chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Bell's palsy, Urticaria
Clinical narrative: general bell's palsy; allergic to covid 19 vaccine; hives; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "general bell's palsy"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic to covid 19 vaccine"; URTICARIA (non-serious), outcome "unknown", described as "hives".  Clinical course: The patient stated that she is allergic to COVID-19 Vaccine, she got general Bell's palsy and hives with the vaccine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 45.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product use in unapproved indication
Clinical narrative: no adverse event; Pharmacist called to report a patient who received their first dose of GARDASIL 9 at 45 years of age missed their next two doses in the series and is now 46 years old.  No symptoms reported.  Consent to correspond was granted.  See related request ca; Indication HPV; This spontaneous report was received from a pharmacist, concerning to a 45-year-old male.  The patient's medical historry, concurrent conditions and concomitant therapies were not reported.  On 03-MAY-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered intramuscularly for Human Papillomavirus (HPV) (Product use in unapproved indication) (strength, lot #, expiry date, and indication were not provided), when he was 45 years old. He missed the next two doses and he was already 46-years-old. (Inappropriate schedule of product administration). No additional adverse event (No adverse event).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her husband has covid/they received with Lot#LN0588; her husband has covid/they received with Lot#LN0588; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LN0588, Expiration Date: 17Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "her husband has covid/they received with Lot#LN0588". No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Caller had Pfizer covid 19 vaccines last 20Sep2024, and on Nov caller was diagnosed with covid; Caller had Pfizer covid 19 vaccines last 20Sep2024, and on Nov caller was diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 75 and a half years old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: Feb-Mar she got COVID as well and took PAXLOVID. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Nov2024, outcome "unknown" and all described as "Caller had Pfizer covid 19 vaccines last 20Sep2024, and on Nov caller was diagnosed with covid". Therapeutic measures were taken as a result of vaccination failure which included Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid rebound; covid rebound; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (PRIMARY SERIES COMPLETE, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2024, outcome "recovering" and all described as "covid rebound". Therapeutic measures were not taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Set of twins were given DTAP, PIV and MMRV on 12/24/2024 by LPN. As per nurse, parent denied children getting vaccines elsewhere. State System was not verified before administration. Staff received a call from NP from Pts' school to advise me that these vaccines were already administered by her on 12/04/2024, as per State System. Provider Dr advised. Provider stated no harm done and vaccines will be invalid. Nurse unable to contact parent on 01/03. Will try again tomorrow.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy lymph gland, Chemotherapy, Colonoscopy, Depression, Diagnostic aspiration
Clinical narrative: I had developed Hodgkin Lymphoma a year after the the vaccine. A few months before my lymphoid on my neck first became swollen, I experienced months of bloody stools. After diagnosis I had to go through several rounds of chemotherapy. Till this day I'm unsure if I'm able to reproduce due to the chemotherapy.  Loss of sex drive, thoughts of suicide had occurred, depression; all after chemotherapy.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Hodgkin's disease, Libido decreased, Lymphadenopathy, Suicidal ideation
Clinical narrative: I had developed Hodgkin Lymphoma a year after the the vaccine. A few months before my lymphoid on my neck first became swollen, I experienced months of bloody stools. After diagnosis I had to go through several rounds of chemotherapy. Till this day I'm unsure if I'm able to reproduce due to the chemotherapy.  Loss of sex drive, thoughts of suicide had occurred, depression; all after chemotherapy.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Ill-defined disorder, Malaise
Clinical narrative: after my parents got that shot they became ill for a little over a month starting feeling a little better but then things went south for both of them. my dad found my mother bleeding out her rectum on the bathroom floor. i have all hospital reports and documents . They both died within days of each other. the only information I was told by the detective was he had a medical issue.  A medical issue? I guess thats what its called.  We need accountability for this insanity
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: the patient had fainted, she felt lightheaded, she did not hurt herself, the mom caught her before hitting the ground. the paramedics were called on
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Patient reporting diarrhea the day following administration. RPh advised patient to increase liquid intake and to take Immodium as directed by the package.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Head injury, Malaise, Nausea, Syncope
Clinical narrative: The child complained of not feeling well about 5-10 minutes after the vaccines.  He said he started feeling nauseous.  He then fainted and fell to the ground.  No one warned us that this might happen, so we were standing in a parking lot and he hit his head on the concrete.
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Small intestinal obstruction
Clinical narrative: employee this vaccine caused a small bowel obstruction
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Abdominal X-ray, Abdominal adhesiolysis, Abdominal distension, Abdominal pain, Anion gap increased
Clinical narrative: employee this vaccine caused a small bowel obstruction
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Biopsy small intestine abnormal, Blood bilirubin increased, Blood culture negative, Blood urea nitrogen/creatinine ratio increased, Carbon dioxide decreased
Clinical narrative: employee this vaccine caused a small bowel obstruction
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Chills, Computerised tomogram abdomen abnormal, Dehydration, Differential white blood cell count abnormal, Fat necrosis
Clinical narrative: employee this vaccine caused a small bowel obstruction
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Full blood count, Gomori methenamine silver stain, Haematocrit normal, Haemoglobin normal, Human chorionic gonadotropin negative
Clinical narrative: employee this vaccine caused a small bowel obstruction
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Induration, Intestinal dilatation, Laparotomy, Lipase normal, Mechanical ileus
Clinical narrative: employee this vaccine caused a small bowel obstruction
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Mesenteric haemorrhage, Metabolic function test, Mycobacterium test negative, Nausea, Neutrophil percentage increased
Clinical narrative: employee this vaccine caused a small bowel obstruction
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Pathology test, Platelet count normal, Shift to the left, Small intestinal resection, Vomiting
Clinical narrative: employee this vaccine caused a small bowel obstruction
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: White blood cell count increased, X-ray abnormal
Clinical narrative: employee this vaccine caused a small bowel obstruction
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Drowning, Fall, Heart rate increased, Hypersomnia
Clinical narrative: Patient has two occasions of fast heart rate after the vaccine. His behavior changed and he slept a lot. Had first seizure on 5/19/2022 that caused his to fall into water and drown.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Patient has two occasions of fast heart rate after the vaccine. His behavior changed and he slept a lot. Had first seizure on 5/19/2022 that caused his to fall into water and drown.
Age: 27.0
Sex: F
Vaccine: COVID19, HEP, COVID19
Symptoms: Rash
Clinical narrative: Rash under and between breast, rash on the left part of the neck, behind the neck, and rash in the left inguinal area. Rash was self-limited
Age: 14.0
Sex: F
Vaccine: COVID19, FLU3, HEPA, VARCEL
Symptoms: Carotid pulse normal, Dizziness, Hyperhidrosis, Mouth injury, Pallor
Clinical narrative: Client (DOB: 08/xx/20xx) received 2nd dose of Varicella, seasonal COVID-19 (Moderna-Spikevax), Hepatitis A and seasonal flu shot (Flulaval) at 2:55 PM. At around 2:57 PM, client stated "I feel like I am going to faint". Staff guided client to the nearest chair. Client was observed to be diaphoretic and pale. At around 2:57 PM client became unresponsive for about 5-10 seconds. Staff assessed carotid pulse at this time. Pulse was regular and strong. Staff called RN who provided blue mat. At this time, client became responsive and Staff assisted client down to supine position. Client was given ice packs to apply on forehead. Client was also given emesis bag. At 3:01 PM, nurses took VS while client was lying down; HR 82, SPO2 100% RA, BP 94/64, RR 22. Client was alert and oriented to person, place, and event. Client denied experiencing any chest pain, shortness of breath, nausea, or headache, but reported she bit the inside of her cheek. Staff assessed mild errythema on the left buccal mucosa. Buccal mucosa was intact, no bleeding or additional complications were assessed. At 3:06 PM, VS were as follows HR 67, BP 104/71, SPO2 96% RA, RR 18.  At 3:12 PM, client was able to sit up on mat by herself.  VS were as follows HR 80, BP 101/83, SPO2 100% RA, RR 16. Client denied any dizziness, nausea, shortness of breath or pain. At 3:14 PM, client stated that she felt like she could sit up on chair. Staff observed client stand and sit in chair. Client denied any dizziness, nausea, shortness of breath or pain. At 3:17PM, client was able stand up on her own and denied experiencing any dizziness, nausea, shortness of breath or pain. Staff took another set of VS while client was standing. VS were as follows HR 91, BP 99/63, SPO2 100% RA, RR 18. Client stated that she felt comfortable walking and requesting to leave. Client's gait appeared steady and skin was normal for ethnicity. Client also confirmed and denied any concerning symptoms. Advised client and client's father to follow up with client's primary care doctor and to seek emergency care if symptoms return, or if client starts experiencing new symptoms.
Age: 14.0
Sex: F
Vaccine: COVID19, FLU3, HEPA, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Client (DOB: 08/xx/20xx) received 2nd dose of Varicella, seasonal COVID-19 (Moderna-Spikevax), Hepatitis A and seasonal flu shot (Flulaval) at 2:55 PM. At around 2:57 PM, client stated "I feel like I am going to faint". Staff guided client to the nearest chair. Client was observed to be diaphoretic and pale. At around 2:57 PM client became unresponsive for about 5-10 seconds. Staff assessed carotid pulse at this time. Pulse was regular and strong. Staff called RN who provided blue mat. At this time, client became responsive and Staff assisted client down to supine position. Client was given ice packs to apply on forehead. Client was also given emesis bag. At 3:01 PM, nurses took VS while client was lying down; HR 82, SPO2 100% RA, BP 94/64, RR 22. Client was alert and oriented to person, place, and event. Client denied experiencing any chest pain, shortness of breath, nausea, or headache, but reported she bit the inside of her cheek. Staff assessed mild errythema on the left buccal mucosa. Buccal mucosa was intact, no bleeding or additional complications were assessed. At 3:06 PM, VS were as follows HR 67, BP 104/71, SPO2 96% RA, RR 18.  At 3:12 PM, client was able to sit up on mat by herself.  VS were as follows HR 80, BP 101/83, SPO2 100% RA, RR 16. Client denied any dizziness, nausea, shortness of breath or pain. At 3:14 PM, client stated that she felt like she could sit up on chair. Staff observed client stand and sit in chair. Client denied any dizziness, nausea, shortness of breath or pain. At 3:17PM, client was able stand up on her own and denied experiencing any dizziness, nausea, shortness of breath or pain. Staff took another set of VS while client was standing. VS were as follows HR 91, BP 99/63, SPO2 100% RA, RR 18. Client stated that she felt comfortable walking and requesting to leave. Client's gait appeared steady and skin was normal for ethnicity. Client also confirmed and denied any concerning symptoms. Advised client and client's father to follow up with client's primary care doctor and to seek emergency care if symptoms return, or if client starts experiencing new symptoms.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Extra dose administered
Clinical narrative: On 10/8/24, pt received MMR vaccine (live vaccine) from store. On 10/13/2024, pt received another live vaccine, Varivax, from our store. Per CDC, "If 2 injected vaccines are administered on separate days, but administered <28 days apart, the second vaccine is invalid and should be re-administered >28 days after the invalid dose.  The mistake was identified when patient came back to pharmacy on 1/6/25 to receive the second doses of MMR and Varivax. Patient was informed of the mistake. He understood the first dose of Varivax he got  on 10/13/24 was invalid. Each dose of MMR and Varivax was given on 1/6/25 at the same time and patient agreed to come back for another dose of Varivax.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Fatigue, Influenza like illness
Clinical narrative: Pt reports experiencing flu like symptoms and tiredness beginning  1-5 at 7pm, then reports a metallic taste when drinking fluids this morning 1-6
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received AREXVY on 1/2/25 after receiving it previously 2 years prior. During patient interaction patient stated they had not received it prior, insurance allowed the claim to be billed, and our system did not recognize the vaccine being administered again. Further investigation of if the patient had received the vaccine was not pursued until later. Patient has had no adverse effects known-to-date from receiving vaccine again.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: Pain, bruise and lump under the skin at injection site beginning 12/31/24. Lump described as larger than a half-dollar.  As of 01/04/25, pain and size of lump have both decreased, but are still present.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site vesicles
Clinical narrative: 24 hours after receiving Varicella, developed area of erythema and induration at the vaccination site. Area examined 1/6, findings of approx. 2cm x 2cm area of discreet vesicles in annular distribution, mild induration.
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Small intestinal obstruction
Clinical narrative: Small bowel obstruction-- On October 28, 2024, two days after completing a 4-capsule, QoD course of oral typhoid vaccine (capsules were taken on 10/20/24, 10/22/24, 10/24/24, and 10/26/24) , I developed severe (9-10/10) generalized abdominal pain and distension which lasted ~12 hours but self-resolved before I sought medical care.  Another episode occurred one month later (11/28/24) and self-resolved within several hours. On the evening of 12/23/24, the symptoms came on again and would not subside.  The severe abdominal pain was accompanied by nausea and an episode of NBNB vomiting, as well as abdominal distension, chills, and warm temperature (TMax 99.6F). Please see "continuation" page for full information.
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Abdominal X-ray, Abdominal adhesiolysis, Abdominal distension, Abdominal pain, Anion gap increased
Clinical narrative: Small bowel obstruction-- On October 28, 2024, two days after completing a 4-capsule, QoD course of oral typhoid vaccine (capsules were taken on 10/20/24, 10/22/24, 10/24/24, and 10/26/24) , I developed severe (9-10/10) generalized abdominal pain and distension which lasted ~12 hours but self-resolved before I sought medical care.  Another episode occurred one month later (11/28/24) and self-resolved within several hours. On the evening of 12/23/24, the symptoms came on again and would not subside.  The severe abdominal pain was accompanied by nausea and an episode of NBNB vomiting, as well as abdominal distension, chills, and warm temperature (TMax 99.6F). Please see "continuation" page for full information.
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Biopsy small intestine abnormal, Blood bilirubin increased, Blood culture negative, Blood urea nitrogen/creatinine ratio increased, Carbon dioxide decreased
Clinical narrative: Small bowel obstruction-- On October 28, 2024, two days after completing a 4-capsule, QoD course of oral typhoid vaccine (capsules were taken on 10/20/24, 10/22/24, 10/24/24, and 10/26/24) , I developed severe (9-10/10) generalized abdominal pain and distension which lasted ~12 hours but self-resolved before I sought medical care.  Another episode occurred one month later (11/28/24) and self-resolved within several hours. On the evening of 12/23/24, the symptoms came on again and would not subside.  The severe abdominal pain was accompanied by nausea and an episode of NBNB vomiting, as well as abdominal distension, chills, and warm temperature (TMax 99.6F). Please see "continuation" page for full information.
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Chills, Computerised tomogram abdomen abnormal, Dehydration, Differential white blood cell count abnormal, Fat necrosis
Clinical narrative: Small bowel obstruction-- On October 28, 2024, two days after completing a 4-capsule, QoD course of oral typhoid vaccine (capsules were taken on 10/20/24, 10/22/24, 10/24/24, and 10/26/24) , I developed severe (9-10/10) generalized abdominal pain and distension which lasted ~12 hours but self-resolved before I sought medical care.  Another episode occurred one month later (11/28/24) and self-resolved within several hours. On the evening of 12/23/24, the symptoms came on again and would not subside.  The severe abdominal pain was accompanied by nausea and an episode of NBNB vomiting, as well as abdominal distension, chills, and warm temperature (TMax 99.6F). Please see "continuation" page for full information.
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Full blood count, Gomori methenamine silver stain, Haematocrit normal, Haemoglobin normal, Human chorionic gonadotropin negative
Clinical narrative: Small bowel obstruction-- On October 28, 2024, two days after completing a 4-capsule, QoD course of oral typhoid vaccine (capsules were taken on 10/20/24, 10/22/24, 10/24/24, and 10/26/24) , I developed severe (9-10/10) generalized abdominal pain and distension which lasted ~12 hours but self-resolved before I sought medical care.  Another episode occurred one month later (11/28/24) and self-resolved within several hours. On the evening of 12/23/24, the symptoms came on again and would not subside.  The severe abdominal pain was accompanied by nausea and an episode of NBNB vomiting, as well as abdominal distension, chills, and warm temperature (TMax 99.6F). Please see "continuation" page for full information.
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Induration, Intestinal dilatation, Laparotomy, Lipase normal, Mechanical ileus
Clinical narrative: Small bowel obstruction-- On October 28, 2024, two days after completing a 4-capsule, QoD course of oral typhoid vaccine (capsules were taken on 10/20/24, 10/22/24, 10/24/24, and 10/26/24) , I developed severe (9-10/10) generalized abdominal pain and distension which lasted ~12 hours but self-resolved before I sought medical care.  Another episode occurred one month later (11/28/24) and self-resolved within several hours. On the evening of 12/23/24, the symptoms came on again and would not subside.  The severe abdominal pain was accompanied by nausea and an episode of NBNB vomiting, as well as abdominal distension, chills, and warm temperature (TMax 99.6F). Please see "continuation" page for full information.
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Mesenteric haemorrhage, Metabolic function test, Mycobacterium test negative, Nausea, Neutrophil percentage increased
Clinical narrative: Small bowel obstruction-- On October 28, 2024, two days after completing a 4-capsule, QoD course of oral typhoid vaccine (capsules were taken on 10/20/24, 10/22/24, 10/24/24, and 10/26/24) , I developed severe (9-10/10) generalized abdominal pain and distension which lasted ~12 hours but self-resolved before I sought medical care.  Another episode occurred one month later (11/28/24) and self-resolved within several hours. On the evening of 12/23/24, the symptoms came on again and would not subside.  The severe abdominal pain was accompanied by nausea and an episode of NBNB vomiting, as well as abdominal distension, chills, and warm temperature (TMax 99.6F). Please see "continuation" page for full information.
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: Pathology test, Platelet count normal, Shift to the left, Small intestinal resection, Vomiting
Clinical narrative: Small bowel obstruction-- On October 28, 2024, two days after completing a 4-capsule, QoD course of oral typhoid vaccine (capsules were taken on 10/20/24, 10/22/24, 10/24/24, and 10/26/24) , I developed severe (9-10/10) generalized abdominal pain and distension which lasted ~12 hours but self-resolved before I sought medical care.  Another episode occurred one month later (11/28/24) and self-resolved within several hours. On the evening of 12/23/24, the symptoms came on again and would not subside.  The severe abdominal pain was accompanied by nausea and an episode of NBNB vomiting, as well as abdominal distension, chills, and warm temperature (TMax 99.6F). Please see "continuation" page for full information.
Age: 47.0
Sex: F
Vaccine: TYP, TYP, TYP
Symptoms: White blood cell count increased, X-ray abnormal
Clinical narrative: Small bowel obstruction-- On October 28, 2024, two days after completing a 4-capsule, QoD course of oral typhoid vaccine (capsules were taken on 10/20/24, 10/22/24, 10/24/24, and 10/26/24) , I developed severe (9-10/10) generalized abdominal pain and distension which lasted ~12 hours but self-resolved before I sought medical care.  Another episode occurred one month later (11/28/24) and self-resolved within several hours. On the evening of 12/23/24, the symptoms came on again and would not subside.  The severe abdominal pain was accompanied by nausea and an episode of NBNB vomiting, as well as abdominal distension, chills, and warm temperature (TMax 99.6F). Please see "continuation" page for full information.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; Inbound from nurse who reports product involved in temperature excursion administered to one patient. Excursion occurred last night, product administered to one patient this morning 12/12/2024.   ?    Names of vaccines involved (including lot/exp); This spontaneous report was received from a nurse and referred 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 12-DEC-2024, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #Y014436, expiration date: 22-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was exposed to temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 17 minutes (Product storage error). No additional AE reported.
Age: 65.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Laboratory test, Postmenopausal haemorrhage, Vaginal haemorrhage
Clinical narrative: I started having heavy post-menopausal vaginal bleeding with clots on 11/22/24, which has continued into January 2025.  I went to the emergency room in late December because of the heavy bleeding/clots and fear of anemia.  I was started on a prescription that slowed the flow somewhat, but it has increased again in January.  This bleeding has continued much too long.
Age: 50.0
Sex: F
Vaccine: HEP, HEPAB
Symptoms: Interchange of vaccine products
Clinical narrative: vaccine Interchangeability with Heplisav (second dose); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 50-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis.   On 30-JUL-2024, the patient received the 1st dose of Twinrix. On an unknown date, the patient received Heplisav b. On an unknown date, an unknown time after receiving Twinrix, the patient experienced interchange of vaccine products (Verbatim: vaccine Interchangeability with Heplisav (second dose)). The outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-DEC-2024 Pharmacist reported that a fifty-year-old female patient received a first dose of Twinrix and then a second dose of Heplisav (Hepatitis B vaccine) which led to interchange of vaccine products. Pharmacist wanted to know about how to proceed, if they need to restart the series/schedule for the patient.  Vaccination date (Twinrix) and patient demographics were retrieved during the call. No further information was obtained from the pharmacist´s end during the call.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Biopsy cervix, Cervicectomy, Maternal exposure before pregnancy, Smear cervix abnormal
Clinical narrative: she had "an abnormal pap while pregnant; In June 2024 she had a Cervical Resection; This spontaneous report was received from a Company Representative regarding a 28-year-old female patient.  The patient's medical history, concurrent conditions, Concomitant therapies, past drug reactions and allergies were unknown by the reporter.   On an unknown date, when the patient was 12 years old, she was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, lot number, expiration date, anatomical site of injection and route of administration were not provided). On an unknown date (also reported as years later), the patient had an abnormal pap while pregnant (Papanicolaou smear abnormal). When revisited a few years later, they did a cervical biopsy. On an unknown date in June 2024, the patient experienced a cervical resection (Cervicectomy). No additional details were available at the time of the call.   The outcome of the events of Papanicolaou smear abnormal and Cervicectomy were not provided.   The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and both events was not reported.   Upon internal review, the event of Cervicectomy was determined to be medically significant (OME).
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAXNEUVANCE (y002643   10/4/2026) Temperature:  4; This spontaneous report was received from an other health care professional (healthcare worker) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 31-DEC-2024, the patient was vaccinated with 1 improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), formulation: injection, lot # Y002643, expiration date: 04-OCT-2026 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature excursion of 46.6 degrees Fahrenheit for 1 hour and 55 minutes (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event was reported; The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAXNEUVANCE (y002643   10/4/2026) Temperature:  4; This spontaneous report was received from healthcare worker 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 30-DEC-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #y002643, expiration date: 04-OCT-2026, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 46.6 degree Farenheit for 1 hour 55 minutes (Product storage error). No additional adverse events were reported.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-DEC-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #y002643, expiration date reported as and upon internal review confirmed to be 04-OCT-2026 (exact dose, route of administration and vaccination site were not provided) administered for prophylaxis. The patient received improperly stored vaccine (temperature: 46.6F; time frame: 1 hour 55 minutes) (product storage error). No previous temperature excursion was noted. No additional adverse events (AEs) were reported (no adverse event). No further information was provided.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: The client had no adverse reaction. The appropriate vaccination was administered. The client was inadvertently given a pediatric/adolescent dose instead of an adult dose.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery bypass, Death, Malaise
Clinical narrative: Patient admitted 11/22 for CABG, wen to rehab on 12/26, re-admitted 12/29 with COVID symptoms, expired 1/6/2025
Age: 94.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second dose of RSV after one year of a prior vaccination.  Spoke with them and they are not experiencing any adverse reactions to the second dose.
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Inflammation, Injection site hypoaesthesia, Injection site pain, Laboratory test, Product administered at inappropriate site
Clinical narrative: pt says after the 1st dose in the left arm he started having tingling in his bicep and pain into the back of his arm and then moved into his chest wall as well as other areas. He saw a doctor for the pain but was told it was not unusual, take tylenol and thought it would go away. Then he received the 2nd dose in the left buttuck. It was numb for a couple of days and then it became it painful.  He can still move his arm but the pain is still there and is now permanent never goes away and the pain on the buttock is still there and is also permanent. The left hand stays inflammed unless he takes anti-inflammitory or goes to sleep. His current PCP had him in therapy for treatment but that did not help with his symptoms. He continues to seek help for relief of these issues from the vaccines. He also received a 2nd opinion but also got an all clear for them also.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-DEC-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #y002643, expiration date reported as and upon internal review confirmed to be 04-OCT-2026 (exact dose, route of administration and vaccination site were not provided) administered for prophylaxis. The patient received improperly stored vaccine (temperature: 46.6F; time frame: 1 hour 55 minutes) (product storage error). No previous temperature excursion was noted. No additional adverse events (AEs) were reported (no adverse event). No further information was provided.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling
Clinical narrative: Swelling of right eye when waking up at 6:00 AM 1/7/2025. Went to urgent care and was told to treat with Benadryl.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: She had a fever start Sat evening and lasted all day Sunday, about 102F. Once the fever broke Sunday night she began to experience injection site reactions on her left arm. Red swollen, and slightly warm. No hives or itching.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: VACCINE WAS GIVEN EARLIER THAN RECOMMENDED GUIDELINE; ACCORDING TO PFIZER GUIDELINE, A PERSON WHO HAD COMPLETED PREVNAR13 AND PNEUMOVAX23 VACCINES IS ELIGIBLE TO GET PREVNAR20 5 YEARS AFTER LAST PNEUMONIA SHOT.   PREVNAR20 WAS  GIVEN EARLIER THAN 5 YEARS.  HIS DUE DATE WOULD HAVE BEEN 08/09/2027.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling and tenderness at injection site
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site rash, Injection site warmth, Rash, Rash erythematous, Rash papular
Clinical narrative: On 12/25/2024 patient started with a localized rash around the site where he received his HPV vaccine in his right arm.  It was raised and red and warm to the touch.  Also itchy.  On 12/28/2024 the rash spread around the arm, then to the feet, legs and cheeks.  Afebrile.  No joint pain.  No other illness symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Rash pruritic
Clinical narrative: On 12/25/2024 patient started with a localized rash around the site where he received his HPV vaccine in his right arm.  It was raised and red and warm to the touch.  Also itchy.  On 12/28/2024 the rash spread around the arm, then to the feet, legs and cheeks.  Afebrile.  No joint pain.  No other illness symptoms.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: vasovagal syncope
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event occurred. Patient was accidently given 3 doses of vaccine at one time.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Pallor, Syncope, Tremor
Clinical narrative: Patient had syncopal episode and fall off patient exam table after vaccination about 1-2 minutes after injections. Syncope lasted less than 1 minute before patient was responding again. Had pallor and some shakiness for several minutes afterwards. Blood pressure was 90/48 and blood sugar 94. Blood pressure improved over the next 15 minutes and patient was able to leave office.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Ear discomfort, Throat tightness, Tinnitus
Clinical narrative: mom states the next day after receiving the bexsero #1  vaccine she had ringing in both ears and they felt clogged. Her throat felt like it was closing. After the 3rd day she started to feel better. No treatment was done.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Computerised tomogram head normal, Head titubation, Magnetic resonance imaging head normal, Movement disorder
Clinical narrative: Symptoms began on November 6, 2021 with a slight tremor in my right arm/hand. Within a week the tremors were affecting all of my limbs, neck and head. I went to my PCP who referred my to a neurologist. I was able to see him on December 22, 2021. He diagnosed me with Functional Movement Disorder.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Symptoms began on November 6, 2021 with a slight tremor in my right arm/hand. Within a week the tremors were affecting all of my limbs, neck and head. I went to my PCP who referred my to a neurologist. I was able to see him on December 22, 2021. He diagnosed me with Functional Movement Disorder.
Age: 0.67
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cough, Nasal congestion, Viral upper respiratory tract infection, Vomiting
Clinical narrative: Cough, nasal congestion, vomiting overnight after an afternoon dose of vaccine. Continued cough and congestion the next day. Symptomatic support. Likely viral URI.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscle spasms
Clinical narrative: Received flu vaccine 12/10/24. On 12/24/24 was exercising (running) and noticed numbness in BLE's. Diminished sensation left side of face, BLE's and LUE for the next two weeks. Had whole body muscle spasms 12/27/24-12/30/24.  Currently (01/07/25) improvement of symptoms, but still experiencing diminished sensation LUE, BLE's and some left side of face numbness. Saw psychiatrist 01/06/25 and he didn't know what was going on and offered neurologist consult.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt received 2 Flu vaccines accidentally- administered by medical assistants.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a second Arexvy shot , He is fine. No side effects. We all thought it was the first one and so did he.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, PNC15, TDAP
Symptoms: Wrong product administered
Clinical narrative: The nurse intended to administer ActHIB but accidentally administered Adacel.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: Patient reported rash around the area
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site rash, Pain in extremity, Rash erythematous
Clinical narrative: Pharmacist placed an adhesive sticker on the skin to assist with vaccine administration into the arm. Upon administration my arm was sore. About 2 days later I experienced 1/2 inch long by 1/8 inch wide red rash that was extremely itchy. The itching has finally resolved however the redness has persisted and is now pink color and slowly fading.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: At approximately 1:45PM, after the client was given the TDAP (Boostrix) vaccine, the nurse noticed a slight red rash forming at the injection site.   25mL of Benadryl was administered orally less than 3 minutes later.  Client was monitored for 20 minutes, and the slight rash was subsiding.  No air way difficulties were noted.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAXNEUVANCE (y002643   10/4/2026) Temperature:  4; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 30-DEC-2024 the patient was vaccinated with improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # Y002643 and expiration date 04-OCT-2026 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The temperature excursion lasted for 1 hour 55 minutes in temperature of 46.6 degrees Fahrenheit (product storage error). Bo additional adverse events were reported (no adverse event).
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose, Computerised tomogram, Electrocardiogram, Fall, Loss of consciousness
Clinical narrative: PATIENT LOST CONSCIOUSNESS SHORTLY AFTER RECEIVING THE VACCINE. SHE FELL ON HER WAY OUT OF THE CLINIC AND BROKE HER TOOTH AND SUSTAINED LACERATIONS DUE TO THE FALL.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Skin laceration, Tooth fracture
Clinical narrative: PATIENT LOST CONSCIOUSNESS SHORTLY AFTER RECEIVING THE VACCINE. SHE FELL ON HER WAY OUT OF THE CLINIC AND BROKE HER TOOTH AND SUSTAINED LACERATIONS DUE TO THE FALL.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Ultrasound scan normal
Clinical narrative: Patient developed left upper arm swelling and pain a few hours later after receiving Men B vaccine on 12/17/24. Went to urgent care on 12/18, given one dose of cephalexin and Ibuprofen in office. Had significant pain, unable to abduct left shoulder on 12/19/24. Seen at ER on 12/19/24. Given acetaminophen, Ibuprofen and Lidocaine patch at ER. POCUS without cobble stoning or fluid collection. Pain improved with analgesia and able to actively range shoulder.  Discharged home, Rxed Lidocaine 5% patch prn.  Had follow up visit in PCP's office on 1/2/25 with condition resolved.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Sensation of foreign body
Clinical narrative: felt like something was stuck in her throat, voice became hoarse, hard to take deep breaths
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Two days after injection of both Flucelvax and Spikevax, patient experienced "deep muscle pain" at the injections site. Patient waited about 2 months to inform the pharmacy of this arm muscle pain. Talked to patient today and she said that the pain is worse.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical assistant administered PCV 23 instead of PCV 20. Provider ordered PCV 20.  Patient did not have any reaction to vaccine administration in the clinic.  Medical director spoke to patient about incident.
Age: 75.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Chest pain, Chills, Ocular hyperaemia, Vomiting
Clinical narrative: throwing up, chest pain, chills, eyes turned red
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Back pain, Mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: 22 yr old female with no significant history who presented to the hospital on 9/10 with mid back pain and paresthesias and pain shooting down legs and up toward neck and shoulders that started one day PTA. She went to urgent care and was given IM Toradol without relief. She subsequently developed progressive weakness in arms and legs to point that she could not move around in her bed. She then presented to the ED. She did receive a Yellow Fever Vaccine a few weeks ago in early August. No recent illnesses nor travel.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Paraesthesia
Clinical narrative: 22 yr old female with no significant history who presented to the hospital on 9/10 with mid back pain and paresthesias and pain shooting down legs and up toward neck and shoulders that started one day PTA. She went to urgent care and was given IM Toradol without relief. She subsequently developed progressive weakness in arms and legs to point that she could not move around in her bed. She then presented to the ED. She did receive a Yellow Fever Vaccine a few weeks ago in early August. No recent illnesses nor travel.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain, Abdominal pain upper, Erythema, Fatigue, Headache
Clinical narrative: Redness and serious swelling of arm muscle; headache, fatigue, muscle aches and pain, fever, stomach pain, abdominal pain
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Muscle swelling, Myalgia, Pyrexia
Clinical narrative: Redness and serious swelling of arm muscle; headache, fatigue, muscle aches and pain, fever, stomach pain, abdominal pain
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Erythema, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: itchy rash on both legs, thigh down to knees with redness and swelling.  RX cetirizine 1mg/ml oral solution, take 2.5 ml PO every day. monitor patient for anaphylaxis,  hives or angiodema and other symptoms.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Flu shot administered on 12/16/24. Soreness at the left shoulder with static positions and motions beginning the day following with progressive worsening over the subsequent 7-10 days. Swelling with pain and soreness eventually developed in forearm to wrist area as shoulder began to gradually improve. Currently beginning to gradually dissipate from forearm and wrist area.