chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact
Clinical narrative: Splash of prepared vaccine to the skin; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure via skin contact with product in a 23-year-old female patient who received Herpes zoster (Shingrix) (batch number 3334Y, expiry date 25-MAR-2027) for prophylaxis.   On 09-APR-2025, the patient received Shingrix. On 09-APR-2025, an unknown time after receiving Shingrix, the patient experienced occupational exposure via skin contact with product (Verbatim: Splash of prepared vaccine to the skin). The outcome of the occupational exposure via skin contact with product was not applicable.   Additional Information: GSK Receipt Date: 09-APR-2025 The nurse reported that the skin exposure to the reconstituted Shingrix vaccine as when they had prepared the dose, a small amount splashed onto their skin.  no vaccine was administered as per worded by the health care professional, but the health care professional expressed she was exposed to it because it splashed on her skin. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: completed his 3 doses of Engerix-B a year ago but in his blood test showed that he has not enough levels of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 61-year-old male patient who received HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis and HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On 04-APR-2024, the patient received the 3rd dose of Engerix B. On an unknown date, the patient received the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased (Verbatim: completed his 3 doses of Engerix-B a year ago but in his blood test showed that he has not enough levels of the vaccine). The outcome of the therapeutic response decreased was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-APR-2025 The pharmacist reported that the patient completed the 3 dose schedule of Engerix-B and took a blood test and he "didn't had enough levels of the Hepatitis-B vaccine which was Engerix-B, which led to therapeutic response decreased.  The reporter asked can he receive a booster dose of Engerix-B because their doctor ordered it and how do they proceed.
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Administration of the Menveo 1-vial presentation to patient under 10 years of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of the Menveo 1-vial presentation to patient under 10 years of age). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK Receipt Date: 09-APR-2025 Pharmacist states a patient was supposed to get the Menveo 2-vial presentation (patient was under 10 years of age) but received the 1-vial presentation instead, which led inappropriate age at vaccine administration.  The health care professional declined that contact information be stored and declined to provide any additional information, therefore did not probe any further. The reporter did not consent to follow-up.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose of Engerix-B to a 21 y/o patient; pediatric dose of Engerix-B to a 21 y/o patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number 233FT, expiry date 12-DEC-2025) for prophylaxis.   On 09-APR-2025, the patient received Engerix B pediatric. On 09-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: pediatric dose of Engerix-B to a 21 y/o patient) and adult use of a child product (Verbatim: pediatric dose of Engerix-B to a 21 y/o patient). The outcome of the underdose and adult use of a child product were not applicable.   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: 10-APR-2025 The nurse requested data on the administration of pediatric dose of Engerix b to a 21ear year old patient which led to underdose and adult use of child product.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: They get the Boostrix  vaccine instead of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   Previously administered products included Infanrix (Received 1st dose on unknown date), Infanrix (Received 2 nd dose on unknown date) and Infanrix (Received 3 rd  dose on unknown date).   On 07-APR-2025, the patient received the 1st dose of Boostrix. On an unknown date, the patient received Infanrix. On 07-APR-2025, an unknown time after receiving Boostrix and Infanrix, the patient experienced wrong vaccine administered (Verbatim: They get the Boostrix  vaccine instead of Infanrix). The outcome of the wrong vaccine administered was not applicable.   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 10-APR-2025 On 10-Apr-2025 Nurse called and reported they were working on the clinic on Monday 07-Apr-2025, a child came in for his immunization, a 4 year old child and he was supposed to get the Dtap Infanrix vaccine, but the medical assistant accidentally pull the wrong vaccine and didn't verify it. And patient get the T-dap Boostrix vaccine, which led to wrong vaccine administered. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Health care professional was mentioned to coworker that the patient had 3 prior Dtap vaccines. Health care professional was didn't specify vaccine brand name.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Headache, Hypotension, Paraesthesia
Clinical narrative: Severe headache, anxiety, paranoia, visual disturbances, dizziness, low blood pressure, paresthesia. Tylenol was administered prior to vaccine by school nurse who accompanied my child.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Paranoia, Visual impairment
Clinical narrative: Severe headache, anxiety, paranoia, visual disturbances, dizziness, low blood pressure, paresthesia. Tylenol was administered prior to vaccine by school nurse who accompanied my child.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Ultrasound scan
Clinical narrative: EE continues to C/O pain in right upper arm since vaccine given on 2/18/25. Was seen at urgent care on 4/14/25. An ultrasound of the right upper extremities was done and Voltaren cream was ordered. Continues to follow up with urgent care.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Joint swelling, Metastases to spine, Prostate cancer metastatic
Clinical narrative: Pt developed L ankle swelling/inflammation 6/4/2021, has intermittently flared up since without clear cause or known trigger.  Pt subsequently diagnosed with metastatic prostate cancer on 2/7/2024 in his spine (no evidence of disease in leg or ankle).
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 10 years old and received Covid Vaccine intended for ages 12 years and older.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU3, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 11 years old and received Covid vaccine intended for ages 12 and older.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: MA did not follow vaccine protocol and administered adult hep a vaccine to 12 month old
Age: 76.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient got one dose of Prevnar 20 on 12/22/2023 and then got another dose of Prevnar 20 on 04/10/2025. Patient had no adverse reactions.
Age: 1.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes simplex test negative, Herpes zoster, Varicella virus test positive
Clinical narrative: Patient with no history of natural chicken pox  seen yesterdays with shingles to left arm.  VZV confirmed by PCR.  Appears to be vaccine induced shingles years after series.
Age: 74.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot swelling at site of injections up to 3 days after  injection
Age: 52.0
Sex: F
Vaccine: PNC20, TYP
Symptoms: Rash
Clinical narrative: Rash on abdomen and behind armpit down arms. Rash on thighs slightly more on right side than left and not below the knee. No itching or other anaphylactic symptoms (swelling, trouble breathing, etc.).
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Unevaluable event
Clinical narrative: none
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shot given before due date. Got tetanus shot back on 9/7/2023 and gave it today 4/18/2025. We told patient about the mistake and he was understanding. We told him nothing serious would happen from getting another tetanus shot early.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of hep b instead of an adult dose.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: baby got extra   half a dose of Rotavirus vaccine. No reaction
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction with erythrma and swelling
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Wernicke's encephalopathy
Clinical narrative: After receiving vaccine my wife was diagnosed with GBS and WE.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Brain fog, Ear pain, Fatigue, Headache, Herpes zoster
Clinical narrative: On Wed. within 15 of vaccine administration, I felt like something warm was moving under my skin.  It reminded me of the contrast solution you received when having a radiological procedure.  It proceeded to move up my shoulder to my neck and left side of my face and head.  I told my husband what was happening in case I had an anaphylactic response. I woke up  the next morning (Thursday) with an extreme headache.  It was not relieved by Tylenol, Motrin, Excedrin Migraine, or sleep.  The headache continues to this day but has lessened in severity and is helped by Excedrin Migraine.  Sunday morning I woke with itchiness and a rash on the left side of my face and jaw.  Swollen lymph nodes in my neck with a sore throat. I had stabbing pain in my left ear.  On Monday I woke up with oozing pustules, the headache was worsening as was the ear pain. I had jaw pain, mouth sores, and the headache continued along with brain fog. I was extremely tired.  On Tuesday I called to make an appointment to see my primary physician.  She was not available so I saw her NP,   She did an exam and asked questions and called Dr. in to confirm it was shingles in my ear, mouth, and face.   I was prescribed Valacyclovir (10 days), Predinose (5 days), and Gabapentin which I used for three weeks.  I did have one more office visit on the following friday. I continue to have intermittent ear pain, headaches, brain fog, and fatigue.  I will be following up with my physician by the end of April.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Herpes zoster oticus, Lymphadenopathy, Oral herpes zoster, Oropharyngeal pain, Pain in jaw
Clinical narrative: On Wed. within 15 of vaccine administration, I felt like something warm was moving under my skin.  It reminded me of the contrast solution you received when having a radiological procedure.  It proceeded to move up my shoulder to my neck and left side of my face and head.  I told my husband what was happening in case I had an anaphylactic response. I woke up  the next morning (Thursday) with an extreme headache.  It was not relieved by Tylenol, Motrin, Excedrin Migraine, or sleep.  The headache continues to this day but has lessened in severity and is helped by Excedrin Migraine.  Sunday morning I woke with itchiness and a rash on the left side of my face and jaw.  Swollen lymph nodes in my neck with a sore throat. I had stabbing pain in my left ear.  On Monday I woke up with oozing pustules, the headache was worsening as was the ear pain. I had jaw pain, mouth sores, and the headache continued along with brain fog. I was extremely tired.  On Tuesday I called to make an appointment to see my primary physician.  She was not available so I saw her NP,   She did an exam and asked questions and called Dr. in to confirm it was shingles in my ear, mouth, and face.   I was prescribed Valacyclovir (10 days), Predinose (5 days), and Gabapentin which I used for three weeks.  I did have one more office visit on the following friday. I continue to have intermittent ear pain, headaches, brain fog, and fatigue.  I will be following up with my physician by the end of April.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Pustule, Rash, Secretion discharge, Sensory disturbance
Clinical narrative: On Wed. within 15 of vaccine administration, I felt like something warm was moving under my skin.  It reminded me of the contrast solution you received when having a radiological procedure.  It proceeded to move up my shoulder to my neck and left side of my face and head.  I told my husband what was happening in case I had an anaphylactic response. I woke up  the next morning (Thursday) with an extreme headache.  It was not relieved by Tylenol, Motrin, Excedrin Migraine, or sleep.  The headache continues to this day but has lessened in severity and is helped by Excedrin Migraine.  Sunday morning I woke with itchiness and a rash on the left side of my face and jaw.  Swollen lymph nodes in my neck with a sore throat. I had stabbing pain in my left ear.  On Monday I woke up with oozing pustules, the headache was worsening as was the ear pain. I had jaw pain, mouth sores, and the headache continued along with brain fog. I was extremely tired.  On Tuesday I called to make an appointment to see my primary physician.  She was not available so I saw her NP,   She did an exam and asked questions and called Dr. in to confirm it was shingles in my ear, mouth, and face.   I was prescribed Valacyclovir (10 days), Predinose (5 days), and Gabapentin which I used for three weeks.  I did have one more office visit on the following friday. I continue to have intermittent ear pain, headaches, brain fog, and fatigue.  I will be following up with my physician by the end of April.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Stomatitis
Clinical narrative: On Wed. within 15 of vaccine administration, I felt like something warm was moving under my skin.  It reminded me of the contrast solution you received when having a radiological procedure.  It proceeded to move up my shoulder to my neck and left side of my face and head.  I told my husband what was happening in case I had an anaphylactic response. I woke up  the next morning (Thursday) with an extreme headache.  It was not relieved by Tylenol, Motrin, Excedrin Migraine, or sleep.  The headache continues to this day but has lessened in severity and is helped by Excedrin Migraine.  Sunday morning I woke with itchiness and a rash on the left side of my face and jaw.  Swollen lymph nodes in my neck with a sore throat. I had stabbing pain in my left ear.  On Monday I woke up with oozing pustules, the headache was worsening as was the ear pain. I had jaw pain, mouth sores, and the headache continued along with brain fog. I was extremely tired.  On Tuesday I called to make an appointment to see my primary physician.  She was not available so I saw her NP,   She did an exam and asked questions and called Dr. in to confirm it was shingles in my ear, mouth, and face.   I was prescribed Valacyclovir (10 days), Predinose (5 days), and Gabapentin which I used for three weeks.  I did have one more office visit on the following friday. I continue to have intermittent ear pain, headaches, brain fog, and fatigue.  I will be following up with my physician by the end of April.
Age: 1.92
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pallor, Injection site rash
Clinical narrative: Patient came in was a large rash on left thigh that had formed over the last 2 days, mother of child states its  red, blanching, hot to touch, painful, hard lump under injection site. Mother did mention that she felt warm last night but has been giving her Tylenol.
Age: 1.92
Sex: F
Vaccine: HEPA
Symptoms: Injection site warmth, Skin warm
Clinical narrative: Patient came in was a large rash on left thigh that had formed over the last 2 days, mother of child states its  red, blanching, hot to touch, painful, hard lump under injection site. Mother did mention that she felt warm last night but has been giving her Tylenol.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3, PNC21
Symptoms: Bacterial infection, Injection site swelling, Peripheral swelling
Clinical narrative: Patient came to the pharmacy stating  that he was hospitalized 3 days after getting 3 vaccines all together on 3/21st. According to the patient, both of his arms become all swollen from up his shoulder down his hands. It was so bad that he needed to call ambulance to transport him to the ER. He was confined to the hospital from March 21st to March 31st, and when he was discharged he will be on hospice thereafter.
Age: 18.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Accidentally gave flu and covid vaccines, when he already had one of each in this season (Sept 2024)
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal distension, Abdominal pain, Computerised tomogram abdomen abnormal, Endoscopy, Flatulence
Clinical narrative: Gastroparesis (Delayed Stomach Emptying). Shorty after receiving a TDAP booster that was recommended by a PCP as it had been more than 10 years since my last dose, I began  experiencing symptoms such as abdominal pain, fullness after only eating a small amount of food, excessive gas and bloating, and regurgitation of food. I went to the hospital once the pain began to increase, where a CT scan was done, I was then referred to a gastroenterologist. I then saw a gastroenterologist who performed a endoscopy and found that bile was throughout my stomach which was causing gastritis and could be due to delayed stomach emptying. A Gastric Emptying study was eventually performed which confirmed that my stomach was emptying slower than normal. I was recommended a diet for gastroparesis. I would like to emphasize that this all began after I received the Tdap Vaccine. I did not have this condition before vaccination.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Gastric emptying study, Gastritis, Impaired gastric emptying, Regurgitation
Clinical narrative: Gastroparesis (Delayed Stomach Emptying). Shorty after receiving a TDAP booster that was recommended by a PCP as it had been more than 10 years since my last dose, I began  experiencing symptoms such as abdominal pain, fullness after only eating a small amount of food, excessive gas and bloating, and regurgitation of food. I went to the hospital once the pain began to increase, where a CT scan was done, I was then referred to a gastroenterologist. I then saw a gastroenterologist who performed a endoscopy and found that bile was throughout my stomach which was causing gastritis and could be due to delayed stomach emptying. A Gastric Emptying study was eventually performed which confirmed that my stomach was emptying slower than normal. I was recommended a diet for gastroparesis. I would like to emphasize that this all began after I received the Tdap Vaccine. I did not have this condition before vaccination.
Age: 55.0
Sex: M
Vaccine: PNC21
Symptoms: Erythema, Pain, Swelling
Clinical narrative: swollen, reddened, painful area. no fever
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity, Thrombosis
Clinical narrative: leg pain in both legs ; blood clots, fatigue, nausea, went to hospital, was given Eliquis, hot and cold packs on legs
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site reaction
Clinical narrative: Red, tender, inflamed, hard and hot lesion on the right deltoid. Patient was treated with Azithromycin 250mg for 5 days and Prednisone for 1 week. Lesion improved and subsided after treatment.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Skin lesion
Clinical narrative: Red, tender, inflamed, hard and hot lesion on the right deltoid. Patient was treated with Azithromycin 250mg for 5 days and Prednisone for 1 week. Lesion improved and subsided after treatment.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: No adverse reaction at time of visit
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Chest discomfort, Chills, Dyspnoea, Injection site reaction, Local reaction
Clinical narrative: SOB/wheezing, chest heaviness, chills, local site reaction
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Wheezing
Clinical narrative: SOB/wheezing, chest heaviness, chills, local site reaction
Age: 63.0
Sex: M
Vaccine: PNC21
Symptoms: Arthralgia, Urticaria
Clinical narrative: Date of vaccination was 4/11/25 in am; knee pain at site of prior pain in afternoon 4/11/25; extensive hives across entire body on evening of 4/14 that continued until 4/16; treated with antihistamines
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Decreased appetite, High-pitched crying
Clinical narrative: high pitched scream for over 6 hours inconsolable and loss of appetite
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Arthritis, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint, Pain
Clinical narrative: I started to notice the itching on 10/11, I wasnt sure what it was, i thought it could be from the pool or the rec center. The doctors office did not know either, they thought i should just drink  more water and buy some cream. At the end of the month i started having issues with my shoulder. On 12/29 they did a MRI of my left shoulder and it showed some tears and arthritis. And i dont remember hurting my arm at all. And at the same time i was having issues with both the top and bottom hurting and i was having trouble with movement, even getting out of bed hurt so bad. So we are still no sure what is going on. Other test are being ordered. The one thing that showed up on my blood test was high protein. I keep having these problems and i can not pin point what is wrong. Its not my diet. I cant do the things i use to normally do before. we are still working on that.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Protein total increased, Pruritus, Rotator cuff syndrome
Clinical narrative: I started to notice the itching on 10/11, I wasnt sure what it was, i thought it could be from the pool or the rec center. The doctors office did not know either, they thought i should just drink  more water and buy some cream. At the end of the month i started having issues with my shoulder. On 12/29 they did a MRI of my left shoulder and it showed some tears and arthritis. And i dont remember hurting my arm at all. And at the same time i was having issues with both the top and bottom hurting and i was having trouble with movement, even getting out of bed hurt so bad. So we are still no sure what is going on. Other test are being ordered. The one thing that showed up on my blood test was high protein. I keep having these problems and i can not pin point what is wrong. Its not my diet. I cant do the things i use to normally do before. we are still working on that.
Age: 58.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt was administered ProQuad today at age 58 instead of receiving a separate dose of varicella and MMR. Vaccine was verified with a 2nd RN prior to administration. Pt's PCP and nursing supervisor were informed. Local Health Department was contacted for recommendations. Pt was informed of vaccine error and questions were answered.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Back pain, Bronchitis, Chest pain
Clinical narrative: breathing difficulties; chronic pain especially back & shoulder; chronic pain especially back & shoulder; chronic pain especially back & shoulder; COPD; Bronchitis; Coughing; Cannot stop/devastating cough/still has a lingering cough; Asthma; chest hurting; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2021 as dose 2, single (Lot number: EWO171) at the age of 53 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "allergy" (ongoing); "BP" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal; MONTELUKAST taken for hypersensitivity. Vaccination history included: BNT162b2 (DOSE1, SINGLE, Lot number: EWO171, intramuscular), administration date: 18May2021, for COVID-19 immunisation, reaction(s): "Coughing; Cannot stop/devastating cough", "Asthma", "chest hurting", "breathing difficulties", "chronic pain especially back & shoulder", "chronic pain especially back & shoulder", "chronic pain especially back & shoulder", "Bronchitis", "COPD". The following information was reported: ASTHMA (non-serious) with onset 2021, outcome "not recovered"; BRONCHITIS (non-serious) with onset 2021, outcome "unknown"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2021, outcome "unknown", described as "COPD"; COUGH (non-serious) with onset 2021, outcome "not recovered", described as "Coughing; Cannot stop/devastating cough/still has a lingering cough"; CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "chest hurting"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing difficulties"; PAIN (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "chronic pain especially back & shoulder". The events "coughing; cannot stop/devastating cough/still has a lingering cough", "asthma" and "chest hurting" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400320279 same patient, different doses;
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Cough, Dyspnoea, Pain
Clinical narrative: breathing difficulties; chronic pain especially back & shoulder; chronic pain especially back & shoulder; chronic pain especially back & shoulder; COPD; Bronchitis; Coughing; Cannot stop/devastating cough/still has a lingering cough; Asthma; chest hurting; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2021 as dose 2, single (Lot number: EWO171) at the age of 53 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "allergy" (ongoing); "BP" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal; MONTELUKAST taken for hypersensitivity. Vaccination history included: BNT162b2 (DOSE1, SINGLE, Lot number: EWO171, intramuscular), administration date: 18May2021, for COVID-19 immunisation, reaction(s): "Coughing; Cannot stop/devastating cough", "Asthma", "chest hurting", "breathing difficulties", "chronic pain especially back & shoulder", "chronic pain especially back & shoulder", "chronic pain especially back & shoulder", "Bronchitis", "COPD". The following information was reported: ASTHMA (non-serious) with onset 2021, outcome "not recovered"; BRONCHITIS (non-serious) with onset 2021, outcome "unknown"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2021, outcome "unknown", described as "COPD"; COUGH (non-serious) with onset 2021, outcome "not recovered", described as "Coughing; Cannot stop/devastating cough/still has a lingering cough"; CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "chest hurting"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing difficulties"; PAIN (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "chronic pain especially back & shoulder". The events "coughing; cannot stop/devastating cough/still has a lingering cough", "asthma" and "chest hurting" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400320279 same patient, different doses;
Age: 76.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt received 1 dose of Capvaxive in her left arm on Monday, 4/14/25. She then presented to the pharmacy today showing us her arm. She said her symptoms started Monday evening. She presented today with redness and swelling from the top of her left arm, down to almost her elbow. The skin was also warm to the touch and she explained her skin as feeling "tight". She said it is not super painful, but just feels tight and warm. They only thing she has taken for her symptoms was Tylenol OTC. She was not in terrible distress, but was concerned about what to do. I helped her find Benadryl OTC for the reaction and told her to apply a cold compress as well for swelling and discomfort. She could continue to take the Tylenol and/or Ibuprofen for pain control. She only obtained one vaccine that day. She did not mention having any fevers or any other symptoms at this time. I encouraged her to seek medical attention with her PCP or an urgent care to be sure there was not infection d/t the symptoms she presented with.
Age: 76.0
Sex: F
Vaccine: PNC21
Symptoms: Skin tightness
Clinical narrative: Pt received 1 dose of Capvaxive in her left arm on Monday, 4/14/25. She then presented to the pharmacy today showing us her arm. She said her symptoms started Monday evening. She presented today with redness and swelling from the top of her left arm, down to almost her elbow. The skin was also warm to the touch and she explained her skin as feeling "tight". She said it is not super painful, but just feels tight and warm. They only thing she has taken for her symptoms was Tylenol OTC. She was not in terrible distress, but was concerned about what to do. I helped her find Benadryl OTC for the reaction and told her to apply a cold compress as well for swelling and discomfort. She could continue to take the Tylenol and/or Ibuprofen for pain control. She only obtained one vaccine that day. She did not mention having any fevers or any other symptoms at this time. I encouraged her to seek medical attention with her PCP or an urgent care to be sure there was not infection d/t the symptoms she presented with.
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Chest X-ray, Dyspnoea, Echocardiogram, Fibrin D dimer, Intensive care
Clinical narrative: Acute high risk submassive pulmonary embolism.  Experienced symptoms of progressive dyspnea beginning 2 days following vaccine.   Admitted to hospital 5 days following vaccine administration.  ICU admission, anticoagulation.  Outcome: discharged home
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: N-terminal prohormone brain natriuretic peptide, Pulmonary embolism, Troponin increased, Ultrasound Doppler, Ventilation/perfusion scan
Clinical narrative: Acute high risk submassive pulmonary embolism.  Experienced symptoms of progressive dyspnea beginning 2 days following vaccine.   Admitted to hospital 5 days following vaccine administration.  ICU admission, anticoagulation.  Outcome: discharged home
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Rash
Age: 48.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Hiberix vaccine accidentally instead of the Hepatitis B vaccine, Heplisav-B. Patient notified shortly thereafter of the error and advised to follow up with pharmacy and/or their primary care provider if they have any issues; advised to return whenever able to start Hepatitis B series as intended. No adverse events to report at this time.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Patient started with signs and symptoms of shingles about 5 days after the vaccine. He started with the nerve pain in leg and hip and then he had the rash. Patient got diagnosed and treated for shingles by his doctor.  He came to reported and also stated that he had a Dupixent dose the day before getting immunized.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: PATIENT SORENESS AND NAUSEA DAY OF VACCINATION, NEXT DAY AFTER TAKING MEDICATIONS SORENESS WORSEN, ON SUNDAY PATIENT EXPERIENCED ITCHINESS AND REDNESS ON INJECTION SITE. ON TUESDAY PATIENT NOTICED SEVERE BRUISING A REDNESS AND BURNING GOING DOWN TO THE ELBOW. PATIENT ALSO HAS A RASH BELOW THE INJECTION SITE.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: PATIENT SORENESS AND NAUSEA DAY OF VACCINATION, NEXT DAY AFTER TAKING MEDICATIONS SORENESS WORSEN, ON SUNDAY PATIENT EXPERIENCED ITCHINESS AND REDNESS ON INJECTION SITE. ON TUESDAY PATIENT NOTICED SEVERE BRUISING A REDNESS AND BURNING GOING DOWN TO THE ELBOW. PATIENT ALSO HAS A RASH BELOW THE INJECTION SITE.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Product preparation issue
Clinical narrative: SEVERE SWELLING AT THE INJECTION SITE. PATIENT WAS INJECTED WITH JUST THE DILUENT INSTEAD OF THE COMPOUNDED INJECTION
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Road traffic accident, Seizure, Spinal fracture, Traumatic fracture
Clinical narrative: I got a new job they said i could not work unless i got the vaccine. So i did it, and that was in September in January i started having seizures. on 03/04/25 i had a stroke and seizure while driving and got into an accident and broke my back in 3 places. I have had a told of 8 seizures all together.  I am no on medications twice a day that cost over $400.
Sex: M
Vaccine: FLU3
Symptoms: Infant irritability, Product administered to patient of inappropriate age
Clinical narrative: No known adverse event. Vaccine given on 4/17/25. Found error on 4/18/25 for vaccine given to child who was not old enough to receive vaccine. Nurse at clinic called and triaged patient. Mother stated child was fussy and had temp of 100 the evening of when child received vaccine. Mother stated patient was given tylenol and has sense not been fussy and the temperature has gone down. Patient did receive other vaccines during this appointment.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to arthropod sting, Aphthous ulcer, Dairy intolerance, Food allergy, Food intolerance
Clinical narrative: Persistent kanker sores that couldn?t be treated to conclusion via any other drug than oral steroids.  His allergies to all foods listed on previous pages occurred post vaccination and had no symptoms prior to it.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Gluten sensitivity
Clinical narrative: Persistent kanker sores that couldn?t be treated to conclusion via any other drug than oral steroids.  His allergies to all foods listed on previous pages occurred post vaccination and had no symptoms prior to it.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: cellulitis
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient began to notice small red bumps on  her face the day after vaccination. They have been present for over a week and are not itchy or painful. Patient was prescribed mupirocin and hydrocortisone cream to alleviate symptoms.
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: Patient received MMRII vaccine on left IM on 3/22/25. Today patient came and told that patient has soreness at the injected side. The pain comes and goes. Other than that, patient is still doing well and no other health concerns. Per patient, patient just has a rotator cuff surgery on the same arm 3 weeks prior to the date she got the vaccination , so it could be pain during healing from surgery .  Pharmacist  couldn't give  vaccine on the other arm because patient has cancer metastasis on right arm. I already counseled patient to use ice packs to help with soreness and take Tylenol incase patient has fever. Patient will have a post-op follow up next month and will check with her doctor to make sure surgical site heals properly.
Age: 73.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Pain in extremity
Clinical narrative: Patient got these two immunizations and a week later on their right arm they were still having a bright red dot on her arm and had a hard lump on her arm from the vaccine. Patient states their arm was sore as well. Patient stated no numbness or tingling and no fevers, redness was just around the vaccine area.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood pressure abnormal, Death, Dyspnoea, Facial paralysis
Clinical narrative: Resident passed away on  4/16.  Resident was on hospice and comfort care. Do not suspect that vaccine caused the death, but reporting to VAERS for compliance sake.                 Resident took her scheduled medication, vitals taken and were as follows: BP :139/72,HR, 90 BPM, oxygen SATS 98%,temperature 98.0 degrees Fahrenheit, and respirations 18 breadth per minute. she then went for PT .The writer was called by staff at 0936 while she was doing therapy. Writer found resident sitting on the wheelchair unresponsive with her mouth drooping to her right side, and assessed the resident EMS contacted at 0938,three nurses present and assessed the resident, vitals taken: Blood sugar 144 mg/dl, HR 50,oxygen sats 90 beats per minute unable to get blood pressure reading, and labored breathing noted. Resident helped in bed ,head of bed elevated and supplemental oxygen administered at 3 liters via nasal cannula. EMT found a heart rate of 10 at arrival, assessed her and then pronounced her dead at 0955.Husband present and stated that he had just talked to her.                          Nursing administration placed a call to county medical examiner's office for resident status update and the examiner evaluated the status and gave ok to release the body whenever family is done with giving their respects to the mortuary of family choosing.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Resident passed away on  4/16.  Resident was on hospice and comfort care. Do not suspect that vaccine caused the death, but reporting to VAERS for compliance sake.                 Resident took her scheduled medication, vitals taken and were as follows: BP :139/72,HR, 90 BPM, oxygen SATS 98%,temperature 98.0 degrees Fahrenheit, and respirations 18 breadth per minute. she then went for PT .The writer was called by staff at 0936 while she was doing therapy. Writer found resident sitting on the wheelchair unresponsive with her mouth drooping to her right side, and assessed the resident EMS contacted at 0938,three nurses present and assessed the resident, vitals taken: Blood sugar 144 mg/dl, HR 50,oxygen sats 90 beats per minute unable to get blood pressure reading, and labored breathing noted. Resident helped in bed ,head of bed elevated and supplemental oxygen administered at 3 liters via nasal cannula. EMT found a heart rate of 10 at arrival, assessed her and then pronounced her dead at 0955.Husband present and stated that he had just talked to her.                          Nursing administration placed a call to county medical examiner's office for resident status update and the examiner evaluated the status and gave ok to release the body whenever family is done with giving their respects to the mortuary of family choosing.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Urticaria
Clinical narrative: patient developed hives about 6 hours after injection, had trouble breathing the next day
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: maximum/minimum temperature reached: 48 °f for 30 minutes and Administered post-excursion with no adverse event; Initial information received on 15-Apr-2025 regarding an unsolicited non-valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] that exposed to maximum/minimum temperature reached: 48 °f for 30 minutes with no adverse event   On an unknown date, the patient received suspect IPV (VERO) Suspension for injection (Unknown strength) with lot X1D141M and expiry date 31-Oct-2026 via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) that exposed to temperature excursion maximum/minimum temperature reached: 48 °f for 30 minutes with no reported adverse event (product storage error) (Unknown latency)  Reportedly, Human error involved. There were no previous excursion. Extended stability data did not cover the excursion. Fridge door was left open for inventory.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: Patient started to get hives-like reaction the day after the vaccination. red bumps around site of injection.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Mental impairment, Pain
Clinical narrative: Headaches, Body aches, Chills, and slow mental processing lasting one week.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reactions at the time of this report. Tdap given instead of Menveo.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of Arexvy outside of guidelines. Original dose given December 2023.
Age: 58.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Headache, fatigue both starting day after immunizations
Age: 56.0
Sex: F
Vaccine: MMR, PNC20
Symptoms: Unevaluable event
Clinical narrative: unknown - unable to reach patient so will continue to contact her to determine side effects
Age: 46.0
Sex: M
Vaccine: HPV9
Symptoms: Intercepted product prescribing error, Product administered to patient of inappropriate age
Clinical narrative: employees: pharmacist and manager refused to provide the second dose of the hpv vaccination, for which my doctor had authorized and pharmacy was provided the authorization when I received the first dose however now these employees and the manager are refusing to provide the second dose of the medication just cause I turned 46 a month ago. They have provide a recommendation brochure form the company who makes the vaccine however I have provided the link and website from the cdc. Well clearly indicates as long as the doctor recommends they?re supposed to provide vaccination and they have refused to provide the oxidation. Therefore, they have refused to provide a medical service. This is a clearly violation of my medical rights. For which I am reporting to the appropriate agencies from the government to report this violation of law.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh area red, swollen, warm, Mom to do warm compress. Motrin, Epsom salt soaks
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Brain fog, Cardiac murmur, Ear discomfort
Clinical narrative: No adverse effects for first 5 doses; 6th dose had a seizure on 04.29.24.                                                                                                                                                1st dose 05.29.21 lot #023C21A; 2nd dose 06.26.21 lot# 023C21A; 3rd dose 12.29.21 lot#032H21A; 4th dose 12.28.22 Bivalent lot# 023H22A; 5th dose 09.23.23 Spikevax lot #AU3833D; 6th dose 04.09.24 Spikevax lot#203G23A
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Neck pain, Palpitations, Seizure
Clinical narrative: No adverse effects for first 5 doses; 6th dose had a seizure on 04.29.24.                                                                                                                                                1st dose 05.29.21 lot #023C21A; 2nd dose 06.26.21 lot# 023C21A; 3rd dose 12.29.21 lot#032H21A; 4th dose 12.28.22 Bivalent lot# 023H22A; 5th dose 09.23.23 Spikevax lot #AU3833D; 6th dose 04.09.24 Spikevax lot#203G23A
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: No adverse effects for first 5 doses; 6th dose had a seizure on 04.29.24.                                                                                                                                                1st dose 05.29.21 lot #023C21A; 2nd dose 06.26.21 lot# 023C21A; 3rd dose 12.29.21 lot#032H21A; 4th dose 12.28.22 Bivalent lot# 023H22A; 5th dose 09.23.23 Spikevax lot #AU3833D; 6th dose 04.09.24 Spikevax lot#203G23A
Age: 71.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Headache, Injected limb mobility decreased, Injection site erythema, Pain
Clinical narrative: Patient received Capraxive on 4/15/26 at 4:13pm and starting experiencing chills, headaches, and heart pounding at night.  She had body ache, redness at injection site and difficulty lifting her injected arm and continued headaches the next day.  Symptoms are slowly subsiding.   She has a follow up appointment with Dr (primary care physician) on 4/21/25.
Age: 71.0
Sex: F
Vaccine: PNC21
Symptoms: Palpitations
Clinical narrative: Patient received Capraxive on 4/15/26 at 4:13pm and starting experiencing chills, headaches, and heart pounding at night.  She had body ache, redness at injection site and difficulty lifting her injected arm and continued headaches the next day.  Symptoms are slowly subsiding.   She has a follow up appointment with Dr (primary care physician) on 4/21/25.