chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Vomiting
Clinical narrative: Throwing up; Nauseous; Couldn't walk; Almost fainted; Labyrinthitis; It feels like my ear needs to pop / Pressure in my ear; Anxious; Lost hearing in my right ear; This spontaneous case, initially received on 10-Nov-2024, was reported by a non health professional and concerns an elderly male patient.  At the time of the event the patient had COPD, asthma, emphysema.  Concomitant medication: refer to appropriate report section, in addition to blood pressure medicine, water pill and natural honey.  Administration of company suspect drug(s): On 21-Oct-2024, the patient received Fluad (TIV) for Prevent flu., Dosage: Not reported, Route of administration: Not reported, Site of administration: Not reported, Lot number: Not reported and requested upon follow-up..  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Oct-2024, the patient experienced Lost hearing in my right ear (Medically Significant, outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Almost fainted (outcome: Not recovered / Not resolved), Anxious (outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Labyrinthitis (outcome: Not recovered / Not resolved). Associated symptoms included: Throwing up, Nauseous, Couldn't walk, It feels like my ear needs to pop / Pressure in my ear.  The reporter stated that on 21-Oct-2024, got a flu shot. The next morning, he had lost hearing in his right ear, was throwing up, nauseous, and couldn't walk. His daughter (a nurse practitioner) got him some anti nausea medicine and some dizziness medicine. The patient had seen ear, nose, and throat (ENT) and had a MRI, blood tests, prednisone, amoxicillin, and 2 shots into his ear of prednisone or something. Nothing had changed. After the ear injection, he couldn't swallow for 15 minutes. He almost fainted. It felt like his ear needed to pop. He had had an ear test and they said it was very bad. They said it was labyrinthitis. His physician had heard of other people with this. It was pressure in hi ear. It made him sometimes anxious and it was overwhelming. The ear, nose, and throat said a hearing aid or cochlear implants wouldn't help.  Fluad (TIV) action taken: Not Applicable Treatment medication: Amoxicillin   , Prednisone, unspecified anti nausea medicine and unspecified dizziness medicine.  Reporter's assessment: The reporter provided the seriousness assessment as unknown but did not provide a causality assessment.; Reporter's Comments: Causality: Related for Presyncope, due to plausible temporal association of next day of vaccination and biological plausibility. Unassessable, for deafness unilateral, labyrinthitis, anxiety. The information provided is insufficient to perform a more in-depth analysis (history of concurrent infections, risk factors, lab reports are not available)
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: Office manager in a medical office reported that a patient received expired VARIVAX on 10/23/2024.  No additional AEs were reported. No further information provided.  No PQC.; Office manager in a medical office reported that a patient received expired VARIVAX on 10/23/2024.  No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2024, the patient received expired varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W031811, expiration date: 05-OCT-2024, administered for prophylaxis (strength, dose, and route of administration were not provided) (Expired product administered). Operator of device was health professional. No additional adverse events (AEs) were reported (No adverse event). The action taken was not applicable.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Office manager in a medical office reported that a patient received expired VARIVAX on 10/23/2024.  No additional AEs were reported. No further information provided.  No PQC.; Office manager in a medical office reported that a patient received expired VARIVAX on 10/23/2024.  No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2024, the patient received expired varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W031811, expiration date: 05-OCT-2024, administered for prophylaxis (strength, dose, and route of administration were not provided) (Expired product administered). Operator of device was health professional. No additional adverse events (AEs) were reported (No adverse event). The action taken was not applicable.
Sex: F
Vaccine: COVID19-2, COVID19, FLUX
Symptoms: Fall, Haemorrhagic stroke, Ischaemic stroke
Clinical narrative: Ischemic hemorrhagic stroke with bleed; Ischemic hemorrhagic stroke with bleed; This is a spontaneous report received from a Consumer or other non HCP.  A female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Sep2024 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 23Sep2024 as dose number unknown, single), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ISCHAEMIC STROKE (hospitalization, medically significant), HAEMORRHAGIC STROKE (hospitalization, medically significant), outcome "unknown" and all described as "Ischemic hemorrhagic stroke with bleed". The patient was hospitalized for ischaemic stroke, haemorrhagic stroke (start date: 01Oct2024, discharge date: 03Oct2024, hospitalization duration: 3 days). Clinical course: on 23Sep2024, the patient had a flu and covid-19 shot on the same day and same arm. Two nights later, the patient fell on the floor (missed the bed by five feet). The patient stated that she wrote on a medical portal to her doctor on 01Oct2024 (as reported). The doctor was not in, therefore, a nurse said to call an ambulance to go to the hospital. The hospital ordered a helicopter to the medical hospital. The patient was released on 03Oct2024. The patient was diagnosed with an ischemic hemorrhagic stroke with bleed.    The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19-2, COVID19, FLUX
Symptoms: Haemorrhagic stroke, Ischaemic stroke
Clinical narrative: Ischemic hemorrhagic stroke with bleed; Ischemic hemorrhagic stroke with bleed; This is a spontaneous report received from a Consumer or other non HCP.  A female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Sep2024 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 23Sep2024 as dose number unknown, single), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ISCHAEMIC STROKE (hospitalization, medically significant), HAEMORRHAGIC STROKE (hospitalization, medically significant), outcome "unknown" and all described as "Ischemic hemorrhagic stroke with bleed". The patient was hospitalized for ischaemic stroke, haemorrhagic stroke (start date: 01Oct2024, discharge date: 03Oct2024, hospitalization duration: 3 days). Clinical course: on 23Sep2024, the patient had a flu and covid-19 shot on the same day and same arm. Two nights later, the patient fell on the floor (missed the bed by five feet). The patient stated that she wrote on a medical portal to her doctor on 01Oct2024 (as reported). The doctor was not in, therefore, a nurse said to call an ambulance to go to the hospital. The hospital ordered a helicopter to the medical hospital. The patient was released on 03Oct2024. The patient was diagnosed with an ischemic hemorrhagic stroke with bleed.    The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: HCP reported patient missed doses of the GARDASIL 9 series.  The patient only received one dose at the age of 14. Patient is now 22 years old.; No symptoms reported./No additional AE; This spontaneous report has been received from a physician and refers to a 22-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On an unknown date (at the age of 14 years old), the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter, as prophylaxis (route of administration, anatomical location and expiration date were not provided). At the reporting, the patient had missed doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) series (product dose omission). No symptoms or additional adverse events reported.  Lot number is being requested and will be submitted if received.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: his daughter received his 2nd dose of Hep A vaccine (VAQTA) 5-9 days earlier than 6 months after 1st dose of Hep A vaccine (HAVRIX)./ he was informed by his daughter's doctor that they dose was given early.; Caller stated his daughter had not had any symptoms and is "now 4 years old and perfectly healthy".; This spontaneous report has been received from the father of a 4-year-old female patient. Her pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On an unknown date (also reported as "a couple of years back"), the patient was vaccinated with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection as prophylaxis (dose, route of administration, anatomical location and expiration date were not provided) 5-9 days earlier than 6 months after the first dose of Hepatitis A Vaccine Inact (HAVRIX) (dose, route of administration, anatomical location, indication, batch number and expiration date were not provided) (product administered to patient of inappropriate age). The patient had not had any symptoms and at the reporting time was perfectly healthy.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; patient received post expiry dose of PROQUAD.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported.  On 29-APR-2024, the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot number reported as: W034210 that has been verified to be valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, expiration date: 24-APR-2024, administered as prophylaxis (strength, dose, frequency, route of administration and anatomical injection site were not provided) administered for prophylaxis (expired product administered). No additional adverse event reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: have sore arms and arms sore to touch; 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "have sore arms and arms sore to touch".  Additional information: The patient would like to know if it was normal to have sore arms and arms sore to touch after getting the Comirnaty vaccine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gait inability, Hyperhidrosis, Nausea
Clinical narrative: dry heaved; chills; sweats; dizziness; extreme injection site pain; nausea; unable to walk to the bathroom unattended; vomited; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Nov2024 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Scleroderma" (unspecified if ongoing); "lung cancer survivor" (not ongoing); "Gluten allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 12Nov2024 at 01:00, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 12Nov2024 at 01:00, outcome "unknown", described as "extreme injection site pain"; NAUSEA (non-serious) with onset 12Nov2024 at 01:00, outcome "unknown"; GAIT INABILITY (non-serious) with onset 12Nov2024 at 01:00, outcome "unknown", described as "unable to walk to the bathroom unattended"; VOMITING (non-serious) with onset 12Nov2024 at 01:00, outcome "unknown", described as "vomited"; CHILLS (non-serious) with onset 13Nov2024, outcome "unknown"; RETCHING (non-serious) with onset 13Nov2024, outcome "recovered", described as "dry heaved"; HYPERHIDROSIS (non-serious) with onset 13Nov2024, outcome "unknown", described as "sweats". Therapeutic measures were not taken as a result of dizziness, vaccination site pain, nausea, gait inability, vomiting, retching, chills, hyperhidrosis.  Additional Information: It was reported that 13 hours after vaccine, due to dizziness, extreme injection site pain and nausea the patient was unable to walk to the bathroom unattended. Once returning to bed she vomited several times. Three evening after vaccine the patient vomited and dry heaved for 2.5 hours. The patient was in bed for 11 hours. The patient did not receive any other vaccines on the same date or within 4 weeks prior to the suspect vaccine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Retching, Vaccination site pain, Vomiting
Clinical narrative: dry heaved; chills; sweats; dizziness; extreme injection site pain; nausea; unable to walk to the bathroom unattended; vomited; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Nov2024 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Scleroderma" (unspecified if ongoing); "lung cancer survivor" (not ongoing); "Gluten allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 12Nov2024 at 01:00, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 12Nov2024 at 01:00, outcome "unknown", described as "extreme injection site pain"; NAUSEA (non-serious) with onset 12Nov2024 at 01:00, outcome "unknown"; GAIT INABILITY (non-serious) with onset 12Nov2024 at 01:00, outcome "unknown", described as "unable to walk to the bathroom unattended"; VOMITING (non-serious) with onset 12Nov2024 at 01:00, outcome "unknown", described as "vomited"; CHILLS (non-serious) with onset 13Nov2024, outcome "unknown"; RETCHING (non-serious) with onset 13Nov2024, outcome "recovered", described as "dry heaved"; HYPERHIDROSIS (non-serious) with onset 13Nov2024, outcome "unknown", described as "sweats". Therapeutic measures were not taken as a result of dizziness, vaccination site pain, nausea, gait inability, vomiting, retching, chills, hyperhidrosis.  Additional Information: It was reported that 13 hours after vaccine, due to dizziness, extreme injection site pain and nausea the patient was unable to walk to the bathroom unattended. Once returning to bed she vomited several times. Three evening after vaccine the patient vomited and dry heaved for 2.5 hours. The patient was in bed for 11 hours. The patient did not receive any other vaccines on the same date or within 4 weeks prior to the suspect vaccine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: got heart conditions; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "got heart conditions".  Additional information: The reporter stated that her brother got heart conditions, after one shot.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Neck pain
Clinical narrative: horrible pain in the neck; started feeling a little weird; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 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: NECK PAIN (non-serious) with onset 2024, outcome "not recovered", described as "horrible pain in the neck"; FEELING ABNORMAL (non-serious) with onset 2024, outcome "unknown", described as "started feeling a little weird".  Additional information: The patient stated that she got the Covid vaccine around noon time and started feeling a little weird after and started getting horrible pain in the neck and still has it. She wants to know is this going to go away and she was in a lot of pain.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Had a fever and fatigue for about 24 hours; Had a fever and fatigue for about 24 hours; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 47-year-old female patient (not pregnant) 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: PYREXIA (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "Had a fever and fatigue for about 24 hours".
Age: 44.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal discomfort, Fatigue, Headache, Vaccination site pain
Clinical narrative: Muscle at site of the injection is sore and tender; Stomach upset; fatigue; headache; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 14Nov2024 at 09:00 as dose 1, single (Lot number: LM2210) at the age of 44 years, in right deltoid for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 14Nov2024 (Lot number: 388527), in left arm. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Nocturnal Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVOTHYROXINE; LAMICTAL; GLUCOSAMINE & CHONDORITIN; NAPROXEN SODIUM. Past drug history included: Sulfa drugs, reaction(s): "allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Nov2024 at 16:00, outcome "recovering", described as "Muscle at site of the injection is sore and tender"; ABDOMINAL DISCOMFORT (non-serious) with onset 14Nov2024 at 16:00, outcome "recovering", described as "Stomach upset"; FATIGUE (non-serious) with onset 14Nov2024 at 16:00, outcome "recovering"; HEADACHE (non-serious) with onset 14Nov2024 at 16:00, outcome "recovering". Therapeutic measures were not taken as a result of vaccination site pain, abdominal discomfort, fatigue, headache.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain in extremity
Clinical narrative: lots of pain in hands and feet; flu like symptoms; Chills; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 2024US007508.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; abaloparatide (TYMLOS), since Sep2024 (ongoing)) at 80 ug daily, subcutaneous for osteoporosis; influenza vaccine (INFLUENZA), in 2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "age-related osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2024, outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2024, outcome "unknown", described as "flu like symptoms"; PAIN IN EXTREMITY (non-serious) with onset 2024, outcome "unknown", described as "lots of pain in hands and feet". The action taken for abaloparatide was dosage not changed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Patient got new covid-19 shot and it made sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: ILLNESS (non-serious), outcome "unknown", described as "Patient got new covid-19 shot and it made sick".  Additional information: Patient got new covid-19 shot at local pharmacy and it made me sick. why do you make drugs to almost kill people.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13 years old patient received fluzone HD with no reported adverse event; Initial information received on 12-Nov-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to US-SA-2024SA334730 and US-SA-2024SA334813.  This case involves 13 years old female patient who received influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone HD] 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 USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot U8429CA, expiry date- 30-Jun-2025) (unknown strength) via unknown route in unknown administration site for Influenza immunization, with no reported adverse event (product administered to patient of inappropriate age) (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-2024SA334730:02302471 (Patient 2) US-SA-2024SA334813:linked case
Age: 68.0
Sex: M
Vaccine: RSV, UNK, COVID19
Symptoms: Death, Mobility decreased, Pain, Pyrexia
Clinical narrative: patient died 10/21/24  was in bed for 2 days with temperature and aches and pains   then died
Age: 68.0
Sex: M
Vaccine: RSV, UNK, COVID19
Symptoms: Death, Malaise
Clinical narrative: patient died 10/21/24  was in bed for 2 days with temperature and aches and pains   then died
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Full blood count normal, Headache, Mobility decreased, Myalgia, Neck pain
Clinical narrative: Within 3 days of the vaccine, my right arm, neck and head experienced pain and myalgia.  This increased over the period of three weeks u til I was unable to get out of bed easily.  My doctor has prescribed a round of steroid trearment.  This has immediate positive effect.  At the end of the course, I note pain beginning to return.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity
Clinical narrative: Within 3 days of the vaccine, my right arm, neck and head experienced pain and myalgia.  This increased over the period of three weeks u til I was unable to get out of bed easily.  My doctor has prescribed a round of steroid trearment.  This has immediate positive effect.  At the end of the course, I note pain beginning to return.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Injection site discolouration, Injection site swelling, Myalgia
Clinical narrative: You would need to call the pharmacy to get the information about the vaccine given to me. It was for a pneumonia vaccine, and it had the number 21 in the name. They said that it was a new vaccine that just came out. I got it at around 6:00 p.m. on November 18, and by 9:00 a.m. on November 19, the injection side was swollen and pink, and every joint and every muscle in my body was very sore. So far, these side effects are still taking place at 11:30 p.m. on November 20.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: HCP mentioned his spouse experienced myalgia for 24 hrs; This non-serious case was reported by a physician via sales rep and described the occurrence of myalgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced myalgia (Verbatim: HCP mentioned his spouse experienced myalgia for 24 hrs). The outcome of the myalgia was resolved (duration 24 hrs).   The reporter considered the myalgia to be related to Shingrix.     The company considered the myalgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-OCT-2024 The case was reported by patient's spouse. The patient experienced myalgia for 24 hours.
Age: 0.5
Sex: F
Vaccine: COVID19, FLU3, UNK
Symptoms: Extra dose administered
Clinical narrative: Pt received Beyfortis (RSV vaccine) on 11/19/24. Pt had previously received Beyfortis on 11/2/24. None
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Malaise, Pancreatitis, Weight decreased
Clinical narrative: After my 2nd Moderna covid 19 vaccine shot i was very sick in bed for a week. Since then I have lost 60 lbs and been diagnosed to have pancreatitis. Haven't drank alcohol in 40 yrs so that's not the reason for this problem. As my Doctor asked that question. I know other people that this has had happened to.This side effect was never told to me. I would have never signed a release is i knew this before the shot. The cost of drugs that I am taking for this conditions is outrageous. Zenpep,Creon etc.The drug companies are making billions of $$ off the vaccine and now I continue to pay for the fact that there was not enough time put into checking the safety of there drugs. I need help with this financially.
Age: 92.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Death, Dysphagia, Dyspnoea, Endotracheal intubation
Clinical narrative: My 92-year-old mother received the RSV vaccine (Arexvy 120 MCG/0.5ML INJ Glaxo) on 7 February 2024. Twelve days later her fingertips began tingling, she felt weakness around her waist, and she was unable to keep food down. She was admitted to the Emergency Room on 19, 20 and 22 February 2024 before being admitted to the ICU when she became too weak to walk, unable to keep food or liquids down, and experienced difficulty swallowing. By 24 February 2024 she was diagnosed with Guillain-Barre Syndrome. She underwent a 5-day Intravenous Immunoglobulin course of treatment, endured intubation, a tracheostomy, and the installation of a percutaneous endoscopic gatrostomy (feeding tube) in her stomach. Throughout this ordeal she battled persistent secretion formation (phlegm production) that interfered with her breathing, sleep, and ability to speak and this required the use of a ventilator for several weeks. Unfortunately, infections around the PEG tube and in her lungs developed and she was transferred to a local hospice on 21 March 2024. She passed away on 3 April 2024. The official cause of death was Guillain-Barre Syndrome. The most likely trigger for the GBS was the RSV vaccine she received on 7 February 2024.
Age: 92.0
Sex: F
Vaccine: RSV
Symptoms: Gait inability, Gastrostomy, Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care
Clinical narrative: My 92-year-old mother received the RSV vaccine (Arexvy 120 MCG/0.5ML INJ Glaxo) on 7 February 2024. Twelve days later her fingertips began tingling, she felt weakness around her waist, and she was unable to keep food down. She was admitted to the Emergency Room on 19, 20 and 22 February 2024 before being admitted to the ICU when she became too weak to walk, unable to keep food or liquids down, and experienced difficulty swallowing. By 24 February 2024 she was diagnosed with Guillain-Barre Syndrome. She underwent a 5-day Intravenous Immunoglobulin course of treatment, endured intubation, a tracheostomy, and the installation of a percutaneous endoscopic gatrostomy (feeding tube) in her stomach. Throughout this ordeal she battled persistent secretion formation (phlegm production) that interfered with her breathing, sleep, and ability to speak and this required the use of a ventilator for several weeks. Unfortunately, infections around the PEG tube and in her lungs developed and she was transferred to a local hospice on 21 March 2024. She passed away on 3 April 2024. The official cause of death was Guillain-Barre Syndrome. The most likely trigger for the GBS was the RSV vaccine she received on 7 February 2024.
Age: 92.0
Sex: F
Vaccine: RSV
Symptoms: Lumbar puncture abnormal, Mechanical ventilation, Medical device site infection, Paraesthesia, Pneumonia
Clinical narrative: My 92-year-old mother received the RSV vaccine (Arexvy 120 MCG/0.5ML INJ Glaxo) on 7 February 2024. Twelve days later her fingertips began tingling, she felt weakness around her waist, and she was unable to keep food down. She was admitted to the Emergency Room on 19, 20 and 22 February 2024 before being admitted to the ICU when she became too weak to walk, unable to keep food or liquids down, and experienced difficulty swallowing. By 24 February 2024 she was diagnosed with Guillain-Barre Syndrome. She underwent a 5-day Intravenous Immunoglobulin course of treatment, endured intubation, a tracheostomy, and the installation of a percutaneous endoscopic gatrostomy (feeding tube) in her stomach. Throughout this ordeal she battled persistent secretion formation (phlegm production) that interfered with her breathing, sleep, and ability to speak and this required the use of a ventilator for several weeks. Unfortunately, infections around the PEG tube and in her lungs developed and she was transferred to a local hospice on 21 March 2024. She passed away on 3 April 2024. The official cause of death was Guillain-Barre Syndrome. The most likely trigger for the GBS was the RSV vaccine she received on 7 February 2024.
Age: 92.0
Sex: F
Vaccine: RSV
Symptoms: Productive cough, Sleep disorder, Speech disorder, Tracheostomy, Vomiting
Clinical narrative: My 92-year-old mother received the RSV vaccine (Arexvy 120 MCG/0.5ML INJ Glaxo) on 7 February 2024. Twelve days later her fingertips began tingling, she felt weakness around her waist, and she was unable to keep food down. She was admitted to the Emergency Room on 19, 20 and 22 February 2024 before being admitted to the ICU when she became too weak to walk, unable to keep food or liquids down, and experienced difficulty swallowing. By 24 February 2024 she was diagnosed with Guillain-Barre Syndrome. She underwent a 5-day Intravenous Immunoglobulin course of treatment, endured intubation, a tracheostomy, and the installation of a percutaneous endoscopic gatrostomy (feeding tube) in her stomach. Throughout this ordeal she battled persistent secretion formation (phlegm production) that interfered with her breathing, sleep, and ability to speak and this required the use of a ventilator for several weeks. Unfortunately, infections around the PEG tube and in her lungs developed and she was transferred to a local hospice on 21 March 2024. She passed away on 3 April 2024. The official cause of death was Guillain-Barre Syndrome. The most likely trigger for the GBS was the RSV vaccine she received on 7 February 2024.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Complication associated with device, Malaise
Clinical narrative: per clinical nurse educator communication: pt's wife reported that patient recently got his covid and flu shots for the season, patient then became ill and also noted his central like was 'bulging' prior to going to the hospital. she reported that patient was hospitalized yesterday and is not on life support with an unknown prognoses. adverse event start date: 11/17/2024. no further info, details available.
Sex: U
Vaccine: VARZOS
Symptoms: Communication disorder, Facial paralysis
Clinical narrative: PT advised she is paralyzed on one side of her face, so it is difficult for her to talk sometimes. PT later mentioned that she received her shingles shot a few weeks ago. No additional information reported or available regarding this event. AE reported by patient who does not consent to follow up.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This 66-year-old female came into the pharmacy on 11/12/24 for the COVID (COMIRNATY) shot. 5 days later after getting the vaccine, she got shingles. Patient wanted us as a pharmacy to report this adverse event.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: pain at injection sight / left shoulder since injection. Pain & decreased ROM for 3 weeks. On 11/20/24 lifted backpack to place on shoulder with presistan pain & very limited ROM. Difficulty preforming ADLs.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Facial discomfort, Migraine, Pain in jaw
Clinical narrative: Migraine to head, jaw pain, facial presssure since 11/4/2024 after receiving pneumonia vaccine at pulmonology appt.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blister, Computerised tomogram head, Hypoaesthesia, Laboratory test
Clinical narrative: Joint pain, stiffness, numbness, tingling rash on elbows & back of head blisters on hands
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Musculoskeletal stiffness, Paraesthesia, Rash
Clinical narrative: Joint pain, stiffness, numbness, tingling rash on elbows & back of head blisters on hands
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Unable to move right arm into certain positions/pain at injection site
Age: 0.33
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: RSV given. Not needed had first dose on 10/28/24
Age: 58.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Employee went to the ER after receiving vaccines. He called the next day reporting he had throat and tongue swelling that progressed. He was given IV medications and was sent on 3 medications to take at home.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, DTAPIPV, FLU3, MMRV
Symptoms: Cyanosis, Death, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: Patient went in for a PCP visit on 11/19/2024 and received 3 vaccinations. The following morning on 11/20 he had complaints of feeling unwell and left school early. Individual stated he was "going to be sick." He was taken home and watched movies on the couch for the afternoon. Father checked on him around 1:30 pm and appeared to be napping.  Mother checked on him again around 2:10 pm and he was found cold to the touch and cyanotic. 911 was called and he was taken to the hospital where he was pronounced in the ER at 3:19 pm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, DTAPIPV, FLU3, MMRV
Symptoms: Peripheral coldness
Clinical narrative: Patient went in for a PCP visit on 11/19/2024 and received 3 vaccinations. The following morning on 11/20 he had complaints of feeling unwell and left school early. Individual stated he was "going to be sick." He was taken home and watched movies on the couch for the afternoon. Father checked on him around 1:30 pm and appeared to be napping.  Mother checked on him again around 2:10 pm and he was found cold to the touch and cyanotic. 911 was called and he was taken to the hospital where he was pronounced in the ER at 3:19 pm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, DTAPIPV, FLU3, MMRV
Symptoms: Cardiac arrest, Death
Clinical narrative: Patient went in for a PCP visit on 11/19/2024 and received 3 vaccinations. The following morning on 11/20 he had complaints of feeling unwell and left school early. Individual stated he was "going to be sick." He was taken home and watched movies on the couch for the afternoon. Father checked on him around 1:30 pm and appeared to be napping.  Mother checked on him again around 2:10 pm and he was found cold to the touch and cyanotic. 911 was called and he was taken to the hospital where he was pronounced in the ER at 3:19 pm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, DTAPIPV, FLU3, MMRV
Symptoms: Cyanosis, Death, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: Patient had a cardiac arrest and died on the day following his 4 Year Well Child Visit
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, DTAPIPV, FLU3, MMRV
Symptoms: Peripheral coldness
Clinical narrative: Patient had a cardiac arrest and died on the day following his 4 Year Well Child Visit
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, DTAPIPV, FLU3, MMRV
Symptoms: Cardiac arrest, Death
Clinical narrative: Patient had a cardiac arrest and died on the day following his 4 Year Well Child Visit
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Employee fainted after receiving a flu vaccine.
Age: 37.0
Sex: F
Vaccine: EBZR
Symptoms: Unevaluable event
Clinical narrative: na
Age: 66.0
Sex: F
Vaccine: COVID19, PPV, PPV
Symptoms: COVID-19, Condition aggravated, Systemic lupus erythematosus
Clinical narrative: Developed a Lupus Flare and caught Covid
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Labyrinthitis, Tinnitus
Clinical narrative: onset increased tinnitus 3 days post Covid Vaccine.  Symptoms same and persistent since onset. Similar symptoms for 3 previous Covid vaccinations in the past.  3 previous covid vaccines symptoms also had dizziness and one episode of labrynthitis
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Influenza like illness
Clinical narrative: Slight flu-like symptoms and soreness for 1 week followed by bruising the size of a half-dollar coin (yellow, black and red) with no swelling, no erythema, and no pain/tenderness still present 12 days after administration
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Myalgia, Pain
Clinical narrative: Influenza vaccine. Initial deltoid tenderness and sharp pain. Injection site tenderness resolved after a few days. Dull pain/burning with certain movements has not resolved. Pain with certain movements. Loss of range of motion and loss of strength. Most noticeable with overhead press and lateral shoulder raises.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: WITHIN SECONDS OF ADMINISTRATION PATIENT PRESENTED WITH NODULE AND SWELLING AT THE ADMIN SITE. NO OTHER SYMPTOMS OR SIGNS OF ALLERGY. NO PAIN AND NO ITCHING.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 3 INCH RED CIRCLE AROUND THE INJECTION SITE AND ITS RAISED A LITTLE, WARM TO THE TOUCH AND ITCHY.  PATIENT WANTED TO TAKE BENADRYL AND THE PROVIDER STATED IT WOULD BE OK TO USE
Age: 66.0
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Flu shot caused no issues in right arm. Prevnar in left arm caused pain in arm down to hand upon injection, increased pain later that day, and decreased mobility, pain, and discomfort the next day. Still hurting now (13 days later).
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Angioedema, Urticaria
Clinical narrative: Severe angioedema around eyes. A few scattered hives on back.   Started 1.5/2 hours after vaccine. Ate lunch (nothing unusual) and went for a run; noticed beginning of a reaction after run
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Urticaria
Clinical narrative: Patient received Flu shot on 11/12/24 in left arm and on 11/18/24 she began to break out in hives on bilateral arms, bilateral thighs, and chest.  She began taking benadryl which helped with the controlling of skin breakout, she has continued that treatment to current time which is 3 days.  The hives are basically gone but there is still a little redness left in the areas listed above.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Tachycardia, Wheezing
Clinical narrative: wheezing, tachycardia, difficulty breathing
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Impaired work ability
Clinical narrative: for first 36 hours (within 12 hours of vaccine) severe body aches/pain, fatigue and tiredness, headache, shivers, sweats, muscle soreness at injection. Slept multiple hours morning and afternoon day after vaccine. Could not work. Similar symptoms to having the FLU. Took acetaminophen for body aches and pain.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: for first 36 hours (within 12 hours of vaccine) severe body aches/pain, fatigue and tiredness, headache, shivers, sweats, muscle soreness at injection. Slept multiple hours morning and afternoon day after vaccine. Could not work. Similar symptoms to having the FLU. Took acetaminophen for body aches and pain.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Received flu shot from employer.  The next day he started to have redness, swelling and developed blisters.  The following day he went to employee health who advised MD visit.  Local reaction in/around injection site.
Age: 46.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: REDNESS, SLIGHT SWELLING, WARMTH, PER PATIENT, SLIGHT ITCHING WITH SORENESS
Age: 1.42
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient received an EUA COVID vaccine for 6 months to 4 years that was not diluted prior to administration. Patient received 0.3 mL of UNdiluted vaccine. No adverse events noted.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Shock, X-ray limb
Clinical narrative: Should sore.  Heard crackling.  Could not raise arm without pain
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second dose of Fluad vaccine; however, he states that he feels good and have not experience any adverse effects
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Asthenia, Impaired work ability, Malaise, Oral herpes
Clinical narrative: After the second dose weeks later on April 29th, 2021. I fell ill the very next day, which I thought was normal, I had a fever and was very week, leading me to close work early, I thought I just needed to rest. Fast forward a couple days I began to notice little bumps developing on my face,  and a cold sore developing as well. I thought it would go away seeing that I wasn t feeling all too well still because of the shot. These small bumps began developing into a full blown break out all over my face. I have never experienced this ever in my life, it got worse and worse and worse, and would not go away, I tried everything but it still persisted. I saw a dermatologist, all they did was prescribe me pills, it seemed to work, but changed the look of my skin completely. Once I stopped taking the pills the breakout returned. (1st appt. AUG 25, 2021  2nd appt. OCT 26, 2021)  they prescribed doxycycline which I took over a period of 5 months. The break out came back afterwords. I am still dealing with the acne, and the scars it left behind,
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: After the second dose weeks later on April 29th, 2021. I fell ill the very next day, which I thought was normal, I had a fever and was very week, leading me to close work early, I thought I just needed to rest. Fast forward a couple days I began to notice little bumps developing on my face,  and a cold sore developing as well. I thought it would go away seeing that I wasn t feeling all too well still because of the shot. These small bumps began developing into a full blown break out all over my face. I have never experienced this ever in my life, it got worse and worse and worse, and would not go away, I tried everything but it still persisted. I saw a dermatologist, all they did was prescribe me pills, it seemed to work, but changed the look of my skin completely. Once I stopped taking the pills the breakout returned. (1st appt. AUG 25, 2021  2nd appt. OCT 26, 2021)  they prescribed doxycycline which I took over a period of 5 months. The break out came back afterwords. I am still dealing with the acne, and the scars it left behind,
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Arthralgia, Haematemesis, Headache, Joint swelling
Clinical narrative: I had swelling in wrists and knees that started about 11 hours after I received the injection long with headache, fever, and general malaise. Although I get headache, fever, and sometimes nausea and vomiting (with Moderna covid vaccine), what was unusual this time was the joint pain and swelling particularly in my hands, wrists, and knees. This was a new and disconcerting symptom since I do not have arthritis. This felt like that. After taking Advil, the swelling in my hands went down, but the swelling in my knees did not. It took almost 2 weeks for the swelling in my knees to get down to how they were before.