chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Dizziness, Nausea
Clinical narrative: patient received four vaccines hepa, polio, varicella, tdap .reported nausea without vomitus and dizziness .fluids was given to patient and ice pack applied. Patient was monitored for any signs of distress but none was noted .left facility in stable condition
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Barium double contrast, Colectomy, Haematochezia, Ileostomy, Infantile vomiting
Clinical narrative: started with vomiting on 7/1/2024, started to have blood in stools on 7/2,  continued with persistent vomiting, and on 7/5 was diagnosed with intussusception.  Failed to reduce with air enema and required surgery with  resection of both large and small bowel.  Ultimately required ileostomy.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Small intestinal resection, Treatment failure, Ultrasound scan abnormal, Vomiting
Clinical narrative: started with vomiting on 7/1/2024, started to have blood in stools on 7/2,  continued with persistent vomiting, and on 7/5 was diagnosed with intussusception.  Failed to reduce with air enema and required surgery with  resection of both large and small bowel.  Ultimately required ileostomy.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: pt was given expired dose of moderna spikevax, I have reported this to Moderna and am currently waiting on a response from the company to see if pt will need to be re-vaccinated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: pt was given expired dose of moderna spikevax, I have reported this to Moderna and am currently waiting on a response from the company to see if pt will need to be re-vaccinated
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, RV1
Symptoms: Blood smear test abnormal, Coagulation test normal, Full blood count normal, Injection site rash, Injection site reaction
Clinical narrative: I was asked to check in on patient after her 2-mo appt w/ Dr. today. She received her PCV immunization in her left leg. W/in 5-10 minutes a rash was noted on her lower left leg below the injection site. On inspection, pt appeared to have scattered nonblanching 1mm erythematous macules. A couple were noted on her right lower extremity as well. No other rash was appreciated. On reevaluation about 30 minutes after vaccines, rash had not worsened but also had not resolved. Discussed w /mother that petechiae immediately after vaccination is an unusual reaction, and given our lack of explanation for such a rash, I would recommend presenting to ED for evaluation for likely CBC and coagulation studies to ensure no underlying bleeding disorder.  I received a follow up call from the PA at ED around 1630 this afternoon. CBC and coagulation studies appeared normal. During IV placement however, pt again developed petechiae but on her arm. Plan was to have pt discharged home to f/u w/ hematology O/P. However, prior to discharge, smear was pending. Call to lab revealed preliminary read of blasts and abnormal leukocytes on smear. Final read was pending at end of day. I discussed w/ PA that if there are blasts on smear, pt should be transferred to hospital for further management.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, RV1
Symptoms: Macule, Petechiae, White blood cell disorder
Clinical narrative: I was asked to check in on patient after her 2-mo appt w/ Dr. today. She received her PCV immunization in her left leg. W/in 5-10 minutes a rash was noted on her lower left leg below the injection site. On inspection, pt appeared to have scattered nonblanching 1mm erythematous macules. A couple were noted on her right lower extremity as well. No other rash was appreciated. On reevaluation about 30 minutes after vaccines, rash had not worsened but also had not resolved. Discussed w /mother that petechiae immediately after vaccination is an unusual reaction, and given our lack of explanation for such a rash, I would recommend presenting to ED for evaluation for likely CBC and coagulation studies to ensure no underlying bleeding disorder.  I received a follow up call from the PA at ED around 1630 this afternoon. CBC and coagulation studies appeared normal. During IV placement however, pt again developed petechiae but on her arm. Plan was to have pt discharged home to f/u w/ hematology O/P. However, prior to discharge, smear was pending. Call to lab revealed preliminary read of blasts and abnormal leukocytes on smear. Final read was pending at end of day. I discussed w/ PA that if there are blasts on smear, pt should be transferred to hospital for further management.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Feeling hot, Headache, Lethargy, Musculoskeletal stiffness
Clinical narrative: Approximately six hours after receiving the dose I started feeling drowsy, lethargic. I took a nap for about 45 minutes and when I woke up I had a headache and a stiff neck and felt feverish and chilled. I took my temperature and it was slightly elevated at 99.9 F. I took two Tylenol 500MG. I went to bed around 9PM and felt a little  better, the headache wasn't as bad. I slept through the night and felt better in the morning. The headache was gone. My temp was 98.6F. But I still felt a little lethargic.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Somnolence
Clinical narrative: Approximately six hours after receiving the dose I started feeling drowsy, lethargic. I took a nap for about 45 minutes and when I woke up I had a headache and a stiff neck and felt feverish and chilled. I took my temperature and it was slightly elevated at 99.9 F. I took two Tylenol 500MG. I went to bed around 9PM and felt a little  better, the headache wasn't as bad. I slept through the night and felt better in the morning. The headache was gone. My temp was 98.6F. But I still felt a little lethargic.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and subcutaneous swelling at the site, lasting at least 1 week
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: EMPLOYEE RECEIVED HEP B VACCINE ON 08/14/2024 AT 04:44PM. EMPLOYEE STATES ITCHING BEGAN ON 08/14/2024 AT 10PM. EMPLOYEE CLEANED SITE WITH SOAP AND WATER NO RELIEF, TODAY AFFECTED AREA RIGHT DELTOID RED, SWOLLEN ITCHING AND WARM TO TOUCH. REACTION IS LOCALIZED TO INJECTION SITE. EMPLOYEE PROVIDED WITH ICE PACK 08/15/2024 AT 1PM. CLINIC CONTACTED, EMPLOYEE ADVISED TO APPLY HYDROCORTISONE CREAM, ICE PACKS TO THE AREA AND TAKE AN ANTIHISTAMINE. EMPLOYEE REACTION RESOLVED 20 MINUTES AFTER ICE PACK WAS APPLIED.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site pain, Pain in extremity
Clinical narrative: At first, pain at injections site.  Later the bottom of both my feet felt like they were walking on too hot sand.  Today, gout-like pain in my right foot, but not like gout like in that it I can bend my foot.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Myalgia
Clinical narrative: PATIENT CAME COMPLANING SHE HAS MUSCLE PAIN AND LACK OF SHOULDER MOVEMENT, PATIENT SAYS IT BEGAN TWO DAYS AFTER VACCINATION. NO KNOWN TREATMENTS AND PATIENT HAS HAD SOME IMPROVEMENT BUT HAS NOT IMPROVED.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Epistaxis
Clinical narrative: Patient reported nosebleed starting approximately 2 hours post injection. Patient has no other symptoms.
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Agency has been notified of this vaccination administration error.
Age: 29.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Cellulitis
Clinical narrative: PATIENT/ DOCTOR SAYS HE DEVELOPED CELLULITIS; PATIENT SELF PRESCRIBED CEFADROXIL
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Pulmonary embolism, Thrombectomy
Clinical narrative: I had a pulmonary embolism 2/28/2024. That is when they discovered it. I had symptoms 6 months before that. They have not been able to find the underlying cause. I had a thrombectomy to remove the clots. I am on Warfarin to prevent the clots from coming back. Until they can find the cause, I will be on Warfarin indefinitely.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Gave adult dose but only part of it. I realized as I was giving it that it was too large of a dose and stopped.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Left Thigh injection site 10cm long and 5 cm wide erythema and warmth. local cellulitis.No abscess and afreile.Child received Keflax antibiotic today with follow up in 1 week.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Pallor, Tremor, Vomiting
Clinical narrative: Patient received those three vaccines and passed out about 2 to 3 minutes after they were administered. White, shaky, and vomited
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed R. upper arm swelling with redness over most of the upper arm  Pain that limited ROM somewhat, approx 8-10 hours after vaccination   They called and were advised to ice the area, take Ibuprofen and a Benadryl by on call provider.  Follow up call made today and patient's mom states his arm was much better when he woke up this AM and he no longer had any limits to his R. arm ROM. No further swelling or  redness noted.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arthralgia, Pain in extremity, Paraesthesia
Clinical narrative: Right sided arm and shoulder pain, tingling within 24 hours of receiving vaccines on 8/9/24 . Symptoms have persisted for >5 days now. Has been seen at urgent care - has been prescribed steroids. Concern for possible brachial neuritis
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to the touch, itchiness appeared after 24 hours post vaccination. Parents administered childrens oral tylenol 5ml via oral
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Roughly a week after started feeling slight soreness.  The pain has increased and I cannot raise my arm without pain and my arm is constantly sore.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Laboratory test, Pain in extremity
Clinical narrative: started getting pain in my knees, hands, feet, shortness of breath
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fatigue, Loss of personal independence in daily activities, Pain
Clinical narrative: Received above vaccines at 15:51 on 8/14/24. Woke up the AM of 8/15 at approximately 07:00 stating that his whole body hurt and was extremely fatigued. Did not go to school.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: right arm with redness, swelling, small induration. patient placed ice, heat was encouraged
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Echocardiogram normal, Electrocardiogram normal, Fibrin D dimer
Clinical narrative: Pt presented on 5/15/21 to an ED with chest pain. Pt described intermittent mid/upper CP since 5/12/21. From ED: Diagnosis management comments: midsternal chest tightness without any associated symptoms. Currently symptoms free.  Low heart score and no ACS risk factors. EKg normal, troponin negative. Well,s perc negative and d dimer <0.19 Chest xray normal. No mediastinal widening. Work up negative. Patient discharged home.     Pt saw cardiologist in 12/2021 to receive consultation prior to receiving a booster shot for COVID-19. He was ordered an ECHO and advised that if ECHO normal he could consider Booster shot w/ Pfizer due to lower risk of myocarditis than with Moderna or J&J. ECHO results were normal. Patient went on to receive a booster shot in 01/2022.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: Pt presented on 5/15/21 to an ED with chest pain. Pt described intermittent mid/upper CP since 5/12/21. From ED: Diagnosis management comments: midsternal chest tightness without any associated symptoms. Currently symptoms free.  Low heart score and no ACS risk factors. EKg normal, troponin negative. Well,s perc negative and d dimer <0.19 Chest xray normal. No mediastinal widening. Work up negative. Patient discharged home.     Pt saw cardiologist in 12/2021 to receive consultation prior to receiving a booster shot for COVID-19. He was ordered an ECHO and advised that if ECHO normal he could consider Booster shot w/ Pfizer due to lower risk of myocarditis than with Moderna or J&J. ECHO results were normal. Patient went on to receive a booster shot in 01/2022.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Product administration error
Clinical narrative: Vaccine ordered, then provider researched that HPV during preg should wait, vaccine deleted, then let MA know that pt ready for MA, MA did not double check orders and gave vaccine that was no longer ordered
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a 3rd dose of Menveo, 4 months after 2nd dose (Men B #2 was to be given).  No reaction at time of injection.
Age: 20.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Ear discomfort, Headache, Hyperhidrosis, Hypoacusis, Lethargy
Clinical narrative: Donor had vaccine and sat for 10 minutes and stated he started feel pressure in his ears that lead to decrease in hearing,  a headache, lethargic, then he became nauseous, pale, and sweaty. He sat with me a while longer and I gave him an ice pack. After nausea subsided he drank a powerade and ate a granola bar and felt better. Lethargy and headache still remain.
Age: 20.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Pallor
Clinical narrative: Donor had vaccine and sat for 10 minutes and stated he started feel pressure in his ears that lead to decrease in hearing,  a headache, lethargic, then he became nauseous, pale, and sweaty. He sat with me a while longer and I gave him an ice pack. After nausea subsided he drank a powerade and ate a granola bar and felt better. Lethargy and headache still remain.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Nasal congestion, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever, nasal congestion, cough, body aches
Age: 0.5
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Tdap (Boostrix) was given instead of DTaP containing vaccine (Pediarix).  As of the submission of this report, infant has not had any symptoms or signs
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Decreased appetite, Dizziness, Headache
Clinical narrative: For 2 days since the morning after getting the shot: strong nausea with very strong dizziness, very strong pain in the upper right abdomen, joint pain and very strong headache. I still have pain in the upper right abdomen and my appetite is still very low. one week after getting the shot. These side effects are more stronger than the ones I had with the 4 other shots I had especially in my upper right abdomen and the join pain.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: For 2 days since the morning after getting the shot: strong nausea with very strong dizziness, very strong pain in the upper right abdomen, joint pain and very strong headache. I still have pain in the upper right abdomen and my appetite is still very low. one week after getting the shot. These side effects are more stronger than the ones I had with the 4 other shots I had especially in my upper right abdomen and the join pain.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: vaccination error. Pentacel vaccine not reconstituted, Dtap and polio only administered. Medical consult place and recommendation was to give a single dose of Hib to child.
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok administered to patient who is 16 years 11 months old, vaccine is approved for 18 years and older. Patient  parent and MD alerted. Patient had no issues result as of today
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: patient passed out about 10 mins after vaccination
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Skin warm
Clinical narrative: patient's left arm is warm to touch and has a red area about the size of a hand near her tricep/upper elbow region. technician remembers giving vaccine correctly friday evening. patient received antibiotic from doctor for cellulitis today.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac disorder, Electrocardiogram, Hypertension, Liver function test abnormal
Clinical narrative: PATIENT HAS BEEN DEALING WITH HIGH BLOOD PRESSURE, CARDIAC ISSUES, HIGH LIVER FUNCTION LEVELS
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: PATIENT HAS BEEN DEALING WITH HIGH BLOOD PRESSURE, CARDIAC ISSUES, HIGH LIVER FUNCTION LEVELS
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Patient says that he passed out and had nausea one hour after receiving the flu vaccine. He went to the hospital and he states that he was only given an antacid. He reports that he's feeling better today (8-15-24)
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improper storage of product in use; This spontaneous report was received from physician and refers to a 4-year-old female patient. The patient's concomitant therapies, medical histories and drug allergies were not reported. The patient has 1 brother.  On 13-MAY-2024, the patient was vaccinated with exposed to multiple temperature excursions vaccines (Product storage error). Including measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, in right thigh (strength, and route of administration were not provided) (lot #W035041, expiration date: 24-MAY-2024); varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, in right thigh (strength, and route of administration were not provided) (lot #X010531, expiration date: 11-APR-2025); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), in left thigh (strength, formulation, lot #, and route of administration were not provided) (expiration date: 10-JUN-2024), all for prophylaxis.  No patient reported any adverse issues or side effects from the administration.; Sender's Comments:  US-009507513-2406USA005882:
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pharmacy intern reported patient recently received first dose of PROQUAD at 15 years of age.; No additional AE reported.; This spontaneous report was received from a pharmacy intern and refers to a 15-year-old patient. 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 (reported as recently), the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, once, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) at 15 years of age (Product administered to patient of inappropriate age). No further information provided at the time of the call. No additional adverse event (AE) reported (No adverse event).  Lot# is being requested and will be submitted if received.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: VARIVAX 2 days before the recommended vaccination interval.; No adverse event; This spontaneous report was received from a physician referring to an adult patient, age and gender was not provided.   Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On an unknown date (also reported as two days before the recommended vaccination interval), the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were unknown by the reporter) (inappropriate schedule of vaccine administered). There was no adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not have the second dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in January 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not have the second dose administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 5-Aug-2024 The patient's husband reported that they both did not had the second dose administered (missed dose).  No further information was known such as date of birth for either husband or wife, demographic information, doctors information. Adverse event filed after call disconnected.  Minimal information was obtained to file adverse event. This is 2 of 2 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024097604:husband case
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Maladministration of the AS01B Adjuvant of Shingrix Alone; Maladministration of the AS01B Adjuvant of Shingrix Alone; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number ME424, expiry date 09-FEB-2026) for prophylaxis.   On 07-AUG-2024, the patient received the 1st dose of Shingrix. On 07-AUG-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-AUG-2024 The reporter reported that a patient received Shingrix adjuvant alone as a first dose (no powder was mixed), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: syringe broke off and it was not able to be reconstituted because of it; syringe broke off and it was not able to be reconstituted because of it; This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9849, Expiration Date: Mar2025) for immunisation, Device Lot Number: HG1756, Device Expiration Date: 31May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "syringe broke off and it was not able to be reconstituted because of it".  Additional information: The pharmacist was calling because they had a defective RSV vaccine, when the pharmacist went to administer it, the syringe broke off and it was not able to be reconstituted because of it. The pharmacist stated, "that would be what, the last part I gave you was for the syringe (adaptor) and the first part I gave you was for the vial." The pharmacist when asked if a sample of the product available to be returned, stated, "yes, we can return it we need to, I have it." The pharmacist when asked if packaging sealed and intact, stated, "to my knowledge, it was fine, but I do not personally receive it."  The reporter considered "syringe broke off and it was not able to be reconstituted because of it" not related to rsv vaccine prot.subunit pref 2v. Causality for "syringe broke off and it was not able to be reconstituted because of it" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: F
Vaccine: COVID19
Symptoms: Crying, Death, Infection, Kidney infection, Pain
Clinical narrative: kidney was infected; always crying at night; had an infection from the vaccine; Passed away; after 1 week she started having pain; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, Primary immunization completed; unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2023, 1 week after the suspect product(s) administration, outcome "unknown", described as "after 1 week she started having pain"; DEATH (death, medically significant), outcome "fatal", described as "Passed away"; KIDNEY INFECTION (hospitalization, medically significant), outcome "unknown", described as "kidney was infected"; CRYING (non-serious), outcome "unknown", described as "always crying at night"; INFECTION (non-serious), outcome "unknown", described as "had an infection from the vaccine". The patient was hospitalized for kidney infection (start date: Oct2023). The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical courses: Caller reported that his wife had an infection from the vaccine. Patient took the medication on 05Oct2023 after 1 week she started having pain, she is always crying at night. She went to the hospital a week later and her kidney was infected. She was suffering so much before she passed away.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: passed away
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Illness, Pyrexia
Clinical narrative: illness; Covid-19; Covid-19; fever/ high fever/ suffered "very high temperatures" from the knees all the way up to the belly and back; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (Booster), SINGLE), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2024, outcome "unknown", described as "fever/ high fever/ suffered "very high temperatures" from the knees all the way up to the belly and back"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jul2024, outcome "unknown" and all described as "Covid-19"; ILLNESS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: a temperature over 100 degrees. Clinical course: Caller mentioned that he has received 4 Pfizer covid-19 vaccine shots including a booster but still go Covid afterwards. He was expecting to not get covid after the vaccinations but he still got one. Three weeks ago (Jul2024), he got Covid-19. After one week, he suffered "very high temperatures" from the knees all the way up to the belly and back. He confirmed that he only has "fever and feeling of high temperatures", and no pain. Still get covid; illness; suffer from very high temperature from the knees all the way up to the belly and back and fever; high fever from my knees all the way up to the belly. After the Vaccine he got the Covid-19 three weeks ago, the illness and then week after that he suffer from very high temperature from the knees all the way up to the belly and back and fever. He confirmed that it is not pain that he was experiencing, he described it as feeling of high temperatures only, no pain.  The information on the batch/lot number for [BNT162b2 omi xbb.1.5] will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: was about to go soon because of the symptoms he was having. He has pain in his left arm; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization completed; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 3, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 4, unknown manufacturer), for COVID-19 immunization. The patient informed that he took the 3rd round of the booster. He reported that he was about to go soon because of the symptoms he was having. He has pain in his left arm. The outcome of the event was unknown.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Pharmacist.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Sep2023  as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; VIT D [COLECALCIFEROL]; BIOTIN. The patient also took other concomitant therapy, including multivitamin. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Aug2024 at 13:00, outcome "recovering" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Aug2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included over the counter medicines.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202201352916 same patient, different drug and dose;
Sex: U
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: Sick; Feeling so horrible; This is a spontaneous report received from a consumer from medical information team., Program ID:.  A patient (age and gender not provided) received BNT162b2 OMI XBB.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "not recovered", described as "Sick"; MALAISE (non-serious), outcome "not recovered", described as "Feeling so horrible".  Additional Information: The patient had been sick since the patient was given the vaccine and had seen no improvements. The patient demanded answers as to what was in the vaccine and why the patient was feeling so horrible; and to why the company was being sued over the COVID-19 vaccine. The patient said that the company can't administer a drug and not warn people about what could possibly happen to them if taking the vaccine as the patient was not given a warning.  The information on the batch/lot number for BNT162b2 OMI XBB.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms or side effects were reported; Nurse reported that a patient was administered an expired dose of GARDASIL 9.; This spontaneous report has been received for a nurse, concerning a patient of an unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.   On 14-AUG-2024, the patient was vaccinated by a nurse with an expired dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection at the dose of 0.5 milliliter (ml), administered for prophylaxis (strength, frequency, route of administration and injection site were not reported; Lot No. W000244 has been verified to be a valid lot number for hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), with an expiration date reported and established as 09-AUG-2024) (Expired product administered). No symptoms or side effects were reported (No adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Needle issue, Underdose
Clinical narrative: the vaccine was spilled on the patient; the vaccine was spilled on the patient; the vaccine was spilled on the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: the vaccine was spilled on the patient), exposure via skin contact (Verbatim: the vaccine was spilled on the patient) and inadvertent exposure to vaccine (Verbatim: the vaccine was spilled on the patient). The outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were not reported.   Additional Information: GSK receipt date: 06-AUG-2024 The reporter reported regarding needle failure for administering Shingrix as that the patient did not receive the full dose. It was reported that during injection the needle popped off and most of the vaccine was spilled on the patient and the Medical assistant administering it which led to underdose, exposure via skin contact and inadvertent exposure to vaccine. The reporter was just wondering if they could get credit for one vial of Shingrix. Since they were unsure how much of the vaccine received would it be better to had the patient come back in 2 months and get a second vaccine and then in another 2 months to receive a full dose so that she would have 2 to 1/2 doses.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus
Clinical narrative: CUSTOMER SAID SHE GOT ITCHY AFTER GETTING THE VACCINE  AFTER 3 DAYS
Age: 12.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was due for meningococcal, Tdap and HPV but was mistakenly given a Dtap and MMRV instead. No known adverse reaction has been noticed so far, pt has tolerated this well and patient's parents have been made aware.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cognitive disorder, Confusional state, Erythema, Rash, Urticaria
Clinical narrative: The ADR (or allergic reaction) was reported a day after the injection. Pt reported hives and rashes initiated on the chest area then spread to the facial area via phone call. Then the patient presented to pharmacy, however rash or hives were hard to distinguish from his skin color. Did not visually see swelling or bright red spots on skins however the area was reddened. Mentally very confused and cognitive impairment was seen.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Neck pain, Nodule
Clinical narrative: Donor reported pain that traveled from right deltoid injection site, up arm and into her right neck area near anterior cervical chain. Donor reported a painful "knot" that then formed in that area. This MSA did feel a small nodule about the size of a jelly bean during  initial examination, but during further examination, it was difficult for donor and this RN to find/feel. Donor denied any other s/s of an adverse reaction and reported she felt "fine".
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Heart rate increased, Pain in extremity
Clinical narrative: Fast heart beat; alluded to but did not specifically state, a very sore arm
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was administered outside of the manufacturer timeframe .
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Diarrhea for 7+ days, low grade fever
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was administered outside of the manufacturer timeframe
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was administered outside of the manufacturer timeframe
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was administered outside of the manufacturer timeframe
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was administered outside of the manufacturer timeframe
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Flu shot given twice. Once on 7/22/24 and second on 8/14/24. No adverse events noted. Reporting that 2 shots were given. Patient is currently in good health with no adverse effects
Age: 26.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 74.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain, Blood pressure increased, Diarrhoea, Nausea, Pain
Clinical narrative: Patient complains of nausea, severe abdominal cramping, diarrhea. Also sinus pressure, sinus headache, congestion. Body aches. Elevated blood pressure (higher than normal readings).
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Paranasal sinus discomfort, Respiratory tract congestion, Sinus headache
Clinical narrative: Patient complains of nausea, severe abdominal cramping, diarrhea. Also sinus pressure, sinus headache, congestion. Body aches. Elevated blood pressure (higher than normal readings).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Anaphylaxis treatment, Drooling, Lip swelling, Swelling of eyelid, Urticaria
Clinical narrative: After receiving her 12 month vaccines, patient started to develop swelling of her bilateral eyelids and both lips. Was given benadryl in clinic, triage response called, and continued to monitor. Airway remained patent, continued to be hemodynamically stable. Developed some scattered urticaria, drooling, and mild wheeze. Was given nebulized albuterol and EpiPen Jr. Triage team arrived and escorted patient and her mother to the EC for further monitoring and management. She remained normotensive, well-perfused, saturating well on room air, and without vomiting throughout the event.  In the EC, she received another dose of EpiPen Jr. and dexamethasone. Improved significantly, was discharged home with daily cetirizine and emergency epipen.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Wheezing
Clinical narrative: After receiving her 12 month vaccines, patient started to develop swelling of her bilateral eyelids and both lips. Was given benadryl in clinic, triage response called, and continued to monitor. Airway remained patent, continued to be hemodynamically stable. Developed some scattered urticaria, drooling, and mild wheeze. Was given nebulized albuterol and EpiPen Jr. Triage team arrived and escorted patient and her mother to the EC for further monitoring and management. She remained normotensive, well-perfused, saturating well on room air, and without vomiting throughout the event.  In the EC, she received another dose of EpiPen Jr. and dexamethasone. Improved significantly, was discharged home with daily cetirizine and emergency epipen.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was given outside of the timeframe of the manufacturer
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Circumstance or information capable of leading to medication error, Injury
Clinical narrative: The nurse was very aggressive and administered the shots terribly and she injured my child severely.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine given outside of the timeframe recommended by the manufacturer
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not have the second dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in January 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not have the second dose administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 5-Aug-2024 The patient's husband reported that they both did not had the second dose administered (missed dose).  No further information was known such as date of birth for either husband or wife, demographic information, doctors information. Adverse event filed after call disconnected.  Minimal information was obtained to file adverse event. This is 1 of 2 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR098275:wife case
Age: 0.17
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Not showing any symptoms at this time.  No additional AE/PQC.; Patient's mother called to report that her 2 month old infant was administered GARDASIL 9 in error. Not showing any symptoms at this time.  No additional AE/PQC.; This spontaneous report was received from the patient's mother regarding her 2-month-old male son. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 08-AUG-2024, the patient was vaccinated in error with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Age: 0.17
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Not showing any symptoms at this time.  No additional AE/PQC.; Patient's mother called to report that her 2 month old infant was administered GARDASIL 9 in error. Not showing any symptoms at this time.  No additional AE/PQC.; This spontaneous report was received from the patient's mother regarding her 2-month-old male son. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 08-AUG-2024, the patient was vaccinated in error with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Age: 20.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Ear discomfort, Headache, Hyperhidrosis, Hypoacusis, Lethargy
Clinical narrative: *THIS REPORT IS IN REFERENCE OF E-REPORT 1028805 COMPLETED ON 8.15.24. MORE INFORMATION HAS BEEN ADDED TO THIS REPORT.  Donor had vaccine after donation and sat for 10 minutes he started to feel pressure in his ears leading to decreased hearing, lethargic, then he became nauseous, pale, and sweaty. He sat a while longer with me and I gave  him an ice pack. After the nausea subsided he drank a Powerade and ate a granola bar and he stated he felt better. Donor states the lethargy and headache remained.
Age: 20.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Pallor
Clinical narrative: *THIS REPORT IS IN REFERENCE OF E-REPORT 1028805 COMPLETED ON 8.15.24. MORE INFORMATION HAS BEEN ADDED TO THIS REPORT.  Donor had vaccine after donation and sat for 10 minutes he started to feel pressure in his ears leading to decreased hearing, lethargic, then he became nauseous, pale, and sweaty. He sat a while longer with me and I gave  him an ice pack. After the nausea subsided he drank a Powerade and ate a granola bar and he stated he felt better. Donor states the lethargy and headache remained.