chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Condition aggravated, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient developed COVID PNA and COPD exacerbation. Received course of remdesivir and methylprednisolone. Improved and was discharged home after 7 days. Other Relevant HX: former smoker, COPD Group 4, pulmonary HTB, HFpEF, chronically on 5 mg on prednisone daily and azithromycin Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient developed COVID PNA and COPD exacerbation. Received course of remdesivir and methylprednisolone. Improved and was discharged home after 7 days. Other Relevant HX: former smoker, COPD Group 4, pulmonary HTB, HFpEF, chronically on 5 mg on prednisone daily and azithromycin Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Breakthrough COVID-19, COVID-19, Cardiac failure acute, Renal impairment
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923: VACCINE BREAKTHROUGH INFECTION; 10084268: COVID-19; Narrative: Patient found to be COVID positive on admission. Was also admitted for acute decompensated heart failure and atrial fibrillation. Due to elevated transaminases and kidney impairment, anti-virals were not given. Patient was mildly symptomatic, but COVID-19 infection was thought to contribute to overall initial presentation. Patient was discharged home after 8 days. Other relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Transaminases increased
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923: VACCINE BREAKTHROUGH INFECTION; 10084268: COVID-19; Narrative: Patient found to be COVID positive on admission. Was also admitted for acute decompensated heart failure and atrial fibrillation. Due to elevated transaminases and kidney impairment, anti-virals were not given. Patient was mildly symptomatic, but COVID-19 infection was thought to contribute to overall initial presentation. Patient was discharged home after 8 days. Other relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Chest X-ray normal, Dyspnoea, Oropharyngeal pain, Procalcitonin normal
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19;  Narrative: Patient presented to the ED for sudden worsening of congestion with SOB that woke him up from his sleep. Reports mild congestion and sore throat for 2 days prior. CXR clear and procalcitonin WNL. O2 saturation was 92% so was placed on oxygen. Received remdesivir and dexamethasone while in the hospital, was discharged home after 2 days with large improvement in symptoms. Other Relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Sleep disorder
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19;  Narrative: Patient presented to the ED for sudden worsening of congestion with SOB that woke him up from his sleep. Reports mild congestion and sore throat for 2 days prior. CXR clear and procalcitonin WNL. O2 saturation was 92% so was placed on oxygen. Received remdesivir and dexamethasone while in the hospital, was discharged home after 2 days with large improvement in symptoms. Other Relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Breakthrough COVID-19, Dysstasia, Electrolyte imbalance
Clinical narrative: Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient presented to the ED due to generalized weakness. He travelled last week, fell sick with URI and then developed generalized weakness on Sat 6/29/24, when he had difficulty standing up. He tested positive for COVID-19 and was found to have AKI and multiple electrolyte abnormalities. Was started on remdesivir, dexamethasone, and IV fluids. Pt improved throughout 3 days and was discharged home. Other Relevant HX: 73-year-old gentleman with a history of HTN, HLD, CKD, CAD, BPH, and anemis who presented to the ER with generalized weakness. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Upper respiratory tract infection, Ventilation/perfusion scan normal
Clinical narrative: Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient presented to the ED due to generalized weakness. He travelled last week, fell sick with URI and then developed generalized weakness on Sat 6/29/24, when he had difficulty standing up. He tested positive for COVID-19 and was found to have AKI and multiple electrolyte abnormalities. Was started on remdesivir, dexamethasone, and IV fluids. Pt improved throughout 3 days and was discharged home. Other Relevant HX: 73-year-old gentleman with a history of HTN, HLD, CKD, CAD, BPH, and anemis who presented to the ER with generalized weakness. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Chest X-ray normal, Chest pain, Computerised tomogram thorax normal, Echocardiogram normal
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was recently diagnosed with COVID-19 about a week ago and being watched at home. She continues to have cough productive of whitish phlegm but sometimes has dark and thick mucus with it. Today, after a prolonged bout of coughing at home and nearly passing out from it, she decided to come to ED. Has not been eating well or drinking enough in past 3 days due to nausea. Cough provokes soreness of the body and chest pain but denies SOB, orthopnea or new leg swelling. ED evaluation was unremarkable including CXR, but the ECG showed new changes including diffuse ST/T changes involving Inferior leads and T-inversion in the anterior-lateral leads. ECG changes thought to be most likely secondary to COVID19 viral cardiomyopathy. Patient was started on dexamethasone x 7 days in the hospital and was discharged to home. Other Relevant HX: Transgender female with a significant past medical history of PTSD, recurrent major depressive disorder (MDD), asthma, and cannabis dependence, presented to the Emergency Department (ED) after nearly passing out from a prolonged bout of coughing. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction normal, Electrocardiogram ST-T change, Electrocardiogram T wave inversion, Hypophagia, Increased viscosity of bronchial secretion
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was recently diagnosed with COVID-19 about a week ago and being watched at home. She continues to have cough productive of whitish phlegm but sometimes has dark and thick mucus with it. Today, after a prolonged bout of coughing at home and nearly passing out from it, she decided to come to ED. Has not been eating well or drinking enough in past 3 days due to nausea. Cough provokes soreness of the body and chest pain but denies SOB, orthopnea or new leg swelling. ED evaluation was unremarkable including CXR, but the ECG showed new changes including diffuse ST/T changes involving Inferior leads and T-inversion in the anterior-lateral leads. ECG changes thought to be most likely secondary to COVID19 viral cardiomyopathy. Patient was started on dexamethasone x 7 days in the hospital and was discharged to home. Other Relevant HX: Transgender female with a significant past medical history of PTSD, recurrent major depressive disorder (MDD), asthma, and cannabis dependence, presented to the Emergency Department (ED) after nearly passing out from a prolonged bout of coughing. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Presyncope, Productive cough, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was recently diagnosed with COVID-19 about a week ago and being watched at home. She continues to have cough productive of whitish phlegm but sometimes has dark and thick mucus with it. Today, after a prolonged bout of coughing at home and nearly passing out from it, she decided to come to ED. Has not been eating well or drinking enough in past 3 days due to nausea. Cough provokes soreness of the body and chest pain but denies SOB, orthopnea or new leg swelling. ED evaluation was unremarkable including CXR, but the ECG showed new changes including diffuse ST/T changes involving Inferior leads and T-inversion in the anterior-lateral leads. ECG changes thought to be most likely secondary to COVID19 viral cardiomyopathy. Patient was started on dexamethasone x 7 days in the hospital and was discharged to home. Other Relevant HX: Transgender female with a significant past medical history of PTSD, recurrent major depressive disorder (MDD), asthma, and cannabis dependence, presented to the Emergency Department (ED) after nearly passing out from a prolonged bout of coughing. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast normal, Sputum discoloured, Viral cardiomyopathy
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was recently diagnosed with COVID-19 about a week ago and being watched at home. She continues to have cough productive of whitish phlegm but sometimes has dark and thick mucus with it. Today, after a prolonged bout of coughing at home and nearly passing out from it, she decided to come to ED. Has not been eating well or drinking enough in past 3 days due to nausea. Cough provokes soreness of the body and chest pain but denies SOB, orthopnea or new leg swelling. ED evaluation was unremarkable including CXR, but the ECG showed new changes including diffuse ST/T changes involving Inferior leads and T-inversion in the anterior-lateral leads. ECG changes thought to be most likely secondary to COVID19 viral cardiomyopathy. Patient was started on dexamethasone x 7 days in the hospital and was discharged to home. Other Relevant HX: Transgender female with a significant past medical history of PTSD, recurrent major depressive disorder (MDD), asthma, and cannabis dependence, presented to the Emergency Department (ED) after nearly passing out from a prolonged bout of coughing. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Cellulitis, Condition aggravated, Dyspnoea
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10084268:COVID-19; Narrative: Patient was admitted on AUG 13, 2024@23:24:54 and discharged Aug 30,2024 Patient is a 83 year old MALE w PMH significant for recent septic shock (Group A strep) due to RLE cellulitis/necrotic ulcer s/p debridement (on vanc and cipro), HFpEF (no records), Afib (on no AC), AAA 4.3cm, COPD, lymphedema, gout who presented to the facility as a transfer from another hospital for celluitus/placement upon discharge. Patient was volume overloaded on admission and aggressively diuresed until he became euvolemic. His R knee pain was treated for gout and eventually improved. Patient became dyspneic with increased cough/sputum and oxygen requirements. He tested positive for COVID and upgraded to ICU for HFNC. He was seen by palliative care who thought the patient did not meet hospice requirements. He was treated with abx and treated with remdesivir/dexamethasone for COVID-19. Pt was discharged back to the hospital facility when he was medically stable. Other Relevant HX: PMH of #acute hypoxic resp failure/ARDS - secondary to COVID pneumonia and HAP- improving #Multilobar Klebsiella Enterobacter PNA with elevated PCT and CRP #Severe pulmonary HTN #COVID + #Hospital acquired pneumonia #COPD #RLE weakness-injury vs deconditioning #RLE cellulitis and necrotic ulcer sp debridement and IV abx #Bilateral Lymphedema #Gout #R knee pain #Septic shock due to group A strep-resolved #HFpEF #Afib #bradycardia #sacral wound #Pancreatic mass #Constipation #HTN #BPH Other: Covid-19 infection during hospitalization
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Hypervolaemia, Intensive care, Polyuria, Productive cough
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10084268:COVID-19; Narrative: Patient was admitted on AUG 13, 2024@23:24:54 and discharged Aug 30,2024 Patient is a 83 year old MALE w PMH significant for recent septic shock (Group A strep) due to RLE cellulitis/necrotic ulcer s/p debridement (on vanc and cipro), HFpEF (no records), Afib (on no AC), AAA 4.3cm, COPD, lymphedema, gout who presented to the facility as a transfer from another hospital for celluitus/placement upon discharge. Patient was volume overloaded on admission and aggressively diuresed until he became euvolemic. His R knee pain was treated for gout and eventually improved. Patient became dyspneic with increased cough/sputum and oxygen requirements. He tested positive for COVID and upgraded to ICU for HFNC. He was seen by palliative care who thought the patient did not meet hospice requirements. He was treated with abx and treated with remdesivir/dexamethasone for COVID-19. Pt was discharged back to the hospital facility when he was medically stable. Other Relevant HX: PMH of #acute hypoxic resp failure/ARDS - secondary to COVID pneumonia and HAP- improving #Multilobar Klebsiella Enterobacter PNA with elevated PCT and CRP #Severe pulmonary HTN #COVID + #Hospital acquired pneumonia #COPD #RLE weakness-injury vs deconditioning #RLE cellulitis and necrotic ulcer sp debridement and IV abx #Bilateral Lymphedema #Gout #R knee pain #Septic shock due to group A strep-resolved #HFpEF #Afib #bradycardia #sacral wound #Pancreatic mass #Constipation #HTN #BPH Other: Covid-19 infection during hospitalization
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10084268:COVID-19; Narrative: Patient was admitted on AUG 13, 2024@23:24:54 and discharged Aug 30,2024 Patient is a 83 year old MALE w PMH significant for recent septic shock (Group A strep) due to RLE cellulitis/necrotic ulcer s/p debridement (on vanc and cipro), HFpEF (no records), Afib (on no AC), AAA 4.3cm, COPD, lymphedema, gout who presented to the facility as a transfer from another hospital for celluitus/placement upon discharge. Patient was volume overloaded on admission and aggressively diuresed until he became euvolemic. His R knee pain was treated for gout and eventually improved. Patient became dyspneic with increased cough/sputum and oxygen requirements. He tested positive for COVID and upgraded to ICU for HFNC. He was seen by palliative care who thought the patient did not meet hospice requirements. He was treated with abx and treated with remdesivir/dexamethasone for COVID-19. Pt was discharged back to the hospital facility when he was medically stable. Other Relevant HX: PMH of #acute hypoxic resp failure/ARDS - secondary to COVID pneumonia and HAP- improving #Multilobar Klebsiella Enterobacter PNA with elevated PCT and CRP #Severe pulmonary HTN #COVID + #Hospital acquired pneumonia #COPD #RLE weakness-injury vs deconditioning #RLE cellulitis and necrotic ulcer sp debridement and IV abx #Bilateral Lymphedema #Gout #R knee pain #Septic shock due to group A strep-resolved #HFpEF #Afib #bradycardia #sacral wound #Pancreatic mass #Constipation #HTN #BPH Other: Covid-19 infection during hospitalization
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Breakthrough COVID-19, Cough, Fatigue, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient admitted for worsening faitgue and cough, found to be COVID + and hospitalized for COVID treatment. Discharged home without complications. Other Relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Discharged home Other Relevant HX: Other:  : Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 1.42
Sex: F
Vaccine: HEPA
Symptoms: Peripheral swelling
Clinical narrative: 7 hours following vaccination with hepatitis A vaccine patient started developing significant swelling in her hands and in her feet and lower legs.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: none he had no reaction
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arms 1 vaccine  in  each  arm  pain in  location  3  years  getting  worse
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was given a second Hep A vaccine that was not supposed to be given. He was to get a Prevnar, but a Hep A was accidentally pulled and administered instead.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Vertigo
Clinical narrative: (Personal hx shingles 2009 affecting right side of head/face, tx zovirax within 1st hr of 1st lesion and limited to 3 lesions. )   Post vax day 2, unexpected vertigo late afternoon, seemingly left leaning resolved after full night's sleep. No fevers or chills. Post vax day 3 noted tingling scalp occipital area, along single line of where I had shingles 2009, but no actual lesions noted, just tingling.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Additional dose administered
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Adult patient was administered a pediatric dose in error . Patient was informed and the provider was informed. No side effects or adverse effect noted. Patient will be booked for an appointment for the full dose
Age: 26.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Cough, Fatigue, Influenza virus test negative, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, fatigue, cough, sore throat
Age: 26.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Fever, fatigue, cough, sore throat
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased
Clinical narrative: 12/23/24 elevated BP started 1/7/2025 172/106; BP still variable
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: 12/23/24 elevated BP started 1/7/2025 172/106; BP still variable
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased
Clinical narrative: Patient reported elevated blood pressures of 172/106 and lightheadedness
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Patient reported elevated blood pressures of 172/106 and lightheadedness
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Feeling of body temperature change, Paraesthesia
Clinical narrative: Left arm,  face and leg paresthesia with preserved reflexes, altered temperature sensation within 10 minutes or administration.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was in for 6 month wcc. And provider ordered a Pentacel, patient was then given the pentacel but the vaccine vials were not mixed and was only given the Dtap and Polio portion. MOC was notified the same day about the vaccine error and informed to come back at earliest convience to recieve the HIB portion of the vaccine. MOC states that she will come back within the next 1-2 weeks to recieve vaccine. There were no additional side affects presented by parents after recieving vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Condition aggravated, Fatigue, Hypersensitivity, Injection site reaction, Injection site swelling
Clinical narrative: Patient was very sick for about two weeks after receiving this round of shots, left leg was swollen and broke out in a terrible spotty rash, almost looked like chicken pox. I have photos that can be attached. He was very tired, lots of throwing up. I spoke with the mother of patient and she said she was told that this was normal. I do not believe that it is and he was very sick. He has been sick multiple times since receiving this round of shots.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Malaise, Milk allergy, Rash vesicular, Vomiting
Clinical narrative: Patient was very sick for about two weeks after receiving this round of shots, left leg was swollen and broke out in a terrible spotty rash, almost looked like chicken pox. I have photos that can be attached. He was very tired, lots of throwing up. I spoke with the mother of patient and she said she was told that this was normal. I do not believe that it is and he was very sick. He has been sick multiple times since receiving this round of shots.
Age: 64.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Palpitations
Clinical narrative: experienced palpitations for a few days after vaccination
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Unevaluable event
Clinical narrative: NONE NOTED
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen and sore arm
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt received a second dose of flu by mistake. First dose was on 11/2024
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, Pregnancy test
Clinical narrative: 3 miscarriages after vaccines. 1st vaccine: 02/26/2021, miscarriage 07/2021, 2nd vaccine: 9/15/2021, 3rd vaccine: 10/13/2021, 2nd miscarriage 01/2022, 3rd miscarriage: 05/2022
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Resident had Flu and Prevnar 20 vaccine on 1/18/2025 at around 9am
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Patient should have received Pediarix, I accidentally gave the Pentacel .  My fault.  Was thinking it contained the Hepatitis b instead of the Hib.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave RSV shot not realizing that she had already received on 9/22/23. Talked to patient, and she did not feal any different and is fine.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscular weakness, X-ray
Clinical narrative: Patient called and spoke to pharmacist on 1/20/25 to report had noticed arm pain in Right arm in where she received 2nd shingrix vaccine on 9/12/24. System has reported as administration into Left arm but patient states remembers getting in right arm since she had a previous masectomy and avoids getting vaccines in left arm so it was in the right arm. She went to  her medical MD and they did an Xray since pain was not resolving and patient then was referred to physical therapy. Did one session of physical therapy as of last week. Patient reports weakness and pain (like a toothache where it hurts all the time) in the right arm. She is using Salonpas and takes Advil for pain. She called to report this adverse event to pharmacy
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Erythema, Heart rate increased, Influenza like illness, Pyrexia
Clinical narrative: Patient developed swelling, redness and warm to touch reaction about 3 days after shot was given.  Later developed fever and flu like symptoms.  ER Doctor diagnosed her with Cellulitis after patient went in
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm, Swelling
Clinical narrative: Patient developed swelling, redness and warm to touch reaction about 3 days after shot was given.  Later developed fever and flu like symptoms.  ER Doctor diagnosed her with Cellulitis after patient went in
Age: 73.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: Duplicate Prevnar 20 vaccine. The system did not flag previous vaccination, and it does not show the 1/28/2023 vaccine in state shots. First dose was 1/28/2023, second dose given 1/16/2025.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 4.25 CM X 3.50 CM INDURATED, ERYTHEMATOUS, WARM AREA TO RIGHT THIGH, TENDER TO TOUCH. PER DAD - NOTED TO HAVE SWOLLEN, RED, AND WARM AREA TO RIGHT THIGH WHEN HE WAS PICKED UP FROM SCHOOL AROUND 3PM ON 1/14/2025. AREA GOT BIGGER OVERNIGHT. NO FEVER. NO RESPIRATORY SYMPTOMS. NO NAUSEA, VOMITING, OR DIARRHEA. TREATMENT WITH CETIRIZINE QAM AND BENADRYL QPM, PRN HYDROCORTISONE CREAM FOR ITCHING.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given an adult Pfizer (12+) vaccine when pt should have been given the pediatric Pfizer vaccine. No adverse effects were reported by patient's parent.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Hypertension
Clinical narrative: High blood pressure
Age: 44.0
Sex: F
Vaccine: HPV9, PNC20, TDAP
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: An area of redness and muscle pain on the left upper arm failed to resolve about an inch beneath the injection site. Pain in the mid left upper arm has continued for for days now. Pain increases when raising left arm above head. No issues with the vaccine administered in the right arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: Recieved vaccine at 4:00 pm on 1/17/25. By 1:00 pm (less than 24 hours) on 1/18/25, observed a rash on stomach. Itchy and painful. By 1/19/25 rash increased in size and pain intensified. Saw family doctor on 1/20/25 at 2:00 pm, who confirmed it was shingles and immediately prescribed Valacyclovir. Have never had shingles before. Physician: Dr.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, FLU3, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: Given flulavel that was on the tray to give the older sibling.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Vaccine, No adverse reaction
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: PATIENT STATED THAT HER ARM WAS RED, PAINFUL, AND SWOLLEN AFTER RECEIVING HER VACCINATION.  IT IS STILL SORE 3 WEEKS AFTER RECEIVING THE VACCINATION.  THERE IS AN AREA THAT IS DISCOLORED ON HER ARM, BUT IS LOWER THAN WHERE THE PATIENT STATES THAT THE VACCINE WAS GIVEN
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9, MENB
Symptoms: Cold sweat, Presyncope
Clinical narrative: Patient was given HPV vaccination by medical assistant and within five minutes of receiving the vaccination, he walked up to front desk, became clammy, and had vasovagal episode-- he did not injure himself during vasovagal event lasting less than a minute-- vitals were normal on recheck.  He went to ER for further evaluation
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9, MENB
Symptoms: Syncope
Clinical narrative: Patient was given HPV vaccination by medical assistant and within five minutes of receiving the vaccination, he walked up to front desk, became clammy, and had vasovagal episode-- he did not injure himself during vasovagal event lasting less than a minute-- vitals were normal on recheck.  He went to ER for further evaluation
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9, MENB
Symptoms: Cold sweat, Presyncope
Clinical narrative: Pt experienced syncope after receiving both immunizations.
Age: 17.0
Sex: M
Vaccine: HPV9, HPV9, MENB
Symptoms: Syncope
Clinical narrative: Pt experienced syncope after receiving both immunizations.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient presented to pharmacy to request vaccine and it was administered. It was by discovered by our clinical service team that patient had received same vaccine on 11/29/2023.  It was no longer in local pharmacy records. Spoke with pt on 1/19/25 and pt did not recall receiving and did not report any adverse events.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Antinuclear antibody positive, Arthralgia, Blood calcium normal, Blood creatine phosphokinase increased
Clinical narrative: Episodic fever, lymph node enlargement, subjective muscle weakness, hives, joint pains without physical findings, mental fogginess, body aches, malaise
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Blood parathyroid hormone normal, Brain fog, Epstein-Barr virus antibody positive, Epstein-Barr virus antigen positive, Epstein-Barr virus infection
Clinical narrative: Episodic fever, lymph node enlargement, subjective muscle weakness, hives, joint pains without physical findings, mental fogginess, body aches, malaise
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Lymphadenopathy, Malaise, Muscular weakness, Pain, Pyrexia
Clinical narrative: Episodic fever, lymph node enlargement, subjective muscle weakness, hives, joint pains without physical findings, mental fogginess, body aches, malaise
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Rheumatoid factor negative, Urticaria
Clinical narrative: Episodic fever, lymph node enlargement, subjective muscle weakness, hives, joint pains without physical findings, mental fogginess, body aches, malaise
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received second dose of vaccine wasn't aware he received a first dose. Was advised by his MD to get one. Patient states he is fine no adverse. effects. No hospital or doctor visit required.
Age: 0.42
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None at this time
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Redness, itchy, warm to the touch
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Eyelid ptosis, Lethargy, Visual impairment
Clinical narrative: The evening of the vaccinations she began to have a droopy right eye. The symptoms lasted about 30 minutes and resolved. 3 days later she had another event of droopy eye that lasted 2+ hours. Her vision seemed affected and had slight bouts of lethargy
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired 1031/2024
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: ROTATEQ vaccine at 8 weeks old and came back at 28 weeks old to the HCP's office without receiving the second dose of the ROTATEQ vaccine; No additional AE; This spontaneous report was received from a pharmacist and refers to an infant patient of unknown age (reported as 28 weeks old at the time of healthcare professional's (HCP) office visit) and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (at 8 weeks old), the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered orally (dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date (at 28 weeks old), the patient returned to HCP's office without receiving the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (inappropriate schedule of product administration). No additional adverse event was reported.  Lot # was requested and will be provided if available.
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported/ No additional AE; PROQUAD vaccine that expired 1/5/2025 and was administered to a patient on 1/15/2025; This spontaneous report was received from Other Health Professional and refers to an 11-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not provided. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 15-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), lot #X018570, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No adverse side effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Pharmacist called stating a 60 year old patient received their 1st dose of VAQTA on 2/14/2023 but missed their 2nd dose.; No additional AE/no PQC reported.; This spontaneous report was received from a pharmacist and refers to a 60-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, drug rection or allergies were not reported.  On 14-FEB-2023, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 adult dose, administered for prophylaxis (dose, lot number, expiration date, and route of administration were not provided), but missed their second dose (product dose omission issue). Caller stated the patient has not had any symptoms.   No additional adverse event (AE) reported.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Discomfort, Product storage error, Swelling
Clinical narrative: Discomfort; Swelling; This spontaneous report was received from a licensed practical nurse and refers to a 5-year-old female.  The patient has no pre-existing allergies, birth defects of medical conditions nor illness at the time of vaccination. None adverse events following a prior vaccination. The patient's concomitant therapies were not reported.   On 05-AUG-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, lot #Y005000, expiration date: 26-AUG-2025, administered subcutaneously  in the left arm for prophylaxis; and  with the first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), lot #1145R, expiration date: 22-AUG-2025, administered intramuscularly in the right arm (formulation and indication were not provided). It was reported that during the day of the vaccine administration, there was a power loss for approximately 2 hours; however, the vaccines were moved to another refrigerator and freeze before they reached the excursion point. All safety guidelines were followed and the vaccines were safe and kept the temperature range.  It was reported that the patient's response to the vaccines was normal; however, on  an unspecified day in 2024, she  experienced swelling and discomfort. No treatment was given for the events. At the time of reporting, the outcome of the events was not known.   The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) was unknown.  This is one of several reports from the same source.; Sender's Comments:  US-009507513-2501USA004806:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: red at the injection site; swollen at the injection site; sore at the injection site; arm is also warm at the injection site; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no reaction on previous exposure to drug (received 1st dose of vaccine on an unknown date). Concomitant products included metformin hydrochloride (Metformin) and losartan potassium (Losartan).   On 21-DEC-2024, the patient received the 2nd dose of Shingrix .5 ml. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: arm is also warm at the injection site). On 22-DEC-2024, the patient experienced injection site pain (Verbatim: sore at the injection site). On 23-DEC-2024, the patient experienced injection site erythema (Verbatim: red at the injection site) and injection site swelling (Verbatim: swollen at the injection site). The outcome of the injection site pain, injection site erythema and injection site swelling were not resolved and the outcome of the injection site warmth was not reported.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-DEC-2024 Patient reported for soreness (From: 22 Dec 2024 To: Ongoing) Dates for Redness: (From: 23 Dec 2024 To: Ongoing) Dates for Swelling arm: (From: 23 Dec 2024 To: Ongoing). Patient did not had a reaction to the first shingles shot.  The second shot patient arm was sore, red and swollen at the injection site.  Patient arm was also warm at the injection site.  It had been a couple of days since the second Shingles shot. Patient had not been able to locate what need to do to reduce the swelling nor how long it will last.  Soreness symptoms not treated. Redness symptoms not treated. Swelling arm not treated.
Sex: U
Vaccine: RSV
Symptoms: Cough, Decreased appetite, Diarrhoea, Pain, Somnolence
Clinical narrative: body pain; coughing; weight loss 12 lbs in 6 days; uncontrolled mucus diarrhea; stopped eating; Sleeping; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain 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 general body pain (Verbatim: body pain), cough (Verbatim: coughing), weight loss (Verbatim: weight loss 12 lbs in 6 days), mucous diarrhea (Verbatim: uncontrolled mucus diarrhea), appetite absent (Verbatim: stopped eating) and sleepiness (Verbatim: Sleeping). The outcome of the general body pain, cough, weight loss, mucous diarrhea, appetite absent and sleepiness were not reported.   It was unknown if the reporter considered the general body pain, cough, weight loss, mucous diarrhea, appetite absent and sleepiness to be related to Arexvy.     It was unknown if the company considered the general body pain, cough, weight loss, mucous diarrhea, appetite absent and sleepiness to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-DEC-2024 This case was reported by a patient via interactive digital media. The patient experienced body pain, coughing, sleeping , stopped eating, weight loss 12 lbs in 6 days, uncontrolled mucus diarrhea. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Weight decreased
Clinical narrative: body pain; coughing; weight loss 12 lbs in 6 days; uncontrolled mucus diarrhea; stopped eating; Sleeping; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain 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 general body pain (Verbatim: body pain), cough (Verbatim: coughing), weight loss (Verbatim: weight loss 12 lbs in 6 days), mucous diarrhea (Verbatim: uncontrolled mucus diarrhea), appetite absent (Verbatim: stopped eating) and sleepiness (Verbatim: Sleeping). The outcome of the general body pain, cough, weight loss, mucous diarrhea, appetite absent and sleepiness were not reported.   It was unknown if the reporter considered the general body pain, cough, weight loss, mucous diarrhea, appetite absent and sleepiness to be related to Arexvy.     It was unknown if the company considered the general body pain, cough, weight loss, mucous diarrhea, appetite absent and sleepiness to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-DEC-2024 This case was reported by a patient via interactive digital media. The patient experienced body pain, coughing, sleeping , stopped eating, weight loss 12 lbs in 6 days, uncontrolled mucus diarrhea. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Oral Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and oral herpes zoster (Verbatim: Oral Shingles). The outcome of the vaccination failure and oral herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and oral herpes zoster to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the oral herpes zoster to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 06-JAN-2025 This case was reported by a patient via interactive digital media. The patient received 2 series shot of Shingles vaccine and experienced oral shingles.  The patient had worse pain ever. This case was considered as suspected vaccination failure as details regarding time to onset for oral herpes zoster and laboratory confirmation regarding oral herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine( 1st dose) and Shingles vaccine (2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Ophthalmic herpes zoster, Pain, Pruritus
Clinical narrative: Suspected vaccination failure; Shingles in eye; Shingles in face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Shingles in face). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingrix.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix.   Additional Information: GSK receipt date: 07-JAN-2025 Patient stated that he/she got the vaccine 4 years ago. And, diagnosed with shingles in the left side of face and eye in early December. At the time of reporting rash was gone, but pain, itch, and impaired vision still very present. Also reported that out of work at least through the end of January when he/she meet with the eye specialist next. 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 herpes zoster were unknown at the time of reporting. This case was reported by a patient via interactive digital media.  The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.