chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Arm started hurting first. I'm a fitness instructor, and raising my arms have been difficult! I'm on day two of arm pain. When my child brushed my shoulder with his hand it hurts pretty bad.  Then I started having fatigue yesterday (Thursday 5/30) and a little bit of joint pain today and still fatigued today (5/31).
Age: 0.33
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects reported.; Pharmacist stated 4-month-old child today (5/21/2024) received inadvertently VARIVAX.; This spontaneous report was received from pharmacist and refers to a 4-month-old patient (unknown gender). No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On 21-MAY-2024, the patient received at age of 4 months an inadvertently dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1st dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to a patient of inappropriate age).  No side effects reported.   Lot number is being requested and will be submitted if received.
Age: 31.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported.  No additional AE/PQ; Caller reported AE on behalf of a patient who was administered an expired dose of MMR-II on 5/28/2024 (w/ no TEs); This spontaneous report was received from a pharmacist on behalf of a patient and refers to a 31-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 28-MAY-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliter/dose, lot #W033287, expiration date: 03-MAY-2024, (strength, and route of administration were not provided) (Expired product administered) administered for prophylaxis in combination with sterile diluent (STERILE DILUENT) expiration date reported as November 2024 (strength, exact dose, lot # and route of administration were not provided). Operator of device was reported as health professional. No temperature excursion reported/ "w)". No symptoms reported. No additional adverse event or product quality complaint reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure before pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; Maternal Exposure Before Pregnancy; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lactose intolerant" (unspecified if ongoing). The patient is expected to deliver a baby(s) on 28Dec2024. The patient's concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious) with onset 09Oct2023, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 22May2024 to 25May2024. Clinical course: Patient had her last menstural period on 14Mar2024.  The information on the batch/lot number for (BNT162b2 omi xbb.1.5) will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hereditary alpha tryptasaemia
Clinical narrative: Immediate metallic taste in mouth.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: The day after the vaccine early AM tremors shaking started.  I?m continuing to have trouble breathing feel like someone is sitting on my chest. Today I?m running fever along with joint pain.  My blood pressure has been reading 95/63 my oxygen has varied from 88/87 I have documented pics.  Feel like the vaccine gave me Covid with the symptoms I?m having.  It is affecting my daily life I have stayed in the bed since yesterday.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: The day after the vaccine early AM tremors shaking started.  I?m continuing to have trouble breathing feel like someone is sitting on my chest. Today I?m running fever along with joint pain.  My blood pressure has been reading 95/63 my oxygen has varied from 88/87 I have documented pics.  Feel like the vaccine gave me Covid with the symptoms I?m having.  It is affecting my daily life I have stayed in the bed since yesterday.
Age: 50.0
Sex: M
Vaccine: VARCEL
Symptoms: Myalgia, Rash vesicular, Skin lesion
Clinical narrative: developed chicken pox like symptoms including myalgias, and skin lesions
Age: 90.0
Sex: M
Vaccine: RSV
Symptoms: Back pain, Fall, Mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: About 9-10 (5/5/24) days after vaccine, patient got pain in legs, can't get out of bed, gradual increase in pain. 2 days later (5/8/24) fell and had dispatch health come and give cyclobenzaprine which did not work.  Then on 5/13 EMT called and took to ED, then admitted to rehab and has been there since.  No progress with extreme leg pain and back pain.  Cannot use right arm/hand.
Age: 90.0
Sex: M
Vaccine: RSV
Symptoms: Therapeutic product ineffective
Clinical narrative: About 9-10 (5/5/24) days after vaccine, patient got pain in legs, can't get out of bed, gradual increase in pain. 2 days later (5/8/24) fell and had dispatch health come and give cyclobenzaprine which did not work.  Then on 5/13 EMT called and took to ED, then admitted to rehab and has been there since.  No progress with extreme leg pain and back pain.  Cannot use right arm/hand.
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Injection site bruising, Swelling
Clinical narrative: Bruising around injection site, redness on arm and swelling
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, COVID-19, Fatigue, Nasal congestion
Clinical narrative: Patient began noticing a scratchy throat on the morning of 5/23/2024. Over the next 36 hours the patient exhibited stuffy nose, sore throat, mild fever, upset stomach, and fatigue. She tested positive for Covid-19 on the evening of 5/24/2024 and the afternoon of 5/25/2024. A 5-day course of Paxlovid commenced on the evening of 5/25/24. Patient felt better on 5/26-5/31. On 6/1 (today) patient is experiencing fatigue, upset stomach, and aching joints. The healthcare professional who prescribed Paxlovid encouraged patient to submit this report, but did not assist with the report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: Patient began noticing a scratchy throat on the morning of 5/23/2024. Over the next 36 hours the patient exhibited stuffy nose, sore throat, mild fever, upset stomach, and fatigue. She tested positive for Covid-19 on the evening of 5/24/2024 and the afternoon of 5/25/2024. A 5-day course of Paxlovid commenced on the evening of 5/25/24. Patient felt better on 5/26-5/31. On 6/1 (today) patient is experiencing fatigue, upset stomach, and aching joints. The healthcare professional who prescribed Paxlovid encouraged patient to submit this report, but did not assist with the report.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: Horrible ache in arm below injection site..painful to lift arm. Horrible headache same day and following day. Taking Tylenol and Aleve for pain relief.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Blister, Burning sensation, Nerve injury, Pain in extremity, Paraesthesia
Clinical narrative: Patient states almost immediately after receiving vaccine that her arm began to hurt/burn/tingle all the way to the fingertips; she did not seek treatment until 5/30/24. Dr prescribed diclofenac 50mg tablets and a prednisone 5mg dose pack for 6 days, recommended that patient call pharmacy and suggested "median nerve damage" possibly due to immunization. Patient also states that beginning today, small blisters are starting to appear.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Echocardiogram, Fatigue, Fibrin D dimer increased
Clinical narrative: Pain to all joints and muscles.  Fatigue, nausea, dizziness, fainting.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Myalgia, Nausea, Platelet count decreased
Clinical narrative: Pain to all joints and muscles.  Fatigue, nausea, dizziness, fainting.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Scan myocardial perfusion, Syncope, Ultrasound chest, White blood cell count increased
Clinical narrative: Pain to all joints and muscles.  Fatigue, nausea, dizziness, fainting.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Dizziness, Fall, Feeling hot, Nausea
Clinical narrative: syncopal episode after vaccines, ~1335 Patient was walking to check out, talking, suddenly asked MA if it's normal to feel lightheaded, then he fainted, fell to floor landing on left side.  Patient was immediately responsive to voice, c/o nausea and feeling hot.  He was kept supine for 30min, kept cool.  Once color returned he was slowly assisted to seated position.  C/O "sore" right lateral neck with palpation, denied any other pain/discomfort. Full ROM noted. Exam done, no visible injuries.  After the 30min Patient was assisted to a chair, kept still with a fan on him, slowly took water then almonds and tolerated well.  aat 1425 Patient was slowly walked to vehicle, tolerated well.  They are going straight to eat . Sent with nuts to continue to eat en route.  Patient had not had food or fluids today.  Frequent VS throughout visit.  Lowest BP 82/60, pulse stayed in the 70s. FSBG 106 while he was still supine.  BP at time of d/c 109/66, HR 78. Color had returned, no diaphoresis.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Neck pain, Pallor, Syncope
Clinical narrative: syncopal episode after vaccines, ~1335 Patient was walking to check out, talking, suddenly asked MA if it's normal to feel lightheaded, then he fainted, fell to floor landing on left side.  Patient was immediately responsive to voice, c/o nausea and feeling hot.  He was kept supine for 30min, kept cool.  Once color returned he was slowly assisted to seated position.  C/O "sore" right lateral neck with palpation, denied any other pain/discomfort. Full ROM noted. Exam done, no visible injuries.  After the 30min Patient was assisted to a chair, kept still with a fan on him, slowly took water then almonds and tolerated well.  aat 1425 Patient was slowly walked to vehicle, tolerated well.  They are going straight to eat . Sent with nuts to continue to eat en route.  Patient had not had food or fluids today.  Frequent VS throughout visit.  Lowest BP 82/60, pulse stayed in the 70s. FSBG 106 while he was still supine.  BP at time of d/c 109/66, HR 78. Color had returned, no diaphoresis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Sleepiness- sleeping on and off all day.  Fever starting about 7pm. Hot, swollen, red arm upon waking the next morning. Painful to touch and move arm. Treated with cool compress and ibuprofen.  2 days later arm is still red, hot and tender when touched.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Somnolence
Clinical narrative: Sleepiness- sleeping on and off all day.  Fever starting about 7pm. Hot, swollen, red arm upon waking the next morning. Painful to touch and move arm. Treated with cool compress and ibuprofen.  2 days later arm is still red, hot and tender when touched.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram thorax abnormal, Cytokine storm, Immune system disorder
Clinical narrative: After vaccine any normal injury even muscular cause a massive immune response which resulted in a pericardiocentesis and then pericarditis. I know have ongoing chest inflammation triggered by any minor thing. If  I get sick or  lose weight or anything that upsets the balance of my body . I am having to take Arcalyst to try to control the inflammation which is now referred to as a cytokine storm . Also with only those two vaccines I also still carry numbers out side of the normal range for SARsCovid. I have been tested twice and  we are in the third year and I still have a massive overabundance of vaccine antibiotics in my body  which is attributed to my issue.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Pericardial drainage, Pericarditis, SARS-CoV-2 antibody test positive, Ultrasound scan
Clinical narrative: After vaccine any normal injury even muscular cause a massive immune response which resulted in a pericardiocentesis and then pericarditis. I know have ongoing chest inflammation triggered by any minor thing. If  I get sick or  lose weight or anything that upsets the balance of my body . I am having to take Arcalyst to try to control the inflammation which is now referred to as a cytokine storm . Also with only those two vaccines I also still carry numbers out side of the normal range for SARsCovid. I have been tested twice and  we are in the third year and I still have a massive overabundance of vaccine antibiotics in my body  which is attributed to my issue.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: After vaccine any normal injury even muscular cause a massive immune response which resulted in a pericardiocentesis and then pericarditis. I know have ongoing chest inflammation triggered by any minor thing. If  I get sick or  lose weight or anything that upsets the balance of my body . I am having to take Arcalyst to try to control the inflammation which is now referred to as a cytokine storm . Also with only those two vaccines I also still carry numbers out side of the normal range for SARsCovid. I have been tested twice and  we are in the third year and I still have a massive overabundance of vaccine antibiotics in my body  which is attributed to my issue.
Age: 61.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Burning sensation, Muscle discomfort, Tenderness
Clinical narrative: Patient felt a burning sensation & sensitivity to touch from right shoulder to the neck; felt like a pulled muscle starting the morning of March 22 lasting for 2 weeks. Patient put ice on the arm and neck also took acetaminophen. Ice didn't help, but the acetaminophen helped somewhat.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pt was given Covid 19 vaccine that had beyond use date of 5/31/2024 at 14:00. The vaccine was given 6/1/2024 at 10:00 am. the box and vial expiration were labeled 07/2024. The pt had no adverse reaction after the vaccination.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash, Rash erythematous, Rash papular
Clinical narrative: Pt came to the Pharmacy on 05312024, requesting the Pharmacist on duty to ask if the rash on her left arm was usual.I looked at the rash pt had on her left arm.It was about 3x3 inches , almost round/oval , raised and red. She confirmed she got the shot on 05292024. I counselled pt about the most common side effects , what to expect from the Shingrix vaccine. I also told her I would call her the next day 06012024 to follow up.Pt , came in herself on 06012024 to show me the rash.The rash spread and was definitely twice the size in dimension , still swollen / raised and red. I told her I will be reporting it to VAERS.
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Oropharyngeal pain, Pain
Clinical narrative: Patient received the influenza vaccine in the right deltoid and Tdap in left deltoid on 5/30/24. Yesterday 5/31/24, she noticed injection site redness and itching. There is a 3.5cm x 3cm area of erythema surrounding the injection site that it slightly tender to touch. This morning, patient noticed erythematous macular rash on palms of hands bilaterally with sinus congestion/drainage, sore throat and body aches. Assessment was performed. Right deltoid does appear to have localized site redness but does not appear to have any infection/infiltration. Rash and symptoms are consistent with hand, foot, mouth. However, given  recent vaccine administration, rash is being reported as a potential adverse event.
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Paranasal sinus hypersecretion, Rash, Rash macular, Sinus congestion
Clinical narrative: Patient received the influenza vaccine in the right deltoid and Tdap in left deltoid on 5/30/24. Yesterday 5/31/24, she noticed injection site redness and itching. There is a 3.5cm x 3cm area of erythema surrounding the injection site that it slightly tender to touch. This morning, patient noticed erythematous macular rash on palms of hands bilaterally with sinus congestion/drainage, sore throat and body aches. Assessment was performed. Right deltoid does appear to have localized site redness but does not appear to have any infection/infiltration. Rash and symptoms are consistent with hand, foot, mouth. However, given  recent vaccine administration, rash is being reported as a potential adverse event.
Age: 66.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Arthritis, Intervertebral disc protrusion, Magnetic resonance imaging spinal abnormal, Mobility decreased, Neck pain
Clinical narrative: Patient had burning lower neck pain starting 2 weeks after the vaccine. Patient also had difficulty moving her neck. Patient used ice and Voltaren gel, but those only helped a little.  Patient had a neurologist appointment and mentioned her neck pain during the appointment.
Age: 66.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pain
Clinical narrative: Patient had burning lower neck pain starting 2 weeks after the vaccine. Patient also had difficulty moving her neck. Patient used ice and Voltaren gel, but those only helped a little.  Patient had a neurologist appointment and mentioned her neck pain during the appointment.
Age: 58.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient complained of her arm reacting (local redness) and swelling. Patient was advised to ice the area and call her PCP for a follow up if not resolved
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Due july 12th 2024
Age: 35.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Severe chills from 8pm to midnight. Headache. Sore right  arm, fatigue
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: PT is due in August, mistakenly received Arexvy instead of Abrysvo. PT reported no adverse effect.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: Violent headache, Fever(100.3), Severe muscle aches, Weakness, Tiredness, Loss of appetite
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Violent headache, Fever(100.3), Severe muscle aches, Weakness, Tiredness, Loss of appetite
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis of the upper limb -- near injection site
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Aphasia, Crying, Immediate post-injection reaction, Pyrexia
Clinical narrative: Fever immediately after receiving the vaccines.  Lost all speech and cried all the time
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Laboratory test, Loss of consciousness, Lower respiratory tract infection
Clinical narrative: Lost  Conscious after a shower and then brought by ambulance to Hospital and the Flown to Hospital by Helicopter and spent 12 days in Hospital.  had a breathing tube down my throat for two or more days. put on Oxygen to breath.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: Heavy fatigue, headache, overall general flu-like achiness and floaty disoriented feeling all from Day 1-3, plus post-nasal drip that started ~1.5 days since injection resulting in sore throat.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Upper-airway cough syndrome
Clinical narrative: Heavy fatigue, headache, overall general flu-like achiness and floaty disoriented feeling all from Day 1-3, plus post-nasal drip that started ~1.5 days since injection resulting in sore throat.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: patient has rashes all over the body , specially on the scalp, armpit and leg with blotches with severe itchy , he is taking Benadryl 50mg every 6 hours and  the Benadryl cream. As of June 2nd , patient still have rashes and itchy
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash erythematous
Clinical narrative: Significant Red rash and large blisters left thigh
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Paraesthesia, Syncope
Clinical narrative: Extremely dizzy the day after injection.  Dizziness lasted several hours.  I fainted when trying to stand.  Even sitting up, I was dizzy for several hours.  Early in the AM, I had some tingling in my legs.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: extreme frontal  lobe headache, muscle aches with upper back pain, shivering with low grade fever, tiredness
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: extreme frontal  lobe headache, muscle aches with upper back pain, shivering with low grade fever, tiredness
Age: 11.0
Sex: M
Vaccine: HPV9, IPV, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itchyness at the entire upper left deltoid area on 6/2/24; vaccines given on 5/31/24. Evalution completed by MD; Benadryl given onsite and prescribed home.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt reports that the evening after she got the vaccine, her arm was red, swollen, and itchy.  She states it has been the same since then and is not getting better.  She put hydrocortisone on it and stated that "helped a little".  I advised her to see her PCP.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Diarrhoea, Headache, Malaise, Muscular weakness, Myalgia
Clinical narrative: Patient reported he was "severely ill", he had a bad headache, muscle pain/ weakness, diarrhea, and loss of bladder control.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Urinary incontinence
Clinical narrative: Patient reported he was "severely ill", he had a bad headache, muscle pain/ weakness, diarrhea, and loss of bladder control.
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: Patient came to the pharmacy on Friday 05/24/24 two days after receiving his Prevnar 20 and informed pharmacy staff that he went to the hospital due to severe pain in his arm after his shot. He did not indicate that it was an allergic reaction. He was released and is now feeling ok. Pharmacist asked to speak with patient to follow up on these symptoms and he indicated he did not feel the need to discuss the issue further and left.  The pharmacist that administered the shot did recall counseling the patient that sore arm was a common side effect of the vaccine.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Device connection issue, Injection site bruising, Underdose
Clinical narrative: After putting the needle in the patient's arm for the injection the needle separated from the syringe before the injection and the vaccine did not go into the patient's arm. The patient was immediately given a new vaccine in the same arm but at a different site. The patient returned to the pharmacy and had a bruise on her arm where the needle/syringe malfunctioned.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient called on 6/2/24 and said that she might have experienced some reactions after 2nd dose of shingrix she received on 4/3/24. She said that day after she got home, she experienced body stiffness multiple times that first day. Also, her leg pain seemed to get worse after the vaccine (Per patient: has multiple medical conditions (hip surgery, arthritis, neck issues..etc) Also, she mentioned that she almost fell multiple times since the vaccine but she stated that she is taking baclofen and that might have contributed to her issue.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness transient, Influenza like illness
Clinical narrative: vision loss happened on 2 occasions day after shot and 2 days after shot. first vision loss was a few seconds, second vision loss was for a longer period of multiple minutes. also flu like symptoms for 2 days
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Cough, Fatigue, Headache
Clinical narrative: Fever from 99.1-101.1 F, generalized muscle pain, injection site soreness/pain, chills, shivering, fatigue, headache, torso (chest, shoulders, abdomen rash), mild chest tightness, dry cough and palpitations.  Took Advil for the fever.  Outcome is I still have a rash but it is now fading. All other symptoms have resolved.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Palpitations, Pyrexia, Rash
Clinical narrative: Fever from 99.1-101.1 F, generalized muscle pain, injection site soreness/pain, chills, shivering, fatigue, headache, torso (chest, shoulders, abdomen rash), mild chest tightness, dry cough and palpitations.  Took Advil for the fever.  Outcome is I still have a rash but it is now fading. All other symptoms have resolved.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Catheter placement, Chest X-ray normal, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: Starting  in early spring 2022 I started getting strong heart, palpitations, fatigue, nausea, shortness of breath.. it has been ongoing since I have reduced stress in my life eat a healthy lifestyle prior to that I was actively backpacking and have hiked in the mountains for health and wellness now I can?t do these things due to the year amount of of fatigue and shortness of breath that I experience on a daily basis
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram abnormal, Electrocardiogram ambulatory, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Starting  in early spring 2022 I started getting strong heart, palpitations, fatigue, nausea, shortness of breath.. it has been ongoing since I have reduced stress in my life eat a healthy lifestyle prior to that I was actively backpacking and have hiked in the mountains for health and wellness now I can?t do these things due to the year amount of of fatigue and shortness of breath that I experience on a daily basis
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Pulmonary embolism, Pulmonary hypertension, Scan
Clinical narrative: Starting  in early spring 2022 I started getting strong heart, palpitations, fatigue, nausea, shortness of breath.. it has been ongoing since I have reduced stress in my life eat a healthy lifestyle prior to that I was actively backpacking and have hiked in the mountains for health and wellness now I can?t do these things due to the year amount of of fatigue and shortness of breath that I experience on a daily basis
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus bradycardia, Ventilation/perfusion scan
Clinical narrative: Starting  in early spring 2022 I started getting strong heart, palpitations, fatigue, nausea, shortness of breath.. it has been ongoing since I have reduced stress in my life eat a healthy lifestyle prior to that I was actively backpacking and have hiked in the mountains for health and wellness now I can?t do these things due to the year amount of of fatigue and shortness of breath that I experience on a daily basis
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever (after about 12 hours, periodic for 36 hours), fatigue (after about 5 hours, ongoing for 48 hours), soreness (about 1 hour, ended after 12), swollen redness at injection site (about 2" in diameter, onset after 15 hours,  still present after 54 hours)
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Pruritus, Rash
Clinical narrative: Ongoing Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAR-2023, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Ongoing Rash). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2024 The reporter stated that she had an ongoing rash from Shingrix, would yet to hear back and like to get some kind response.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Ongoing Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAR-2023, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Ongoing Rash). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2024 The reporter stated that she had an ongoing rash from Shingrix, would yet to hear back and like to get some kind response.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Suspected product contamination
Clinical narrative: BLOOD CLOT; VACCINE WAS CONTAMINATED; KIDNEY ON STAGE 6; COUGHS OUT BLOOD; KNOT IN HER CHEST; LIVER ON STAGE 6; VACCINE WAS LEFT OUT; POOR QUALITY VACCINE ADMINISTERED; HEART WENT DOWN; BLEEDING FROM MOUTH; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-APR-2020 for covid-19 prophylaxis. Batch number was not provided and have been requested. No concomitant medications were reported. Triage agent said that the patient reported she had blood clot (dose series 1). Triage agent then warm transferred the caller. Caller reported that she got the Janssen Covid 19 vaccine on 05-APR-2020. She said the vaccine was contaminated (dose series 1) because it was left out (dose series 1) and poor quality vaccine administered (dose series 1). She said 3 days after receiving the vaccine, she started bleeding from the mouth (dose series 1). They ran some tests in the hospital and she was placed on a blood thinner. She said her heart went down (dose series 1), her kidney and liver were on stage 6 (dose series 1), she could not go do dialysis. She said she tried a remedy (one cucumber, ginger, mint, ice, water) by her grandmother which kept her alive, it repaired her. Her heart was brand new. She would drink it 2 times a month and now monthly. She said she was 70 years old, has grandchildren from 12 to 1 years. She said she had to pay $200 for her records. She was seen by 3 heart specialists, lung specialist. They ran tests every 10 days. She still coughs out blood (dose series 1), she has a knot in her chest (dose series 1). She said the vaccine was given to her in little town, it was a facility. She used to work 2 jobs, now she needs help. If Janssen can help her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coughs out blood, and the outcome of blood clot, vaccine was contaminated, bleeding from mouth, knot in her chest, kidney on stage 6, liver on stage 6, vaccine was left out, poor quality vaccine administered and heart went down was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20240560214.; Sender's Comments: V0:  Thrombosis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Chest discomfort, Haemoptysis, Liver disorder, Mouth haemorrhage
Clinical narrative: BLOOD CLOT; VACCINE WAS CONTAMINATED; KIDNEY ON STAGE 6; COUGHS OUT BLOOD; KNOT IN HER CHEST; LIVER ON STAGE 6; VACCINE WAS LEFT OUT; POOR QUALITY VACCINE ADMINISTERED; HEART WENT DOWN; BLEEDING FROM MOUTH; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-APR-2020 for covid-19 prophylaxis. Batch number was not provided and have been requested. No concomitant medications were reported. Triage agent said that the patient reported she had blood clot (dose series 1). Triage agent then warm transferred the caller. Caller reported that she got the Janssen Covid 19 vaccine on 05-APR-2020. She said the vaccine was contaminated (dose series 1) because it was left out (dose series 1) and poor quality vaccine administered (dose series 1). She said 3 days after receiving the vaccine, she started bleeding from the mouth (dose series 1). They ran some tests in the hospital and she was placed on a blood thinner. She said her heart went down (dose series 1), her kidney and liver were on stage 6 (dose series 1), she could not go do dialysis. She said she tried a remedy (one cucumber, ginger, mint, ice, water) by her grandmother which kept her alive, it repaired her. Her heart was brand new. She would drink it 2 times a month and now monthly. She said she was 70 years old, has grandchildren from 12 to 1 years. She said she had to pay $200 for her records. She was seen by 3 heart specialists, lung specialist. They ran tests every 10 days. She still coughs out blood (dose series 1), she has a knot in her chest (dose series 1). She said the vaccine was given to her in little town, it was a facility. She used to work 2 jobs, now she needs help. If Janssen can help her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coughs out blood, and the outcome of blood clot, vaccine was contaminated, bleeding from mouth, knot in her chest, kidney on stage 6, liver on stage 6, vaccine was left out, poor quality vaccine administered and heart went down was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20240560214.; Sender's Comments: V0:  Thrombosis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error, Renal disorder, Suspected product contamination, Thrombosis
Clinical narrative: BLOOD CLOT; VACCINE WAS CONTAMINATED; KIDNEY ON STAGE 6; COUGHS OUT BLOOD; KNOT IN HER CHEST; LIVER ON STAGE 6; VACCINE WAS LEFT OUT; POOR QUALITY VACCINE ADMINISTERED; HEART WENT DOWN; BLEEDING FROM MOUTH; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-APR-2020 for covid-19 prophylaxis. Batch number was not provided and have been requested. No concomitant medications were reported. Triage agent said that the patient reported she had blood clot (dose series 1). Triage agent then warm transferred the caller. Caller reported that she got the Janssen Covid 19 vaccine on 05-APR-2020. She said the vaccine was contaminated (dose series 1) because it was left out (dose series 1) and poor quality vaccine administered (dose series 1). She said 3 days after receiving the vaccine, she started bleeding from the mouth (dose series 1). They ran some tests in the hospital and she was placed on a blood thinner. She said her heart went down (dose series 1), her kidney and liver were on stage 6 (dose series 1), she could not go do dialysis. She said she tried a remedy (one cucumber, ginger, mint, ice, water) by her grandmother which kept her alive, it repaired her. Her heart was brand new. She would drink it 2 times a month and now monthly. She said she was 70 years old, has grandchildren from 12 to 1 years. She said she had to pay $200 for her records. She was seen by 3 heart specialists, lung specialist. They ran tests every 10 days. She still coughs out blood (dose series 1), she has a knot in her chest (dose series 1). She said the vaccine was given to her in little town, it was a facility. She used to work 2 jobs, now she needs help. If Janssen can help her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coughs out blood, and the outcome of blood clot, vaccine was contaminated, bleeding from mouth, knot in her chest, kidney on stage 6, liver on stage 6, vaccine was left out, poor quality vaccine administered and heart went down was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20240560214.; Sender's Comments: V0:  Thrombosis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: MEN, MMR, PNC15, PPV
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Febrile convulsion
Clinical narrative: Dyspnoea; Febrile convulsion; Pyrexia; Syncope; chills; cough; Information was obtained on a request by The Company from the agency via Regulatory Authority (agency # AU-TGA-0000775784) on 27-MAY-2024.  This spontaneous report was received from a physician, concerning a 1-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported. Previous vaccine reactions: No.   On 07-FEB-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered on the left arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); with either pneumococcal 23v polysaccharide vaccine (manufacturer unknown) injection, administered on the right arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) or with pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) syringe, administered on the right arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (reported as an unspecified pneumococcal vaccine); and with meningococcal vaccine a/c/y/w polysacch (MENCEVAX ACWY) administered on the left leg (strength, formulation, lot #, expiry date, route of administration, and indication were not provided).  On 12-FEB-2023, the patient experienced chills, cough, had a febrile convulsion, pyrexia, and experienced a syncope. Simple Febrile seizure in context of probable viral gastroenteritis Day 3. Additional: fever: NA deg C Chills; Fatigue/Tiredness; Fainted/loss of consciousness, other symptoms at faint: Cough; Shortness of breath; Noisy or difficult breathing, added from Mgt of Event unstructured: Outcome is known. Further details as provided: Simple febrile convulsion, self-resolving. 2 minutes in total. No anticonvulsant medication required. Temperature resolved with antipyretic. On 12-FEB-2023, the patient recovered from the febrile convulsion, pyrexia, and the event of syncope. On 12-MAY-2023, the patient experienced dyspnea. The outcome of the event of chills, cough and dyspnea was unknown.   The reporter considered the evens to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), and either pneumococcal 23v polysaccharide vaccine (manufacturer unknown) or pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) (reported as causality possible).  Additional information is not expected.
Sex: M
Vaccine: MEN, MMR, PNC15, PPV
Symptoms: Gastroenteritis viral, Loss of consciousness, Pyrexia, Syncope
Clinical narrative: Dyspnoea; Febrile convulsion; Pyrexia; Syncope; chills; cough; Information was obtained on a request by The Company from the agency via Regulatory Authority (agency # AU-TGA-0000775784) on 27-MAY-2024.  This spontaneous report was received from a physician, concerning a 1-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported. Previous vaccine reactions: No.   On 07-FEB-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered on the left arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); with either pneumococcal 23v polysaccharide vaccine (manufacturer unknown) injection, administered on the right arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) or with pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) syringe, administered on the right arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (reported as an unspecified pneumococcal vaccine); and with meningococcal vaccine a/c/y/w polysacch (MENCEVAX ACWY) administered on the left leg (strength, formulation, lot #, expiry date, route of administration, and indication were not provided).  On 12-FEB-2023, the patient experienced chills, cough, had a febrile convulsion, pyrexia, and experienced a syncope. Simple Febrile seizure in context of probable viral gastroenteritis Day 3. Additional: fever: NA deg C Chills; Fatigue/Tiredness; Fainted/loss of consciousness, other symptoms at faint: Cough; Shortness of breath; Noisy or difficult breathing, added from Mgt of Event unstructured: Outcome is known. Further details as provided: Simple febrile convulsion, self-resolving. 2 minutes in total. No anticonvulsant medication required. Temperature resolved with antipyretic. On 12-FEB-2023, the patient recovered from the febrile convulsion, pyrexia, and the event of syncope. On 12-MAY-2023, the patient experienced dyspnea. The outcome of the event of chills, cough and dyspnea was unknown.   The reporter considered the evens to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), and either pneumococcal 23v polysaccharide vaccine (manufacturer unknown) or pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) (reported as causality possible).  Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP did not report any side effects from the administration of the expired dose; a patient was inadverntly administered an expired dose of the MMR II vaccine.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 28-MAY-2024, the patient was inadvertently administered with an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) injection, lot #W035041, expiration date: 24-MAY-2024, (strength, exact dose and route of administration were not provided) (Expired product administered) administered for prophylaxis. The nurse did not report any side effects from the administration of the expired dose. There were no temperature excursions for the MMR II vaccine reported. The nurse was provided information from the article. No additional adverse event or product quality complaint reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired drug used; This non-serious case was reported by a nurse via patient support programs and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 23-MAY-2024, the patient received Kinrix. On 23-MAY-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired drug used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2024 This report was submitted via the online direct entry reporting system. The patient received expired Kinrix vaccine, which led to expired vaccine used.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 year old patient was given an Infanrix vaccine instead of a Boostrix vaccine in October; 12 year old patient was given an Infanrix vaccine; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received DTPa (Infanrix) for prophylaxis.   On 01-OCT-2023, the patient received Infanrix (unknown arm). On 01-OCT-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: 12 year old patient was given an Infanrix vaccine instead of a Boostrix vaccine in October) and inappropriate age at vaccine administration (Verbatim: 12 year old patient was given an Infanrix vaccine). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-MAY-2024 The licensed practical nurse (LPN) reported that the patient at an inappropriate age was given an Infanrix vaccine instead of a Boostrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consent to follow-up via email.