chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: received standard dose influenza vaccine which was the fluzone qivinstead of the high dose formulation with no reported adverse event; Initial information received on 05-Dec-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves a 85 years old male patient who received standard dose influenza vaccine which was the fluzone qiv instead of the influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] high dose formulation with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Dec-2023, the patient received (strength- 0.7 ml) and 0.7 ml dose of suspect influenza quadrival a-b high dose hv vaccine (lot- U8162EA and expiration date- 30-Jun-2024) via intramuscular route in the right arm (formulation: not provided) for Immunisation (incorrect dose administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 84.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event
Clinical narrative: patient received standard dose of FLUZONE QIV with no reported adverse event; Initial information received on 05-Dec-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 84 years old female patient who received standard dose of Influenza Quadrival A-B multidose vaccine preserved [Fluzone] instead of Influenza Quadrival A-B High dose HV vaccine [Fluzone High-dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Oct-2023, the patient received an unknown dose of suspect Influenza Quadrival A-B Multidose vaccine preserved Suspension for injection (strength, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization). Information on the batch number was requested.  On 02-Dec-2023, the patient received 0.7 ml dose of suspect Influenza Quadrival A-B High Dose HV vaccine of lot U8162EA and expiry: 30-Jun-2024 via intramuscular route in left arm for immunization.  On 24-Oct-2023, the patient received standard dose of Influenza Quadrival A-B multidose vaccine preserved with no reported adverse event (wrong product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA381364:01866753
Age: 1.25
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 15-month old patient was accidently administered the ADACEL with no reported adverse event; Initial information was received on 05-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 15-month old patient was accidently administered the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, 15 months old patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, suspension for injection (lot U7928AA and expiry 23-Nov-25) (product administered to patient of inappropriate age, latency same day) (dose, strength: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient had been administered with a double dose of fluzone high dose with no reported adverse event; Initial information received on 05-Dec-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 84-year-old male patient who had been administered with a double dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), and family history were not provided.  concomitant: No other vaccines.  On an unknown date Oct-2023, the patient received 0.7 mL first dose and then on 05-Dec-2023, the patient received the extra 0.7 mL second dose of suspect influenza quadrival A-B high dose HV vaccine (Strength: High Dose) (formulation, lot number, expiry date: unknown) via intramuscular route in unknown administration site for immunization; patient had been administered with a double dose with no reported adverse event (extra dose administered) (same day latency).   Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: product was given to a 4-month-old child with no reported adverse event; Initial information received on 05-Dec-2023 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 4 months old patient who received Influenza Quadrival A-B Vaccine [Fluzone Qiv], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine, suspension for injection (strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.  On an unknown date the 4-month-old child patient received Influenza Quadrival A-B Vaccine, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data reported.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Blood test, Computerised tomogram, Diabetic neuropathy, Headache, IIIrd nerve paralysis
Clinical narrative: Patient was diagnosed after 2 urgent care visits and 1 ER visit over the course of 1 week.  Persistent headache with eyes both not tracking the same. ER visit was 12-10-23 prescribed Prochloperizine and Hydrocodone. Picked up meds on 12-11-23 and notified about adverse reaction. Official diagnosis is diabetic cranial third nerve palsy
Age: 65.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Magnetic resonance imaging
Clinical narrative: Patient was diagnosed after 2 urgent care visits and 1 ER visit over the course of 1 week.  Persistent headache with eyes both not tracking the same. ER visit was 12-10-23 prescribed Prochloperizine and Hydrocodone. Picked up meds on 12-11-23 and notified about adverse reaction. Official diagnosis is diabetic cranial third nerve palsy
Age: 76.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Heart rate increased, Pain, Pain in extremity
Clinical narrative: Patient stated that her left arm (where COVID-19 Comirnaty 23-24 dose) was administered was severely sore and hurt upon exertion. Patient also stated that her heart rate was elevated at 110 BPM checked by her home health nurse.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Limb discomfort, Peripheral swelling
Clinical narrative: Vaccinated arm became swollen leading to discomfort, making it difficult for her to move her arm.   She saw a physician to evaluate and was only instructed to keep her arm elevated.  Adverse reaction resolved after about 1 week.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Pain
Clinical narrative: Patient came in to the pharmacy on 12/11/23 reporting a mild pain when not moving arm and moderate pain with movement  13 days after receiving his vaccination. No swelling, no fever, and patient feels well otherwise. Patient did not try any OTC treatments for the pain. Reported this pain to his PCP and will follow up with patient in a few days.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: Fatigue, headache, lightheaded,  fever, achy joints, sore/hot arm
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Fatigue, headache, lightheaded,  fever, achy joints, sore/hot arm
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Patient received flu shot on 12/7 and a second flu vaccine on 12/9. Reported symptoms of muscle pain, fatigue, headache, fever which resolved by 12/11/23
Age: 1.58
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Alopecia, Decreased appetite, Dyspnoea, Irritability
Clinical narrative: Pt received influenza and Hep A vaccines. She became unusually fussy. Within a couple of days she developed alopecia and now (6 days later) has significant areas of alopecia (hair loss of scalp)  No singes of infection, ringworm, trauma, or it being rubbed or pulled out.  No fever, No vomiting or diarrhea. No cough. "Breathing heavy" sometimes. Decreased appetite
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diagnostic aspiration, Facial paralysis, Hodgkin's disease, Horner's syndrome, Injection site reaction
Clinical narrative: A short time after the Covid booster in March 2022, my lymph nodes near and around the injection site started to swell, got disturbingly large, and never returned to normal (they would reduce in size then swell up again, and the swelling started to migrate over to my left side).    In September 2023 my heart began to race uncontrollably and I was admitted to the emergency room where it was discovered that a 10 cm mass caused by stage 4 Hodgkin's Lymphoma was pressing up against my Superior Vena Cava. Additionally, my left eye began to droop along with my left pupil being a lot more 'closed' than the right (Horner's Syndrome) due to the mass pressing up against the related nerve.  This was one continuous process almost certainly triggered by the Covid booster.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lymphadenopathy, Mass, Palpitations, Superior vena cava syndrome
Clinical narrative: A short time after the Covid booster in March 2022, my lymph nodes near and around the injection site started to swell, got disturbingly large, and never returned to normal (they would reduce in size then swell up again, and the swelling started to migrate over to my left side).    In September 2023 my heart began to race uncontrollably and I was admitted to the emergency room where it was discovered that a 10 cm mass caused by stage 4 Hodgkin's Lymphoma was pressing up against my Superior Vena Cava. Additionally, my left eye began to droop along with my left pupil being a lot more 'closed' than the right (Horner's Syndrome) due to the mass pressing up against the related nerve.  This was one continuous process almost certainly triggered by the Covid booster.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: A short time after the Covid booster in March 2022, my lymph nodes near and around the injection site started to swell, got disturbingly large, and never returned to normal (they would reduce in size then swell up again, and the swelling started to migrate over to my left side).    In September 2023 my heart began to race uncontrollably and I was admitted to the emergency room where it was discovered that a 10 cm mass caused by stage 4 Hodgkin's Lymphoma was pressing up against my Superior Vena Cava. Additionally, my left eye began to droop along with my left pupil being a lot more 'closed' than the right (Horner's Syndrome) due to the mass pressing up against the related nerve.  This was one continuous process almost certainly triggered by the Covid booster.
Age: 69.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Asthenia, Back pain, Blood glucose normal, Dizziness, Feeling abnormal
Clinical narrative: 1035 vaccines given 1040 Patient started complaining of leg weakness, back hurting, states feels weak Patient walked to couch and laid down. Then sat up and stood up and sit in a chair. Stated feels jittery. Peanut Butter given to patient. Walked with walker back to kitchen and sat in chair. States feels worse 1058= BP 110/70, 78. 99%, BG 160 1104 BP 108/70, 99% O2 sat, lungs clear. No difficulty breathing. Only c/o weakness. Feels like passing out. Patient awake alert and oriented x3. No LOC during visit. Patient walked to stretcher outside of home and was taken to ER.
Age: 69.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Feeling jittery, Muscular weakness
Clinical narrative: 1035 vaccines given 1040 Patient started complaining of leg weakness, back hurting, states feels weak Patient walked to couch and laid down. Then sat up and stood up and sit in a chair. Stated feels jittery. Peanut Butter given to patient. Walked with walker back to kitchen and sat in chair. States feels worse 1058= BP 110/70, 78. 99%, BG 160 1104 BP 108/70, 99% O2 sat, lungs clear. No difficulty breathing. Only c/o weakness. Feels like passing out. Patient awake alert and oriented x3. No LOC during visit. Patient walked to stretcher outside of home and was taken to ER.
Age: 66.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Angiogram cerebral, Arteriogram carotid, Coagulation factor, Computerised tomogram head abnormal, Electrocardiogram
Clinical narrative: Patient transfere by ambulance after having a stroke, CT scan showed (R) parietal stroke, thrombolitic therapy started and patient developed intracranial bleed, had to be intubated and transfered to neuro ICU. CT showed left thalamic intraparenchymal hemorrhage and some intraventricular hemorrhage. Patient was moved to inhospital physical therapy on Oct. 24 with prominent right side weakness of arm and leg, right facial numbness. Patient discharged from hospital on Nov. 14th, still with right side weakness to continue PT and OT at home.
Age: 66.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Endotracheal intubation, Haemorrhage intracranial, Hemiparesis, Hypoaesthesia, Intensive care
Clinical narrative: Patient transfere by ambulance after having a stroke, CT scan showed (R) parietal stroke, thrombolitic therapy started and patient developed intracranial bleed, had to be intubated and transfered to neuro ICU. CT showed left thalamic intraparenchymal hemorrhage and some intraventricular hemorrhage. Patient was moved to inhospital physical therapy on Oct. 24 with prominent right side weakness of arm and leg, right facial numbness. Patient discharged from hospital on Nov. 14th, still with right side weakness to continue PT and OT at home.
Age: 66.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Intraventricular haemorrhage, Parietal lobe stroke, Thalamus haemorrhage, Transfusion
Clinical narrative: Patient transfere by ambulance after having a stroke, CT scan showed (R) parietal stroke, thrombolitic therapy started and patient developed intracranial bleed, had to be intubated and transfered to neuro ICU. CT showed left thalamic intraparenchymal hemorrhage and some intraventricular hemorrhage. Patient was moved to inhospital physical therapy on Oct. 24 with prominent right side weakness of arm and leg, right facial numbness. Patient discharged from hospital on Nov. 14th, still with right side weakness to continue PT and OT at home.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Brain scan normal, Cardiac stress test normal, Chest X-ray normal, Depressed mood, Head titubation
Clinical narrative: Body tremors on awakening from sleep. Upper abdomen and upper arms then 3 weeks later including my head. At first, only when waking in the morning, then gradually lasting from 30 minutes to 3 hours. Then they began when tired or falling asleep. At times, once or twice weekly, they would come and go all day. Included feeling of deep depression. Now, 2/12 months later, symptoms are getting lighter. Hoping they will go away.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Magnetic resonance imaging normal, Nervousness, Tremor
Clinical narrative: Body tremors on awakening from sleep. Upper abdomen and upper arms then 3 weeks later including my head. At first, only when waking in the morning, then gradually lasting from 30 minutes to 3 hours. Then they began when tired or falling asleep. At times, once or twice weekly, they would come and go all day. Included feeling of deep depression. Now, 2/12 months later, symptoms are getting lighter. Hoping they will go away.
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that had been sitting at room temperature for 5.5 days.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Epistaxis, Injection site nodule, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Starting 12/7 at 10am my arm began itching. On 12/8 my arm was itching, there was a knot at the injection site, and I began to feel congested- later that evening around 5pm, I began to have a nosebleed. On 12/9 I had itching/swelling at injection site plus more congestion. 12/10 I was the same as 12/9. 12/11, I have been congested, nosebleed, small knot and itching at injection site.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory tract congestion
Clinical narrative: Starting 12/7 at 10am my arm began itching. On 12/8 my arm was itching, there was a knot at the injection site, and I began to feel congested- later that evening around 5pm, I began to have a nosebleed. On 12/9 I had itching/swelling at injection site plus more congestion. 12/10 I was the same as 12/9. 12/11, I have been congested, nosebleed, small knot and itching at injection site.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient given the 12 and older vaccine, no adverse outcomes noted
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient given the 12 and older vaccine, no adverse outcomes noted
Age: 60.0
Sex: F
Vaccine: COVID19, FLUR4, COVID19, FLU4, RSV
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: No idea on manufacturer as no paperwork or info was given. Pharmacist was obviously having a bad day, seemed rushed and complained about being short staffed. I received one shot in my left arm ( the RSV) and two in my right, the flu and covid. I am left handed. I do recall one bandage per arm. Some tenderness, which was to be expected, but lingering pain, discomfort and pain with movement of right arm ( hard to take clothes on and off, pain wakes me at night when I move my arm a certain way). Tried Tylenol, heat, various balms etc. Still hurts and limited movement after two months plus.
Age: 60.0
Sex: F
Vaccine: COVID19, FLUR4, COVID19, FLU4, RSV
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: No idea on manufacturer as no paperwork or info was given. Pharmacist was obviously having a bad day, seemed rushed and complained about being short staffed. I received one shot in my left arm ( the RSV) and two in my right, the flu and covid. I am left handed. I do recall one bandage per arm. Some tenderness, which was to be expected, but lingering pain, discomfort and pain with movement of right arm ( hard to take clothes on and off, pain wakes me at night when I move my arm a certain way). Tried Tylenol, heat, various balms etc. Still hurts and limited movement after two months plus.
Age: 60.0
Sex: F
Vaccine: COVID19, FLUR4, COVID19, FLU4, RSV
Symptoms: Tenderness
Clinical narrative: No idea on manufacturer as no paperwork or info was given. Pharmacist was obviously having a bad day, seemed rushed and complained about being short staffed. I received one shot in my left arm ( the RSV) and two in my right, the flu and covid. I am left handed. I do recall one bandage per arm. Some tenderness, which was to be expected, but lingering pain, discomfort and pain with movement of right arm ( hard to take clothes on and off, pain wakes me at night when I move my arm a certain way). Tried Tylenol, heat, various balms etc. Still hurts and limited movement after two months plus.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: There were no side effects, adverse outcomes, or unexpected reactions experienced by the patient; A HBP called to report a TE for PEDVAX HIB (Lot #W032686; expiration 06/12/2025) that had been administered.  The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excursions and an evaluation ou; This spontaneous report was received from an office manager and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-NOV-2023, the patient was vaccinated with an improperly storage Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter/once, lot #W032686, expiration date: 12-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). The temperature excursion (TE) details were a low temperature of 33.15 F for 1 hour and 8 minutes (on 18-NOV-2023) with zero previous excursions and an evaluation outcome that was supported.  There were no side effects, adverse outcomes, or unexpected reactions experienced by the patient (No adverse event).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid; Vaccine did not work; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid) and VACCINATION FAILURE (Vaccine did not work) in a 45-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3834B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced COVID-19 (Covid) and VACCINATION FAILURE (Vaccine did not work). At the time of the report, COVID-19 (Covid) and VACCINATION FAILURE (Vaccine did not work) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.   Company Comment: This is a spontaneous case concerning a 45-year-old, female patient with no reported medical history, who experienced the non-serious unexpected events of COVID 19 and vaccination failure. The events occurred on an unknown date, after a dose of SPIKEVAX 2023-2024 (onset date and dose number were not reported, hence, latency could not be calculated). Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the events was not provided. The event Vaccination failure was considered unrelated to the vaccine with the information provided at this time because onset date of COVID-19 and details on vaccination schedule were not provided. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Feeling abnormal, Paranoia, Vertigo
Clinical narrative: patient was paranoid or something like that; dizziness / light head; things got fuzzy for the next few days; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 75-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 20Nov2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for pneumococcal immunisation; for pneumococcal immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 20Nov2023, outcome "not recovered", described as "things got fuzzy for the next few days"; DIZZINESS (non-serious) with onset 21Nov2023, outcome "not recovered", described as "dizziness / light head"; PARANOIA (non-serious), outcome "unknown", described as "patient was paranoid or something like that". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient got vaccine on 20Nov2023, and got home okay. Then room started spinning around, things got fuzzy for the next few days. Woke up the next morning and was really lightheaded, and then every single day lightheadedness got a little better. Was really lightheaded, half of brain was feeling like air, was really odd. She states had dizziness after vaccine and then light head, states having this symptom for an entire week. It was now a week later and still has a little bit of lightheadedness in back of head, every day has gotten less and less. Patient stated it seems like with vaccines hardly anyone gets side effects, so she stated maybe she had this same vaccine ages ago and maybe did not remember, as if someone who has had a double dose, concerned. A week later every day gets less lightheaded, feels like top of brain to back was lightened. Asking does this sometimes happen to people. Patient stated maybe she was paranoid or something like that. Stated most people do not get a reaction. Causality: Lightheadedness: Yes, stating caller was totally healthy when caller went to doctor. She stated she was perfectly healthy and does not take medications. Time the Vaccination Was Given: Probably around 10:30AM or 10:45AM. No Emergency room or physician office visited. None family medical history relevant to AE. For Lightheadedness: Seriousness: First started with whole head getting really lightheaded, every day got a little better, but today can still feel lightheaded at top of head, when started it gradually moved up and today was still present in background, still bothersome.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: significant headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "patent foramen ovale" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "significant headaches".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300441514 same patient, different events after different doses of the vaccine;
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Angioedema, Post-acute COVID-19 syndrome, Urticaria
Clinical narrative: angiodema; long covid; hives; This spontaneous case was reported by a patient and describes the occurrence of ANGIOEDEMA (angiodema) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    Concurrent medical conditions included Autoimmune disorder (Autoimmune issues), Hashimoto's thyroiditis and Celiac disease.   On 21-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) .5 milliliter and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On 22-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POST-ACUTE COVID-19 SYNDROME (long covid) and URTICARIA (hives). On an unknown date, the patient experienced ANGIOEDEMA (angiodema) (seriousness criterion medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency and EPINEPHRINE at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (angiodema), POST-ACUTE COVID-19 SYNDROME (long covid) and URTICARIA (hives) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Lab data/results were reported as doctor diagnoses was vaccine induced long covid.  Treatment medications also included steroid inhalers, epinephrine at ER, antihistamines. Company Comment: This is a spontaneous case concerning a 60-year-old female patient with a history of Autoimmune disorder, Hashimoto's thyroiditis and Celiac disease, who experienced the serious (due to medically significant) unexpected event of Angioedema, which occurred on an unknown date after a dose of mRNA-1273 Bivalent .222 original and omicron BA.4/BA.5 vaccine. It was reported that treatment medications included steroid inhalers, epinephrine at ER, antihistamines. The outcome of the event was reported as not recovered. Patient´s medical history could be a contributing factor for the event. Influenza vaccine was considered as a co-suspect drug since it was administered on the same day of mRNA-1273 Bivalent .222. The benefit-risk relationship of mRNA-1273 Bivalent .222 original and omicron BA.4/BA.5 vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Musculoskeletal pain
Clinical narrative: Generalized skeletomuscular pain, fatigue, headache for 48 hrs; redness and swelling of left upper arm, progressively worse, persisting even now (4 days) since vaccination.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Administered outside of approved indication; This non-serious prospective pregnancy case was reported by a consumer and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Administered outside of approved indication). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 32 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 02-DEC-2023 The reporter stated that pregnant female patient received Arexvy vaccine. The patient was yet to be informed. This case had been linked with US2023AMR169831, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR169831:same reporter
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chronic kidney disease, Chronic obstructive pulmonary disease
Clinical narrative: Hospitalization for COVID-19 viral infection/pneumonia with acute hypoxic failure, COPD with mild exacerbation, type two diabetes, hypertension, hyperlipidemia, seizure disorder, CKD, chronic pain with pain pump, GERD, generalized anxiety order on dates 11/10/2023- 11/22/2023.  Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Gastrooesophageal reflux disease, Generalised anxiety disorder, Hyperlipidaemia, Hypertension
Clinical narrative: Hospitalization for COVID-19 viral infection/pneumonia with acute hypoxic failure, COPD with mild exacerbation, type two diabetes, hypertension, hyperlipidemia, seizure disorder, CKD, chronic pain with pain pump, GERD, generalized anxiety order on dates 11/10/2023- 11/22/2023.  Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Seizure, Type 2 diabetes mellitus
Clinical narrative: Hospitalization for COVID-19 viral infection/pneumonia with acute hypoxic failure, COPD with mild exacerbation, type two diabetes, hypertension, hyperlipidemia, seizure disorder, CKD, chronic pain with pain pump, GERD, generalized anxiety order on dates 11/10/2023- 11/22/2023.  Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient came to clinic to receive Twinrix vaccine but Boostrix vaccine was administered in error. No treatment required. Patient to return to clinic to receive Twinrix.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Gastritis, Hyponatraemia, Nausea
Clinical narrative: Hospitalization for Nausea/vomiting due to gastritis or COVID-19 infection, hyponatremia, acute hypoxemic respiratory failure  on dates 11/11/2023- 11/13/2023. Treated with dexamethasone.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Hospitalization for Nausea/vomiting due to gastritis or COVID-19 infection, hyponatremia, acute hypoxemic respiratory failure  on dates 11/11/2023- 11/13/2023. Treated with dexamethasone.
Age: 48.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Fatigue, Listless, Nausea, Pain, Pyrexia
Clinical narrative: tired, listless, nausea, vomiting, achy, slight fever,
Age: 48.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Vomiting
Clinical narrative: tired, listless, nausea, vomiting, achy, slight fever,
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19
Clinical narrative: Hospitalization for acute hypoxic respiratory failure, COVID-19 on dates 11/13/2023- 11/17/2023.  Treated with dexamethasone, Remdesivir, zinc 50 mg PO daily.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Biopsy skin, Blood cholesterol, Blood folate, Chills
Clinical narrative: moderna vaccine- fever/severe chills within 24 hours.  Next day- fulminant rash starting on abdomen-- has been now persistent for over 2.5 months.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Metabolic function test, Pyrexia, Rash, Vitamin B12
Clinical narrative: moderna vaccine- fever/severe chills within 24 hours.  Next day- fulminant rash starting on abdomen-- has been now persistent for over 2.5 months.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D
Clinical narrative: moderna vaccine- fever/severe chills within 24 hours.  Next day- fulminant rash starting on abdomen-- has been now persistent for over 2.5 months.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: itchy at the injection site.  Still a bit sore.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Hyponatraemia, Liver function test increased, Thrombocytopenia
Clinical narrative: Hospitalization for COVID-19 acute hypoxic respiratory failure, hyponatremia, thrombocytopenia, elevated LFT, alcohol use on dates 11/14/2023- 11/16/2023. Treated with dexamethasone, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 1.58
Sex: M
Vaccine: DTPPVHBHPB, HEPA
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: Patient was given an adult Hep A Vaqta vaccine instead of the pediatric. Per report of mother the only problem he experienced was his legs were sore for a few days.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Fatigue, Hyponatraemia, Metabolic encephalopathy
Clinical narrative: Hospitalization for COVID-19 viral infection, fatigue, hyponatremia, metabolic encephalopathy, urinary tract infection, Atrial fibrillation on dates 11/14/2023- 11/19/2023.  Treated with no COVID-19 related medications.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Hospitalization for COVID-19 viral infection, fatigue, hyponatremia, metabolic encephalopathy, urinary tract infection, Atrial fibrillation on dates 11/14/2023- 11/19/2023.  Treated with no COVID-19 related medications.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood creatinine increased, Blood lactic acid, Blood urea increased, COVID-19
Clinical narrative: Patient presented to the ER with progressive acute shortness of breath. Patient o2 sat was 57% on room air in the ED. Initial labs revealed a white count of 2000, hemoglobin of 7.6 and hematocrit of 22, and BUN creatinine of 43 and 1.9 with out any previous labs to compare with.  Lactate was 2.4.  COVID-19 NAAT was positive.  Chest x-ray is significant for dense confluent bilateral lung infiltrates consistent with acute pneumonia. Patient diagnosed with covid pneumonia and acute hypoxemic respiratory failure. Patient received Decadron, Remdesivir, IV abx. Patient was initially placed on high-flow nasal cannula and non-rebreather but required intubation. Patient developed worsening renal function and family chose to transition to comfort care. Life support was withdrawn and patient passed away on 2.8.22.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray abnormal, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: Patient presented to the ER with progressive acute shortness of breath. Patient o2 sat was 57% on room air in the ED. Initial labs revealed a white count of 2000, hemoglobin of 7.6 and hematocrit of 22, and BUN creatinine of 43 and 1.9 with out any previous labs to compare with.  Lactate was 2.4.  COVID-19 NAAT was positive.  Chest x-ray is significant for dense confluent bilateral lung infiltrates consistent with acute pneumonia. Patient diagnosed with covid pneumonia and acute hypoxemic respiratory failure. Patient received Decadron, Remdesivir, IV abx. Patient was initially placed on high-flow nasal cannula and non-rebreather but required intubation. Patient developed worsening renal function and family chose to transition to comfort care. Life support was withdrawn and patient passed away on 2.8.22.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Lung infiltration, Pneumonia, Renal impairment
Clinical narrative: Patient presented to the ER with progressive acute shortness of breath. Patient o2 sat was 57% on room air in the ED. Initial labs revealed a white count of 2000, hemoglobin of 7.6 and hematocrit of 22, and BUN creatinine of 43 and 1.9 with out any previous labs to compare with.  Lactate was 2.4.  COVID-19 NAAT was positive.  Chest x-ray is significant for dense confluent bilateral lung infiltrates consistent with acute pneumonia. Patient diagnosed with covid pneumonia and acute hypoxemic respiratory failure. Patient received Decadron, Remdesivir, IV abx. Patient was initially placed on high-flow nasal cannula and non-rebreather but required intubation. Patient developed worsening renal function and family chose to transition to comfort care. Life support was withdrawn and patient passed away on 2.8.22.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, White blood cell count decreased, Withdrawal of life support
Clinical narrative: Patient presented to the ER with progressive acute shortness of breath. Patient o2 sat was 57% on room air in the ED. Initial labs revealed a white count of 2000, hemoglobin of 7.6 and hematocrit of 22, and BUN creatinine of 43 and 1.9 with out any previous labs to compare with.  Lactate was 2.4.  COVID-19 NAAT was positive.  Chest x-ray is significant for dense confluent bilateral lung infiltrates consistent with acute pneumonia. Patient diagnosed with covid pneumonia and acute hypoxemic respiratory failure. Patient received Decadron, Remdesivir, IV abx. Patient was initially placed on high-flow nasal cannula and non-rebreather but required intubation. Patient developed worsening renal function and family chose to transition to comfort care. Life support was withdrawn and patient passed away on 2.8.22.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray abnormal, Clostridium test negative, Death
Clinical narrative: Patient presented to the hospital with reports of worsening mental status, with loss, diarrhea and generalized weakness.  He reportedly has had diarrhea for the past 1 month and had been evaluated by Gastroenterology team.  Clostridium difficile test was reportedly negative.  On evaluation in the emergency room, he tested positive for COVID-19.  Chest x-ray interpreted as follows - Faint residual densities over the lower lungs could represent mild atypical infection. Patient diagnosed with pneumonia due to covid 19. Patient received IV abx and remdesivir. Patient was weaned off oxygen by discharge. Patient was discharged to SNU but was readmitted on 1.28.22 for worsening respiratory status requiring BiPAP on admission. Family opted to transition to comfort care and patient was transferred to inpatient hospice on 2.13.22.  Patient passed away on 2.16.22.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Mental status changes, Pneumonia, Positive airway pressure therapy, Respiratory distress
Clinical narrative: Patient presented to the hospital with reports of worsening mental status, with loss, diarrhea and generalized weakness.  He reportedly has had diarrhea for the past 1 month and had been evaluated by Gastroenterology team.  Clostridium difficile test was reportedly negative.  On evaluation in the emergency room, he tested positive for COVID-19.  Chest x-ray interpreted as follows - Faint residual densities over the lower lungs could represent mild atypical infection. Patient diagnosed with pneumonia due to covid 19. Patient received IV abx and remdesivir. Patient was weaned off oxygen by discharge. Patient was discharged to SNU but was readmitted on 1.28.22 for worsening respiratory status requiring BiPAP on admission. Family opted to transition to comfort care and patient was transferred to inpatient hospice on 2.13.22.  Patient passed away on 2.16.22.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient presented to the hospital with reports of worsening mental status, with loss, diarrhea and generalized weakness.  He reportedly has had diarrhea for the past 1 month and had been evaluated by Gastroenterology team.  Clostridium difficile test was reportedly negative.  On evaluation in the emergency room, he tested positive for COVID-19.  Chest x-ray interpreted as follows - Faint residual densities over the lower lungs could represent mild atypical infection. Patient diagnosed with pneumonia due to covid 19. Patient received IV abx and remdesivir. Patient was weaned off oxygen by discharge. Patient was discharged to SNU but was readmitted on 1.28.22 for worsening respiratory status requiring BiPAP on admission. Family opted to transition to comfort care and patient was transferred to inpatient hospice on 2.13.22.  Patient passed away on 2.16.22.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardiac arrest, Chest discomfort, Chronic obstructive pulmonary disease
Clinical narrative: Patient presented to the ER with complaints of SOB and chest tightness. While in the ER, when patient went to get CT scan, patient had a cardiac arrest. CPR initiated, ROSC achieved in 10 minutes. Patient was admitted on vasopressor support to critical care. Patient was diagnosed with acute hypoxic respiratory failure due to Covid-19 infection, COPD and cardiac arrest. MRI also showed acute small ischemic infarcts. Renal function worsened. Daughter requested inpatient hospice, made patient DNR. Patient was transferred to inpatient hospice on 2.11.22 and patient passed away on 2.12.22.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Death, Dyspnoea, Intensive care, Ischaemic cerebral infarction
Clinical narrative: Patient presented to the ER with complaints of SOB and chest tightness. While in the ER, when patient went to get CT scan, patient had a cardiac arrest. CPR initiated, ROSC achieved in 10 minutes. Patient was admitted on vasopressor support to critical care. Patient was diagnosed with acute hypoxic respiratory failure due to Covid-19 infection, COPD and cardiac arrest. MRI also showed acute small ischemic infarcts. Renal function worsened. Daughter requested inpatient hospice, made patient DNR. Patient was transferred to inpatient hospice on 2.11.22 and patient passed away on 2.12.22.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Renal impairment, Resuscitation
Clinical narrative: Patient presented to the ER with complaints of SOB and chest tightness. While in the ER, when patient went to get CT scan, patient had a cardiac arrest. CPR initiated, ROSC achieved in 10 minutes. Patient was admitted on vasopressor support to critical care. Patient was diagnosed with acute hypoxic respiratory failure due to Covid-19 infection, COPD and cardiac arrest. MRI also showed acute small ischemic infarcts. Renal function worsened. Daughter requested inpatient hospice, made patient DNR. Patient was transferred to inpatient hospice on 2.11.22 and patient passed away on 2.12.22.