection site, warm; pain, redness at injection site, asthma attack,
Age: 32.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 29.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 29.0
Sex: U
Vaccine: UNK
Symptoms: Condition aggravated, Headache, Migraine
Clinical narrative: Constant headaches lasting multiple days at a time going from headache to severe migraines
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: Local swelling and erythema of left arm
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was administered Moderna Spikevax 2023-2024 (12 yrs up). Patient was monitored and did not have any adverse reactions.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This vaccine had reached the 10-week beyond use date on 6/23/24, and was administered to the patient on 7/1/24.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient presented today after having one Bexero dose in August of 2023. The clinic typically carries low stock of  Bexero and mainly only Trumenba. Due to this the nurse giving him his second Meningococcal B vaccine did not see the one dose of Bexero in the fridge present that was in a deeper location in the fridge out of plain sight and gave a dose of Trumenba as this was what he believed to be the only option and explained to the patient he would need one more dose of either vaccine to complete the series. Patient aware and expressed no adverse events following vaccine. It was discovered after the vaccine administration that there was in fact one Bexero dose tucked in the back of the fridge that the patient should have received. No adverse effects noted. Patient aware of need for additional dose.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in requesting Meningitis B vaccination and Meningitis ACWY was administered. Patient has already gotten 2 doses of Menveo. No reported adverse events to additional vaccine at this time
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Patient and mother called to voice complaint of had HPV vaccine at 800am, symptoms started immediately became worse through out the day., 103.7 head scanner at time of call Had tylenol 45 minutes ago, but vomited 10 minutes after taking tylenol, vomiting 6-7 x within last 1.5 hours. took tylenol and ibuprofen. Developed ongoing nausea, body aches, fevers, improved next day a little bit
Age: 55.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individual beyond use date of 8 weeks after vaccine had been thawed. The individual has been notified of this error and offered to be revaccinated per guidelines. Our local Department of Public Health has been notified of this vaccination administration error.
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individual beyond use date of 8 weeks after vaccine had been thawed. The individual has been notified of this error and offered to be revaccinated per guidelines. Our local Department of Public Health has been notified of this vaccination administration error.
Age: 44.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individual beyond use date of 8 weeks after vaccine had been thawed. The individual has been notified of this error and offered to be revaccinated per guidelines. Our local Department of Public Health has been notified of this vaccination administration error.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Vitreous floaters
Clinical narrative: 16 July 2024 09:00 I received second (2) Shingrix shot; 18 July 2024 0700 I woke up with eye floats on my right eye, 25 July 2024 I called the Medical Center about the condition. The RN recommended to me to report my condition.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: pulled wrong vaccine.   I always check cheat sheet paper of imms that are grouped by month. Chart was pulled before appointment.
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 55.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram normal, Angiogram pulmonary, Chest pain, Detoxification, Echocardiogram
Clinical narrative: PFIZER #1 1/28/2021 PFIZER #2 2/17/2021 PFIZER #3 8/27/2021 DEVELOPED CHEST PAIN WAS HOSPITALIZED WITH CHEST PAIN AND NEAR SYNCOPE RECEIVED CPR, CT ANGIOGRAM NEGATIVE.  WAS DIAGNOSED WITH COVID-19 VACCINE PERICARDITIS, POTS, AND POST COVID VACCINE FATIGUE SYNDROME.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION, COLCHICINE, NICOTINE PATCH, AND NADOLOL.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Immunisation reaction, Laboratory test, Pericarditis
Clinical narrative: PFIZER #1 1/28/2021 PFIZER #2 2/17/2021 PFIZER #3 8/27/2021 DEVELOPED CHEST PAIN WAS HOSPITALIZED WITH CHEST PAIN AND NEAR SYNCOPE RECEIVED CPR, CT ANGIOGRAM NEGATIVE.  WAS DIAGNOSED WITH COVID-19 VACCINE PERICARDITIS, POTS, AND POST COVID VACCINE FATIGUE SYNDROME.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION, COLCHICINE, NICOTINE PATCH, AND NADOLOL.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Presyncope, Resuscitation
Clinical narrative: PFIZER #1 1/28/2021 PFIZER #2 2/17/2021 PFIZER #3 8/27/2021 DEVELOPED CHEST PAIN WAS HOSPITALIZED WITH CHEST PAIN AND NEAR SYNCOPE RECEIVED CPR, CT ANGIOGRAM NEGATIVE.  WAS DIAGNOSED WITH COVID-19 VACCINE PERICARDITIS, POTS, AND POST COVID VACCINE FATIGUE SYNDROME.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION, COLCHICINE, NICOTINE PATCH, AND NADOLOL.
Age: 40.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individual beyond use date of 8 weeks after vaccine had been thawed. The individual has been notified of this error and offered to be revaccinated per guidelines. Our local Department of Public Health has been notified of this vaccination administration error.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Eye movement disorder, Head injury, Syncope, Vision blurred
Clinical narrative: Patient's eyes started darting back and forth and they complained of blurred vision. Patient then fainted and hit head on a table. Doctor gave sugar, cheese and cold water while the Patient sat and rested. Patient is now resting at home and drinking water. Seems to be recovering well.
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individual beyond use date of 8 weeks after vaccine had been thawed. The individual has been notified of this error and offered to be revaccinated per guidelines. Our local Department of Public Health has been notified of this vaccination administration error.
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Band neutrophil count increased, Blood glucose normal, Blood urea normal, Haemoglobin normal, Hepatic enzyme
Clinical narrative: A few hours after immunizations, the injection site got reddish swelling with tenderness. Blisters were seen afterwards. Seen in ER two days later. The diagnosis was mild cellulitis after immunization. Prescribed Cephalexin po for 10 days. Seen in my office today (7/25/24). No more local swelling or pain noted. But there were several irregular-shaped whitish depigmentation areas around the injection site. Mother was very concerned.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: A few hours after immunizations, the injection site got reddish swelling with tenderness. Blisters were seen afterwards. Seen in ER two days later. The diagnosis was mild cellulitis after immunization. Prescribed Cephalexin po for 10 days. Seen in my office today (7/25/24). No more local swelling or pain noted. But there were several irregular-shaped whitish depigmentation areas around the injection site. Mother was very concerned.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site vesicles, Neutrophil percentage, Skin depigmentation, White blood cell count normal
Clinical narrative: A few hours after immunizations, the injection site got reddish swelling with tenderness. Blisters were seen afterwards. Seen in ER two days later. The diagnosis was mild cellulitis after immunization. Prescribed Cephalexin po for 10 days. Seen in my office today (7/25/24). No more local swelling or pain noted. But there were several irregular-shaped whitish depigmentation areas around the injection site. Mother was very concerned.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Patient had soreness of the arm, followed by a "knot" at the site of injection. She took acetaminophen to help with the soreness, and she states at this time that the soreness has decreased slowly over time.
Age: 73.0
Sex: F
Vaccine: PNC20, RSV, VARZOS
Symptoms: Arthralgia, Dyspnoea
Clinical narrative: hours after vaccine administration, patient became short of breath and called EMS. ems came. she did not go to hospital. she used albuterol and symbicort which she had at house and felt better. per patient, ems said her blood pressure and breathing were good. patient said her left shoulder became very sore but is feeling better now (2 days later). no rash and no swelling of lips or tongue.
Sex: F
Vaccine: RSV
Symptoms: Dry skin, Injection site erythema, Injection site pain, Injection site swelling, Skin abrasion
Clinical narrative: burning at the injection site; redness at the injection site; swelling at the injection site; tenderness; warm to touch; Dry skin; Flaking skin; Chafed skin; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site burning in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In JUN-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site burning (Verbatim: burning at the injection site), injection site erythema (Verbatim: redness at the injection site), injection site swelling (Verbatim: swelling at the injection site), tenderness (Verbatim: tenderness), skin warm (Verbatim: warm to touch), dry skin (Verbatim: Dry skin), flaking skin (Verbatim: Flaking skin) and chafed skin (Verbatim: Chafed skin). The outcome of the injection site burning was resolving and the outcome of the injection site erythema, injection site swelling, tenderness, skin warm, dry skin, flaking skin and chafed skin were not reported.   It was unknown if the reporter considered the injection site burning, injection site erythema, injection site swelling, tenderness, skin warm, dry skin, flaking skin and chafed skin to be related to Arexvy.     It was unknown if the company considered the injection site burning, injection site erythema, injection site swelling, tenderness, skin warm, dry skin, flaking skin and chafed skin to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-JUL-2024 Healthcare professional shared with me that the patient showed burning, redness, swelling at the injection site as well as warm to touch and tenderness. Injection was over 4 weeks ago and patients arm now looks like it was recovering from a burn and skin was dry, flaking and chafed.
Sex: F
Vaccine: RSV
Symptoms: Skin exfoliation, Skin warm, Tenderness
Clinical narrative: burning at the injection site; redness at the injection site; swelling at the injection site; tenderness; warm to touch; Dry skin; Flaking skin; Chafed skin; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site burning in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In JUN-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site burning (Verbatim: burning at the injection site), injection site erythema (Verbatim: redness at the injection site), injection site swelling (Verbatim: swelling at the injection site), tenderness (Verbatim: tenderness), skin warm (Verbatim: warm to touch), dry skin (Verbatim: Dry skin), flaking skin (Verbatim: Flaking skin) and chafed skin (Verbatim: Chafed skin). The outcome of the injection site burning was resolving and the outcome of the injection site erythema, injection site swelling, tenderness, skin warm, dry skin, flaking skin and chafed skin were not reported.   It was unknown if the reporter considered the injection site burning, injection site erythema, injection site swelling, tenderness, skin warm, dry skin, flaking skin and chafed skin to be related to Arexvy.     It was unknown if the company considered the injection site burning, injection site erythema, injection site swelling, tenderness, skin warm, dry skin, flaking skin and chafed skin to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-JUL-2024 Healthcare professional shared with me that the patient showed burning, redness, swelling at the injection site as well as warm to touch and tenderness. Injection was over 4 weeks ago and patients arm now looks like it was recovering from a burn and skin was dry, flaking and chafed.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: A subsequent dose Extra dose administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 17-JUL-2024, the patient received Menveo (right arm). On 17-JUL-2024, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: A subsequent dose Extra dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GS Receipt Date: 18-JUL-2024 This report was submitted via the online direct entry reporting system.  The oversight patient needed men B not mcv4 (Menveo), which led to extra dose administered. It was routine vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin discolouration
Clinical narrative: red rash; red spot on chest; red on the skin/color of the spots change/spots are more red and other times they go away and look white; This non-serious case was reported by a consumer and described the occurrence of red rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced red rash (Verbatim: red rash), red spotty rash (Verbatim: red spot on chest) and skin discoloration (Verbatim: red on the skin/color of the spots change/spots are more red and other times they go away and look white). The patient was treated with hydrocortisone. The outcome of the red rash, red spotty rash and skin discoloration were not reported.   It was unknown if the reporter considered the red rash, red spotty rash and skin discoloration to be related to Shingrix.     It was unknown if the company considered the red rash, red spotty rash and skin discoloration to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUL-2024, 15-JUL-2024 and 16-JUL-2024 The patient received first dose of Shingrix vaccine 2 to 3 months before the second shot. The reporter stated after first dose of shingles vaccine there was a red rash on various passes of patient body.  The rash was still on same spots and did not disappear after second dose.  The spots were only on the upper part of his body, all over the elbows, and a couple little spots on his chest. They were not itchy and did not bother him. They just do not look good.  The reporter said that the spots were red on the skin and they were not moving, they were in the same shape in the same spot but that sometimes the color of the spots change.  Sometimes the spots were more red and other times they go away and look white.  The pharmacist had advised for him to use hydrocortisone topical cream on the elbow.
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain  in arm; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Shingrix and Arexvy. On an unknown date, an unknown time after receiving Shingrix and Arexvy, the patient experienced pain in arm (Verbatim: pain  in arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix and Arexvy.     It was unknown if the company considered the pain in arm to be related to Shingrix and Arexvy.   Additional Information: GSK Receipt Date: 16-JUL-2024 The patient reports pain in arm with administration of dose 1 Shingrix and a single dose of Arexvy on same date. He reported no other side effects due to having both vaccines on the same day.
Sex: F
Vaccine: MENB
Symptoms: Malaise, Pharyngitis streptococcal
Clinical narrative: sick; strep throat; This non-serious case was reported by a consumer via call center representative and described the occurrence of streptococcal sore throat in a neonate female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on 5 weeks ago and felt icky for a couple days, reference case US2024085860). Concurrent medical conditions included sore throat and feeling unwell.   On 06-JUL-2024, the patient received the 2nd dose of Bexsero. On 06-JUL-2024, less than a day after receiving Bexsero, the patient experienced sickness (Verbatim: sick). In JUL-2024, the patient experienced streptococcal sore throat (Verbatim: strep throat). On 07-JUL-2024, the outcome of the sickness was resolved (duration 1 day). The outcome of the streptococcal sore throat was unknown.   The reporter considered the streptococcal sore throat and sickness to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device.   The company considered the streptococcal sore throat and sickness to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2024085860   Additional Information: GSK receipt date: 10-JUL-2024 The reporter was the mother.  The reporter said that her daughter had two shots of Bexsero because she was going to college. The first shot was 5 weeks ago and received the second shot was on Saturday but her daughter was not feeling well that day (she had a sore throat) but she still received the immunization anyway.  It ended up being strep throat and she was put on antibiotics.  The patient was sick over the weekend but the mother said, that she did not thought it was from the shot.  The reporter did not want to provide her daughter's name or initials and did not want a report to be filed.  Did not consent to follow-up. Call
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Pain, Pain in extremity
Clinical narrative: he had a large, hard, red lump/lump was located an inch back from where the original red lump was; hard lump; red lump; arm hurt more and more/lot of pain in his arm/aching pain when lifting his arm high; really hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tendonitis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 2 days after receiving Shingrix, the patient experienced local swelling (Verbatim: he had a large, hard, red lump/lump was located an inch back from where the original red lump was), induration (Verbatim: hard lump), erythema (Verbatim: red lump), pain in arm (Verbatim: arm hurt more and more/lot of pain in his arm/aching pain when lifting his arm high) and pain (Verbatim: really hurt). The outcome of the local swelling, induration, erythema and pain were unknown and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the local swelling, induration, erythema, pain in arm and pain to be related to Shingrix.     It was unknown if the company considered the local swelling, induration, erythema, pain in arm and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUL-2024 The patient received his first dose of Shingrix in his left arm in either November or December 2023, and reported that when he received the vaccine, it really hurt. 2 days after receiving the vaccine (no specific date provided), he had a large, hard, red lump about 2 inches below where the injection was administered. The patient reported that this lump was there for 3 weeks and after 3 weeks, the lump was located an inch back from where the original red lump was, and his arm hurt more and more.  The patient reported that he had a lot of pain in his arm, aching pain when lifting his arm high, and his arm was still hurting at the time of reporting. The patient reported that he scheduled surgery for tendonitis in his right arm after receiving the Shingrix vaccine, and the physician performing the surgery told him the lump felt like a cyst about 3 centimeter in size. After a patient arm healed from the tendonitis surgery, he went back to his physician about this lump, and the physician told him the cyst had shrunk to 1 and 1 or 2 centimeter and had moved to the back side of his left arm between his triceps and deltoid and the physician performed an ultra sound.  The physician did not see anything, but said there could be something in the muscle, and sent the patient for another ultrasound.  This second ultrasound also did not show anything; but the physician were stated that might be there was something where the skin and muscle meet, like a fatty pack, but there were no cyst.  The patient had been referred to a dermatologist and has scheduled an appointment.  The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Tendon operation, Tendonitis, Ultrasound scan normal
Clinical narrative: he had a large, hard, red lump/lump was located an inch back from where the original red lump was; hard lump; red lump; arm hurt more and more/lot of pain in his arm/aching pain when lifting his arm high; really hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tendonitis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 2 days after receiving Shingrix, the patient experienced local swelling (Verbatim: he had a large, hard, red lump/lump was located an inch back from where the original red lump was), induration (Verbatim: hard lump), erythema (Verbatim: red lump), pain in arm (Verbatim: arm hurt more and more/lot of pain in his arm/aching pain when lifting his arm high) and pain (Verbatim: really hurt). The outcome of the local swelling, induration, erythema and pain were unknown and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the local swelling, induration, erythema, pain in arm and pain to be related to Shingrix.     It was unknown if the company considered the local swelling, induration, erythema, pain in arm and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUL-2024 The patient received his first dose of Shingrix in his left arm in either November or December 2023, and reported that when he received the vaccine, it really hurt. 2 days after receiving the vaccine (no specific date provided), he had a large, hard, red lump about 2 inches below where the injection was administered. The patient reported that this lump was there for 3 weeks and after 3 weeks, the lump was located an inch back from where the original red lump was, and his arm hurt more and more.  The patient reported that he had a lot of pain in his arm, aching pain when lifting his arm high, and his arm was still hurting at the time of reporting. The patient reported that he scheduled surgery for tendonitis in his right arm after receiving the Shingrix vaccine, and the physician performing the surgery told him the lump felt like a cyst about 3 centimeter in size. After a patient arm healed from the tendonitis surgery, he went back to his physician about this lump, and the physician told him the cyst had shrunk to 1 and 1 or 2 centimeter and had moved to the back side of his left arm between his triceps and deltoid and the physician performed an ultra sound.  The physician did not see anything, but said there could be something in the muscle, and sent the patient for another ultrasound.  This second ultrasound also did not show anything; but the physician were stated that might be there was something where the skin and muscle meet, like a fatty pack, but there were no cyst.  The patient had been referred to a dermatologist and has scheduled an appointment.  The reporter consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Malaise
Clinical narrative: felt "icky for a couple days; This non-serious case was reported by a consumer via call center representative and described the occurrence of malaise in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   In JUN-2024, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced malaise (Verbatim: felt "icky for a couple days). The outcome of the malaise was resolved.   It was unknown if the reporter considered the malaise to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the malaise to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2024AMR092786   Additional Information: GSK Receipt Date: 10-JUL-2024 The patient's mother reported this case. The mother said that her daughter (patient) had 1st shot of Bexsero because she was going to college.  The first shot was 5 weeks ago and she felt icky for a couple days. The reporter did not consent to follow-up. For tolerance to 2nd dose, refer case US2024AMR092786. This case is linked with US2024AMR092786, reported by same reporter.
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Kinrix used as primary series of Dtap; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 5-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix used as primary series of Dtap). The outcome of the inappropriate schedule of vaccine administered 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: 15-JUL-2024 Nurse reported that a kid who was doing a catch up schedule, received Kinrix at age 4 years and he was due for another Dtap/Ipv which led to inappropriate age at vaccine administration. Nurse questioned could they use another Kinrix or Infanrix plus Ipv a the 4th Dtap dose. Patient was 5 years old at the time of reporting.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Onychalgia, Peripheral swelling, Sensory disturbance
Clinical narrative: Nail pain; Nail redness; Nail swelling/swelling around the nails; Nail lifting sensation; This non-serious case was reported by a other health professional via call center representative and described the occurrence of nail pain in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 2Y393, expiry date 30-APR-2027) for prophylaxis.   On 08-JUL-2024, the patient received Bexsero. On 08-JUL-2024, less than a day after receiving Bexsero, the patient experienced nail pain (Verbatim: Nail pain), erythema of extremities (Verbatim: Nail redness), swelling (Verbatim: Nail swelling/swelling around the nails) and feeling abnormal (Verbatim: Nail lifting sensation). The outcome of the nail pain, erythema of extremities, swelling and feeling abnormal were unknown.   It was unknown if the reporter considered the nail pain, erythema of extremities, swelling and feeling abnormal to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the nail pain, erythema of extremities, swelling and feeling abnormal to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-JUL-2024 Healthcare professional reported that a patient reported the following adverse reaction following the administration of Bexsero which included pain, redness and swelling around the nails and nail lifting sensation.  The healthcare professional asked if this could be related to vaccination.