chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Bell's palsy, Blood test, Facial paralysis, Headache, Herpes simplex
Clinical narrative: 1/19/24: had Pfizer Covid 19 and Shingrix vaccine on same day - no reaction 2/9/24: had a severe HSV1 breakout that lasted a week - treated with Abreva 2/27/24: had terrible headache in the evening. Took Alleve and went to bed (I don't get headaches) 2/28/24: woke up with drooping face, right eye wouldn't blink or close. Went to urgent care and was transported to ER by ambulance.  MRI was done and diagnosis of Bell's Palsy received. released to home with Acyclovir and Prednisone.
Age: 71.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Magnetic resonance imaging abnormal
Clinical narrative: 1/19/24: had Pfizer Covid 19 and Shingrix vaccine on same day - no reaction 2/9/24: had a severe HSV1 breakout that lasted a week - treated with Abreva 2/27/24: had terrible headache in the evening. Took Alleve and went to bed (I don't get headaches) 2/28/24: woke up with drooping face, right eye wouldn't blink or close. Went to urgent care and was transported to ER by ambulance.  MRI was done and diagnosis of Bell's Palsy received. released to home with Acyclovir and Prednisone.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired, no adverse effects
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This was given 2 days after BUD
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Kinrix (Dtap/IPV) vaccine at 3 years of age. The recommended age is 4-6 years old. Reported to manufacturer.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired, no adverse effects
Age: 24.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Expired product administered
Clinical narrative: This was given 3 days after the BUD
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects
Age: 0.83
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Kinrix (Dtap/IPV) at 10 months of age. The recommended age is 4-6 years old. Reported to manufacturer.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Lip swelling, Urticaria
Clinical narrative: Redness around site the night of vaccine, hives around site and down arm started yesterday,  uticaria of tongue, lips swollen
Age: 0.83
Sex: M
Vaccine: DTAPIPV, FLU4, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Kinrix (Dtap/IPV) at 10 months of age. It is recommended at ages 4-6 years old. Reported to manufacturer
Age: 87.0
Sex: F
Vaccine: PNC20
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Patient developed L arm pain and numbness from shoulder to fingertips the day of the vaccine and the day after.  From the 3rd day, numbness and pain from shoulder to elbow. Cannot abduct arm and still in pain.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia, Petechiae
Clinical narrative: Patient reports that 3 days after her first injection on 4/2/24 she had "pins and needles" feeling in both hands that lasted for 1 week. Day 4 post injection she had what patient described as "petechiae" on her left wrist and back of her hand that resolved within 48 hours. Patient did not report this directly to the office when it occurred only voiced this at her visit for second dose when asked how she did after her first injection. Patient was not given the second dose at visit by recommendation  of provider in office.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given second dose of Menveo too early per age recommendation.  Patient's guardian contacted and made aware of event. Also documented in patient medical records.
Age: 47.0
Sex: F
Vaccine: FLUA4
Symptoms: Urticaria
Clinical narrative: I received the flu shot on Jan. 13th and my symptoms started 8 weeks later with getting hives. I?m still getting the hives too.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Brain fog, Fatigue, Headache, Migraine with aura
Clinical narrative: on 4/2/24 I had a headache, fever, fatigue, aches in my muscles and joints, brain fog, aura from migraine, light sensitive. I went to lunch a while later and I picked up my food and my hands felt disconnected from me. A lot of brain fog. I went to see if my face was ok, I wondered if I was having a stroke. Since then I have been tired. I had all those things for a week. It went away. I was working out in my yard a couple days during the week. My knees felt weak. I was wearing my knee braces as I have had knee weakness before. On 4/26 my knees were so weak they gave way. 4/27 I felt good. 4/28 I felt like i had something out of place in my back and ribs and assumed I needed to go to the chiropractor. The knee weakness was off and on over the next few days. 5/1 I went to the store. My right leg of weak and my foot didn't feel right  I went home and rested and iced it. Still feeling weakness in my knees.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Muscular weakness, Myalgia, Orthosis user, Photophobia, Pyrexia
Clinical narrative: on 4/2/24 I had a headache, fever, fatigue, aches in my muscles and joints, brain fog, aura from migraine, light sensitive. I went to lunch a while later and I picked up my food and my hands felt disconnected from me. A lot of brain fog. I went to see if my face was ok, I wondered if I was having a stroke. Since then I have been tired. I had all those things for a week. It went away. I was working out in my yard a couple days during the week. My knees felt weak. I was wearing my knee braces as I have had knee weakness before. On 4/26 my knees were so weak they gave way. 4/27 I felt good. 4/28 I felt like i had something out of place in my back and ribs and assumed I needed to go to the chiropractor. The knee weakness was off and on over the next few days. 5/1 I went to the store. My right leg of weak and my foot didn't feel right  I went home and rested and iced it. Still feeling weakness in my knees.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Sensory disturbance
Clinical narrative: on 4/2/24 I had a headache, fever, fatigue, aches in my muscles and joints, brain fog, aura from migraine, light sensitive. I went to lunch a while later and I picked up my food and my hands felt disconnected from me. A lot of brain fog. I went to see if my face was ok, I wondered if I was having a stroke. Since then I have been tired. I had all those things for a week. It went away. I was working out in my yard a couple days during the week. My knees felt weak. I was wearing my knee braces as I have had knee weakness before. On 4/26 my knees were so weak they gave way. 4/27 I felt good. 4/28 I felt like i had something out of place in my back and ribs and assumed I needed to go to the chiropractor. The knee weakness was off and on over the next few days. 5/1 I went to the store. My right leg of weak and my foot didn't feel right  I went home and rested and iced it. Still feeling weakness in my knees.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, Feeling abnormal, Migraine, Muscular weakness, Pain
Clinical narrative: on 4/2/24 I had a headache, fever, fatigue, aches in my muscles and joints, brain fog, aura from migraine, light sensitive. I went to lunch a while later and I picked up my food and my hands felt disconnected from me. A lot of brain fog. I went to see if my face was ok, I wondered if I was having a stroke. Since then I have been tired. I had all those things for a week. It went away. I was working out in my yard a couple days during the week. My knees felt weak. I was wearing my knee braces as I have had knee weakness before. On 4/26 my knees were so weak they gave way. 4/27 I felt good. 4/28 I felt like i had something out of place in my back and ribs and assumed I needed to go to the chiropractor. The knee weakness was off and on over the next few days. 5/1 I went to the store. My right leg of weak and my foot didn't feel right  I went home and rested and iced it. Still feeling weakness in my knees.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Photophobia, Pyrexia
Clinical narrative: on 4/2/24 I had a headache, fever, fatigue, aches in my muscles and joints, brain fog, aura from migraine, light sensitive. I went to lunch a while later and I picked up my food and my hands felt disconnected from me. A lot of brain fog. I went to see if my face was ok, I wondered if I was having a stroke. Since then I have been tired. I had all those things for a week. It went away. I was working out in my yard a couple days during the week. My knees felt weak. I was wearing my knee braces as I have had knee weakness before. On 4/26 my knees were so weak they gave way. 4/27 I felt good. 4/28 I felt like i had something out of place in my back and ribs and assumed I needed to go to the chiropractor. The knee weakness was off and on over the next few days. 5/1 I went to the store. My right leg of weak and my foot didn't feel right  I went home and rested and iced it. Still feeling weakness in my knees.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Brain fog, Fatigue, Headache, Migraine with aura
Clinical narrative: The patient states she had body aches, fever and weakness for the first week after receiving the Arexvy. Then in week 2 after receiving Arexvy the patient states she has had migraines, light sensitivity and knee weakness. The patient states she still doesn't feel right.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Muscular weakness, Myalgia, Orthosis user, Photophobia, Pyrexia
Clinical narrative: The patient states she had body aches, fever and weakness for the first week after receiving the Arexvy. Then in week 2 after receiving Arexvy the patient states she has had migraines, light sensitivity and knee weakness. The patient states she still doesn't feel right.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Sensory disturbance
Clinical narrative: The patient states she had body aches, fever and weakness for the first week after receiving the Arexvy. Then in week 2 after receiving Arexvy the patient states she has had migraines, light sensitivity and knee weakness. The patient states she still doesn't feel right.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, Feeling abnormal, Migraine, Muscular weakness, Pain
Clinical narrative: The patient states she had body aches, fever and weakness for the first week after receiving the Arexvy. Then in week 2 after receiving Arexvy the patient states she has had migraines, light sensitivity and knee weakness. The patient states she still doesn't feel right.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Photophobia, Pyrexia
Clinical narrative: The patient states she had body aches, fever and weakness for the first week after receiving the Arexvy. Then in week 2 after receiving Arexvy the patient states she has had migraines, light sensitivity and knee weakness. The patient states she still doesn't feel right.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine. Expiration date was 04/29/2024
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Nausea, Orthostatic hypotension
Clinical narrative: Nausea, headache, postural hypotension
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: AREXVY WAS GIVEN TO PATIENT SECOND TIME IN ERROR (1ST DOSE ADMINISTERED SEPTEMBER 5, 2023)
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Initially patient presented with non-localized redness and non-localized swelling of the injection that proceeded into several hive cluster formations peri-administration site. Provider was notified or redness at its onset. When provider arrived, hive formation began. Provider ordered 1.25 mL of oral Benadryl 12.5 mg/5 mL. Patient's symptoms resolved shortly thereafter and was kept in clinic for about a 30 minutes period for continual assessment before being released to home.
Age: 0.08
Sex: F
Vaccine: HEP, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Rotarix vaccine given to infant less than 6 weeks old, no adverse event to report at this time
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site rash, Rash, Skin warm
Clinical narrative: 5/1/24 Spoke w mom about pt reaction to MMRV. Per mom -  4/16/24 MMRV given several days post vaccine pt developed honeycomb rash to opposite leg of MMRV injection (leg that Kinrix given) but this was the first dose of MMRV, pt third dose of IPV/DTap and 2nd dose of Hep A. Mom reports pt having a fever of 101/102 several days post vaccine but that mom has been unable to check temp since as they have lost the thermometer.  4/24/24 site of MMRV injection developed bumps localized to site 4/25/24 rash developed to site of MMRV injection 4/28/24 rash noted all over body 5/1/24 Pt still w rash but mom reports it is getting better
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: I administered the incorrect kind of vaccination to the patient. Patient needed a pediatric dosage and I administered an adult dose
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Doctor asked nurse to give shots. Nurse went and drew up shots and administered to child. when putting order in a reviewing chart noticed that Hep A was given instead of Hep B. child was not having any allergic reaction to vaccine. Doctor and family notified and notified that child would have to come back to receive the Hep B shot.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Chest X-ray abnormal, Chest discomfort, Chills, Cough
Clinical narrative: 1. Runny nose. 2. Sore throat. 3. Unusual tiredness and weak-slept for 3 days straight. 4. Body aches and coughing.  5. Fever, very, very bad chills.  6. Difficulty breathing, could not even talk without coughing. During all this I never had phlegm.  It felt as if I had something squeezing my solar plexus and I could not breathe. About 2 weeks after getting the vaccine I went to my doctor.  She said my lungs were clear and to take cough medicine.  She did not believe it was an adverse reaction to the vaccine.  About a week after that:  I was very weak and was hardly able to get out of bed.  I went to the walk-in clinic and saw Dr. He did not believe me when I told him I was sure it was an adverse reaction to the vaccine and that I had Bronchitis.  I never had any phlegm!  I took the cough medicine prescribed by Dr.  It didn't help at all.  I took the medicine prescribed by Dr. and it made me very sick.  I projectile vomited for about 2 hours after takeing it.  On April 11th, 2024 My daughter took me to the Emergency Department. Finally there the doctors took x-rays of my lungs.  They saiid it was an air blockage in the lower left lung or the begining of pneumonia?  Again, no one believed me when I said it was an adverse reaction to the vaccine I had gotten.  Please call me if you need more information.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Dyspnoea, Fatigue, Hypersomnia, Lung disorder, Mobility decreased
Clinical narrative: 1. Runny nose. 2. Sore throat. 3. Unusual tiredness and weak-slept for 3 days straight. 4. Body aches and coughing.  5. Fever, very, very bad chills.  6. Difficulty breathing, could not even talk without coughing. During all this I never had phlegm.  It felt as if I had something squeezing my solar plexus and I could not breathe. About 2 weeks after getting the vaccine I went to my doctor.  She said my lungs were clear and to take cough medicine.  She did not believe it was an adverse reaction to the vaccine.  About a week after that:  I was very weak and was hardly able to get out of bed.  I went to the walk-in clinic and saw Dr. He did not believe me when I told him I was sure it was an adverse reaction to the vaccine and that I had Bronchitis.  I never had any phlegm!  I took the cough medicine prescribed by Dr.  It didn't help at all.  I took the medicine prescribed by Dr. and it made me very sick.  I projectile vomited for about 2 hours after takeing it.  On April 11th, 2024 My daughter took me to the Emergency Department. Finally there the doctors took x-rays of my lungs.  They saiid it was an air blockage in the lower left lung or the begining of pneumonia?  Again, no one believed me when I said it was an adverse reaction to the vaccine I had gotten.  Please call me if you need more information.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Oropharyngeal pain, Pain, Pneumonia, Pyrexia, Rhinorrhoea
Clinical narrative: 1. Runny nose. 2. Sore throat. 3. Unusual tiredness and weak-slept for 3 days straight. 4. Body aches and coughing.  5. Fever, very, very bad chills.  6. Difficulty breathing, could not even talk without coughing. During all this I never had phlegm.  It felt as if I had something squeezing my solar plexus and I could not breathe. About 2 weeks after getting the vaccine I went to my doctor.  She said my lungs were clear and to take cough medicine.  She did not believe it was an adverse reaction to the vaccine.  About a week after that:  I was very weak and was hardly able to get out of bed.  I went to the walk-in clinic and saw Dr. He did not believe me when I told him I was sure it was an adverse reaction to the vaccine and that I had Bronchitis.  I never had any phlegm!  I took the cough medicine prescribed by Dr.  It didn't help at all.  I took the medicine prescribed by Dr. and it made me very sick.  I projectile vomited for about 2 hours after takeing it.  On April 11th, 2024 My daughter took me to the Emergency Department. Finally there the doctors took x-rays of my lungs.  They saiid it was an air blockage in the lower left lung or the begining of pneumonia?  Again, no one believed me when I said it was an adverse reaction to the vaccine I had gotten.  Please call me if you need more information.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Vomiting projectile
Clinical narrative: 1. Runny nose. 2. Sore throat. 3. Unusual tiredness and weak-slept for 3 days straight. 4. Body aches and coughing.  5. Fever, very, very bad chills.  6. Difficulty breathing, could not even talk without coughing. During all this I never had phlegm.  It felt as if I had something squeezing my solar plexus and I could not breathe. About 2 weeks after getting the vaccine I went to my doctor.  She said my lungs were clear and to take cough medicine.  She did not believe it was an adverse reaction to the vaccine.  About a week after that:  I was very weak and was hardly able to get out of bed.  I went to the walk-in clinic and saw Dr. He did not believe me when I told him I was sure it was an adverse reaction to the vaccine and that I had Bronchitis.  I never had any phlegm!  I took the cough medicine prescribed by Dr.  It didn't help at all.  I took the medicine prescribed by Dr. and it made me very sick.  I projectile vomited for about 2 hours after takeing it.  On April 11th, 2024 My daughter took me to the Emergency Department. Finally there the doctors took x-rays of my lungs.  They saiid it was an air blockage in the lower left lung or the begining of pneumonia?  Again, no one believed me when I said it was an adverse reaction to the vaccine I had gotten.  Please call me if you need more information.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Injection site pain, Nausea, Vomiting
Clinical narrative: 8:30PM the patient started to feel nauseous and then shortly after started to vomit with slight chest pain. pt then proceeded to vomit all night and this morning she woke up with arm pain at the injection site which was also present after the 1st dose.
Age: 73.0
Sex: F
Vaccine: COVID19, HEP
Symptoms: Diverticulum, Haematochezia
Clinical narrative: Diarhhea with bloody stools - 1 event only
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Patient experienced swollen lymph nodes ("adenopatia" in her own words) and received treatment with antibiotic therapy which resolved the condition.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events. Expired Dtap (Daptacel) vaccine was given to patient on 4/16/2024. Vaccine expired on 4/06/2024.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Irritability, Lethargy, Mobility decreased, Pain in extremity
Clinical narrative: Starting evening of vaccination:  right leg pain, fever 102.1f , lethargic, fussy, poor appetite.  Wont walk on right leg. Developed red rash on 5/2
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Starting evening of vaccination:  right leg pain, fever 102.1f , lethargic, fussy, poor appetite.  Wont walk on right leg. Developed red rash on 5/2
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Father called stating that every time patient feeds she vomits and is having about 4-5 loose stools since vaccines Wednesday. Patient got Pentacel, Prevnar, and rotateq. Patient is still having good wet diapers. Patients membranes are still moist. Patient did have a fever of 100.5 after vaccines, but has not had one since. Father wondering if this reaction could be from vaccines or could possibly be a gastro bug.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt does not present any symptom. Pt received the vaccine at 3 years old. Vaccine is for patients 4-6 years of age.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blood pressure decreased, Dyspnoea, Loss of consciousness
Clinical narrative: Patient passed out 10 minutes after receiving the vaccines. We called an ambulance straight away while one person observed the patient. The patient was breathing heavily but eyes were closed. She came around in about two minutes and was fully conscious. The ambulance arrived in about 10 minutes and checked her vitals. Her blood pressure was very low. They recommended for her to go to the hospital. Patient refused. On further questioning the patient the ambulance crew determined that the patient had donated blood earlier in the day. The patient did not relay this information before we gave her the vaccines. We observed the patient for 24 minutes after the ambulance crew left and she was perfectly fine. Her husband came to pick her up and she walked perfectly well to his car.
Age: 0.17
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: MMR inadvertently given to 2 month old female instead of Hib
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient received an erroneous third Hep A vaccine dose on 3/26/24 after completing the series on 3/15/24 due to language barrier issues/communication. No information was provided for what exact Hep A vaccine or what lot/site for the erroneous admin. Was unable to get that information upon researching error - please do not reach out for clarification.
Age: 0.75
Sex: F
Vaccine: DTAPIPV, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 9 month old and vaccine indicated for 4-6 years old.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: red ,swollen and warm to the touch
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient here due to reaction from recent Men B vaccine administered on 4/30/2024. Patient presents with raised area on left deltoid that is approximately 3-4 inches in diameter.  Area has erythema and warmth on palpation. Patient stated pain is 8/10 today. Patient stated the sxs onset the day of immunization (4/30/2024) and she felt weak and had vomiting in addition to the area of swelling on left deltoid x 1 day. Patient stated she took Benadryl, but it did not help much. Patient stated the erythema on left deltoid is improved today since yesterday. Denies itching or fevers.  Denies drainage. Patient stated she did not have any reaction to the first Men B vaccine she received.  She also noted that she received a Botox injection 4/22/2024 and is unsure if that contributed to sxs. Patient's vitals in office today are stable. Dr. verbally informed.  Per Dr.: Sounds like localized reaction versus true allergy, especially since no reaction to the first Men B administration.  As long as kidney function is fine, advise patient to take OTC antiinflammatories and apply ice pack.  Monitor for signs of cellulitis. Patient informed of above recommendations from provider.  Also advised to call office right away if any new or worsening sxs or if sxs do not resolve with recommended treatments. Patient verbalized understanding and agreeable.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Local reaction, Vomiting
Clinical narrative: Patient here due to reaction from recent Men B vaccine administered on 4/30/2024. Patient presents with raised area on left deltoid that is approximately 3-4 inches in diameter.  Area has erythema and warmth on palpation. Patient stated pain is 8/10 today. Patient stated the sxs onset the day of immunization (4/30/2024) and she felt weak and had vomiting in addition to the area of swelling on left deltoid x 1 day. Patient stated she took Benadryl, but it did not help much. Patient stated the erythema on left deltoid is improved today since yesterday. Denies itching or fevers.  Denies drainage. Patient stated she did not have any reaction to the first Men B vaccine she received.  She also noted that she received a Botox injection 4/22/2024 and is unsure if that contributed to sxs. Patient's vitals in office today are stable. Dr. verbally informed.  Per Dr.: Sounds like localized reaction versus true allergy, especially since no reaction to the first Men B administration.  As long as kidney function is fine, advise patient to take OTC antiinflammatories and apply ice pack.  Monitor for signs of cellulitis. Patient informed of above recommendations from provider.  Also advised to call office right away if any new or worsening sxs or if sxs do not resolve with recommended treatments. Patient verbalized understanding and agreeable.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac monitoring abnormal, Cardiomyopathy, Echocardiogram normal, Electrocardiogram abnormal, Magnetic resonance imaging heart abnormal
Clinical narrative: Sudden death, Ventricular tachycardia
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sudden death, Ventricular tachycardia
Clinical narrative: Sudden death, Ventricular tachycardia
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had no adverse effects. Patient was given a second dose of Arexvy on 4/27/2024.  Initial Arexvy dose was given on 10/23/2023.
Age: 64.0
Sex: M
Vaccine: PNC20
Symptoms: Facial paralysis, Swelling of eyelid
Clinical narrative: Patient received the Prevnar 20 on 4/26/24 at 12:00pm. On 4/29/24, patient presented with right eye drooping, right upper/lower lip swollen, and his smile was asymmetrical.
Age: 16.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Fall, Loss of consciousness
Clinical narrative: within 2 minutes of vaccines, patient passed out and fell onto the exam room floor. She became responsive quickly thereafter, and remained supine on the floor while the nurse and NP attended the patient. Blood pressures were checked, pulse ox, heart rate, and patient examined. When patient was stable (approx 35 mins later), she was allowed to stand and begin to ambulate. She was escorted to her car and checked on via phone call to mom 30 minutes later.
Age: 42.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Pt was seen today for an appt with their provider and was due for their 2nd dose of Mpox vaccine. The MA gave the injection to the pt Intramuscular when it should have been subcutaneous. The pt did not complain of any discomfort or pain when receiving the vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: No problem day of immunization.  Immunization site had no swelling  or redness.  Patient complained that 2 days after Shingrex  she started itching and became worse over the next few days. She went to the doctor today and got steroids and anti histamine
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, PNC20, VARCEL
Symptoms: Crying, Decreased appetite, Gait disturbance, Injection site bruising, Injection site pain
Clinical narrative: mom stated inconsolable crying unless being held and no one is touching RT.  noted visually a small bruise on top RT IM injection, but unable to determine which vaccine it is Pentacel or HBV. patient has lack of appetite but drinks water/juice per mother.  and refuses to walk and doesn't sleep unless being held. constant off/on crying and wanting mom. mom stated fever but no thermometer and mother used hand to forehead only and gave tylenol. advised motrin for pain/fever and to buy a thermometer and only give med if temp under arm is 98.6 or greater. mother stated understanding. told mom if this continues see MD at local Urgent care, no insurance but no doctors on site in clinics.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, PNC20, VARCEL
Symptoms: Insomnia, Irritability, Skin warm
Clinical narrative: mom stated inconsolable crying unless being held and no one is touching RT.  noted visually a small bruise on top RT IM injection, but unable to determine which vaccine it is Pentacel or HBV. patient has lack of appetite but drinks water/juice per mother.  and refuses to walk and doesn't sleep unless being held. constant off/on crying and wanting mom. mom stated fever but no thermometer and mother used hand to forehead only and gave tylenol. advised motrin for pain/fever and to buy a thermometer and only give med if temp under arm is 98.6 or greater. mother stated understanding. told mom if this continues see MD at local Urgent care, no insurance but no doctors on site in clinics.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE EVENT HAPPENED,  patient received vaccine at age 8 yrs when vaccine is supposed to be given between 4-6 yrs.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no adverse effects
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Back pain, Fatigue, Injection site erythema, Neck pain
Clinical narrative: Pt had redness  at site of injection and also was very tired, weak and pain in neck and back
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Head injury, Syncope
Clinical narrative: Patient fainted after getting vaccine. They did not let us know before hand that they have fainted once before. Patient fell and hit head. Had him stay around for 15 minutes to monitor and said felt fine afterwards. Was told that they could also go get checked out regarding hitting their head as well. No ambulance was called and patient is okay.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient came in to office today for his 4 year old well visit and State Shots data base was not checked. Parent of patient stated patient was behind on vaccines and due to being in the office for 4 year physical patient received Kinrix and ProQuad. Patient waited in the office for 15 minutes after vaccine was administered, patient had no symptoms during this time.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Patient developed headache, left upper arm swelling, left upper arm redness and left upper arm tightness. Pain with touch.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Lymphadenopathy, Malaise
Clinical narrative: fatigue, chills, racing heart, swollen lymphnodes under left arm,no appetite, malaise
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: fatigue, chills, racing heart, swollen lymphnodes under left arm,no appetite, malaise
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Haemorrhage, Skin discolouration
Clinical narrative: patient said that when she got home her arm was bleeding (on Saturday). I told her to ice it, take take ibuprofen if it was painful. patient called back to say that it looks like a half-dollar sized bruise, and it is dark in color (black/blue). it is not painful to the patient currently.
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injection site erythema
Clinical narrative: Patient had a red streak about 3 inches long  from the admin site starting 2 days after the shot.  Four days later the patient experienced very bad knee pain in one knee.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Ejection fraction normal, Electrocardiogram ST segment elevation, Fatigue, Immunisation reaction
Clinical narrative: PFIZER #1 3/22/2021 PFIZER #2 4/12/2021 4/15/2021 DEVELOPED FEVER, MALAISE, EXHAUSTION, UNABLE TO GO TO SCHOOL AND THEN LATER DEVELOPED COVID-19 MRNA PERICARDITIS.  THIS WAS TREATED WITH COLCHICINE AND PROTOCOL.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Malaise, Pericardial effusion, Pericarditis
Clinical narrative: PFIZER #1 3/22/2021 PFIZER #2 4/12/2021 4/15/2021 DEVELOPED FEVER, MALAISE, EXHAUSTION, UNABLE TO GO TO SCHOOL AND THEN LATER DEVELOPED COVID-19 MRNA PERICARDITIS.  THIS WAS TREATED WITH COLCHICINE AND PROTOCOL.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: PFIZER #1 3/22/2021 PFIZER #2 4/12/2021 4/15/2021 DEVELOPED FEVER, MALAISE, EXHAUSTION, UNABLE TO GO TO SCHOOL AND THEN LATER DEVELOPED COVID-19 MRNA PERICARDITIS.  THIS WAS TREATED WITH COLCHICINE AND PROTOCOL.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Full blood count, Injection site urticaria
Clinical narrative: Hives appeared around injection site and spread over thigh.  PO dose of diphenhydramine given.  S/S of allergic reaction were controlled to the hives on the left leg.  No need for further intervention.
Age: 16.0
Sex: F
Vaccine: HEPA, IPV, MENB, MNQ, VARCEL
Symptoms: Nausea, Pallor, Peripheral coldness, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Clinic- A 16 year old female received 5 immunizations.  Vaccines Hep A (#423NL), Men B (#GF4143) was given IM in RD and Varicella (#X04648) was given Sq in RA. Vaccines Polio (#W1C83M) given IM in LD and MCV4 (#U7945BC) was the last vaccine given. About 1130 am patient skin tone in face became pale, unable to talk, hands slightly cold, head lean back to wall and nauseated. Vitals taken @ 1133 BP-92/58, P78,Temp-97.8 02sats99%.. Provider present. Vitals retaken again 1145am 97/63-p-80, o2sats 99%. Patient alert sitting in chair. Vitals Retaken again @ 1158am BP-101/67 P-74, O2sats @100%. No nausea or paleness to face. Patient able to stand, ate an orange, drank water before leaving. Mother Refused Ambulance Transport. Consent signed.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: PT HAS HIVES ON UPPER/LOWER STOMACH AREA/UPPER LOWER BACK, (L) LEG. NO OTHER SX. Advise to give 5 ml of Benadryl now for hives. If rash continues or worsens would advise to report to walk in clinic.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects
Age: 17.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE; a 17-year-old child received their 3rd dose of RECOMBIVAX HB as the adult formulation. Confirmed it was adult formulation.; a 17-year-old child received their 3rd dose of RECOMBIVAX HB as the adult formulation. Confirmed it was adult formulation.; This spontaneous report was received from an registered nurse referring to a 17-year-old patient with unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 02-APR-2024, a health professional given the patient the 3rd dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 10 microgram per millilitre intramuscular injection (reported as adult prefilled syringe), 1 prefilled syringe (10 microgram), lot #X025237, expiration date: 17-MAY-2026, administered for prophylaxis (route of administration and anatomical site of administration were not provided), confirmed it was adult formulation (product administered to patient of inappropriate age, incorrect dose administered). No additional adverse event (AE).
Age: 7.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects reported; GARDASIL 9 was administered to a 7 year old boy; This spontaneous report has been received from a nurse referring to a 7-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-APR-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot# X019625 had been verified to be a valid lot number and expiration date was 23-APR-2025; strength, dose, and route of administration were not provided) for prophylaxis (Product administered to patient of inappropriate age). There were no side effects reported.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Chromaturia, Headache, Liver function test, Ocular icterus, Pain in extremity
Clinical narrative: leg pain; dark urine; headache; skin yellow; eye yellow; This spontaneous report was received from the pharmacist and referred to a 22-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Historical drugs included pseudoephedrine hydrochloride (SUDAFED). Concomitant medications included ethinylestradiol (+) ferrous fumarate (+) norethisterone acetate (HAILEY 24 FE). Relevant drug reactions/allergies were unknown.   On an unknown date, the patient received the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, after 2 hours of vaccination, the patient experienced leg pain and darked urine. On the next day, the patient woke up with a headache and her skin and eye were yellow. The patient was treated with paracetamol (TYLENOL)and ibuprofen. The patient had done liver function test, but result was not known. The patient been sought medical attention. The patient's symptom resolved with a day or two. The patient's present status was recovered, the outcome of all events was considered as recovered.   The causality between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Yellow skin
Clinical narrative: leg pain; dark urine; headache; skin yellow; eye yellow; This spontaneous report was received from the pharmacist and referred to a 22-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Historical drugs included pseudoephedrine hydrochloride (SUDAFED). Concomitant medications included ethinylestradiol (+) ferrous fumarate (+) norethisterone acetate (HAILEY 24 FE). Relevant drug reactions/allergies were unknown.   On an unknown date, the patient received the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, after 2 hours of vaccination, the patient experienced leg pain and darked urine. On the next day, the patient woke up with a headache and her skin and eye were yellow. The patient was treated with paracetamol (TYLENOL)and ibuprofen. The patient had done liver function test, but result was not known. The patient been sought medical attention. The patient's symptom resolved with a day or two. The patient's present status was recovered, the outcome of all events was considered as recovered.   The causality between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No side effects reported/ No additional AE/PQC; patient who simultaneously received PROQUAD and VARIVAX on 26APR2024; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 26-APR-2024, the patient was simultaneously vaccinated with dose of varicella virus vaccine live (oka/merck)(VARIVAX), formulation: injection, lot # X017484, expiration date: 25-JUN-2025 (exact dose, route of administration and anatomical location were not provided); and with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), formulation: injection, lot # was reported as: X026957 (non-valid), expiration date was reported as: 11-MAY-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (Vaccine overdose). No additional side effects and adverse event reported (No Adverse Event).  Lot Number X026957 is not valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and does not match any Company product.
Sex: F
Vaccine: VARZOS
Symptoms: Butterfly rash, Chronic cutaneous lupus erythematosus
Clinical narrative: developed discoid lupus; malar rash; This serious case was reported by a consumer and described the occurrence of discoid lupus erythematosus in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 06-JAN-2024, the patient received the 2nd dose of Shingles vaccine. On 13-FEB-2024, 38 days after receiving Shingles vaccine, the patient experienced discoid lupus erythematosus (Verbatim: developed discoid lupus) (serious criteria GSK medically significant) and malar rash (Verbatim: malar rash). The patient was treated with hydroxychloroquine sulfate (Plaquenil). The outcome of the discoid lupus erythematosus and malar rash were not resolved.   It was unknown if the reporter considered the discoid lupus erythematosus and malar rash to be related to Shingles vaccine.     It was unknown if the company considered the discoid lupus erythematosus and malar rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-APR-2024 The reporter reported that the patient had received Shingles vaccine and experienced malar rash, discoid lupus after she received the second shingles vaccine. The reporter requested to consent the follow up.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Patient received 3rd dose; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: Patient received 3rd dose). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 25-APR-2024 The case was received from the patient via interactive digital media. The patient had all three shots and had a very bad case of shingles which led to extra dose administered. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer 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: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 3 months).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-Apr-2024 The reporter was a patient's sister. The reporter reported that these commercials are lied to scare people. The reporter stated that the patient received Shingles vaccine and experienced Shingles for 3 months. 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.
Sex: U
Vaccine: RSV
Symptoms: Cough
Clinical narrative: Cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: Cough). The outcome of the cough was not reported.   It was unknown if the reporter considered the cough to be related to Arexvy.     It was unknown if the company considered the cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-APR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient described the symptoms especially the cough. This case has been linked with US2024AMR052799, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR052799:Same reporter / same product