chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: On 2/10/2023, I began to have symptoms of what I now know was COVID-19. I had a fever, chills, body aches, and slight difficulty breathing. I treated my breathing difficulties with a nebulizer. I took TYLENOL for my fever and body aches. I also had a cough and fatigue, sore throat, and nasal congestion (my most bothersome symptom). On about 2/12/2023, I took a PCR test and got a positive result. I also took a home antigen test on 2/11/2023 and got a positive result. On 2/13/2023, I had a telehealth appointment with a PA. She prescribed me prednisone and nirmatrelvir-ritonavir, plus, she refilled my albuterol inhaler. She advised me to keep an eye on my pulse oximeter, because it was averaging between 93 and 96. If it ever went below 90 and was persistent, I was to contact my doctor's office. I think that the antiviral stopped the symptoms in their tracks; it took a couple of days for the symptoms to subside, but the antiviral helped keep them from worsening. The steroids also helped my breathing, and I was able to overcome my breathing difficulty pretty quickly. I used my nebulizer maybe about two or three times a day for the first three days. After that, I switched to my albuterol inhaler, which I used every four to six hours. I spent much of the time napping, because I was so fatigued. I was out of work until 2/20/2023. I'm doing okay now. This is the third time I have had COVID-19, and I think I recovered more quickly this time than I did the two previous times. After this last bout of COVID-19, though, I began getting headaches one to two times a week. They were sometimes migraines that characterized by sensitivity to light. I have also had occasional lightheadedness. At the time of this writing, I still sometimes experience the headaches and the lightheadedness.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Impaired work ability, Migraine, Nasal congestion
Clinical narrative: On 2/10/2023, I began to have symptoms of what I now know was COVID-19. I had a fever, chills, body aches, and slight difficulty breathing. I treated my breathing difficulties with a nebulizer. I took TYLENOL for my fever and body aches. I also had a cough and fatigue, sore throat, and nasal congestion (my most bothersome symptom). On about 2/12/2023, I took a PCR test and got a positive result. I also took a home antigen test on 2/11/2023 and got a positive result. On 2/13/2023, I had a telehealth appointment with a PA. She prescribed me prednisone and nirmatrelvir-ritonavir, plus, she refilled my albuterol inhaler. She advised me to keep an eye on my pulse oximeter, because it was averaging between 93 and 96. If it ever went below 90 and was persistent, I was to contact my doctor's office. I think that the antiviral stopped the symptoms in their tracks; it took a couple of days for the symptoms to subside, but the antiviral helped keep them from worsening. The steroids also helped my breathing, and I was able to overcome my breathing difficulty pretty quickly. I used my nebulizer maybe about two or three times a day for the first three days. After that, I switched to my albuterol inhaler, which I used every four to six hours. I spent much of the time napping, because I was so fatigued. I was out of work until 2/20/2023. I'm doing okay now. This is the third time I have had COVID-19, and I think I recovered more quickly this time than I did the two previous times. After this last bout of COVID-19, though, I began getting headaches one to two times a week. They were sometimes migraines that characterized by sensitivity to light. I have also had occasional lightheadedness. At the time of this writing, I still sometimes experience the headaches and the lightheadedness.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pain, Photophobia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On 2/10/2023, I began to have symptoms of what I now know was COVID-19. I had a fever, chills, body aches, and slight difficulty breathing. I treated my breathing difficulties with a nebulizer. I took TYLENOL for my fever and body aches. I also had a cough and fatigue, sore throat, and nasal congestion (my most bothersome symptom). On about 2/12/2023, I took a PCR test and got a positive result. I also took a home antigen test on 2/11/2023 and got a positive result. On 2/13/2023, I had a telehealth appointment with a PA. She prescribed me prednisone and nirmatrelvir-ritonavir, plus, she refilled my albuterol inhaler. She advised me to keep an eye on my pulse oximeter, because it was averaging between 93 and 96. If it ever went below 90 and was persistent, I was to contact my doctor's office. I think that the antiviral stopped the symptoms in their tracks; it took a couple of days for the symptoms to subside, but the antiviral helped keep them from worsening. The steroids also helped my breathing, and I was able to overcome my breathing difficulty pretty quickly. I used my nebulizer maybe about two or three times a day for the first three days. After that, I switched to my albuterol inhaler, which I used every four to six hours. I spent much of the time napping, because I was so fatigued. I was out of work until 2/20/2023. I'm doing okay now. This is the third time I have had COVID-19, and I think I recovered more quickly this time than I did the two previous times. After this last bout of COVID-19, though, I began getting headaches one to two times a week. They were sometimes migraines that characterized by sensitivity to light. I have also had occasional lightheadedness. At the time of this writing, I still sometimes experience the headaches and the lightheadedness.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Rash, Urticaria
Clinical narrative: parent returned to clinic with baby, reporting rash/hives and irritability approximately 2 1/2-3 hours after vaccine administration - face, neck, torso, thighs; no respiratory symptoms; treated initially with Bendryl, sent home on Zyrtec; referred to Allergy for consultation
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Hypoglycaemia, Neuropathy peripheral
Clinical narrative: NEUROPATHY 3/17/2023 ORAL HYPOGLYCEMIC OVERDOSE, ACCIDENTAL, INIT
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic arteriosclerosis, Cardiac failure congestive, Neuropathy peripheral
Clinical narrative: NEUROPATHY 3/8/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED NEUROPATHY 3/8/2023 ATHEROSCLEROSIS OF AORTA
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Back pain, Neck pain
Clinical narrative: Lots of soreness of the back and sometimes neck.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Hypoxia, Microalbuminuria, Respiratory failure, Type 2 diabetes mellitus
Clinical narrative: Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------- CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 DM 2 W MICROALBUMINURIA HYPOXIA 4/13/2023 DM 2 W MICROALBUMINURIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 DM 2 W MIXED HYPERLIPIDEMIA HYPOXIA 4/13/2023 DM 2 W MIXED HYPERLIPIDEMIA
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Type V hyperlipidaemia
Clinical narrative: Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------- CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 DM 2 W MICROALBUMINURIA HYPOXIA 4/13/2023 DM 2 W MICROALBUMINURIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 DM 2 W MIXED HYPERLIPIDEMIA HYPOXIA 4/13/2023 DM 2 W MIXED HYPERLIPIDEMIA
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pregnancy, Third trimester pregnancy
Clinical narrative: HYPOTENSION 4/22/2023 SUPERVISION NORMAL PREGNANCY, SROM CHECK, THIRD TRIMESTER
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: I26.99 ACUTE PULMONARY EMBOLISM 4/2/2023 ACUTE PULMONARY EMBOLISM
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Benign prostatic hyperplasia, Cerebral artery occlusion, Cerebrovascular accident
Clinical narrative: I63.522 ACUTE STROKE DUE TO OCCLUSION OF LEFT ANTERIOR CEREBRAL ARTERY 4/19/2023 BPH (BENIGN PROSTATIC HYPERPLASIA)
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Troponin I increased
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 5/2/2023 ELEVATED TROPONIN I
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Lung adenocarcinoma
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/27/2023 ADENOCARCINOMA, RIGHT LUNG LOWER LOBE R09.02 HYPOXIA 4/26/2023 ADENOCARCINOMA, RIGHT LUNG LOWER LOBE
Age: 33.0
Sex: F
Vaccine: COVID19-2, HEP, HEPA, VARCEL
Symptoms: Abdominal pain upper, Dizziness, Flushing, Injection site induration, Injection site pain
Clinical narrative: Gave vaccines at around 10:15 AM. Afterwards patient requested vaccine records be in sealed envelope. This RN printed records, stamped them, and sealed records then brought them to patient at 10:30. At this time patient asked if her arm was having a "normal reaction." Pt showed this RN her right arm in which the varicella and moderna bivalent vaccines were administered IM. Superior to vaccination sites and closer to where varicella was administered there was a hard knot slightly larger than a quarter that was tender to the touch. No erythema or discoloration at site. This RN got another RN to examine site, obtained a full set of VS at 10:37 (HR: 80, BP: 130/90, and O2: 93%) and assessed for signs of anaphylaxis. Patient's face was flushed and she endorsed feeling dizzy then shortly after endorsed stomach pain. Administered 50mg PO Benadryl with second set of VS at 10:45 (HR: 84, BP: 134/92, O2: 92%). Messaged senior nurse practitioner who was onsite to inform her of situation. Simultaneously second nurse called Dr. who happened to be entering building at this time. Dr. is familiar with patient from different clinic, assessed patient, and patient informed Dr. she felt better. Obtained one more set of VS at 11:05 (HR: 70, BP: 130/90, O2: 98%). By this time patient endorsed no signs and symptoms of anaphylaxis and left building at 11:15, roughly 1 hour after vaccination. Patient educated on signs and symptoms of anaphylaxis and instructed to call 911 if symptoms arise later. VAERS report
Age: 76.0
Sex: M
Vaccine: HEPA
Symptoms: Anxiety, Condition aggravated, Headache, Post-traumatic stress disorder
Clinical narrative: On 6/16/2023 at approximately 10:00 AM, client requested Hepatitis A vaccine from nurses. Nurse asked client for demographic information and confirmed client's immunization record and vaccine eligibility in electronic database. Upon assessment by RN, client denied having any history of allergies and completed the screening questions for Hepatitis A vaccine. Client reported history of stroke, anxiety, PTSD, hypertension and was hospitalized yesterday for hypertension. Client reported he went AMA at the hospital, but has an appointment today with his cardiologist at 11:30 am, and primary care provider at 4 pm. Client denied having any headache or blurry vision today, and denied prior vaccine reactions. At 10:17 am PHN administered Havrix lot # 772YT exp 9/23/2025 in the right deltoid intramuscularly. At 10:20 am client complained of a headache on the left side that started after the vaccine was given. Client denied blurry vision, denied feeling dizzy. Upon observation by PHN client had no visible rashes, no trouble breathing, client denied signs and symptoms of itching. Vitals taken by PHN at 10:22 am :HR 64bpm, SpO2 97%, RR 18 (no labored breathing observed), BP 170/98 in the left arm. Client alert and oriented to person, place, time, and situation.  At 10:25 am PHN continued to asses client's symptoms but client stated he was more anxious to the point where he has to "run out of here. I've reached a point where I'm going to start throwing tables. " Client then stated "its not my head anymore. Its just my PTSD." Client remained sitting at the table. Client refused a second set of vitals and refused to answer anymore questions, stating his "anxiety was getting too high." PHN walked away from the client and sat on the other side of the table. Client remained sitting and calmly continued to eat his breakfast. Client initiated conversation again with PHN about other topics, and stated this helps to distract him. At 10:40 am, client calmly stood up and walked away with a steady gait and refused assistance. Client stated he is worried about his blood pressure and plans to walk now to his doctor appointment.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after 30 day mark
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reporting a temperature excursion. HCP confirmed this vaccine was administered on 12MAY2023 after the temperature excursion. Additional AE's filed in 02390911, 02390925, 02390931, 02390933. No other AEs, No PQCs.   ?    Names of vaccines invol; HCP reporting a temperature excursion. HCP confirmed this vaccine was administered on 12MAY2023 after the temperature excursion. Additional AE's filed in 02390911, 02390925, 02390931, 02390933. No other AEs, No PQCs.   ?    Names of vaccines invol; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-MAY-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot number 1938967 and expiration date on 25-APR-2024 (administration route was not provided) for prophylaxis. No adverse effects were reported.  The vaccine had thee temperature excursions, one of 1.8 Celsius degrees (C) for 0 hours 9 minutes; the second of 1.3 C for 1 hour 12 minutes and the last excursion of 1.2 C for 1 hour 58 minutes. It was confirmed that no previous temperature excursions occurred.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AEs; HCP called to report that VARIVAX was administered to 27 year old female patient less than 4 weeks from  administration of first live vaccine, MMR II.; This spontaneous report was received from a pharmacist referred to a 27-year-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date in 2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, as prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 18-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, lot #W031812, expiration date not reported, but upon internal validation established as 05-OCT-2024, as prophylaxis (strength, and route of administration were not provided), which was less than 4 weeks from administration of first live vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Inappropriate schedule of product administration). There was no additional adverse event (No adverse event).
Sex: M
Vaccine: PNC15, PPV
Symptoms: B-lymphocyte count, Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Carbohydrate deficient transferrin test, Immunoglobulin therapy
Clinical narrative: impaired response to the Streptococcus pneumoniae vaccine; Literature report.  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a to a 6-year-old male patient.  The patient presented to the immunology clinic with recurrent infections. He started to have recurrent otitis media at the age of 18 months. He also had multiple sinus infections and 34 episodes of pneumonia. Immunologic evaluation revealed an IgG of 498 (ref 6081229 mg/dL), an IgA of 20.8 (ref 33200 mg/dL).  He also has a history of eczema, chronic cough and environmental allergies for which he receives allergenspecific subcutaneous immunotherapy in addition to treatment with an inhaled corticosteroid and omalizumab. The patient also had persistent skin warts on his hands and extensive molluscum contagiosum lesions  On an unknown date, the patient started therapy with Streptococcus pneumoniae vaccine (pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection) administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced impaired response to the Streptococcus pneumoniae vaccine. T and B lymphocyte counts were normal. He was started on subcutaneous immunoglobulin replacement therapy after which his IgG level normalized and his frequency of sinopulmonary infections improved. He underwent targeted genetic testing for a primary immunodeficiencywhich revealed a hemizygous pathogenic variant in the magnesium transporter 1 (MAGT1) gene. The patient subsequently underwent a carbohydrate deficient transferrin test (CDT) for congenital disorders of glycosylation (CDG) that revealed moderately elevated transferrin monooligosaccharide to di-oligosaccharide and Apo CIII-1/Apo CIII-2 ratios, consistent with the diagnosis of MAGT1-CDG (XMEN; X-linked immunodeficiency with magnesium defect, EBV infection, and neoplasia).  The reporter considered impaired response to the Streptococcus pneumoniae vaccine to be related to Streptococcus pneumoniae vaccine (pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE)). The outcome of the event was unknown.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: PNC15, PPV
Symptoms: Infection, Pneumonia, Sinusitis, T-lymphocyte count normal, Vaccination failure
Clinical narrative: impaired response to the Streptococcus pneumoniae vaccine; Literature report.  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a to a 6-year-old male patient.  The patient presented to the immunology clinic with recurrent infections. He started to have recurrent otitis media at the age of 18 months. He also had multiple sinus infections and 34 episodes of pneumonia. Immunologic evaluation revealed an IgG of 498 (ref 6081229 mg/dL), an IgA of 20.8 (ref 33200 mg/dL).  He also has a history of eczema, chronic cough and environmental allergies for which he receives allergenspecific subcutaneous immunotherapy in addition to treatment with an inhaled corticosteroid and omalizumab. The patient also had persistent skin warts on his hands and extensive molluscum contagiosum lesions  On an unknown date, the patient started therapy with Streptococcus pneumoniae vaccine (pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection) administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced impaired response to the Streptococcus pneumoniae vaccine. T and B lymphocyte counts were normal. He was started on subcutaneous immunoglobulin replacement therapy after which his IgG level normalized and his frequency of sinopulmonary infections improved. He underwent targeted genetic testing for a primary immunodeficiencywhich revealed a hemizygous pathogenic variant in the magnesium transporter 1 (MAGT1) gene. The patient subsequently underwent a carbohydrate deficient transferrin test (CDT) for congenital disorders of glycosylation (CDG) that revealed moderately elevated transferrin monooligosaccharide to di-oligosaccharide and Apo CIII-1/Apo CIII-2 ratios, consistent with the diagnosis of MAGT1-CDG (XMEN; X-linked immunodeficiency with magnesium defect, EBV infection, and neoplasia).  The reporter considered impaired response to the Streptococcus pneumoniae vaccine to be related to Streptococcus pneumoniae vaccine (pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE)). The outcome of the event was unknown.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported.; an expired dose of MMR II vaccine was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions or concomitant therapies were not reported.  On 09-JUN-2023, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #u017524, expiration date: 03-JUN-2023 (strength, route of administration, and indication were not provided) (expired product administered). No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported.; Inbound call from pharmacist calling to report temperature excursion for MMR-II that was administered to a patient.  Product was evaluated and found to be supported.  Confirmed that no symptomatic AE's were reported.  Reporter declined to provide fu; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, lot #W017555, expiration date: 24-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 09-JUN-2023, there was inbound call from pharmacist calling to report temperature excursion for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)that was administered to a patient. Product was evaluated and found to be supported. Temperature excursion was 50 F for 1 hour. Confirmed that no symptomatic AE's were reported. Reporter declined to provide full patient demographics and only provided  initials. HCP declined correspondence regarding this AE. No additional AE/PQC reported.  Lot Number W017555 is valid for V205C and albumin status is rHA.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received An Expired Dose; Initial Report Received 14-Mar-2023  This is a spontaneous report received from a Certified Medical Assistant (CMA) who reported that a 26-year-old female who received HEPLISAV-B for Hepatitis B immunization received an expired dose of HEPLISAV B.     There were no medications or additional medical history provided.  The patient was not pregnant at the time.   On 13-Mar-2023, dose 1 of HEPLISAV-B (Lot# 937233, NDC 43528-003-01, Expiration Date 11-Mar-2023) was administered intramuscularly in the right deltoid.    On 13-Mar-2023, the patient received HEPLISAV-B that was 2 days past the expiration date.  There were no adverse reactions reported.    No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received An Expired Dose; Initial Report Received on 17-Mar-2023  This spontaneous report was received from a Medical Assistant who reported that a 42-year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 17-Mar-2023, the patient received the first dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023 and NDC # 43528-003-05) intramuscularly in the left deltoid (inferior region). The patient also received a Hepatitis A vaccine in the left deltoid (superior region) for which no other details were specified.   On 17-Mar-2023, the patient was receiving an physical and received 2 vaccines (HEPLISAV-B and a Hepatitis A vaccine).  The HEPLISAV-B vaccine administered was 6 days past the expiry date.      It was reported that the patient did not report any adverse reaction.    No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B virus test positive
Clinical narrative: Received 1st Dose of Heplisav-B, Patient Tested Positive for Hepatits B After Vaccination; Initial Report Received on 17-Mar-2023  A physician reported to a company representative that a patient received HEPLISAV-B for Hepatitis B immunization and subsequently tested positive for hepatitis B after having received the first dose of HEPLISAV B.    There were no medications or additional medical history provided.   On an unspecified date, dose 1 of HEPLISAV-B (Lot # and expiration date not reported, NDC 43528-002-01), was administered.    The patient reportedly was screened for hepatitis B after vaccination and the results indicated the patient was positive for hepatitis B.    No additional information was provided.   Company Comment: The company assessed the event as non-serious and non-immunologically confirmed for lack of efficacy since vaccine series was not completed, and no titer or time to titer was reported.; Sender's Comments: The company assessed the event as non-serious and non-immunologically confirmed for lack of efficacy since vaccine series was not completed, and no titer or time to titer was reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received An Expired Dose; Initial Report Received on 17-Mar-2023  This spontaneous report was received from a nurse regarding a 26-year-old male patient who received an expired dose of HEPLISAV-B that was administered for "titers" that were 6.6.   Medical history included that the patient received a previous series of a hepatitis B vaccine (details not specified) and not had any previous allergic reactions or reaction to other vaccines.  Concomitant medications included Flomax (tamsulosin).   It was reported that on 10-Mar-2022, "titers" were drawn which resulted in a value of 6.6.  The reporter noted that the values should be 9.9 so they gave the dose of HEPLISAV-B.    On 17-Mar-2023, a dose of HEPLISAV-B (Lot # 935849 and expiration date 13-Jan-2023, NDC 43528-003-05), was administered in the right upper arm.    The nurse reported that she checked the expiration date on the box, and it was "really tiny" and thought it read 2025 and it actually read 2023.  There were no adverse reactions reported by the patient.    No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Breast feeding
Clinical narrative: Heplisav-B Administered While Lactating; Initial Report Received on 11-APR-2023.  A registered nurse reported that a female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient is lactating/breastfeeding.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot number, expiration date, and NDC number, route, and site not reported).  On an unspecified date, after having been vaccinated with HEPLISAV-B, the patient was reported to be lactating and breastfeeding.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered; Administered second dose 7 months after first dose; Initial Report Received on 11-APR-2023.  A pharmacist reported that a 38 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization second dose 7 months after first dose and that the second dose was expired.  Medical history included no allergies or previous reactions to other vaccines.  No relevant concomitant medications were reported.    On 27-AUG-2022, the patient received the first dose of HEPLISAV-B (Lot number, expiration date, NDC number, route, site not reported). On 01-APR-2023, approximately 7 months after the first dose, the patient received the second dose of HEPLISAV-B (Lot number 937233, expiration date 11-MAR-2023, and NDC number 43528-003-05) in the left arm from a pharmacist.   On 01-APR-2023 the patient was vaccinated with dose 2 of  HEPLISAV-B that had expired on 11-MAR-2023.  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received Engerix as First Does, and Heplisav-B For Second Dose; Product administered to patient of inappropriate age; Initial Report Received on 17-Apr-2023   A physician reported that a 16-year-old female patient (race and ethnicity unknown), received Engerix for the first dose and was mistakenly given HEPLISAV-B (hepatitis B vaccine) as a second dose for hepatitis B immunization.    Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.    On an unknown date, the patient received Engerix as the first dose (no details provided).   On 10-Apr-2023, the patient received HEPLISAV-B vaccine (Lot # 941580, expiration date 06-Jan-2025, and NDC # unknown) intramuscularly in the left deltoid as the second dose. The patient did not report any adverse effects.   No additional information was provided.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Serology negative
Clinical narrative: Nonreactive Serological Test; Initial Report Received 18-Apr-2023  This spontaneous report was received from a nurse regarding 57-year-old female patient who received HEPLISAV-B for hepatitis B immunization.   Medical history included no previous reactions to other vaccines.   Concomitant medications were not reported.   On 31-Jan-2023, dose 1 of HEPLISAV-B (Lot# 941055, expiration 29-Nov-2024, NDC 43528-002-01) was administered in the right deltoid.   On 01-Mar-2023, dose 2 of HEPLISAV-B (Lot# 941055, expiration 29-Nov-2024, NDC 43528-002-01) was administered in the left deltoid.   On 14-Apr-2023, serological testing (not specified) was performed, and the results were reported as nonreactive.  No adverse reactions were reported by the patient.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Hypoaesthesia, Pain, Vaccination failure
Clinical narrative: Got mild case after having 2 shot and a booster/suspected Vaccination failure; Got mild case after having 2 shot and a booster; Still have 2 numb fingers and top of hand was also numb; having 2 shot and a booster; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got mild case after having 2 shot and a booster/suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got mild case after having 2 shot and a booster), numbness in hand (Verbatim: Still have 2 numb fingers and top of hand was also numb) and extra dose administered (Verbatim: having 2 shot and a booster). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported and the outcome of the numbness in hand was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and numbness in hand to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and numbness in hand to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2023 The case was received from the patient via interactive digital media. The patient got mild case of shingles after having 2 shots and booster. That was 3 months ago. The patient still had 2 numb fingers and the top of hand was also numb. The patient stated that it was not fun and advised to get the shot as a full blown case of shingles was horrible and very painful? This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient had three shingles shots, which led to extra dose administered. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got them 3 year ago and still got them / suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got them 3 year ago and still got them / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-JUN-2023 This case was reported by the patient via interactive digital media.  The reporter reported that he/she got them 3 years ago and still got them. They would not go away. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: After taking it got shingles twice/ Suspected vaccination failure; Got shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: After taking it got shingles twice/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by a consumer via interactive digital media. The reporter reported that he or she sat at the table at the wedding as three peoples shared as they all received Shingles vaccine. The reporter stated that after received Shingles vaccine the patient experienced Shingles twice. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR082619:same patient/same event
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shingle vaccine also got shingles/ Suspected vaccination failure; Shingles; Worst pain ever had; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingle vaccine also got shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Worst pain ever had). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JUN-2023 This case was reported by consumer via interactive digital media. The reporter reported that after receiving Shingle vaccine he or she got shingles three years later. The reporter reported that he or she had worst pain ever. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: l knowk someone who got the shot and still got shingles/suspected vaccination failure; l knowk someone who got the shot and still got 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: l knowk someone who got the shot and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: l knowk someone who got the shot and still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023 This case was reported by a consumer via interactive digital media. The reporter knew someone who got the shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have the vaccine and I'm now enduring shingles on my scalp and head/suspected vaccination failure; shingles on scalp and head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have the vaccine and I'm now enduring shingles on my scalp and head/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on scalp and head). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-JUN-2023 This case was reported by a consumer via interactive digital media.  The patient had the vaccine and was now enduring shingles on his/her scalp and head. It was awful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Illness
Clinical narrative: I felt sick; also had tube side effects for 3 weeks and was just in bed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I felt sick) and bedridden (Verbatim: also had tube side effects for 3 weeks and was just in bed). The outcome of the sickness and bedridden were not reported.   It was unknown if the reporter considered the sickness and bedridden to be related to Shingles vaccine.     It was unknown if the company considered the sickness and bedridden to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 09-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and the day after the vaccine he/she felt sick. Patient also states that he/she also had tube side effects for 3 weeks and was just in bed. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: It hurt for about 5 or 6 days and then the pain disappears; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: It hurt for about 5 or 6 days and then the pain disappears). The outcome of the pain was resolved (duration 6 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR084567   Additional Information: GSK Receipt Date: 09-JUN-2023 This case was reported by the patient via interactive digital media. The patient received 1st dose and had pain for 5 to 6 days and then the pain disappears, the patient stated that the first vaccine hurt more the second and almost not but if it hurts a lot. put patches of warm water and everything would be fine. The follow-up could not be possible as no contact details were available. For tolerance of 2nd dose refer case US2023AMR084567, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR084567:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Headache; had a lot of chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headache) and chills (Verbatim: had a lot of chills). The outcome of the headache and chills were not reported.   It was unknown if the reporter considered the headache and chills to be related to Shingles vaccine.     It was unknown if the company considered the headache and chills to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received the shingles vaccine and experienced lot of chills and Headache. The patient states that he/she felt like a beaten dog but it is better to get vaccinated because the problems are worse and imagine your whole body full of little bumps and then you get an unbearable Itch when they Burst. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain
Clinical narrative: sick; hurt badly; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick) and pain (Verbatim: hurt badly). The outcome of the sickness and pain were resolved (duration 2 days).   It was unknown if the reporter considered the sickness and pain to be related to Shingles vaccine.     It was unknown if the company considered the sickness and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 13-JUN-2023 This case was reported by patient via interactive digital media. The reporter reported that his/her friend states that he or she received Shingles vaccine and experienced sick as a dog and it hurt badly for 2 days. Follow up was not possible, as no contact details were available.